Heidi Splete

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

Collection of an oseltamivir-resistant pandemic influenza A(H1N1) isolate in a 59-year-old man taking the drug prophylactically underscores the need to limit antiviral prophylaxis of pandemic flu, according to correspondence published online in the New England Journal of Medicine on Nov. 11.

Oseltamivir was prescribed to all household contacts of the man's 13-year-old son (the index patient), whose infection was confirmed by a reverse-transcriptase polymerase-chain reaction test. The patient's father, mother, and sisters (aged 15 and 18 years) were prescribed 75 mg oseltamivir once daily for 10 days as prophylaxis.

The patient's father was taking 5 mg prednisone daily and had chronic obstructive pulmonary disease. The father developed flulike symptoms approximately 24 hours after prophylaxis began.

On prophylaxis day 8, the father was seen by his physician for a persistent cough, and an H1N1-positive nasopharyngeal aspirate was collected. After an uneventful course of illness, a second sample was negative, the investigators wrote. The case was reported by Mariana Baz, M.Sc., of the Centre Hospitalier Universitaire de Québec, and colleagues (N. Engl. J. Med. 2009 Nov. 11 [Epub doi: 10.1056/NEJMC0910060]).

The sample from the father showed a neuraminidase mutation (H275Y) that has been associated with oseltamivir resistance in seasonal H1N1

"We hypothesize that the presence of subtherapeutic levels of oseltamivir at a time when viral replication had already begun was an important factor that led to the emergence of the resistant virus in the father of our index patient," they wrote.

The case supports the need to limit prophylactic treatment with oseltamivir in persons who have already been exposed to the H1N1 virus, the investigators noted. They also suggested that patients receiving once-daily antiviral prophylaxis convert to a twice-daily regimen as soon as they develop flulike symptoms.

A conflict of interest disclosure statement for the authors was unavailable at press time.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

BOSTON — Malnutrition could send obese patients to the emergency department if they have a history of bariatric surgery, Dr. Joshua Broder said at the annual meeting of the American College of Emergency Physicians.

Dr. Broder, of Duke University in Durham, N.C., reviewed the following complications that can arise after different types of bariatric procedures:

▸ Laparoscopic adjustable gastric banding. There have been reports of mechanical problems including breakage, infection, and erosion of the band into the GI tract. Patients often are discharged on the same day or 1 day after undergoing this procedure, he noted.

Early complications include obstruction, edema from intravenous fluids, and proximal migration of the band. Late complications include obstruction and proximal band migration that may cause gastric necrosis and perforation. In cases of gastroesophageal obstruction, deflate the band as soon as possible.

▸ Roux-en-Y gastric bypass. The Roux-en-Y procedure currently is the most common surgery performed to help morbidly obese patients lose weight, Dr. Broder said. It is arguably the most effective because it bypasses a segment of the small bowel and limits the amount of food that can be eaten at a single meal. Early complications from this procedure include anastomosis, found in approximately 2%-11% of these patients.

Long-term complications include systemic nutritional deficiencies because nutrients aren't being absorbed in a section of the small bowel, Dr. Broder said. And the bypassed segment of the small bowel can become obstructed, which produces highly variable symptoms.

▸ Biliopancreatic diversion. The potential for weight loss is high with this type of surgery, but so are the metabolic risks, he noted. All the possible complications of a Roux-en-Y are much more likely, including nutritional deficiencies of fat-soluble vitamins, selenium, and zinc. Studies have shown that about 2% of these patients experience hepatic dysfunction, said Dr. Broder, who disclosed having no financial conflicts.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the U.S. Food and Drug Administration. If approved, they will provide additional options for treating obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a double-blind trial of 1,496 adults with an average age of 44 years and an average BMI of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients. Lorcaserin was not associated with increased valvulopathy, said Dr. Kaplan, who has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

Women seeking fertility treatments—and all women planning a pregnancy—should be vaccinated against both the seasonal flu and pandemic influenza A(H1N1), according to a joint statement from the Centers for Disease Control and Prevention and the American Society for Reproductive Medicine.

