Miriam E. Tucker

Overall rates of smoking-attributable mortality declined in 49 states and the District of Columbia from 1996–1999 to 2000–2004, with the greatest drops occurring in Nevada, California, and Virginia.

New state-specific data on smoking-attributable mortality (SAM) and years of potential life lost (YPLL) from the Centers for Disease Control and Prevention show that average annual overall SAM rates decreased during the two time periods by 44.4/100,000 population older than 35 years of age in Nevada, by 37.8/100,000 in California, and by 33.4/100,000 in Virginia. Oklahoma was the only state that experienced an increase in SAM, by 26.9/100,000 (MMWR 2009;58:29–33).

Sex- and age-specific SAMs were calculated by multiplying the total number of deaths among adults older than 35 years from 19 diseases caused by cigarette smoking by estimates of the smoking-attributable fraction of preventable deaths for each disease.

Compared with 1996–1999, the average annual SAM rates declined in 2000–2004 among men in all states except Oklahoma, but increased among women in several states (Alabama, Arizona, Arkansas, Georgia, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Michigan, North Carolina, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas) and D.C. For every state, the annual number of smoking-related deaths was higher among males than among females, the CDC said.

The release of these state-specific data follow a 2008 report that cigarette smoking and exposure to secondhand smoke resulted in an estimated 443,000 deaths and 5.1 million YPLL annually in the United States during 2000–2004 (MMWR 2008;57:1226–8).

During 2000–2004, overall average annual SAM rates per 100,000 population were lowest in Utah (138.3), Hawaii (167.6), and Minnesota (215.1), and highest in Kentucky (370.6), West Virginia (344.3), and Nevada (343.7). Median SAM rates per 100,000 population overall were 288.1 for 1996–1999 and 263.3 for 2000–2004.

Smoking-attributable YPLL were estimated by multiplying sex- and age-specific SAM by remaining life expectancy at the time of death. The average annual YPLL estimates ranged from 7,762 (Alaska) to 481,529 (California). The YPLL estimates for males ranged from 4,586 (Alaska) to 288,823 (California), and from 3,176 (Alaska) to 192,706 (California) for females.

To reduce SAM rates further, the CDC said, comprehensive evidence-based approaches for preventing smoking initiation and increasing cessation need to be implemented fully, and states should fund tobacco control activities at the level recommended by CDC. The CDC's guide on tobacco control activities can be found on the Web at (www.cdc.gov/tobacco/tobacco_control_programs/stateandcommunity/best_practices

Overall rates of smoking-attributable mortality declined in 49 states and the District of Columbia from 1996–1999 to 2000–2004, with the greatest drops occurring in Nevada, California, and Virginia.

New state-specific data on smoking-attributable mortality (SAM) and years of potential life lost (YPLL) from the Centers for Disease Control and Prevention show that average annual overall SAM rates decreased during the two time periods by 44.4/100,000 population older than 35 years of age in Nevada, by 37.8/100,000 in California, and by 33.4/100,000 in Virginia. Oklahoma was the only state that experienced an increase in SAM, by 26.9/100,000 (MMWR 2009;58:29–33).

Sex- and age-specific SAMs were calculated by multiplying the total number of deaths among adults older than 35 years from 19 diseases caused by cigarette smoking by estimates of the smoking-attributable fraction of preventable deaths for each disease.

Compared with 1996–1999, the average annual SAM rates declined in 2000–2004 among men in all states except Oklahoma, but increased among women in several states (Alabama, Arizona, Arkansas, Georgia, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Michigan, North Carolina, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas) and D.C. For every state, the annual number of smoking-related deaths was higher among males than among females, the CDC said.

The release of these state-specific data follow a 2008 report that cigarette smoking and exposure to secondhand smoke resulted in an estimated 443,000 deaths and 5.1 million YPLL annually in the United States during 2000–2004 (MMWR 2008;57:1226–8).

During 2000–2004, overall average annual SAM rates per 100,000 population were lowest in Utah (138.3), Hawaii (167.6), and Minnesota (215.1), and highest in Kentucky (370.6), West Virginia (344.3), and Nevada (343.7). Median SAM rates per 100,000 population overall were 288.1 for 1996–1999 and 263.3 for 2000–2004.

