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FDA broadens nintedanib interstitial lung disease indication
A new indication for the tyrosine kinase inhibitor nintedanib approved by the Food and Drug Administration on March 9, 2020, broadened the drug’s targeted population to include patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
This new group of patients eligible for nintedanib treatment extends the drug’s labeling beyond patients with idiopathic pulmonary fibrosis (IPF) or interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma, and may come close to doubling the total number of eligible patients.
The new, expanded indication “helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now,” said Banu Karimi-Shah, MD, acting deputy director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research, in a written agency statement that announced the new indication.
The FDA first approved nintedanib (Ofev) for treating IPF in October 2014, and then granted a second indication in September 2019 for ILD associated with systemic sclerosis or scleroderma.
A recent assessment of 1,285 Canadian patients diagnosed with fibrotic ILD and entered into a national registry (CARE-PF) showed that IPF was the associated diagnosis for 25% of patients, and that the majority of patients had other primary diagnoses such as connective tissue disease ILD in 33% of enrolled patients, unclassifiable ILD in 22%, chronic sensitivity pneumonitis in about 8%, sarcoidosis in 3%, as well as other types (BMC Pulm Med. 2019 Nov 27. doi: 10.1186/s12890-019-0986-4).
It remains unclear right now what percentage of patients with fibrotic ILD have the progressive form that would make them eligible for nintedanib treatment under the new indication, but it’s probably about another quarter of the entire ILD population, or roughly similar to the number of patients with an IPF etiology who are already eligible to get the drug, commented Martin Kolb, MD, a professor of respirology at McMaster University, Hamilton, Ont., and a coinvestigator on the CARE-PF registry. A goal of the registry, which has now enrolled nearly 3,700 ILD patients, is to track them serially to get a better handle on the prevalence of progressive disease. The percentage of patients with ILD associated with systemic sclerosis or scleroderma is “relatively small,” compared with these other two patients subgroups, Dr. Kolb said in an interview.
The evidence base for treating patients with progressive ILD is “really strong,” he noted, and comes primarily from a major trial reported last year – the INBUILD study – that randomized 663 patients to treatment with either nintedanib or placebo and showed that nintedanib treatment significantly cut the rate of decline in forced vital capacity during 1 year of treatment (New Engl J Med. 2019 Oct 31;381[18]:1718-27). The patients entered the study as referrals from routine practice with documented ILD with progressive fibrosis that was not responsive to treatment with steroids or other immunosuppressive drugs, and reflects real-world, community practice, Dr. Kolb said.
“Conceptually, it makes so much sense” to treat the patients enrolled in INBUILD, the same patients who fit the new indication, with an agent like nintedanib that slows fibrosis progression, and in some patients may bring progression to a virtual halt, said Dr. Kolb, a coinvestigator on the INBUILD study. Future treatment of these patients will likely involve coupling an antifibrotic drug like nintedanib with an anti-inflammatory agent, although combined treatment of this type needs more study, he noted. In the more than 5 years since nintedanib came onto the U.S. market, it has been used on more than 10,000 patients and has generated no new safety concerns beyond those first included in the drug’s label.
The INBUILD study was sponsored by Boehringer Ingelheim, the company that markets nintedanib. Dr. Kolb has been a consultant to, received honoraria from, and received research funding from Boehringer Ingelheim. He has also received consulting fees or honoraria from Genoa, Gilead, GlaxoSmithKline, Indalo, Prometic, Roche, and Third Pole, and he has received research funding from Actelion, Alkermes, Gilead, GlaxoSmithKline, Pharmaxis, Prometic, RespiVert, and Roche.
A new indication for the tyrosine kinase inhibitor nintedanib approved by the Food and Drug Administration on March 9, 2020, broadened the drug’s targeted population to include patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
This new group of patients eligible for nintedanib treatment extends the drug’s labeling beyond patients with idiopathic pulmonary fibrosis (IPF) or interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma, and may come close to doubling the total number of eligible patients.
The new, expanded indication “helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now,” said Banu Karimi-Shah, MD, acting deputy director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research, in a written agency statement that announced the new indication.
The FDA first approved nintedanib (Ofev) for treating IPF in October 2014, and then granted a second indication in September 2019 for ILD associated with systemic sclerosis or scleroderma.
