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Brain memory signals appear to regulate metabolism
Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.
“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.
“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.
The study was published online August 11 in Nature.
It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.
In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.
“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.
These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.
As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.
“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.
Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.
The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.
“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.
“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.
The study was published online August 11 in Nature.
It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.
In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.
“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.
These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.
As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.
“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.
Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.
The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.
“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.
“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.
The study was published online August 11 in Nature.
It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.
In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.
“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.
These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.
As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.
“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.
Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.
The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
25% of patients with cancer lack immunity against measles
Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.
“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.
Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.
So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.
They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.
The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.
“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.
And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.
“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.
In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said
“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.
The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
Three subgroups more likely to have deficits
The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits: those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.
In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.
As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.
A study author explained why the study included mumps, a less threatening infection.
“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.
Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.
The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.
“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.
Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.
So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.
They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.
The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.
“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.
And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.
“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.
In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said
“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.
The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
Three subgroups more likely to have deficits
The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits: those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.
In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.
As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.
A study author explained why the study included mumps, a less threatening infection.
“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.
Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.
The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Before the onslaught of COVID-19, researchers at the Fred Hutchinson Cancer Research Center in Seattle had another infectious disease worry: an “unprecedented” outbreak of measles.
“In 2019, we saw the most measles cases in any year since the 1990s,” said Sara Marquis, MPH, a clinical research coordinator at the center. The worry, she says, was that various oncology treatments, such as bone marrow transplantations and assorted biologics, “may leave cancer patients severely immunosuppressed” and thus vulnerable to infectious diseases.
Measles-related illness is typically not severe but can lead to pneumonia, deafness, and death, even in immunocompetent people, Ms. Marquis added.
So in 2019, a team at Fred Hutchinson initiated a study to get a sense of immunity to measles among patients with cancer.
They now report that of a group of 900-plus patients, 25% lacked protective antibodies for measles. That’s “significantly more” than the general population, in which about 8% of people lack these antibodies, Ms. Marquis said.
The study, published online in JAMA Network Open, also found that 38% lacked protection against the less-worrisome infectious disease of mumps, which is more than the 13% found in the general population.
“The scary thing about measles is that it is one of the most contagious diseases known,” Ms. Marquis told this news organization, adding that it is about twice as contagious as the COVID-19 Delta variant.
And it’s not just in the state of Washington. “We’re seeing it more and more in the community,” as various outbreaks continue to happen, she said.
“Deficits in protective antibodies underscore patients’ increased risk during outbreaks and emphasize the need for community-based efforts to increase herd immunity to protect this population,” the study authors conclude.
In short, administration of the measles-mumps-rubella (MMR) vaccine, introduced in 1963, must continue universally, they said
“We’ve had so many incredible advances in cancer treatment in recent years. … it would be devastating to see something like measles, which is a vaccine-preventable disease, come through and negate those efforts,” said study coauthor Elizabeth Krantz, MS, a biostatistician at Fred Hutchinson.
The health care teams and family caregivers of patients with cancer should also make sure they are vaccinated, said Ms. Marquis. However, some patients may not be able to get a measles booster vaccine because it is a live vaccine or because they cannot generate enough antibodies for it to be protective, she explained.
Three subgroups more likely to have deficits
The new study, which is one of the first to measure measles and mumps seroprevalence among patients with cancer in the modern era of cancer treatment, also identified three subgroups that more commonly had immunity deficits: those aged 30-59 years; those with hematologic malignant neoplasms, and those who had received a hematopoietic cell transplant.
In the study, residual clinical plasma samples were obtained from 959 consecutive patients with cancer at Seattle Cancer Care Alliance and Fred Hutchinson in August 2019. These samples were tested for measles and mumps IgG by using a commercial enzyme-linked immunosorbent assay. In all, 60% of patients had a solid tumor and 40% had a blood cancer.