Smoking-attributable YPLL were estimated by multiplying sex- and age-specific SAM by remaining life expectancy at the time of death. The average annual YPLL estimates ranged from 7,762 (Alaska) to 481,529 (California). The YPLL estimates for males ranged from 4,586 (Alaska) to 288,823 (California), and from 3,176 (Alaska) to 192,706 (California) for females.

To reduce SAM rates further, the CDC said, comprehensive evidence-based approaches for preventing smoking initiation and increasing cessation need to be implemented fully, and states should fund tobacco control activities at the level recommended by CDC. The CDC's guide on tobacco control activities can be found on the Web at (www.cdc.gov/tobacco/tobacco_control_programs/stateandcommunity/best_practices

Overall rates of smoking-attributable mortality declined in 49 states and the District of Columbia from 1996–1999 to 2000–2004, with the greatest drops occurring in Nevada, California, and Virginia.

New state-specific data on smoking-attributable mortality (SAM) and years of potential life lost (YPLL) from the Centers for Disease Control and Prevention show that average annual overall SAM rates decreased during the two time periods by 44.4/100,000 population older than 35 years of age in Nevada, by 37.8/100,000 in California, and by 33.4/100,000 in Virginia. Oklahoma was the only state that experienced an increase in SAM, by 26.9/100,000 (MMWR 2009;58:29–33).

Sex- and age-specific SAMs were calculated by multiplying the total number of deaths among adults older than 35 years from 19 diseases caused by cigarette smoking by estimates of the smoking-attributable fraction of preventable deaths for each disease.

Compared with 1996–1999, the average annual SAM rates declined in 2000–2004 among men in all states except Oklahoma, but increased among women in several states (Alabama, Arizona, Arkansas, Georgia, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Michigan, North Carolina, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas) and D.C. For every state, the annual number of smoking-related deaths was higher among males than among females, the CDC said.

The release of these state-specific data follow a 2008 report that cigarette smoking and exposure to secondhand smoke resulted in an estimated 443,000 deaths and 5.1 million YPLL annually in the United States during 2000–2004 (MMWR 2008;57:1226–8).

During 2000–2004, overall average annual SAM rates per 100,000 population were lowest in Utah (138.3), Hawaii (167.6), and Minnesota (215.1), and highest in Kentucky (370.6), West Virginia (344.3), and Nevada (343.7). Median SAM rates per 100,000 population overall were 288.1 for 1996–1999 and 263.3 for 2000–2004.

Smoking-attributable YPLL were estimated by multiplying sex- and age-specific SAM by remaining life expectancy at the time of death. The average annual YPLL estimates ranged from 7,762 (Alaska) to 481,529 (California). The YPLL estimates for males ranged from 4,586 (Alaska) to 288,823 (California), and from 3,176 (Alaska) to 192,706 (California) for females.

To reduce SAM rates further, the CDC said, comprehensive evidence-based approaches for preventing smoking initiation and increasing cessation need to be implemented fully, and states should fund tobacco control activities at the level recommended by CDC. The CDC's guide on tobacco control activities can be found on the Web at (www.cdc.gov/tobacco/tobacco_control_programs/stateandcommunity/best_practices

A novel and relatively inexpensive experimental wireless device worn by health care workers was highly accurate in automatically tracking hand-hygiene compliance in a hospital setting.

Despite evidence that hand hygiene is one of the most effective ways to prevent transmission of infection to patients, compliance among health care workers remains low.

Monitoring of hand hygiene compliance is a requirement for hospitals to be credentialed by the Joint Commission, Dr. Philip M. Polgreen said during a telephone press briefing held prior to his presentation of the findings at the annual meeting of the Society for Healthcare Epidemiology of America in San Diego.

Currently, the most commonly used methods for tracking hand hygiene include having a person visually observe health care workers.

Visual observation is labor intensive and is subject to inconsistency as well as to the “Hawthorne effect,” in which people behave differently when they know they're being watched. Another common approach is the use of a radiofrequency identification system, which requires the installation of infrastructure that can be prohibitively expensive, said Dr. Polgreen of the University of Iowa, Iowa City, who is director of the Infectious Disease Society of America's Emerging Infections Network.

The experimental device, which is worn as a pager-size badge, wirelessly detects the use of tagged hand-hygiene dispensers for alcohol-based sanitizer (or soap dispensers). The device automatically logs the date, time, and length of use, as well as the dispenser identification number. The health care worker's location at the time before and after hand-hygiene events is determined by the placement of “beacon” radio probes inside patient rooms, hallways, and other strategic locations.

