CDC ACIP 3193-11

ATLANTA – Routine infant or toddler immunization against meningococcal disease does not appear to be a cost-effective measure, according to an assessment from a working group of the Advisory Committee on Immunization Practices.

That conclusion was presented to the full committee at its October meeting. If a conjugate meningococcal vaccine is licensed for use in infants before the next Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting Feb. 22-23, the committee will vote on it then, said Dr. Amanda Cohn of the CDC’s National Center for Immunization and Respiratory Disease (NCIRD).

The working group’s assessment was based primarily on the low proportion of preventable disease cases and the high cost of vaccinating infants or toddlers with meningococcal vaccine per case prevented. Moreover, although current meningococcal conjugate vaccines are safe and immunogenic, they show evidence of declining antibodies after about 3 years, suggesting that a booster dose at age 6 years would likely be needed to protect children until the routine 11-to 12-year-old (adolescent) immunization, Dr. Cohn noted.

Jessica MacNeil, MPH, also with NCIRD, presented epidemiologic data showing that meningococcal disease has been declining in all age groups. The data do not suggest this is due to the adolescent immunization program.** The first evidence of an impact of the adolescent immunization program was detected in 2008-2009, when the incidence was 0.14 per 100,000 population among those aged 11-19 years and 0.82 among children less than 1 year of age. In contrast, those rates in 2006-2007 were 0.27 and 1.07, respectively. Moreover, the largest proportion of cases in children aged less than 5 years is due to meningococcal serotype B, which is not included in the any of the vaccines, she noted.

Surveillance data from 1993-2009 show that while 86% of children under 5 years of age who contract meningococcal disease are hospitalized, the case-fatality ratio is low, ranging from 1% for serogroup Y to 10% for serogroup C. A large majority – 75%-80% of children under 5 years with meningococcal disease – survives and recover. Major complications – including skin necrosis, amputation, hearing loss, and death – are less frequent in infants than in adolescents, Ms. MacNeil noted.

In a cost-effectiveness analysis presented by Ismael Ortega-Sanchez, Ph.D., the cost per quality-adjusted life year (QALY) saved for either giving four doses of the vaccine to infants at 2, 4, 6, and 12 months or two doses to toddlers at 9 and 12 months varied with different assumptions of what the vaccine will cost and whether it was given during a season of high or low disease incidence. Assuming a cost of $60 per vaccine dose and an average incidence rate, the costs would be approximately $1,015,000* per QALY saved for infants and $1,036,000* per QALY saved for toddlers.

"Vaccinating infants or toddlers with meningococcal vaccine has a high cost per case prevented, even at a low vaccine price. Cost estimates are much higher than prior analyses because of declining incidence and shorter duration of protection. Infant vaccination prevents twice as many cases as toddler vaccination but at twice the cost," said Dr. Ortega-Sanchez, also with NCIRD.

No conjugate meningococcal vaccine is yet licensed for use in young infants. MenACWY-D (Sanofi Pasteur’s Menactra) is licensed for persons aged 2-55 years as a single dose. In April 2011, it was also licensed as a two-dose series for ages 9-23 months (on a 9- and 12-month schedule). MenACWY-CRM (Novartis’ Menveo), is also licensed as a single dose for ages 2-55 years, and an indication for a 4-dose infant series at 2, 4, 6, and 12 months is under review by the Food and Drug Administration. A combination product, HibMenCY-T (GlaxoSmithKline’s MenHibrix) is under FDA review for a 4 dose infant series, also at 2, 4, 6, and 12 months.

Sanofi Pasteur said in a statement, "With the current incidence of meningococcal disease at an all time low in the United States, a recommendation for children at highest risk is a prudent course of action. CDC has indicated that ACIP would consider making a routine infant recommendation in the future, should U.S. meningococcal disease incidence rates return to the historically higher levels observed prior to the introduction of meningococcal conjugate vaccines in adolescents.

"Sanofi Pasteur supports the ACIP’s recommendation calling for a 2-dose series of meningococcal vaccine for infants and children 9 through 23 months of age who are at high risk for getting meningococcal disease, including those traveling to countries where meningococcal infection is endemic, and those with human immunodeficiency virus (HIV) infection or certain complement component deficiencies. Given the rapid and potentially devastating nature of meningococcal disease and the incidence of infection in children under 1 year of age, we believe this recommendation will make significant strides in helping to protect those at greatest risk for the disease.