As noted above, the seroprevalence of measles antibodies was 0.75 and the seroprevalence of mumps antibodies was 0.62.
A study author explained why the study included mumps, a less threatening infection.
“We assessed mumps in this study out of interest to compare response in the MMR vaccine component – particularly as we could assess a potent vaccine (measles) versus one that has a weaker immunologic response (mumps). We remain worried about outbreaks of mumps as MMR vaccination rates drop across the U.S.,” wrote Steven Pergam, MD, MPH, infectious disease specialist at Fred Hutchinson, in an email.
Vaccination vigilance is one of the study’s messages. “We all need to do our part to make sure we are up to date with our vaccinations so we can make sure we protect those who are vulnerable,” said Ms. Krantz.
The study was funded by the National Cancer Institute and Seattle Cancer Care Alliance. Multiple study authors have ties to pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Heparin’s COVID-19 benefit greatest in moderately ill patients
Critically ill derive no benefit
Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.
COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.
Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.
“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
Outcomes based on disease severity
The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).
The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.
In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.
ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.
However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.
The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.
Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.
As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.
Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
Explaining heparin’s varying effects
The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.
He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”
As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”
However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.
That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.
The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.
Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.
“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”
He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”
The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.
Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.
Critically ill derive no benefit
Critically ill derive no benefit
Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.
COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.
Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.
“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
Outcomes based on disease severity
The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).
The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.
In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.
ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.
However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.
The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.
Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.
As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.
Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
Explaining heparin’s varying effects
The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.
He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”
As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”
However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.
That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.
The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.
Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.
“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”
He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”
The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.
Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.
Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.
COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.
Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.
“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
Outcomes based on disease severity
The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).
The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.
In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.
ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.
However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.
The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.
Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.
As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.
Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
Explaining heparin’s varying effects
The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.
He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”
As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”
However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.
That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.
The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.
Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.
“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”
He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”
The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.
Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
FDA authorizes booster shot for immunocompromised Americans
The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.
Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.
Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.
“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”
He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”
White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.
The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.
Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.
In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.
A version of this article first appeared on WebMD.com.
The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.
Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.
Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.
“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”
He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”
White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.
The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.
Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.
In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.
A version of this article first appeared on WebMD.com.
The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.
“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.
Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.
Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.
“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”
He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”
White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.
The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.
Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.
In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.
A version of this article first appeared on WebMD.com.
Novel antidepressant shines in phase 2 trial, but FDA has issues with its NDA
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Hospitals struggle to find nurses, beds, even oxygen as Delta surges
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
FDA may okay COVID booster for vulnerable adults before weekend: Media
according to multiple media reports.
The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.
About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis.
Immune function also wanes with age, so the FDA could consider boosters for the elderly.
New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose.
A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”
It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.
The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.
The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.
The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.
The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.
A version of this article first appeared on Medscape.com.
according to multiple media reports.
The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.
About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis.
Immune function also wanes with age, so the FDA could consider boosters for the elderly.
New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose.
A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”
It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.
The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.
The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.
The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.
The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.
A version of this article first appeared on Medscape.com.
according to multiple media reports.
The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.
About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis.
Immune function also wanes with age, so the FDA could consider boosters for the elderly.
New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose.
A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”
It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.
The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.
The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.
The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.
The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.
A version of this article first appeared on Medscape.com.
COVID-19 mitigation measures led to shifts in typical annual respiratory virus patterns
Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.
Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.
“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.
The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.
Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.
“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.
The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.
Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.
The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.
A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”
Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.
“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”
Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.
RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.
The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.
The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.
Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.
Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.
Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.
“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”
Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.
The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.
The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”
Dr. Brewer, of UCLA, agreed.
All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”
The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.
Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.
Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.
Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.
The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.
Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.
“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.
The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.
Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.
“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.
The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.
Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.
The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.
A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”
Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.
“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”
Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.
RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.
The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.
The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.
Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.
Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.
Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.
“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”
Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.
The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.
The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”
Dr. Brewer, of UCLA, agreed.