Data from the badges can be collected and analyzed without any manual data entry, and results can be fed back to users.

In a pilot study, research assistants and health care workers entered and exited unoccupied rooms of different types and configurations hundreds of times while being observed by human observers to compare the subjects' actual location with the signals generated by the “active badges.” When the subjects stayed in the room for 30 seconds, the system achieved a sensitivity of 91.1%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.7%. When time within rooms was increased to 60 seconds, sensitivity was 97.7%, specificity was 100%, positive predictive value was 100%, and negative predictive value 98.9%.

The system can be installed and removed easily, and is far less expensive than either direct observation by staff or installation of a radiofrequency identification system, Dr. Polgreen said.

Asked whether some health care workers might object to wearing these devices, Dr. Polgreen said that the system can be designed to consolidate data to yield unit-level compliance rates that don't identify particular offenders. SHEA vice president Dr. Neil Fishman noted that “ultimately, our goal is to provide the safest care environment for the patients we take care of. … We just have to maintain that focus as opposed to the policing aspect of it.”

As a next step, Dr. Polgreen and his associates are about to begin pilot-testing the system in active inpatient units with real patients. “Hopefully we'll have lots of data within the next few months,” he said.

In an interview, Dr. Polgreen said that he, along with lead computer scientist Ted Herman, Ph.D., and other associates, assembled the devices themselves at University of Iowa and have not received any corporate or industry funding for the project. All funding came from the National Science Foundation, the National Institutes of Health, and a pilot grant from the University of Iowa's department of internal medicine.

The pager-size badges that are worn by health care workers wirelessly detect the use of tagged hand-hygiene dispensers for alcohol-based sanitizer or soap. The devices automatically log the date, time, and length of use. Chris Hlady

A novel and relatively inexpensive experimental wireless device worn by health care workers was highly accurate in automatically tracking hand-hygiene compliance in a hospital setting.

Despite evidence that hand hygiene is one of the most effective ways to prevent transmission of infection to patients, compliance among health care workers remains low.

Monitoring of hand hygiene compliance is a requirement for hospitals to be credentialed by the Joint Commission, Dr. Philip M. Polgreen said during a telephone press briefing held prior to his presentation of the findings at the annual meeting of the Society for Healthcare Epidemiology of America in San Diego.

Currently, the most commonly used methods for tracking hand hygiene include having a person visually observe health care workers.

Visual observation is labor intensive and is subject to inconsistency as well as to the “Hawthorne effect,” in which people behave differently when they know they're being watched. Another common approach is the use of a radiofrequency identification system, which requires the installation of infrastructure that can be prohibitively expensive, said Dr. Polgreen of the University of Iowa, Iowa City, who is director of the Infectious Disease Society of America's Emerging Infections Network.

The experimental device, which is worn as a pager-size badge, wirelessly detects the use of tagged hand-hygiene dispensers for alcohol-based sanitizer (or soap dispensers). The device automatically logs the date, time, and length of use, as well as the dispenser identification number. The health care worker's location at the time before and after hand-hygiene events is determined by the placement of “beacon” radio probes inside patient rooms, hallways, and other strategic locations.

Data from the badges can be collected and analyzed without any manual data entry, and results can be fed back to users.

In a pilot study, research assistants and health care workers entered and exited unoccupied rooms of different types and configurations hundreds of times while being observed by human observers to compare the subjects' actual location with the signals generated by the “active badges.” When the subjects stayed in the room for 30 seconds, the system achieved a sensitivity of 91.1%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.7%. When time within rooms was increased to 60 seconds, sensitivity was 97.7%, specificity was 100%, positive predictive value was 100%, and negative predictive value 98.9%.

The system can be installed and removed easily, and is far less expensive than either direct observation by staff or installation of a radiofrequency identification system, Dr. Polgreen said.

Asked whether some health care workers might object to wearing these devices, Dr. Polgreen said that the system can be designed to consolidate data to yield unit-level compliance rates that don't identify particular offenders. SHEA vice president Dr. Neil Fishman noted that “ultimately, our goal is to provide the safest care environment for the patients we take care of. … We just have to maintain that focus as opposed to the policing aspect of it.”