And, in a statement from Novartis, "When looking at the incidence of meningococcal disease, it is important to not only look at the number of cases but also the substantial life-long effects of the disease, which include significant psychosocial, economic, and emotional burden for victims’ families and their communities. Novartis believes that health care professionals and parents should have the choice to immunize infants against the potentially devastating consequences of this disease. We will continue our dialogue with the CDC and with ACIP prior to their vote on this matter in February, 2012.

"Infants are at highest risk for meningococcal disease due to the relative immaturity of their immune systems. Approximately 1 in 10 infants under 1 year of age die after contracting meningococcal disease, even with appropriate medical care, and as many as 1 in 5 will suffer serious life-long complications such as limb amputations, seizures, paralysis, hearing loss, and learning disabilities. The health care costs associated with meningococcal disease and the long-term management of its complications are substantial and present a significant public health burden.

"At Novartis, we are committed to eliminating meningococcal disease and we have made a significant effort to develop a safe and effective vaccine to help protect infants."

And, from GSK: "GlaxoSmithKline is committed to making MenHibrix available in the United States. We believe there is a clear public health benefit in recommending meningococcal vaccines for use in infants and toddlers in the United States. Rates of meningococcal disease are highest in infants and toddlers younger than 2 years of age. Approximately 300 cases of meningococcal disease from all serogroups were reported annually in the United States in this age group between 1998 and 2007."

As a CDC employee, Dr. Cohn has no conflicts of interest.

*Correction, 11/8/2011: An earlier version of this story gave the incorrect cost savings per QALY for infants and toddlers with certain doses of the vaccine.

**Correction, 11/9/2011: An earlier version of this story misstated the impact of the adolescent immunization program.

ATLANTA – Routine infant or toddler immunization against meningococcal disease does not appear to be a cost-effective measure, according to an assessment from a working group of the Advisory Committee on Immunization Practices.

That conclusion was presented to the full committee at its October meeting. If a conjugate meningococcal vaccine is licensed for use in infants before the next Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting Feb. 22-23, the committee will vote on it then, said Dr. Amanda Cohn of the CDC’s National Center for Immunization and Respiratory Disease (NCIRD).

The working group’s assessment was based primarily on the low proportion of preventable disease cases and the high cost of vaccinating infants or toddlers with meningococcal vaccine per case prevented. Moreover, although current meningococcal conjugate vaccines are safe and immunogenic, they show evidence of declining antibodies after about 3 years, suggesting that a booster dose at age 6 years would likely be needed to protect children until the routine 11-to 12-year-old (adolescent) immunization, Dr. Cohn noted.

Jessica MacNeil, MPH, also with NCIRD, presented epidemiologic data showing that meningococcal disease has been declining in all age groups. The data do not suggest this is due to the adolescent immunization program.** The first evidence of an impact of the adolescent immunization program was detected in 2008-2009, when the incidence was 0.14 per 100,000 population among those aged 11-19 years and 0.82 among children less than 1 year of age. In contrast, those rates in 2006-2007 were 0.27 and 1.07, respectively. Moreover, the largest proportion of cases in children aged less than 5 years is due to meningococcal serotype B, which is not included in the any of the vaccines, she noted.

Surveillance data from 1993-2009 show that while 86% of children under 5 years of age who contract meningococcal disease are hospitalized, the case-fatality ratio is low, ranging from 1% for serogroup Y to 10% for serogroup C. A large majority – 75%-80% of children under 5 years with meningococcal disease – survives and recover. Major complications – including skin necrosis, amputation, hearing loss, and death – are less frequent in infants than in adolescents, Ms. MacNeil noted.

In a cost-effectiveness analysis presented by Ismael Ortega-Sanchez, Ph.D., the cost per quality-adjusted life year (QALY) saved for either giving four doses of the vaccine to infants at 2, 4, 6, and 12 months or two doses to toddlers at 9 and 12 months varied with different assumptions of what the vaccine will cost and whether it was given during a season of high or low disease incidence. Assuming a cost of $60 per vaccine dose and an average incidence rate, the costs would be approximately $1,015,000* per QALY saved for infants and $1,036,000* per QALY saved for toddlers.

"Vaccinating infants or toddlers with meningococcal vaccine has a high cost per case prevented, even at a low vaccine price. Cost estimates are much higher than prior analyses because of declining incidence and shorter duration of protection. Infant vaccination prevents twice as many cases as toddler vaccination but at twice the cost," said Dr. Ortega-Sanchez, also with NCIRD.