“Fertility clinics should encourage patients planning pregnancy to be vaccinated for both seasonal influenza and 2009 H1N1,” the statement noted. Since certain areas of the United States may have the H1N1 vaccine available only for those in initial target groups—including women who are already pregnant or those who are caring for infants younger than age 6 months—some who are planning a pregnancy may have to wait until more H1N1 vaccine is available. Women planning a pregnancy can receive the seasonal flu shot at any time.

Women who are pregnant should receive the inactivated injectable vaccine for both the H1N1 and seasonal flu vaccines (not the live, activated nasal spray vaccine). Women who are planning a pregnancy and have no medical contraindications for the live, activated vaccine can receive either the injection or the nasal spray for both vaccines before conceiving, according to the statement.

Data have shown that pregnant women infected with the pandemic H1N1 virus have higher rates of hospitalization and death from flu-related complications, compared with the general population.

Visit cdc.gov/h1n1fluflu.gov

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years.

ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations.

The quadrivalent vaccine (Merck & Co.'s Gardasil) protects against genital warts associated with HPV types 6 and 11, in addition to protecting against diseases caused by HPV types 16 and 18.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference.

The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses. The vaccine can be initiated as young as 9 years, and catch-up vaccination is recommended for females aged 13-26 years.

In addition, ACIP voted to move information about pregnancy to the precautions section. Pregnancy is not currently a contraindication for the vaccine. But Dr. Frank DeStefano of the CDC's immunization safety office said that post-marketing safety surveillance studies would be conducted on the bivalent HPV vaccine using the Vaccine Adverse Event Reporting System (VAERS).

The committee voted to add the bivalent vaccine to the CDC's Vaccines for Children program.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — The meningococcal working group of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices “believes that the ACIP should consider not adding meningococcal conjugate vaccines to the routine infant vaccine schedule at this time,” said working group member Dr. Amanda Cohn.

At its fall meeting, the ACIP discussed safety and epidemiology data on meningococcal vaccines in development for infants. These products have not yet been licensed.

The low burden of meningococcal disease in infants raises the question of whether every vaccine that is shown to be safe and effective should be recommended if the burden of disease is low, said Dr. H. Cody Meissner, chair of the working group.

The last ACIP recommendations for meningococcal vaccines were published in May 2005, and an update is planned for 2010, he noted.

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — If it is approved for use in the United States, a 13-valent pneumococcal conjugate vaccine in children would have recommendations mirroring those already in place for the 7-valent vaccine. Draft guidelines on PCV13 were presented at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Committee member Dr. Michael Marcy introduced the discussion of the 13-valent pneumococcal conjugate vaccine (PCV13) and cited recent data from the CDC's Morbidity and Mortality Weekly Report that showed a significant association between bacterial coinfections and severe cases of the pandemic influenza A(H1N1) virus.

The timing of the licensure may allow for the use of PCV13 during the 2009/2010 flu season, noted Dr. Pekka Nuorti of the CDC, who presented the draft recommendations. The Food and Drug Administration's review of the vaccine is ongoing, and a decision is expected this month, said Dr. Peter Paradiso of Wyeth Pharmaceuticals, which makes PCV13.

The vaccine is designed to protect infants and young children against the pneumococcal diseases caused by the seven serotypes in the PCV7 vaccine, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. PCV13 is currently licensed in Chile and Mexico, Dr. Paradiso said.

To expedite a potential transition to PCV13, the CDC said provisions are in place for voting on vaccine recommendations in advance of the next scheduled ACIP meeting in February.

The draft recommendations involve four groups: unvaccinated infants and children, children who have started their PCV vaccine schedules with PCV7, children who have completed the PCV7 schedule, and immunocompromised children or children with chronic illness.