A recent assessment of 1,285 Canadian patients diagnosed with fibrotic ILD and entered into a national registry (CARE-PF) showed that IPF was the associated diagnosis for 25% of patients, and that the majority of patients had other primary diagnoses such as connective tissue disease ILD in 33% of enrolled patients, unclassifiable ILD in 22%, chronic sensitivity pneumonitis in about 8%, sarcoidosis in 3%, as well as other types (BMC Pulm Med. 2019 Nov 27. doi: 10.1186/s12890-019-0986-4).
It remains unclear right now what percentage of patients with fibrotic ILD have the progressive form that would make them eligible for nintedanib treatment under the new indication, but it’s probably about another quarter of the entire ILD population, or roughly similar to the number of patients with an IPF etiology who are already eligible to get the drug, commented Martin Kolb, MD, a professor of respirology at McMaster University, Hamilton, Ont., and a coinvestigator on the CARE-PF registry. A goal of the registry, which has now enrolled nearly 3,700 ILD patients, is to track them serially to get a better handle on the prevalence of progressive disease. The percentage of patients with ILD associated with systemic sclerosis or scleroderma is “relatively small,” compared with these other two patients subgroups, Dr. Kolb said in an interview.
The evidence base for treating patients with progressive ILD is “really strong,” he noted, and comes primarily from a major trial reported last year – the INBUILD study – that randomized 663 patients to treatment with either nintedanib or placebo and showed that nintedanib treatment significantly cut the rate of decline in forced vital capacity during 1 year of treatment (New Engl J Med. 2019 Oct 31;381[18]:1718-27). The patients entered the study as referrals from routine practice with documented ILD with progressive fibrosis that was not responsive to treatment with steroids or other immunosuppressive drugs, and reflects real-world, community practice, Dr. Kolb said.
“Conceptually, it makes so much sense” to treat the patients enrolled in INBUILD, the same patients who fit the new indication, with an agent like nintedanib that slows fibrosis progression, and in some patients may bring progression to a virtual halt, said Dr. Kolb, a coinvestigator on the INBUILD study. Future treatment of these patients will likely involve coupling an antifibrotic drug like nintedanib with an anti-inflammatory agent, although combined treatment of this type needs more study, he noted. In the more than 5 years since nintedanib came onto the U.S. market, it has been used on more than 10,000 patients and has generated no new safety concerns beyond those first included in the drug’s label.
The INBUILD study was sponsored by Boehringer Ingelheim, the company that markets nintedanib. Dr. Kolb has been a consultant to, received honoraria from, and received research funding from Boehringer Ingelheim. He has also received consulting fees or honoraria from Genoa, Gilead, GlaxoSmithKline, Indalo, Prometic, Roche, and Third Pole, and he has received research funding from Actelion, Alkermes, Gilead, GlaxoSmithKline, Pharmaxis, Prometic, RespiVert, and Roche.
A new indication for the tyrosine kinase inhibitor nintedanib approved by the Food and Drug Administration on March 9, 2020, broadened the drug’s targeted population to include patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
This new group of patients eligible for nintedanib treatment extends the drug’s labeling beyond patients with idiopathic pulmonary fibrosis (IPF) or interstitial lung disease (ILD) associated with systemic sclerosis or scleroderma, and may come close to doubling the total number of eligible patients.
The new, expanded indication “helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now,” said Banu Karimi-Shah, MD, acting deputy director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research, in a written agency statement that announced the new indication.
The FDA first approved nintedanib (Ofev) for treating IPF in October 2014, and then granted a second indication in September 2019 for ILD associated with systemic sclerosis or scleroderma.
A recent assessment of 1,285 Canadian patients diagnosed with fibrotic ILD and entered into a national registry (CARE-PF) showed that IPF was the associated diagnosis for 25% of patients, and that the majority of patients had other primary diagnoses such as connective tissue disease ILD in 33% of enrolled patients, unclassifiable ILD in 22%, chronic sensitivity pneumonitis in about 8%, sarcoidosis in 3%, as well as other types (BMC Pulm Med. 2019 Nov 27. doi: 10.1186/s12890-019-0986-4).