No conjugate meningococcal vaccine is yet licensed for use in young infants. MenACWY-D (Sanofi Pasteur’s Menactra) is licensed for persons aged 2-55 years as a single dose. In April 2011, it was also licensed as a two-dose series for ages 9-23 months (on a 9- and 12-month schedule). MenACWY-CRM (Novartis’ Menveo), is also licensed as a single dose for ages 2-55 years, and an indication for a 4-dose infant series at 2, 4, 6, and 12 months is under review by the Food and Drug Administration. A combination product, HibMenCY-T (GlaxoSmithKline’s MenHibrix) is under FDA review for a 4 dose infant series, also at 2, 4, 6, and 12 months.

Sanofi Pasteur said in a statement, "With the current incidence of meningococcal disease at an all time low in the United States, a recommendation for children at highest risk is a prudent course of action. CDC has indicated that ACIP would consider making a routine infant recommendation in the future, should U.S. meningococcal disease incidence rates return to the historically higher levels observed prior to the introduction of meningococcal conjugate vaccines in adolescents.

"Sanofi Pasteur supports the ACIP’s recommendation calling for a 2-dose series of meningococcal vaccine for infants and children 9 through 23 months of age who are at high risk for getting meningococcal disease, including those traveling to countries where meningococcal infection is endemic, and those with human immunodeficiency virus (HIV) infection or certain complement component deficiencies. Given the rapid and potentially devastating nature of meningococcal disease and the incidence of infection in children under 1 year of age, we believe this recommendation will make significant strides in helping to protect those at greatest risk for the disease.

And, in a statement from Novartis, "When looking at the incidence of meningococcal disease, it is important to not only look at the number of cases but also the substantial life-long effects of the disease, which include significant psychosocial, economic, and emotional burden for victims’ families and their communities. Novartis believes that health care professionals and parents should have the choice to immunize infants against the potentially devastating consequences of this disease. We will continue our dialogue with the CDC and with ACIP prior to their vote on this matter in February, 2012.

"Infants are at highest risk for meningococcal disease due to the relative immaturity of their immune systems. Approximately 1 in 10 infants under 1 year of age die after contracting meningococcal disease, even with appropriate medical care, and as many as 1 in 5 will suffer serious life-long complications such as limb amputations, seizures, paralysis, hearing loss, and learning disabilities. The health care costs associated with meningococcal disease and the long-term management of its complications are substantial and present a significant public health burden.

"At Novartis, we are committed to eliminating meningococcal disease and we have made a significant effort to develop a safe and effective vaccine to help protect infants."

And, from GSK: "GlaxoSmithKline is committed to making MenHibrix available in the United States. We believe there is a clear public health benefit in recommending meningococcal vaccines for use in infants and toddlers in the United States. Rates of meningococcal disease are highest in infants and toddlers younger than 2 years of age. Approximately 300 cases of meningococcal disease from all serogroups were reported annually in the United States in this age group between 1998 and 2007."

As a CDC employee, Dr. Cohn has no conflicts of interest.

*Correction, 11/8/2011: An earlier version of this story gave the incorrect cost savings per QALY for infants and toddlers with certain doses of the vaccine.

**Correction, 11/9/2011: An earlier version of this story misstated the impact of the adolescent immunization program.

ATLANTA – Routine infant or toddler immunization against meningococcal disease does not appear to be a cost-effective measure, according to an assessment from a working group of the Advisory Committee on Immunization Practices.

That conclusion was presented to the full committee at its October meeting. If a conjugate meningococcal vaccine is licensed for use in infants before the next Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting Feb. 22-23, the committee will vote on it then, said Dr. Amanda Cohn of the CDC’s National Center for Immunization and Respiratory Disease (NCIRD).

The working group’s assessment was based primarily on the low proportion of preventable disease cases and the high cost of vaccinating infants or toddlers with meningococcal vaccine per case prevented. Moreover, although current meningococcal conjugate vaccines are safe and immunogenic, they show evidence of declining antibodies after about 3 years, suggesting that a booster dose at age 6 years would likely be needed to protect children until the routine 11-to 12-year-old (adolescent) immunization, Dr. Cohn noted.

Jessica MacNeil, MPH, also with NCIRD, presented epidemiologic data showing that meningococcal disease has been declining in all age groups. The data do not suggest this is due to the adolescent immunization program.** The first evidence of an impact of the adolescent immunization program was detected in 2008-2009, when the incidence was 0.14 per 100,000 population among those aged 11-19 years and 0.82 among children less than 1 year of age. In contrast, those rates in 2006-2007 were 0.27 and 1.07, respectively. Moreover, the largest proportion of cases in children aged less than 5 years is due to meningococcal serotype B, which is not included in the any of the vaccines, she noted.