For unvaccinated infants and children, the recommendations are the same as for PCV7, with PCV13 replacing PCV7 for all doses, said Dr. Nuorti.

The draft recommendations also state that children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, and children who have completed the primary infant series with PCV7 should receive a single PCV13 dose during the second year of life to provide protection against the six additional serotypes.

Dr. Nuorti added that the proposed recommendations for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) after PCV13 for individuals aged 2 years and older with underlying medical conditions are the same as those currently recommended for the use of PPSV23 after PCV7, although no safety and immunogenicity data are yet available for this vaccine sequence.

Dr. Paradiso of Wyeth reviewed safety and immunogenicity data presented at an ACIP meeting earlier this year, including comparison data from a study including 125 children aged 15 months to 2 years, and 182 children aged 2 years to 5 years. The studies suggest that the safety profiles and immune responses were similar to those seen with PCV7.

Children who began their vaccination series with PCV7 can complete the series with PCV13 at any point in the schedule, said Dr. Pekka Nuorti of the CDC.

Source Parker Smith/Elsevier Global Medical News

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were re-randomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48). “This was a chance to see if there was a higher dose needed,” she said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

The patients in the treatment group reported significant decreases in food cravings compared with baseline, Dr. Apovian said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation rates due to adverse events were low. Nausea, which was the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” she said.

The combination drug seemed to be well tolerated and the safety profile was consistent with previous data on the two drugs when used separately, she added. Dr. Apovian serves on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Lilly and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University, Boston, presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients, aged 18-65 years, for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively. The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

ATLANTA — The yellow fever vaccine is contraindicated for individuals receiving immunosuppressive therapies and for those with immunosuppressant conditions, but it can be used with caution in pregnant and breastfeeding women and in HIV-infected individuals with mild immunosuppression and no symptoms.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached this conclusion during its fall meeting based on an evaluation of vaccine-associated serious adverse events in certain populations.

ACIP recommended that the CDC update its current advisory for the use of yellow fever vaccine for U.S. citizens traveling to high-risk areas.

“Approximately 30,000 deaths are caused by yellow fever each year,” according to Dr. J. Erin Staples of the CDC. A traveler's risk for yellow fever is based on several factors, including season of travel, immunization status, activities while traveling, and duration of exposure.

Decisions regarding vaccination must balance the risk of contracting the disease against the risk of vaccine side effects, Dr. Staples said. The yellow fever vaccine is a live, attenuated vaccine, given as a single dose with a booster every 10 years.

Some countries require proof of vaccination for travelers arriving from high-risk areas, she noted.

Safety studies have shown that approximately 10%-30% of vaccinees report mild systemic adverse events. Recent data suggest that the rate of serious events among vaccinees is 0.8/100,000 doses.

Serious adverse events associated with the vaccine can include anaphylaxis, yellow fever–associated neurologic disease, and yellow fever vaccine–associated viscerotropic disease, she said.

The ACIP yellow fever working group determined that, based on the latest safety information, yellow fever vaccination is contraindicated for anyone with immunosuppression, including individuals with primary immunodeficiencies, malignant neoplasms, thymus disorder, organ transplants, and HIV infection with severe immunodeficiencies.

The vaccine also is contraindicated in persons receiving radiation therapy, chemotherapy, high-dose systemic corticosteroids, and immunomodulatory drugs. Likewise, the vaccine is contraindicated for infants younger than 6 months of age and individuals with hypersensitivity to any of the vaccine's components.

The risk of transmission via breastfeeding is unknown. The working group recommended that yellow fever vaccine should be available to breastfeeding women if their travel to a high-risk area cannot be avoided or postponed, she said.

If a pregnant woman is planning to visit a region where the vaccine's potential risks outweigh the likelihood of contracting yellow fever, she should receive a medical waiver to fulfill international travel requirements, Dr. Staples said.

A section of the recommendations spells out additional circumstances for providing medical waivers, Dr. Staples said.