It remains unclear right now what percentage of patients with fibrotic ILD have the progressive form that would make them eligible for nintedanib treatment under the new indication, but it’s probably about another quarter of the entire ILD population, or roughly similar to the number of patients with an IPF etiology who are already eligible to get the drug, commented Martin Kolb, MD, a professor of respirology at McMaster University, Hamilton, Ont., and a coinvestigator on the CARE-PF registry. A goal of the registry, which has now enrolled nearly 3,700 ILD patients, is to track them serially to get a better handle on the prevalence of progressive disease. The percentage of patients with ILD associated with systemic sclerosis or scleroderma is “relatively small,” compared with these other two patients subgroups, Dr. Kolb said in an interview.
The evidence base for treating patients with progressive ILD is “really strong,” he noted, and comes primarily from a major trial reported last year – the INBUILD study – that randomized 663 patients to treatment with either nintedanib or placebo and showed that nintedanib treatment significantly cut the rate of decline in forced vital capacity during 1 year of treatment (New Engl J Med. 2019 Oct 31;381[18]:1718-27). The patients entered the study as referrals from routine practice with documented ILD with progressive fibrosis that was not responsive to treatment with steroids or other immunosuppressive drugs, and reflects real-world, community practice, Dr. Kolb said.
“Conceptually, it makes so much sense” to treat the patients enrolled in INBUILD, the same patients who fit the new indication, with an agent like nintedanib that slows fibrosis progression, and in some patients may bring progression to a virtual halt, said Dr. Kolb, a coinvestigator on the INBUILD study. Future treatment of these patients will likely involve coupling an antifibrotic drug like nintedanib with an anti-inflammatory agent, although combined treatment of this type needs more study, he noted. In the more than 5 years since nintedanib came onto the U.S. market, it has been used on more than 10,000 patients and has generated no new safety concerns beyond those first included in the drug’s label.
The INBUILD study was sponsored by Boehringer Ingelheim, the company that markets nintedanib. Dr. Kolb has been a consultant to, received honoraria from, and received research funding from Boehringer Ingelheim. He has also received consulting fees or honoraria from Genoa, Gilead, GlaxoSmithKline, Indalo, Prometic, Roche, and Third Pole, and he has received research funding from Actelion, Alkermes, Gilead, GlaxoSmithKline, Pharmaxis, Prometic, RespiVert, and Roche.
COVID-19 update: Transmission 5% or less among close contacts
The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.
The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.
, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.
Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.
Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.
The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.
Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.
It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.
Meanwhile, there’s been no evidence of perinatal transmission; the virus has not been detected in amniotic fluid, cord blood, neonatal throat swabs, or breast milk. Maternal morbidity appears to be similar to uninfected women. “The data around pregnancy are reassuring,” said John Brooks, MD, chief medical officers for HIV/AIDS prevention at the Centers for Disease Control and Prevention, Atlanta, who has been involved with CDC’s containment efforts.
There’s no data yet for immunocompromised people, but for people with HIV, he said, “we think the risk of severe illness would be greater” with lower CD4 counts and unsuppressed viral loads. “People living with HIV should take precautions against this new virus,” including having at least a 30-day supply of HIV medications; keeping up flu and pneumonia vaccinations; and having a care plan if quarantined. Setting up telemedicine might be a good idea.
The usual incubation period for COVID-19 is 4-6 days but can be longer. Recovery time is about 2 weeks in mild cases and 3-6 weeks in more severe cases. People who die do so within 2 months of symptom onset.
The most common symptoms among hospitalized patients in China are fever, dry cough, fatigue, and headache. Truly asymptomatic cases are not common; most go on to develop symptoms. There have been reports of diarrhea before other symptoms by a day or two, but it’s probably a red herring. The virus has been isolated from stool, but there is no evidence of fecal-oral transmission, Dr. Wu said.
Eighty percent of COVID-19 cases are mild or moderate and most patients recover spontaneously, especially middle aged and younger people. There is no meaningful difference in distribution between the sexes.
There are limited pediatric data perhaps due to underreporting, “but we know [children] experience milder illness than adults,” the CDC’s Dr. Brooks said.
He pegged the latest case fatality estimate at 0.5% to 3.5%, which is considerably higher than seasonal flu, but might well drop as more mild cases are detected and added to the denominator, he said.
For now, death rates top 5% in adults over 60 years old and climb further with increasing age, approaching 16% in people 80 years or older. Patients with hypertension, diabetes, cardiovascular disease, and chronic respiratory illness are at increased risk. The ultimate cause of death is acute respiratory distress syndrome, said Ralph Baric, PhD, a coronavirus expert and epidemiology professor at the University of North Carolina, Chapel Hill, who also presented at the meeting.