As a next step, Dr. Polgreen and his associates are about to begin pilot-testing the system in active inpatient units with real patients. “Hopefully we'll have lots of data within the next few months,” he said.

In an interview, Dr. Polgreen said that he, along with lead computer scientist Ted Herman, Ph.D., and other associates, assembled the devices themselves at University of Iowa and have not received any corporate or industry funding for the project. All funding came from the National Science Foundation, the National Institutes of Health, and a pilot grant from the University of Iowa's department of internal medicine.

The pager-size badges that are worn by health care workers wirelessly detect the use of tagged hand-hygiene dispensers for alcohol-based sanitizer or soap. The devices automatically log the date, time, and length of use. Chris Hlady

A novel and relatively inexpensive experimental wireless device worn by health care workers was highly accurate in automatically tracking hand-hygiene compliance in a hospital setting.

Despite evidence that hand hygiene is one of the most effective ways to prevent transmission of infection to patients, compliance among health care workers remains low.

Monitoring of hand hygiene compliance is a requirement for hospitals to be credentialed by the Joint Commission, Dr. Philip M. Polgreen said during a telephone press briefing held prior to his presentation of the findings at the annual meeting of the Society for Healthcare Epidemiology of America in San Diego.

Currently, the most commonly used methods for tracking hand hygiene include having a person visually observe health care workers.

Visual observation is labor intensive and is subject to inconsistency as well as to the “Hawthorne effect,” in which people behave differently when they know they're being watched. Another common approach is the use of a radiofrequency identification system, which requires the installation of infrastructure that can be prohibitively expensive, said Dr. Polgreen of the University of Iowa, Iowa City, who is director of the Infectious Disease Society of America's Emerging Infections Network.

The experimental device, which is worn as a pager-size badge, wirelessly detects the use of tagged hand-hygiene dispensers for alcohol-based sanitizer (or soap dispensers). The device automatically logs the date, time, and length of use, as well as the dispenser identification number. The health care worker's location at the time before and after hand-hygiene events is determined by the placement of “beacon” radio probes inside patient rooms, hallways, and other strategic locations.

Data from the badges can be collected and analyzed without any manual data entry, and results can be fed back to users.

In a pilot study, research assistants and health care workers entered and exited unoccupied rooms of different types and configurations hundreds of times while being observed by human observers to compare the subjects' actual location with the signals generated by the “active badges.” When the subjects stayed in the room for 30 seconds, the system achieved a sensitivity of 91.1%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 95.7%. When time within rooms was increased to 60 seconds, sensitivity was 97.7%, specificity was 100%, positive predictive value was 100%, and negative predictive value 98.9%.

The system can be installed and removed easily, and is far less expensive than either direct observation by staff or installation of a radiofrequency identification system, Dr. Polgreen said.

Asked whether some health care workers might object to wearing these devices, Dr. Polgreen said that the system can be designed to consolidate data to yield unit-level compliance rates that don't identify particular offenders. SHEA vice president Dr. Neil Fishman noted that “ultimately, our goal is to provide the safest care environment for the patients we take care of. … We just have to maintain that focus as opposed to the policing aspect of it.”

As a next step, Dr. Polgreen and his associates are about to begin pilot-testing the system in active inpatient units with real patients. “Hopefully we'll have lots of data within the next few months,” he said.

In an interview, Dr. Polgreen said that he, along with lead computer scientist Ted Herman, Ph.D., and other associates, assembled the devices themselves at University of Iowa and have not received any corporate or industry funding for the project. All funding came from the National Science Foundation, the National Institutes of Health, and a pilot grant from the University of Iowa's department of internal medicine.