“Both infants and older adults are at increased risk for vaccine-associated serious adverse events,” Dr. Staples noted. The recommendations do not contraindicate the following conditions, but urge precautions when vaccinating infants aged 6-8 months, adults aged 60 years and older, pregnant and breastfeeding women, and HIV-infected persons with moderate immune suppression and no symptoms.

ATLANTA — The yellow fever vaccine is contraindicated for individuals receiving immunosuppressive therapies and for those with immunosuppressant conditions, but it can be used with caution in pregnant and breastfeeding women and in HIV-infected individuals with mild immunosuppression and no symptoms.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached this conclusion during its fall meeting based on an evaluation of vaccine-associated serious adverse events in certain populations.

ACIP recommended that the CDC update its current advisory for the use of yellow fever vaccine for U.S. citizens traveling to high-risk areas.

“Approximately 30,000 deaths are caused by yellow fever each year,” according to Dr. J. Erin Staples of the CDC. A traveler's risk for yellow fever is based on several factors, including season of travel, immunization status, activities while traveling, and duration of exposure.

Decisions regarding vaccination must balance the risk of contracting the disease against the risk of vaccine side effects, Dr. Staples said. The yellow fever vaccine is a live, attenuated vaccine, given as a single dose with a booster every 10 years.

Some countries require proof of vaccination for travelers arriving from high-risk areas, she noted.

Safety studies have shown that approximately 10%-30% of vaccinees report mild systemic adverse events. Recent data suggest that the rate of serious events among vaccinees is 0.8/100,000 doses.

Serious adverse events associated with the vaccine can include anaphylaxis, yellow fever–associated neurologic disease, and yellow fever vaccine–associated viscerotropic disease, she said.

The ACIP yellow fever working group determined that, based on the latest safety information, yellow fever vaccination is contraindicated for anyone with immunosuppression, including individuals with primary immunodeficiencies, malignant neoplasms, thymus disorder, organ transplants, and HIV infection with severe immunodeficiencies.

The vaccine also is contraindicated in persons receiving radiation therapy, chemotherapy, high-dose systemic corticosteroids, and immunomodulatory drugs. Likewise, the vaccine is contraindicated for infants younger than 6 months of age and individuals with hypersensitivity to any of the vaccine's components.

The risk of transmission via breastfeeding is unknown. The working group recommended that yellow fever vaccine should be available to breastfeeding women if their travel to a high-risk area cannot be avoided or postponed, she said.

If a pregnant woman is planning to visit a region where the vaccine's potential risks outweigh the likelihood of contracting yellow fever, she should receive a medical waiver to fulfill international travel requirements, Dr. Staples said.

A section of the recommendations spells out additional circumstances for providing medical waivers, Dr. Staples said.

“Both infants and older adults are at increased risk for vaccine-associated serious adverse events,” Dr. Staples noted. The recommendations do not contraindicate the following conditions, but urge precautions when vaccinating infants aged 6-8 months, adults aged 60 years and older, pregnant and breastfeeding women, and HIV-infected persons with moderate immune suppression and no symptoms.

ATLANTA — The yellow fever vaccine is contraindicated for individuals receiving immunosuppressive therapies and for those with immunosuppressant conditions, but it can be used with caution in pregnant and breastfeeding women and in HIV-infected individuals with mild immunosuppression and no symptoms.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached this conclusion during its fall meeting based on an evaluation of vaccine-associated serious adverse events in certain populations.

ACIP recommended that the CDC update its current advisory for the use of yellow fever vaccine for U.S. citizens traveling to high-risk areas.

“Approximately 30,000 deaths are caused by yellow fever each year,” according to Dr. J. Erin Staples of the CDC. A traveler's risk for yellow fever is based on several factors, including season of travel, immunization status, activities while traveling, and duration of exposure.

Decisions regarding vaccination must balance the risk of contracting the disease against the risk of vaccine side effects, Dr. Staples said. The yellow fever vaccine is a live, attenuated vaccine, given as a single dose with a booster every 10 years.