Several drug and vaccine candidates are under study for the infection. An intriguing possibility is that angiotensin converting enzyme (ACE) inhibitors might help. Hypertension is a known risk factor for severe infection; the virus makes use of ACE receptor pathways to infect airway epithelial cells; and there have been reports of ACE inhibitors having effect against the virus that caused severe acute respiratory syndrome (SARS), another coronavirus outbreak in 2003.
“I think it’s a very good idea to go back and re-explore use of these drugs,” Dr. Baric said.
The presenters didn’t have any relevant disclosures.
The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.
The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.
, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.
Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.
Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.
The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.
Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.
It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.
Meanwhile, there’s been no evidence of perinatal transmission; the virus has not been detected in amniotic fluid, cord blood, neonatal throat swabs, or breast milk. Maternal morbidity appears to be similar to uninfected women. “The data around pregnancy are reassuring,” said John Brooks, MD, chief medical officers for HIV/AIDS prevention at the Centers for Disease Control and Prevention, Atlanta, who has been involved with CDC’s containment efforts.
There’s no data yet for immunocompromised people, but for people with HIV, he said, “we think the risk of severe illness would be greater” with lower CD4 counts and unsuppressed viral loads. “People living with HIV should take precautions against this new virus,” including having at least a 30-day supply of HIV medications; keeping up flu and pneumonia vaccinations; and having a care plan if quarantined. Setting up telemedicine might be a good idea.
The usual incubation period for COVID-19 is 4-6 days but can be longer. Recovery time is about 2 weeks in mild cases and 3-6 weeks in more severe cases. People who die do so within 2 months of symptom onset.
The most common symptoms among hospitalized patients in China are fever, dry cough, fatigue, and headache. Truly asymptomatic cases are not common; most go on to develop symptoms. There have been reports of diarrhea before other symptoms by a day or two, but it’s probably a red herring. The virus has been isolated from stool, but there is no evidence of fecal-oral transmission, Dr. Wu said.
Eighty percent of COVID-19 cases are mild or moderate and most patients recover spontaneously, especially middle aged and younger people. There is no meaningful difference in distribution between the sexes.
There are limited pediatric data perhaps due to underreporting, “but we know [children] experience milder illness than adults,” the CDC’s Dr. Brooks said.
He pegged the latest case fatality estimate at 0.5% to 3.5%, which is considerably higher than seasonal flu, but might well drop as more mild cases are detected and added to the denominator, he said.
For now, death rates top 5% in adults over 60 years old and climb further with increasing age, approaching 16% in people 80 years or older. Patients with hypertension, diabetes, cardiovascular disease, and chronic respiratory illness are at increased risk. The ultimate cause of death is acute respiratory distress syndrome, said Ralph Baric, PhD, a coronavirus expert and epidemiology professor at the University of North Carolina, Chapel Hill, who also presented at the meeting.
Several drug and vaccine candidates are under study for the infection. An intriguing possibility is that angiotensin converting enzyme (ACE) inhibitors might help. Hypertension is a known risk factor for severe infection; the virus makes use of ACE receptor pathways to infect airway epithelial cells; and there have been reports of ACE inhibitors having effect against the virus that caused severe acute respiratory syndrome (SARS), another coronavirus outbreak in 2003.
“I think it’s a very good idea to go back and re-explore use of these drugs,” Dr. Baric said.
The presenters didn’t have any relevant disclosures.
The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.
The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.
, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.
Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.
Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.
The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.
Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.
It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.
Meanwhile, there’s been no evidence of perinatal transmission; the virus has not been detected in amniotic fluid, cord blood, neonatal throat swabs, or breast milk. Maternal morbidity appears to be similar to uninfected women. “The data around pregnancy are reassuring,” said John Brooks, MD, chief medical officers for HIV/AIDS prevention at the Centers for Disease Control and Prevention, Atlanta, who has been involved with CDC’s containment efforts.
There’s no data yet for immunocompromised people, but for people with HIV, he said, “we think the risk of severe illness would be greater” with lower CD4 counts and unsuppressed viral loads. “People living with HIV should take precautions against this new virus,” including having at least a 30-day supply of HIV medications; keeping up flu and pneumonia vaccinations; and having a care plan if quarantined. Setting up telemedicine might be a good idea.