The pager-size badges that are worn by health care workers wirelessly detect the use of tagged hand-hygiene dispensers for alcohol-based sanitizer or soap. The devices automatically log the date, time, and length of use. Chris Hlady

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16–26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9–15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and "gender-neutral" vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

ACIP is expected to recommend the vaccine for use in males aged 11–12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

"There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time," said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16–23 years and 602 males aged 16–26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. With the results of PCR and serology combined, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that "the vast majority would benefit from the vaccine," Dr. Haupt said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three of those results were statistically significant, he said.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations were uncommon and were not different between the Gardasil and placebo groups, Dr. Haupt reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9–26 years.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16–26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9–15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and "gender-neutral" vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

ACIP is expected to recommend the vaccine for use in males aged 11–12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

"There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time," said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16–23 years and 602 males aged 16–26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. With the results of PCR and serology combined, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that "the vast majority would benefit from the vaccine," Dr. Haupt said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three of those results were statistically significant, he said.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations were uncommon and were not different between the Gardasil and placebo groups, Dr. Haupt reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9–26 years.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16–26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9–15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and "gender-neutral" vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

ACIP is expected to recommend the vaccine for use in males aged 11–12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

"There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time," said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16–23 years and 602 males aged 16–26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. With the results of PCR and serology combined, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that "the vast majority would benefit from the vaccine," Dr. Haupt said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three of those results were statistically significant, he said.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations were uncommon and were not different between the Gardasil and placebo groups, Dr. Haupt reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9–26 years.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

The unanimous vote is in line with the American Academy of Pediatrics' position and will be reflected in the upcoming edition of the Red Book, AAP liaison Dr. Joseph A. Bocchini Jr. said in an interview.

According to the statement approved by ACIP, when adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified.

The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee.

Previous ACIP recommendations called for vaccination only of adoptive parents and others actually travelling to the country with high or intermediate endemicity of hepatitis A, said Dr. Sandra Chaves of the CDC's Division of Viral Hepatitis.

The issue came to the CDC's attention in June 2007 when a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins were not jaundiced, but were confirmed to have hepatitis A. That case prompted further investigation, with the discovery of 20 additional cases of hepatitis A among nontraveling contacts of international adoptees from six states during 2006-2007, Dr. Chaves said.

The proportion of hepatitis A-infected individuals who are asymptomatic is 70% among children younger than 6 years, compared with 20%-50% of infected children aged 6-17 years. The ACIP considered recommending vaccination of contacts of only those adoptees younger than 6 years, but ultimately voted to include contacts of adoptees in all age groups.

By statistical estimation, the risk of hepatitis A infection is approximately 106 per 100,000 close contacts of international adoptees in the United States, compared with the actual annual incidence of 1.2/100,000 in 2006 in the general population, Dr. Chaves said.

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

The unanimous vote is in line with the American Academy of Pediatrics' position and will be reflected in the upcoming edition of the Red Book, AAP liaison Dr. Joseph A. Bocchini Jr. said in an interview.

According to the statement approved by ACIP, when adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified.

The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee.

Previous ACIP recommendations called for vaccination only of adoptive parents and others actually travelling to the country with high or intermediate endemicity of hepatitis A, said Dr. Sandra Chaves of the CDC's Division of Viral Hepatitis.

The issue came to the CDC's attention in June 2007 when a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins were not jaundiced, but were confirmed to have hepatitis A. That case prompted further investigation, with the discovery of 20 additional cases of hepatitis A among nontraveling contacts of international adoptees from six states during 2006-2007, Dr. Chaves said.

The proportion of hepatitis A-infected individuals who are asymptomatic is 70% among children younger than 6 years, compared with 20%-50% of infected children aged 6-17 years. The ACIP considered recommending vaccination of contacts of only those adoptees younger than 6 years, but ultimately voted to include contacts of adoptees in all age groups.

By statistical estimation, the risk of hepatitis A infection is approximately 106 per 100,000 close contacts of international adoptees in the United States, compared with the actual annual incidence of 1.2/100,000 in 2006 in the general population, Dr. Chaves said.

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

The unanimous vote is in line with the American Academy of Pediatrics' position and will be reflected in the upcoming edition of the Red Book, AAP liaison Dr. Joseph A. Bocchini Jr. said in an interview.

According to the statement approved by ACIP, when adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified.

The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee.

Previous ACIP recommendations called for vaccination only of adoptive parents and others actually travelling to the country with high or intermediate endemicity of hepatitis A, said Dr. Sandra Chaves of the CDC's Division of Viral Hepatitis.

The issue came to the CDC's attention in June 2007 when a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins were not jaundiced, but were confirmed to have hepatitis A. That case prompted further investigation, with the discovery of 20 additional cases of hepatitis A among nontraveling contacts of international adoptees from six states during 2006-2007, Dr. Chaves said.