All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”
The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.
Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.
Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.
Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.
The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.
Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.
“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.
The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.
Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.
“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.
The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.
Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.
The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.
A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”
Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.
“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”
Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.
RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.
The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.
The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.
Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.
Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.
Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.
“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”
Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.
The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.
The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”
Dr. Brewer, of UCLA, agreed.
All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”
The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.
Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.
Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.
Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.
The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA approves new enzyme replacement therapy for Pompe disease
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Pompe disease is a rare genetic disease that occurs in an estimated 1 in 40,000 births. It is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA), which leads to a buildup of glycogen in skeletal and cardiac muscle cells, causing muscle weakness and premature death from respiratory failure or heart failure.
Nexviazyme, administered by intravenous infusion every 2 weeks, supplements GAA and helps reduce glycogen accumulation.
The approval of this product “brings patients with Pompe disease another enzyme replacement therapy option for this rare disease,” said Janet Maynard, MD, deputy director, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research, in a news release.
In 2010, the FDA approved alglucosidase alfa (Lumizyme) for the treatment of late-onset Pompe disease.
“The FDA will continue to work with stakeholders to advance the development of additional new, effective, and safe therapies for rare diseases, including Pompe disease,” said Dr. Maynard.
The approval is based on positive phase 3 data that demonstrated improvements in key disease burden measures, including respiratory function and walking disease, and that established the drug’s safety profile, Genzyme said in a news release.
The most common side effects were headache, fatigue, diarrhea, nausea, joint pain, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Serious reactions included hypersensitivity reactions, such as anaphylaxis, and infusion-associated reactions, including respiratory distress, chills, and pyrexia.
Patients susceptible to fluid volume overload or those with compromised cardiac or respiratory function may be at risk for serious acute cardiorespiratory failure.
The FDA granted Nexviazyme orphan drug designation, priority review, and breakthrough status.
Genzyme expects the new therapy to be available in the United States in the coming weeks and said it will be priced on par with Lumizyme.
A version of this article first appeared on Medscape.com.
Surge of new child COVID cases continues for 6th consecutive week
The current COVID-19 surge has brought new cases in children to their highest level since February, according to a new report.
New pediatric cases rose for the 6th straight week, with almost 94,000 reported for the week ending Aug. 5.
That weekly total was up by 31% over the previous week and by over 1,000% since late June, when the new-case figure was at its lowest point (8,447) since early in the pandemic, the American Academy of Pediatrics and the Children’s Hospital Association said. COVID-related deaths – 13 for the week – were also higher than at any time since March 2021.
Almost 4.3 million children have been infected with SARS-CoV-2, which is 14.3% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. Children represented 15.0% of the new cases reported in those jurisdictions during the week ending Aug. 5, the AAP and CHA said in their weekly report.
Another measure that has been trending upward recently is vaccine initiation among 12- to 15-year-olds, although the latest weekly total is still well below the high of 1.4 million seen in May. First-time vaccinations reached almost 411,000 for the week of Aug. 3-9, marking the fourth consecutive increase in that age group, the Centers for Disease Control and Prevention said on its COVID Data Tracker. Vaccinations also increased, although more modestly, for 16- and 17-year-olds in the most recent week.
Cumulative figures for children aged 12-17 show that almost 10.4 million have received at least one dose and that 7.7 million are fully vaccinated as of Aug. 9. By age group, 42.2% of those aged 12-15 have received at least one dose, and 30.4% have completed the vaccine regimen. Among those aged 16-17 years, 52.2% have gotten their first dose, and 41.4% are fully vaccinated, according to the COVID Data Tracker.
Looking at vaccination rates on the state level shows that only 20% of children aged 12-17 in Wyoming and 21% in Mississippi have gotten at least one dose as of Aug. 4, while Massachusetts is up to 68% and Vermont reports 70%. Rates for full vaccination range from 11% in Mississippi and Alabama to 61% in Vermont, based on an AAP analysis of CDC data, which is not available for Idaho.