The usual incubation period for COVID-19 is 4-6 days but can be longer. Recovery time is about 2 weeks in mild cases and 3-6 weeks in more severe cases. People who die do so within 2 months of symptom onset.
The most common symptoms among hospitalized patients in China are fever, dry cough, fatigue, and headache. Truly asymptomatic cases are not common; most go on to develop symptoms. There have been reports of diarrhea before other symptoms by a day or two, but it’s probably a red herring. The virus has been isolated from stool, but there is no evidence of fecal-oral transmission, Dr. Wu said.
Eighty percent of COVID-19 cases are mild or moderate and most patients recover spontaneously, especially middle aged and younger people. There is no meaningful difference in distribution between the sexes.
There are limited pediatric data perhaps due to underreporting, “but we know [children] experience milder illness than adults,” the CDC’s Dr. Brooks said.
He pegged the latest case fatality estimate at 0.5% to 3.5%, which is considerably higher than seasonal flu, but might well drop as more mild cases are detected and added to the denominator, he said.
For now, death rates top 5% in adults over 60 years old and climb further with increasing age, approaching 16% in people 80 years or older. Patients with hypertension, diabetes, cardiovascular disease, and chronic respiratory illness are at increased risk. The ultimate cause of death is acute respiratory distress syndrome, said Ralph Baric, PhD, a coronavirus expert and epidemiology professor at the University of North Carolina, Chapel Hill, who also presented at the meeting.
Several drug and vaccine candidates are under study for the infection. An intriguing possibility is that angiotensin converting enzyme (ACE) inhibitors might help. Hypertension is a known risk factor for severe infection; the virus makes use of ACE receptor pathways to infect airway epithelial cells; and there have been reports of ACE inhibitors having effect against the virus that caused severe acute respiratory syndrome (SARS), another coronavirus outbreak in 2003.
“I think it’s a very good idea to go back and re-explore use of these drugs,” Dr. Baric said.
The presenters didn’t have any relevant disclosures.
FROM CROI 2020
Flu activity declines again but remains high
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
CMS issues guidance on containing spread of coronavirus
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
FDA issues stronger warning on neuropsychiatric event risk linked to montelukast
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
DoD ‘Taking all Necessary Precautions’ Against COVID-19
In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.
Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.
The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.
Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”
He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.
The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.
In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.
In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.”
In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”
“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.
The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.
Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”
In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.
Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.
The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.
Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”
He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.
The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.
In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.
In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.”
In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”
“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.
The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.
Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”
In late February, a soldier stationed at Camp Carroll near Daegu, South Korea, was the first military member to test positive for the coronavirus (COVID-19). Before being diagnosed, he visited other areas, including Camp Walker in Daegu, according to a statement released by US Forces Korea. More than 75,000 troops are stationed in countries with virus outbreaks, including Japan, Italy, and Bahrain.
Military research laboratories are working “feverishly around the horn” to come up with a vaccine, Joint Chiefs of Staff Chairman Gen. Mark A. Milley said in a March 2, 2020, news conference. At the same conference, Defense Secretary Mark T. Esper, MD, said US Department of Defense (DoD) civilian and military leadership are working together to prepare for short-and long-term scenarios.
The US Northern Command is the “global integrator,” Esper said, with the DoD communicating regularly with operational commanders to assess how the virus might impact exercises and ongoing operations around the world. For example, a command post exercise in South Korea has been postponed; Exercise Cobra Gold in Thailand is continuing.
Commanders are taking all necessary precautions because the virus is unique to every situation and every location, Esper said: “We’re relying on them to make good judgments.”
He emphasized that commanders at all levels have the authority and guidance they need to operate. In a late February video teleconference, Esper had told commanders deployed overseas that he wanted them to give him a heads-up before making decisions related to protecting their troops, according to The New York Times.
The New York Times article cited an exchange in which Gen. Robert Abrams, commander of American forces in South Korea, where > 4,000 coronavirus cases have been confirmed, discussed his options to protect American military personnel against the virus. Esper said he wanted advance notice, according to an official briefed on the call and quoted in the Times article. Gen. Abrams said although he would try to give Sec. Esper advance warning, he might have to make urgent health decisions before receiving final approval from Washington.
In a statement responding to the Times article, Jonathan Hoffman, Assistant to the Secretary of Defense for Public Affairs, said the Secretary of Defense has given the Global Combatant Commanders the “clear and unequivocal authority” to take any and all actions necessary to ensure the health and safety of US service members, civilian DoD personnel, families, and dependents.