The proportion of hepatitis A-infected individuals who are asymptomatic is 70% among children younger than 6 years, compared with 20%-50% of infected children aged 6-17 years. The ACIP considered recommending vaccination of contacts of only those adoptees younger than 6 years, but ultimately voted to include contacts of adoptees in all age groups.

By statistical estimation, the risk of hepatitis A infection is approximately 106 per 100,000 close contacts of international adoptees in the United States, compared with the actual annual incidence of 1.2/100,000 in 2006 in the general population, Dr. Chaves said.

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

When adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified. The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee, according to ACIP.

Previously, ACIP recommended vaccination only of adoptive parents and others who actually travel to the country with high or intermediate hepatitis A endemicity, said Dr. Sandra Chaves of the CDC's division of viral hepatitis.

In June 2007, a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins had hepatitis A but were not jaundiced. That case prompted the discovery of 20 more cases of hepatitis A among nontraveling contacts of international adoptees during 2006–2007. Nearly all of the countries from which Americans adopt children are endemic for hepatitis A, Dr. Chaves noted.

The risk of hepatitis A infection is about 106 per 100,000 close contacts of international adoptees in the United States, and about 1.2/100,000 in the general population, Dr. Chaves said.

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

When adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified. The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee, according to ACIP.

Previously, ACIP recommended vaccination only of adoptive parents and others who actually travel to the country with high or intermediate hepatitis A endemicity, said Dr. Sandra Chaves of the CDC's division of viral hepatitis.

In June 2007, a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins had hepatitis A but were not jaundiced. That case prompted the discovery of 20 more cases of hepatitis A among nontraveling contacts of international adoptees during 2006–2007. Nearly all of the countries from which Americans adopt children are endemic for hepatitis A, Dr. Chaves noted.

The risk of hepatitis A infection is about 106 per 100,000 close contacts of international adoptees in the United States, and about 1.2/100,000 in the general population, Dr. Chaves said.

ATLANTA — Hepatitis A vaccination should be given to all previously unvaccinated nontraveling individuals who will be in close personal contact with an internationally adopted child, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its winter meeting.

When adoption is planned for a child from a country of high or intermediate hepatitis endemicity, persons who will have close personal contact with the adoptee during the first 60 days following arrival of the adoptee in the United States should be identified. The first dose of hepatitis A vaccine should be administered as soon as the adoption is planned, and ideally the first two doses given at least 2 weeks prior to the arrival of the adoptee, according to ACIP.

Previously, ACIP recommended vaccination only of adoptive parents and others who actually travel to the country with high or intermediate hepatitis A endemicity, said Dr. Sandra Chaves of the CDC's division of viral hepatitis.

In June 2007, a 51-year-old grandmother of 12-month-old adopted twins developed fatal fulminant hepatitis A. The twins had hepatitis A but were not jaundiced. That case prompted the discovery of 20 more cases of hepatitis A among nontraveling contacts of international adoptees during 2006–2007. Nearly all of the countries from which Americans adopt children are endemic for hepatitis A, Dr. Chaves noted.

The risk of hepatitis A infection is about 106 per 100,000 close contacts of international adoptees in the United States, and about 1.2/100,000 in the general population, Dr. Chaves said.

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome after receipt of MCV4 (Menactra). In December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265–6). The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15–19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration that provides data from 8.8 million members annually.

Between April 2006 and February 2009, 642,493 doses of MCV4 were administered in the eight VSD sites. Among those, five cases of GBS were reported to have occurred in 42 days or less after vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS. That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, none had received MCV4—or any other vaccination—within 42 days. “These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

Dr. Baker stated that she had no disclosures to make.

Interim data from a study of 4.5 million 11- to 18-year-olds also failed to find a tie between MCV4 and GBS. DR. BAKER

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome after receipt of MCV4 (Menactra). In December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265–6). The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15–19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration that provides data from 8.8 million members annually.

Between April 2006 and February 2009, 642,493 doses of MCV4 were administered in the eight VSD sites. Among those, five cases of GBS were reported to have occurred in 42 days or less after vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS. That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, none had received MCV4—or any other vaccination—within 42 days. “These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

Dr. Baker stated that she had no disclosures to make.

Interim data from a study of 4.5 million 11- to 18-year-olds also failed to find a tie between MCV4 and GBS. DR. BAKER

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome after receipt of MCV4 (Menactra). In December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265–6). The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15–19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration that provides data from 8.8 million members annually.

