CDC ACIP 3090-11

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its June meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its latest meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its latest meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – No changes are being made to the current recommendation of herpes zoster vaccination for adults aged 60 years and older, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reported at its latest meeting.

The Food and Drug Administration licensed the herpes zoster vaccine (Zostavax) for use in adults aged 50-59 years in March 2011, said Dr. Paul Cieslak, chair of the zoster working group. However, the working group does not currently propose changes to the current recommendations.

Data from studies conducted by Merck, the maker of Zostavax, have shown vaccine efficacy in the 50-59 age group, but there is insufficient evidence regarding the duration of vaccine protection when it is given well before the peak age for zoster incidence, Dr. Cieslak noted.

Also, "it might be inappropriate to expand recommendations while the vaccine remains in short supply," he said, adding that the incidence could increase "if limited supply is used at time of low incidence." He also pointed out, however, that "the decision of the working group at this time is not intended to prejudice future deliberations."

ACIP currently recommends the herpes zoster vaccine (HZV) for all adults aged 60 years and older with no contraindications and for adults older than 80 years with chronic illnesses.

James Robinson, vice president of vaccine product and technology operations at Merck, spoke to the committee about the company’s plans to address production issues that limited the vaccine supply in recent years. According to Mr. Robinson, Merck distributed 2 million doses of zoster vaccine in the first 7 months of 2011 and expects to distribute another 2 million doses between July and December 2011, which approximately doubles the production from previous years.

New Study Results: Duration of Protection

ACIP’s research, however, suggests that more data are needed before a vote is reconsidered. The duration of the vaccine’s protection in younger adults is a key unknown factor, as is the cost effectiveness, said Dr. Rafael Harpaz of the CDC.

Dr. Harpaz presented data that showed protection of 3-4 years after zoster vaccination and possibly a few years longer. "What we don’t know: Will HZV protect 15 years or 30 years when it really counts?" he asked. Government data estimate that the average 50-year-old man in the United States can expect to live another 29 years, and the average 50-year-old woman can expect to live another 32 years, so there would be a substantial excess of zoster in older adults if a limited supply were diverted to younger adults, he noted.

Studies of the cost effectiveness of the zoster vaccine show a J-shaped curve. "Among adults aged 60 years and older, cost effectiveness of HZV is less favorable at the youngest and oldest ages of that range," Dr. Harpaz said. Cost effectiveness is reduced at younger ages because the protection is likely to wane by the time the recipient reaches the age when the disease burden of herpes zoster is highest. Cost effectiveness is also reduced in the elderly because of death and the decline in vaccine effectiveness over time.

Dr. Harpaz also addressed past supply shortages. Expanding recommendations before sustainable supplies are assured "can jeopardize the credibility of all players in the vaccine enterprise," he said. "ACIP has never adopted an expansion of a vaccination program in the midst of a supply shortage."

Other factors that prompted ACIP to refrain from recommending the zoster vaccine for adults aged 50-59 years include price, storage and handling issues, and complicated relationships of drug plans with pharmacies, he said.

The next steps include a Notice to Readers from the CDC that will appear on the CDC herpes zoster website to alert health care providers and the public to the change in licensure for the zoster vaccine and to emphasize that the ACIP recommendations have not changed.

The zoster working group recognized that some providers might wish to use the zoster vaccine for some patients aged 50-59 years, said Dr. Harpaz. The working group suggested that the CDC provide limited technical guidance for nonrecommended use in these patients, based on the current ACIP recommendations for adults aged 60 years and older.

Neither Dr. Cieslak nor Dr. Harpaz had any relevant financial conflicts to disclose.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Influenza vaccine should be given to persons with less severe egg allergies, as long as certain conditions are observed, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 23 meeting.

People with a less severe allergy were defined as "individuals who have experienced only hives following exposure to egg." Flu vaccination information for persons at risk for more severe reactions will be handled differently, said ACIP chair Dr. Carol Baker, who is professor of pediatrics, molecular virology, and microbiology at the Baylor College of Medicine, Houston.

The ACIP voted that individuals who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures:

• As studies published to date involved use of TIV (trivalent inactivated vaccine), TIV rather than LAIV (live attenuated influenza vaccine) should be used.

• Vaccine should be administered by a health care provider who is familiar with the subject of egg allergy.

• Vaccine recipients should be observed for at least 30 minutes for signs of a reaction following administration of each vaccine dose.

The ACIP recommendation also notes that "other measures, such as dividing and administering the vaccine by a two-step approach and skin testing with vaccine, are not necessary." In addition, "egg allergy may be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for IgE antibodies to egg proteins," according to the recommendations.

During the discussion period, several ACIP members emphasized that the recommendations are for the upcoming 2011-2012 flu season.

In a separate vote, the ACIP voted to accept the virus strains for the upcoming season, which are the same as last year: A/California/7/2009 (H1N1-like), A/Perth/16/2009 (H3N2-like), and B/Brisbane/60/2008-like.

"We will be making note of the new intradermal vaccine, which is proposed to be an alternative" for the indicated age groups, Dr. Baker noted.

The vote on vaccine strains also included the recommendation for influenza vaccine in children aged 6 months through 8 years. For this age group, children who received at least one dose of vaccine during the 2010-2011 flu season should have one dose this year. Children in this age group who are receiving their first flu vaccine in 2011-2012, or whose vaccination status is unknown, should receive two doses at least 4 weeks apart.

The ACIP also voted to include a footnote stating that children aged 6 months through 8 years who received at least one dose of flu vaccine prior to the 2010-2011 season should receive one dose this season.

The ACIP recommendations were based on data presented by Dr. John M. Kelso, an allergist and immunologist at the Scripps Clinic in San Diego, Calif. Dr. Kelso and members of the Clinical Immunization Safety Assessment (CISA) Network Hypersensitivity Working Group reviewed data from 17 studies, including more that 2,600 egg-allergic persons, most of whom were children, who showed no serious reactions (such as respiratory distress or hypertension) and a low rate of minor reactions (such as hives and wheezing).

"It is very likely that there’s just not enough ovalbumin in the vaccine to cause a problem," Dr. Kelso said.

Although specific recommendations for the amount of ovalbumin in flu vaccines were cut from the ACIP recommendations, Dr. Kelso noted that the studies he reviewed showed no serious reactions at doses up to 0.7 mcg per 0.5 mL of vaccine.

None of the presenters reported any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

©pressdigital/istockphoto.com

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.