In the video teleconference, Hoffman said, Secretary Espers “directed commanders to take all force health protection measures, and to notify their chain of command when actions are taken so that DoD leadership can inform the interagency—including US Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Department of Homeland Security, the State Department, and the White House—and the American people.” Esper “explicitly did not direct them to ‘clear’ their force health decisions in advance,” Hoffman said. “[T]hat is a dangerous and inaccurate mischaracterization.”
In January, the Office of the Under Secretary of Defense released a memorandum on force health protection guidance for the coronavirus outbreak. The DoD, it says, will follow the CDC guidance and will “closely coordinate with interagency partners to ensure accurate and timely information is available.”
“An informed, common-sense approach minimizes the chances of getting sick,” military health officials say. But, “due to the dynamic nature of this outbreak,” people should frequently check the CDC website for additional updates. Related Military Health System information and links to the CDC are available at https://www.health.mil/News/In-the-Spotlight/Coronavirus.
The CDC provides a summary of its latest recommendations and DoD health care providers can access COVID-19–specific guidance, including information on evaluating “persons under investigation,” at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html.
Sec. Esper, in the Monday news conference, said, “My number-one priority remains to protect our forces and their families; second is to safeguard our mission capabilities and third [is] to support the interagency whole-of-government’s approach. We will continue to take all necessary precautions to ensure that our people are safe and able to continue their very important mission.”
FDA moves to expand coronavirus testing capacity; CDC clarifies testing criteria
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
FROM A PRESS BRIEFING BY THE WHITE HOUSE CORONAVIRUS TASK FORCE
What medical conferences are being canceled by coronavirus?
In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.
So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.
In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.
APS Physics Meetings
@APSMeetings
Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch
734 9:59 PM - Feb 29, 2020
Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.
Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.
All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.
Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:
- Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
- American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
- American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
- American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
- American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
- Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
- American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
- American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
- American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.
This article originally appeared on Medscape.com.
In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.
So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.
In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.
APS Physics Meetings
@APSMeetings
Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch
734 9:59 PM - Feb 29, 2020
Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.
Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.
All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.
Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:
- Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
- American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
- American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
- American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
- American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
- Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
- American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
- American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
- American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.
This article originally appeared on Medscape.com.
In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.
So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.
In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.
APS Physics Meetings
@APSMeetings
Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch
734 9:59 PM - Feb 29, 2020
Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.
Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.
All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.
Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:
- Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
- American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
- American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
- American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
- American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
- Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
- American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
- American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
- American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.
This article originally appeared on Medscape.com.
Upcoming vaccine may offset surge in polio subtypes
Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.
Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).
In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.
Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.
The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.
The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.
A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.
Dr. Cochi had no relevant financial conflicts to disclose.
Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.
Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).
In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.
Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.
The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.
The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.
A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.
Dr. Cochi had no relevant financial conflicts to disclose.
Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.
Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).
In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.
Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.
The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.
The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.
A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.
Dr. Cochi had no relevant financial conflicts to disclose.
FROM AN ACIP MEETING
Washington State grapples with coronavirus outbreak
As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.
Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.
Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.
Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.
“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”
Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.
Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.
The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.
No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.
Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.
Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.
“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.
Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.
Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.
“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.
“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.
A summary of deaths and ongoing cases, drawn from the press release, is below:
The four new cases are:
• A male in his 50s, hospitalized at Highline Hospital. He has no known exposures. He is in stable but critical condition. He had no underlying health conditions.
• A male in his 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The man had underlying health conditions, and died March 1.
• A female in her 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The woman had underlying health conditions, and died March 1.
• A female in her 80s, a resident of Life Care, was hospitalized at EvergreenHealth. She is in critical condition.
In addition, a woman in her 80s, who was already reported as in critical condition at Evergreen, has died. She died on March 1.
Ten other cases, already reported earlier by Public Health, include:
• A female in her 80s, hospitalized at EvergreenHealth in Kirkland. This person has now died, and is reported as such above.
• A female in her 90s, hospitalized at EvergreenHealth in Kirkland. The woman has underlying health conditions, and is in critical condition.
• A male in his 70s, hospitalized at EvergreenHealth in Kirkland. The man has underlying health conditions, and is in critical condition.
• A male in his 70s was hospitalized at EvergreenHealth. He had underlying health conditions and died on Feb. 29.