The current COVID-19 surge has brought new cases in children to their highest level since February, according to a new report.
New pediatric cases rose for the 6th straight week, with almost 94,000 reported for the week ending Aug. 5.
That weekly total was up by 31% over the previous week and by over 1,000% since late June, when the new-case figure was at its lowest point (8,447) since early in the pandemic, the American Academy of Pediatrics and the Children’s Hospital Association said. COVID-related deaths – 13 for the week – were also higher than at any time since March 2021.
Almost 4.3 million children have been infected with SARS-CoV-2, which is 14.3% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. Children represented 15.0% of the new cases reported in those jurisdictions during the week ending Aug. 5, the AAP and CHA said in their weekly report.
Another measure that has been trending upward recently is vaccine initiation among 12- to 15-year-olds, although the latest weekly total is still well below the high of 1.4 million seen in May. First-time vaccinations reached almost 411,000 for the week of Aug. 3-9, marking the fourth consecutive increase in that age group, the Centers for Disease Control and Prevention said on its COVID Data Tracker. Vaccinations also increased, although more modestly, for 16- and 17-year-olds in the most recent week.
Cumulative figures for children aged 12-17 show that almost 10.4 million have received at least one dose and that 7.7 million are fully vaccinated as of Aug. 9. By age group, 42.2% of those aged 12-15 have received at least one dose, and 30.4% have completed the vaccine regimen. Among those aged 16-17 years, 52.2% have gotten their first dose, and 41.4% are fully vaccinated, according to the COVID Data Tracker.
Looking at vaccination rates on the state level shows that only 20% of children aged 12-17 in Wyoming and 21% in Mississippi have gotten at least one dose as of Aug. 4, while Massachusetts is up to 68% and Vermont reports 70%. Rates for full vaccination range from 11% in Mississippi and Alabama to 61% in Vermont, based on an AAP analysis of CDC data, which is not available for Idaho.
The current COVID-19 surge has brought new cases in children to their highest level since February, according to a new report.
New pediatric cases rose for the 6th straight week, with almost 94,000 reported for the week ending Aug. 5.
That weekly total was up by 31% over the previous week and by over 1,000% since late June, when the new-case figure was at its lowest point (8,447) since early in the pandemic, the American Academy of Pediatrics and the Children’s Hospital Association said. COVID-related deaths – 13 for the week – were also higher than at any time since March 2021.
Almost 4.3 million children have been infected with SARS-CoV-2, which is 14.3% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. Children represented 15.0% of the new cases reported in those jurisdictions during the week ending Aug. 5, the AAP and CHA said in their weekly report.
Another measure that has been trending upward recently is vaccine initiation among 12- to 15-year-olds, although the latest weekly total is still well below the high of 1.4 million seen in May. First-time vaccinations reached almost 411,000 for the week of Aug. 3-9, marking the fourth consecutive increase in that age group, the Centers for Disease Control and Prevention said on its COVID Data Tracker. Vaccinations also increased, although more modestly, for 16- and 17-year-olds in the most recent week.
Cumulative figures for children aged 12-17 show that almost 10.4 million have received at least one dose and that 7.7 million are fully vaccinated as of Aug. 9. By age group, 42.2% of those aged 12-15 have received at least one dose, and 30.4% have completed the vaccine regimen. Among those aged 16-17 years, 52.2% have gotten their first dose, and 41.4% are fully vaccinated, according to the COVID Data Tracker.
Looking at vaccination rates on the state level shows that only 20% of children aged 12-17 in Wyoming and 21% in Mississippi have gotten at least one dose as of Aug. 4, while Massachusetts is up to 68% and Vermont reports 70%. Rates for full vaccination range from 11% in Mississippi and Alabama to 61% in Vermont, based on an AAP analysis of CDC data, which is not available for Idaho.