Surveillance data from 1993-2009 show that while 86% of children under 5 years of age who contract meningococcal disease are hospitalized, the case-fatality ratio is low, ranging from 1% for serogroup Y to 10% for serogroup C. A large majority – 75%-80% of children under 5 years with meningococcal disease – survives and recover. Major complications – including skin necrosis, amputation, hearing loss, and death – are less frequent in infants than in adolescents, Ms. MacNeil noted.

In a cost-effectiveness analysis presented by Ismael Ortega-Sanchez, Ph.D., the cost per quality-adjusted life year (QALY) saved for either giving four doses of the vaccine to infants at 2, 4, 6, and 12 months or two doses to toddlers at 9 and 12 months varied with different assumptions of what the vaccine will cost and whether it was given during a season of high or low disease incidence. Assuming a cost of $60 per vaccine dose and an average incidence rate, the costs would be approximately $1,015,000* per QALY saved for infants and $1,036,000* per QALY saved for toddlers.

"Vaccinating infants or toddlers with meningococcal vaccine has a high cost per case prevented, even at a low vaccine price. Cost estimates are much higher than prior analyses because of declining incidence and shorter duration of protection. Infant vaccination prevents twice as many cases as toddler vaccination but at twice the cost," said Dr. Ortega-Sanchez, also with NCIRD.

No conjugate meningococcal vaccine is yet licensed for use in young infants. MenACWY-D (Sanofi Pasteur’s Menactra) is licensed for persons aged 2-55 years as a single dose. In April 2011, it was also licensed as a two-dose series for ages 9-23 months (on a 9- and 12-month schedule). MenACWY-CRM (Novartis’ Menveo), is also licensed as a single dose for ages 2-55 years, and an indication for a 4-dose infant series at 2, 4, 6, and 12 months is under review by the Food and Drug Administration. A combination product, HibMenCY-T (GlaxoSmithKline’s MenHibrix) is under FDA review for a 4 dose infant series, also at 2, 4, 6, and 12 months.

Sanofi Pasteur said in a statement, "With the current incidence of meningococcal disease at an all time low in the United States, a recommendation for children at highest risk is a prudent course of action. CDC has indicated that ACIP would consider making a routine infant recommendation in the future, should U.S. meningococcal disease incidence rates return to the historically higher levels observed prior to the introduction of meningococcal conjugate vaccines in adolescents.

"Sanofi Pasteur supports the ACIP’s recommendation calling for a 2-dose series of meningococcal vaccine for infants and children 9 through 23 months of age who are at high risk for getting meningococcal disease, including those traveling to countries where meningococcal infection is endemic, and those with human immunodeficiency virus (HIV) infection or certain complement component deficiencies. Given the rapid and potentially devastating nature of meningococcal disease and the incidence of infection in children under 1 year of age, we believe this recommendation will make significant strides in helping to protect those at greatest risk for the disease.

And, in a statement from Novartis, "When looking at the incidence of meningococcal disease, it is important to not only look at the number of cases but also the substantial life-long effects of the disease, which include significant psychosocial, economic, and emotional burden for victims’ families and their communities. Novartis believes that health care professionals and parents should have the choice to immunize infants against the potentially devastating consequences of this disease. We will continue our dialogue with the CDC and with ACIP prior to their vote on this matter in February, 2012.

"Infants are at highest risk for meningococcal disease due to the relative immaturity of their immune systems. Approximately 1 in 10 infants under 1 year of age die after contracting meningococcal disease, even with appropriate medical care, and as many as 1 in 5 will suffer serious life-long complications such as limb amputations, seizures, paralysis, hearing loss, and learning disabilities. The health care costs associated with meningococcal disease and the long-term management of its complications are substantial and present a significant public health burden.

"At Novartis, we are committed to eliminating meningococcal disease and we have made a significant effort to develop a safe and effective vaccine to help protect infants."

And, from GSK: "GlaxoSmithKline is committed to making MenHibrix available in the United States. We believe there is a clear public health benefit in recommending meningococcal vaccines for use in infants and toddlers in the United States. Rates of meningococcal disease are highest in infants and toddlers younger than 2 years of age. Approximately 300 cases of meningococcal disease from all serogroups were reported annually in the United States in this age group between 1998 and 2007."

As a CDC employee, Dr. Cohn has no conflicts of interest.

*Correction, 11/8/2011: An earlier version of this story gave the incorrect cost savings per QALY for infants and toddlers with certain doses of the vaccine.

**Correction, 11/9/2011: An earlier version of this story misstated the impact of the adolescent immunization program.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

ATLANTA – Hepatitis B vaccination should be routinely given to previously unvaccinated adults with diabetes who are younger than 60 years of age, according to recommendations by the Centers for Disease Control’s Advisory Committee on Immunization Practices.