• A man in his 60s, hospitalized at Valley Medical Center in Renton.
• A man in 60s, hospitalized at Virginia Mason Medical Center.
• A woman in her 50s, who had traveled to South Korea; recovering at home.
• A woman in her 70s, who was a resident of Life Care in Kirkland, hospitalized at EvergreenHealth.
• A woman in her 40s, employed by Life Care, who is hospitalized at Overlake Medical Center.
• A man in his 50s, who was hospitalized and died at EvergreenHealth.
As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.
Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.
Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.
Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.
“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”
Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.
Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.
The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.
No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.
Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.
Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.
“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.
Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.
Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.
“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.
“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.
A summary of deaths and ongoing cases, drawn from the press release, is below:
The four new cases are:
• A male in his 50s, hospitalized at Highline Hospital. He has no known exposures. He is in stable but critical condition. He had no underlying health conditions.
• A male in his 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The man had underlying health conditions, and died March 1.
• A female in her 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The woman had underlying health conditions, and died March 1.
• A female in her 80s, a resident of Life Care, was hospitalized at EvergreenHealth. She is in critical condition.
In addition, a woman in her 80s, who was already reported as in critical condition at Evergreen, has died. She died on March 1.
Ten other cases, already reported earlier by Public Health, include:
• A female in her 80s, hospitalized at EvergreenHealth in Kirkland. This person has now died, and is reported as such above.
• A female in her 90s, hospitalized at EvergreenHealth in Kirkland. The woman has underlying health conditions, and is in critical condition.
• A male in his 70s, hospitalized at EvergreenHealth in Kirkland. The man has underlying health conditions, and is in critical condition.
• A male in his 70s was hospitalized at EvergreenHealth. He had underlying health conditions and died on Feb. 29.
• A man in his 60s, hospitalized at Valley Medical Center in Renton.
• A man in 60s, hospitalized at Virginia Mason Medical Center.
• A woman in her 50s, who had traveled to South Korea; recovering at home.
• A woman in her 70s, who was a resident of Life Care in Kirkland, hospitalized at EvergreenHealth.
• A woman in her 40s, employed by Life Care, who is hospitalized at Overlake Medical Center.
• A man in his 50s, who was hospitalized and died at EvergreenHealth.
As the first COVID-19 outbreak in the United States emerges in Washington State, the city of Seattle, King County, and Washington State health officials provided the beginnings of a roadmap for how the region will address the rapidly evolving health crisis.
Health officials announced that four new cases were reported over the weekend in King County, Wash. There have now been 10 hospitalizations and 6 COVID-19 deaths at Evergreen Health, Kirkland, Wash. Of the deaths, five were King County residents and one was a resident of Snohomish County. Three patients died on March 1; all were in their 70s or 80s with comorbidities. Two had been residents of the Life Care senior residential facility that is at the center of the Kirkland outbreak. The number of cases in Washington now totals 18, with four cases in Snohomish County and the balance in neighboring King County.
Approximately 29 cases are under investigation with test results pending; a Centers for Disease Control and Prevention (CDC) team is on-site.
Speaking at a news conference March 2, officials sought to strike a balance between giving the community a realistic appraisal of the likely scope of the COVID-19 outbreak and avoiding sparking a panic.
“This is a complex and unprecedented challenge nationally, globally, and locally. The vast majority of the infected have mild or moderate disease and do not need hospitalization,” said Jeffrey Duchin, MD, health officer and chief, Communicable Disease EPI/Immunization Section, Public Health, Seattle and King County, and a professor of infectious diseases at the University of Washington, Seattle. “On the other hand, it’s obvious that this infection can cause very serious disease in people who are older and have underlying health conditions. We expect cases to continue to increase. We are taking the situation extremely seriously; the risk for all of us becoming infected is increasing. ...There is the potential for many to become ill at the same time.”
Among the measures being taken immediately are the purchase by King County of a hotel to house individuals who require isolation and those who are convalescing from the virus. Officials are also placing a number of prefabricated stand-alone housing units on public grounds in Seattle, with the recognition that the area has a large transient and homeless community. The stand-alone units will house homeless individuals who need isolation, treatment, or recuperation but who aren’t ill enough to be hospitalized.
Dr. Duchin said that testing capacity is ramping up rapidly in Washington State: The state lab can now accommodate up to about 200 tests daily, and expects to be able to do up to 1,000 daily soon. The University of Washington’s testing capacity will come online March 2 or 3 as a testing facility with similar initial and future peak testing capacities.