Some countries require proof of vaccination for travelers arriving from high-risk areas, she noted.

Safety studies have shown that approximately 10%-30% of vaccinees report mild systemic adverse events. Recent data suggest that the rate of serious events among vaccinees is 0.8/100,000 doses.

Serious adverse events associated with the vaccine can include anaphylaxis, yellow fever–associated neurologic disease, and yellow fever vaccine–associated viscerotropic disease, she said.

The ACIP yellow fever working group determined that, based on the latest safety information, yellow fever vaccination is contraindicated for anyone with immunosuppression, including individuals with primary immunodeficiencies, malignant neoplasms, thymus disorder, organ transplants, and HIV infection with severe immunodeficiencies.

The vaccine also is contraindicated in persons receiving radiation therapy, chemotherapy, high-dose systemic corticosteroids, and immunomodulatory drugs. Likewise, the vaccine is contraindicated for infants younger than 6 months of age and individuals with hypersensitivity to any of the vaccine's components.

The risk of transmission via breastfeeding is unknown. The working group recommended that yellow fever vaccine should be available to breastfeeding women if their travel to a high-risk area cannot be avoided or postponed, she said.

If a pregnant woman is planning to visit a region where the vaccine's potential risks outweigh the likelihood of contracting yellow fever, she should receive a medical waiver to fulfill international travel requirements, Dr. Staples said.

A section of the recommendations spells out additional circumstances for providing medical waivers, Dr. Staples said.

“Both infants and older adults are at increased risk for vaccine-associated serious adverse events,” Dr. Staples noted. The recommendations do not contraindicate the following conditions, but urge precautions when vaccinating infants aged 6-8 months, adults aged 60 years and older, pregnant and breastfeeding women, and HIV-infected persons with moderate immune suppression and no symptoms.

The American Medical Association has created a new Current Procedural Terminology code (90470) and revised an existing code (90663) for use with H1N1 vaccinations, the association said in a statement.

The details of the codes are as follows:

▸ 90470: H1N1 immunization, both intramuscular and intranasal, including counseling

▸ 90663: Influenza virus vaccine (pandemic H1N1 formulation)

Both codes are effective immediately. Code 90470 was created for use when reporting H1N1 vaccination and counseling, while code 90663 was revised to include the specific H1N1 vaccine product.

To be paid for H1N1 vaccine administration, providers should bill 90663 in conjunction with 90470. The 90663 code should be billed at zero dollars, because the vaccine itself is being provided by the federal government at no charge.

The American Medical Association has created a new Current Procedural Terminology code (90470) and revised an existing code (90663) for use with H1N1 vaccinations, the association said in a statement.

The details of the codes are as follows:

▸ 90470: H1N1 immunization, both intramuscular and intranasal, including counseling

▸ 90663: Influenza virus vaccine (pandemic H1N1 formulation)

Both codes are effective immediately. Code 90470 was created for use when reporting H1N1 vaccination and counseling, while code 90663 was revised to include the specific H1N1 vaccine product.

To be paid for H1N1 vaccine administration, providers should bill 90663 in conjunction with 90470. The 90663 code should be billed at zero dollars, because the vaccine itself is being provided by the federal government at no charge.

The American Medical Association has created a new Current Procedural Terminology code (90470) and revised an existing code (90663) for use with H1N1 vaccinations, the association said in a statement.

The details of the codes are as follows:

▸ 90470: H1N1 immunization, both intramuscular and intranasal, including counseling

▸ 90663: Influenza virus vaccine (pandemic H1N1 formulation)

Both codes are effective immediately. Code 90470 was created for use when reporting H1N1 vaccination and counseling, while code 90663 was revised to include the specific H1N1 vaccine product.

To be paid for H1N1 vaccine administration, providers should bill 90663 in conjunction with 90470. The 90663 code should be billed at zero dollars, because the vaccine itself is being provided by the federal government at no charge.