The recommendation is based on the finding that U.S. adults with diabetes patients face a roughly twofold increased risk for hepatitis B infection. Vaccination is advised based on the individual patient’s risk of acquiring hepatitis B infection.

An additional recommendation, which must be published by the CDC before it becomes official, is likely to say that people aged 60 years and older with diabetes who live in nursing homes and assisted living facilities are at increased risk for hepatitis B and should be considered for vaccine prioritization.

Results from CDC investigations identified inadequately cleaned blood glucose monitors as a major route of hepatitis B virus transmission among patients with diabetes, Meredith L. Reilly, a CDC epidemiologist, noted at the earlier annual meeting of the Infectious Diseases Society of America.

"Over the past several years, we’ve observed outbreaks of hepatitis B among patients with diabetes in places where they undergo assisted blood glucose monitoring, with more than one person using the monitor," such as assisted-living facilities, physician offices, and at pharmacies, said Dr. Trudy V. Murphy, head of the vaccine unit in the Division of Viral Hepatitis at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention in Atlanta. A total of 24 of 28 outbreaks at long-term care facilities identified different aspects of blood glucose monitoring as the source of the infection."

The advised age cutoff was based on estimates of disease risk and cost effectiveness. An analysis of data from more than 91,000 individuals participating in the CDC’s Emerging Infection Program (EIP) found that among people without traditional risk factors for hepatitis B (use of injectable drugs, unprotected sex with multiple partners), the adjusted odds ratio for acute hepatitis B among those with diabetes was 1.89, compared to those without diabetes, suggesting that diabetes is an independent marker for the infection, according to the CDC’s Dr. Sarah Schillie.

Among people with hepatitis B risk factors, those with diabetes had a 1.1 odds ratio of infection, compared with non-diabetics in that group.

After controlling for sex, race/ethnicity, and age, the overall odds ratio for acute hepatitis B among those with diabetes compared with those without was 2.09 in people aged 23-59, which was statistically significant. Among adults aged 60 and older, the odds ratio was 1.45, which was not significant.

The costs per quality-adjusted life year (QALY) saved of vaccinating adults with diabetes (assuming the private vaccine price), was calculated to be $75,094 for adults aged 20-59, compared with $2,8 million among those aged 60 and older, Dr. Schillie reported.

Many more patients with diabetes are sharing glucose monitors in a wide variety of settings, including households in which more than one family member has diabetes, worksite health clinics, schools, and diabetes camps. "We’re seeing more and more use of one glucose meter for multiple people," noted Dr. Pam Allweiss of the CDC’s Division of Diabetes Translation.

Because a large proportion of people with diabetes who are in institutions are older than 60, the ACIP debated whether to simply recommend the hepatitis vaccine for everyone with diabetes, rather than using cost-effectiveness as a guide for the age cutoff.

Prior to the vote, American College of Physicians liaison Dr. Sandra Fryhofer said that the ACP’s Adult Immunization Technical Advisory Committee supported a universal recommendation: "I urge you to recommend routine hepatitis B vaccination for diabetics of all ages," she told the ACIP.

In an interview after the vote, Dr. Fryhofer said of the College’s vaccine advisory committee, "We’re disappointed that we didn’t have a routine hepatitis B immunization recommendation for all diabetics of all ages. We know that diabetes is the 7th leading cause of death in this country, and the data show that if you have diabetes, it increases your risk of getting hepatitis B by 1.5 to 2 times, and it doubles your risk of death." However, she said, it’s unlikely that ACP will issue a different recommendation from ACIP’s.

Internist William Golden, however, disagreed with the idea of a universal approach. "Vaccinating everyone probably should not be a knee jerk reaction. ... One should first check to see if the patient already has antibodies conferring immunity. Secondly, one should inquire or warn about risks of sharing equipment. Make sure the patient has insurance coverage for the injections to avoid unpleasant surprises. Finally, review the need for frequent home glucose checks," he said. "Stable type 2 diabetics on oral medication may not need home checks more than one or two times a week, if at all. So, in short, assess the risks for the patient before offering a one size fits all strategy," said Dr. Golden, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock.

As CDC employees, Dr. Schillie, Dr. Murphy, and Dr. Allweiss have no financial conflicts. Dr. Fryhofer stated that she had no disclosures.

Mitchel Zoler contributed to this report.

10/28/11: UPDATE - This story has been revised and updated with additional information.

ATLANTA – Boys aged 11-12 years routinely should be given the quadrivalent human papillomavirus vaccine, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended.