The testing strategy will continue to include very ill individuals with pneumonia or other respiratory illness of unknown etiology, but will also expand to include less ill people. This shift is being made in accordance with a shift in CDC guidelines, because of increased testing capacity, and to provide a better picture of the severity, scope, geography, and timing of the current COVID-19 outbreak in the greater Seattle area.
No school closures or cancellation of gatherings are currently recommended by public health authorities. There are currently no COVID-19 cases in Washington schools. The expectation is that any recommendations regarding closures will be re-evaluated as the outbreak progresses.
Repeatedly, officials asked the general public to employ basic measures such as handwashing and avoidance of touching the face, and to spare masks for the ill and for those who care for them. “The vast majority of people will not have serious illness. In turn we need to do everything we can to help those health care workers. I’m asking the public to do things like save the masks for our health care workers. …We need assets for our front-line health care workers and also for those who may be needing them,” said King County Health Department director Patty Hayes, RN, MN.
Now is also the time for households to initiate basic emergency preparedness measures, such as having adequate food and medication, and to make arrangements for childcare in the event of school closures, said several officials.
“We can decrease the impact on our health care system by reducing our individual risk. We are making individual- and community-level recommendations to limit the spread of disease. These are very similar to what we recommend for influenza,” said Dr. Duchin.
Ettore Palazzo, MD, chief medical and quality officer at EvergreenHealth, gave a sense of how the hospital is coping with being Ground Zero for COVID-19 in the United States. “We have made adjustments for airborne precautions,” he said, including transforming the entire critical care unit to a negative pressure unit. “We have these capabilities in other parts of the hospital as well.” Staff are working hard, but thus far staffing has kept pace with demand, he said, but all are feeling the strain already.
Dr. Duchin made the point that Washington is relatively well equipped to handle the increasingly likely scenario of a large spike in coronavirus cases, since it’s part of the Northwest Healthcare Response Network. The network is planning for sharing resources such as staff, respirators, and intensive care unit beds as circumstances warrant.
“What you just heard illustrates the challenge of this disease,” said Dr. Duchin, summing up. “The public health service and clinical health care delivery systems don’t have the capacity to track down every case in the community. I’m guessing we will see more cases of coronavirus than we see of influenza. At some point we will be shifting from counting every case” to focusing on outbreaks and the critically ill in hospitals, he said.
“We are still trying to contain the outbreak, but we are at the same time pivoting to a more community-based approach,” similar to the approach with influenza, said Dr. Duchin.
A summary of deaths and ongoing cases, drawn from the press release, is below:
The four new cases are:
• A male in his 50s, hospitalized at Highline Hospital. He has no known exposures. He is in stable but critical condition. He had no underlying health conditions.
• A male in his 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The man had underlying health conditions, and died March 1.
• A female in her 70s, a resident of Life Care, hospitalized at EvergreenHealth in Kirkland. The woman had underlying health conditions, and died March 1.
• A female in her 80s, a resident of Life Care, was hospitalized at EvergreenHealth. She is in critical condition.
In addition, a woman in her 80s, who was already reported as in critical condition at Evergreen, has died. She died on March 1.
Ten other cases, already reported earlier by Public Health, include:
• A female in her 80s, hospitalized at EvergreenHealth in Kirkland. This person has now died, and is reported as such above.
• A female in her 90s, hospitalized at EvergreenHealth in Kirkland. The woman has underlying health conditions, and is in critical condition.
• A male in his 70s, hospitalized at EvergreenHealth in Kirkland. The man has underlying health conditions, and is in critical condition.
• A male in his 70s was hospitalized at EvergreenHealth. He had underlying health conditions and died on Feb. 29.
• A man in his 60s, hospitalized at Valley Medical Center in Renton.
• A man in 60s, hospitalized at Virginia Mason Medical Center.
• A woman in her 50s, who had traveled to South Korea; recovering at home.
• A woman in her 70s, who was a resident of Life Care in Kirkland, hospitalized at EvergreenHealth.
• A woman in her 40s, employed by Life Care, who is hospitalized at Overlake Medical Center.
• A man in his 50s, who was hospitalized and died at EvergreenHealth.
FROM A KING COUNTY, WASH. NEWS BRIEFING