The recommendation for boys aged 11-12 years to receive three doses of the vaccine is identical to the one currently in place for girls, except that it does not mention the other, bivalent HPV vaccine, which is not licensed for males. The vote was unanimous with one abstention, despite concerns voiced by several committee members about cost-effectiveness of the vaccine’s use in males. The vaccine becomes less cost-effective in males the more its coverage among females increases, the CDC’s Dr. Lauri Markowitz said.

The American Academy of Pediatrics Committee on Infectious Disease had previously voted for the same recommendation, Dr. Michael T. Brady, the AAP liaison to ACIP, said in an interview. The American Academy of Family Practice is expected to endorse it as well, said Dr. James Loehr, the AAFP liaison. The vote “made sense, and could possibly help with vaccination of females since now there won’t be a gender difference,” he noted.

Although routine vaccination of girls aged 11-12 years has been shown to be cost-effective in most scenarios, there is more uncertainty in cost-effectiveness estimates in women and in males. Routine HPV vaccination of boys at age 12 years could be cost-effective, particularly when female coverage is less than 50%. Those estimates range from $24,000 to $62,000 per quality-adjusted life-year (QALY) in published studies. In 2010, coverage rates in females were 49% for one dose and 32% for all three doses, Dr. Markowitz reported.

First-year costs of giving the vaccine to boys aged 11-12 years is estimated at $136,000,000, assuming an 11% probability of initiating the series and a 70% probability of completing it – somewhat lower than the uptake seen in females – at a cost of $119/dose, she said.

Some committee members voiced concern about whether cost-effectiveness estimates for males would become less favorable if vaccination rates increase in females beginning in 2012, when the proportion of girls who receive all three HPV vaccine doses by their 13th birthday will be a HEDIS (Healthcare Effectiveness Data and Information Set) measure.

Estimated costs per QALY also differed between calculations that included only diseases for which the vaccine is indicated (cervical disease, vulvar/vaginal disease, genital warts, and anal cancer) and those that also included prevention of other HPV-related conditions for which the vaccine isn’t indicated, including recurrent respiratory papillomatosis, oropharyngeal cancer, and penile cancer.

In all, most of the cost-effectiveness benefit obtained from routinely giving the vaccine to boys aged 11-12 years came from the prevention of cervical cancer in female partners, and prevention of oropharyngeal cancer in both males and females, Dr. Markowitz said.

The committee also recommended the vaccine’s use for catch-up in males aged 13-21 years who have not been previously vaccinated or who have not completed the three-dose series. Males aged 22-26 years also “may be vaccinated.” This vote was split, 8-5, with several members expressing concern that this recommendation is not harmonized with the uniform recommendation for females aged 9-26 years. Again, the different age cutoff was chosen due to cost-effectiveness considerations. However, the committee did vote to recommend the vaccine for males through age 26 years who have sex with other males and for those who are HIV-infected. For all males who have sex with males, the vaccine is cost-effective at less than $50,000/QALY.

In a joint interview, Dr. Brady and Dr. Loehr both commented that the relatively recent inclusion of cost-effectiveness considerations in the making of vaccine policy is a major shift from the past and now often overshadows other relevant information.

“It’s a huge concern, and it’s something the ACIP is wrestling with, how to incorporate cost-effectiveness data into decision-making. … I’m not sure there’s been clear guidance as to how the cost-effectiveness data is supposed to be applied,” said Dr. Loehr of Cayuga Family Medicine, Ithaca, N.Y.

Indeed, Dr. Brady pointed out that many older vaccines, such as those that prevent polio and Haemophilus influenzae type B, are cost saving because they prevent more costs than they actually cost. But, the licensure of the pneumococcal conjugate vaccine in 2000 began the shift. “As soon as Prevnar came, that changed the thought process. … Now there is cost, and the question is whether it’s a cost we feel is reasonable.”

“A lot of people believe that ACIP should only determine if something is appropriate and someone else should be responsible for the cost issues, because these are scientists, not economists,” said Dr. Brady, chair of the department of pediatrics, Ohio State University, Columbus.

Dr. Loehr noted that although the ACIP’s charter lists cost effectiveness as just one of several considerations for making vaccine recommendations, it was the main subject of discussion and questions from committee members surrounding the HPV recommendation for males. “It really does get people hung up.”

Dr. Brady and Dr. Loehr both stated that they have no financial disclosures. As a CDC employee, Dr. Markowitz has no conflicts of interest.

10/28/11: UPDATE - This story has been revised and updated with additional information.

ATLANTA – Boys aged 11-12 years routinely should be given the quadrivalent human papillomavirus vaccine, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended.

The recommendation for boys aged 11-12 years to receive three doses of the vaccine is identical to the one currently in place for girls, except that it does not mention the other, bivalent HPV vaccine, which is not licensed for males. The vote was unanimous with one abstention, despite concerns voiced by several committee members about cost-effectiveness of the vaccine’s use in males. The vaccine becomes less cost-effective in males the more its coverage among females increases, the CDC’s Dr. Lauri Markowitz said.

The American Academy of Pediatrics Committee on Infectious Disease had previously voted for the same recommendation, Dr. Michael T. Brady, the AAP liaison to ACIP, said in an interview. The American Academy of Family Practice is expected to endorse it as well, said Dr. James Loehr, the AAFP liaison. The vote “made sense, and could possibly help with vaccination of females since now there won’t be a gender difference,” he noted.

Although routine vaccination of girls aged 11-12 years has been shown to be cost-effective in most scenarios, there is more uncertainty in cost-effectiveness estimates in women and in males. Routine HPV vaccination of boys at age 12 years could be cost-effective, particularly when female coverage is less than 50%. Those estimates range from $24,000 to $62,000 per quality-adjusted life-year (QALY) in published studies. In 2010, coverage rates in females were 49% for one dose and 32% for all three doses, Dr. Markowitz reported.

First-year costs of giving the vaccine to boys aged 11-12 years is estimated at $136,000,000, assuming an 11% probability of initiating the series and a 70% probability of completing it – somewhat lower than the uptake seen in females – at a cost of $119/dose, she said.

Some committee members voiced concern about whether cost-effectiveness estimates for males would become less favorable if vaccination rates increase in females beginning in 2012, when the proportion of girls who receive all three HPV vaccine doses by their 13th birthday will be a HEDIS (Healthcare Effectiveness Data and Information Set) measure.

Estimated costs per QALY also differed between calculations that included only diseases for which the vaccine is indicated (cervical disease, vulvar/vaginal disease, genital warts, and anal cancer) and those that also included prevention of other HPV-related conditions for which the vaccine isn’t indicated, including recurrent respiratory papillomatosis, oropharyngeal cancer, and penile cancer.

In all, most of the cost-effectiveness benefit obtained from routinely giving the vaccine to boys aged 11-12 years came from the prevention of cervical cancer in female partners, and prevention of oropharyngeal cancer in both males and females, Dr. Markowitz said.

The committee also recommended the vaccine’s use for catch-up in males aged 13-21 years who have not been previously vaccinated or who have not completed the three-dose series. Males aged 22-26 years also “may be vaccinated.” This vote was split, 8-5, with several members expressing concern that this recommendation is not harmonized with the uniform recommendation for females aged 9-26 years. Again, the different age cutoff was chosen due to cost-effectiveness considerations. However, the committee did vote to recommend the vaccine for males through age 26 years who have sex with other males and for those who are HIV-infected. For all males who have sex with males, the vaccine is cost-effective at less than $50,000/QALY.

In a joint interview, Dr. Brady and Dr. Loehr both commented that the relatively recent inclusion of cost-effectiveness considerations in the making of vaccine policy is a major shift from the past and now often overshadows other relevant information.

“It’s a huge concern, and it’s something the ACIP is wrestling with, how to incorporate cost-effectiveness data into decision-making. … I’m not sure there’s been clear guidance as to how the cost-effectiveness data is supposed to be applied,” said Dr. Loehr of Cayuga Family Medicine, Ithaca, N.Y.

Indeed, Dr. Brady pointed out that many older vaccines, such as those that prevent polio and Haemophilus influenzae type B, are cost saving because they prevent more costs than they actually cost. But, the licensure of the pneumococcal conjugate vaccine in 2000 began the shift. “As soon as Prevnar came, that changed the thought process. … Now there is cost, and the question is whether it’s a cost we feel is reasonable.”

“A lot of people believe that ACIP should only determine if something is appropriate and someone else should be responsible for the cost issues, because these are scientists, not economists,” said Dr. Brady, chair of the department of pediatrics, Ohio State University, Columbus.

Dr. Loehr noted that although the ACIP’s charter lists cost effectiveness as just one of several considerations for making vaccine recommendations, it was the main subject of discussion and questions from committee members surrounding the HPV recommendation for males. “It really does get people hung up.”

Dr. Brady and Dr. Loehr both stated that they have no financial disclosures. As a CDC employee, Dr. Markowitz has no conflicts of interest.

10/28/11: UPDATE - This story has been revised and updated with additional information.

ATLANTA – Boys aged 11-12 years routinely should be given the quadrivalent human papillomavirus vaccine, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended.

The recommendation for boys aged 11-12 years to receive three doses of the vaccine is identical to the one currently in place for girls, except that it does not mention the other, bivalent HPV vaccine, which is not licensed for males. The vote was unanimous with one abstention, despite concerns voiced by several committee members about cost-effectiveness of the vaccine’s use in males. The vaccine becomes less cost-effective in males the more its coverage among females increases, the CDC’s Dr. Lauri Markowitz said.

The American Academy of Pediatrics Committee on Infectious Disease had previously voted for the same recommendation, Dr. Michael T. Brady, the AAP liaison to ACIP, said in an interview. The American Academy of Family Practice is expected to endorse it as well, said Dr. James Loehr, the AAFP liaison. The vote “made sense, and could possibly help with vaccination of females since now there won’t be a gender difference,” he noted.

Although routine vaccination of girls aged 11-12 years has been shown to be cost-effective in most scenarios, there is more uncertainty in cost-effectiveness estimates in women and in males. Routine HPV vaccination of boys at age 12 years could be cost-effective, particularly when female coverage is less than 50%. Those estimates range from $24,000 to $62,000 per quality-adjusted life-year (QALY) in published studies. In 2010, coverage rates in females were 49% for one dose and 32% for all three doses, Dr. Markowitz reported.

First-year costs of giving the vaccine to boys aged 11-12 years is estimated at $136,000,000, assuming an 11% probability of initiating the series and a 70% probability of completing it – somewhat lower than the uptake seen in females – at a cost of $119/dose, she said.

Some committee members voiced concern about whether cost-effectiveness estimates for males would become less favorable if vaccination rates increase in females beginning in 2012, when the proportion of girls who receive all three HPV vaccine doses by their 13th birthday will be a HEDIS (Healthcare Effectiveness Data and Information Set) measure.

Estimated costs per QALY also differed between calculations that included only diseases for which the vaccine is indicated (cervical disease, vulvar/vaginal disease, genital warts, and anal cancer) and those that also included prevention of other HPV-related conditions for which the vaccine isn’t indicated, including recurrent respiratory papillomatosis, oropharyngeal cancer, and penile cancer.

In all, most of the cost-effectiveness benefit obtained from routinely giving the vaccine to boys aged 11-12 years came from the prevention of cervical cancer in female partners, and prevention of oropharyngeal cancer in both males and females, Dr. Markowitz said.

The committee also recommended the vaccine’s use for catch-up in males aged 13-21 years who have not been previously vaccinated or who have not completed the three-dose series. Males aged 22-26 years also “may be vaccinated.” This vote was split, 8-5, with several members expressing concern that this recommendation is not harmonized with the uniform recommendation for females aged 9-26 years. Again, the different age cutoff was chosen due to cost-effectiveness considerations. However, the committee did vote to recommend the vaccine for males through age 26 years who have sex with other males and for those who are HIV-infected. For all males who have sex with males, the vaccine is cost-effective at less than $50,000/QALY.

In a joint interview, Dr. Brady and Dr. Loehr both commented that the relatively recent inclusion of cost-effectiveness considerations in the making of vaccine policy is a major shift from the past and now often overshadows other relevant information.

“It’s a huge concern, and it’s something the ACIP is wrestling with, how to incorporate cost-effectiveness data into decision-making. … I’m not sure there’s been clear guidance as to how the cost-effectiveness data is supposed to be applied,” said Dr. Loehr of Cayuga Family Medicine, Ithaca, N.Y.

Indeed, Dr. Brady pointed out that many older vaccines, such as those that prevent polio and Haemophilus influenzae type B, are cost saving because they prevent more costs than they actually cost. But, the licensure of the pneumococcal conjugate vaccine in 2000 began the shift. “As soon as Prevnar came, that changed the thought process. … Now there is cost, and the question is whether it’s a cost we feel is reasonable.”

“A lot of people believe that ACIP should only determine if something is appropriate and someone else should be responsible for the cost issues, because these are scientists, not economists,” said Dr. Brady, chair of the department of pediatrics, Ohio State University, Columbus.

Dr. Loehr noted that although the ACIP’s charter lists cost effectiveness as just one of several considerations for making vaccine recommendations, it was the main subject of discussion and questions from committee members surrounding the HPV recommendation for males. “It really does get people hung up.”

Dr. Brady and Dr. Loehr both stated that they have no financial disclosures. As a CDC employee, Dr. Markowitz has no conflicts of interest.