Between April 2006 and February 2009, 642,493 doses of MCV4 were administered in the eight VSD sites. Among those, five cases of GBS were reported to have occurred in 42 days or less after vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS. That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, none had received MCV4—or any other vaccination—within 42 days. “These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

Dr. Baker stated that she had no disclosures to make.

Interim data from a study of 4.5 million 11- to 18-year-olds also failed to find a tie between MCV4 and GBS. DR. BAKER

ATLANTA — Clarifications to existing vaccine guidelines aimed at ensuring appropriate vaccine storage temperatures were approved by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The new language will be added to the “storage and handling” section of the committee's revised General Recommendations on Immunization, which were last published in 2006 (MMWR 2006;55[RR15]:1-48). The document is directed to providers who give many different vaccines on a daily basis, Dr. Andrew Kroger said at ACIP's winter meeting.

According to the current statement, “Refrigerators without freezers and stand-alone freezers (either manual defrost or automatic defrost) usually perform best at maintaining the precise temperatures required for vaccine storage, and such single-purpose units sold for home use are less expensive alternatives to medical specialty equipment.” The new statement will add “and are preferable to combination units” to the end of that sentence.

The committee also approved language stating that new units may need 2 or more days of operation to establish a stable operating temperature after being set up, and that vaccine should not be stored in the unit until the appropriate temperature has stabilized.

Other language was “weakened” somewhat from the current statement with reference to situations in which a temperature problem can't be resolved, such as when the unit is unplugged or the door left open. The current statement advises that in such instances “a plan should be developed to transfer vaccine to a predesignated alternative emergency storage site.” The new statement simply says that such a transfer “might be necessary.”

The rationale for that change is that in certain environments, it might actually be dangerous for staff to enter. Moreover, external temperature monitoring may reduce the need for staff to enter the environment and open the door, and vaccine stability is enhanced if the door is not opened, noted Dr. Kroger of the CDC's immunization services division.

ATLANTA — Clarifications to existing vaccine guidelines aimed at ensuring appropriate vaccine storage temperatures were approved by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The new language will be added to the “storage and handling” section of the committee's revised General Recommendations on Immunization, which were last published in 2006 (MMWR 2006;55[RR15]:1-48). The document is directed to providers who give many different vaccines on a daily basis, Dr. Andrew Kroger said at ACIP's winter meeting.

According to the current statement, “Refrigerators without freezers and stand-alone freezers (either manual defrost or automatic defrost) usually perform best at maintaining the precise temperatures required for vaccine storage, and such single-purpose units sold for home use are less expensive alternatives to medical specialty equipment.” The new statement will add “and are preferable to combination units” to the end of that sentence.

The committee also approved language stating that new units may need 2 or more days of operation to establish a stable operating temperature after being set up, and that vaccine should not be stored in the unit until the appropriate temperature has stabilized.

Other language was “weakened” somewhat from the current statement with reference to situations in which a temperature problem can't be resolved, such as when the unit is unplugged or the door left open. The current statement advises that in such instances “a plan should be developed to transfer vaccine to a predesignated alternative emergency storage site.” The new statement simply says that such a transfer “might be necessary.”

The rationale for that change is that in certain environments, it might actually be dangerous for staff to enter. Moreover, external temperature monitoring may reduce the need for staff to enter the environment and open the door, and vaccine stability is enhanced if the door is not opened, noted Dr. Kroger of the CDC's immunization services division.

ATLANTA — Clarifications to existing vaccine guidelines aimed at ensuring appropriate vaccine storage temperatures were approved by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The new language will be added to the “storage and handling” section of the committee's revised General Recommendations on Immunization, which were last published in 2006 (MMWR 2006;55[RR15]:1-48). The document is directed to providers who give many different vaccines on a daily basis, Dr. Andrew Kroger said at ACIP's winter meeting.

According to the current statement, “Refrigerators without freezers and stand-alone freezers (either manual defrost or automatic defrost) usually perform best at maintaining the precise temperatures required for vaccine storage, and such single-purpose units sold for home use are less expensive alternatives to medical specialty equipment.” The new statement will add “and are preferable to combination units” to the end of that sentence.

The committee also approved language stating that new units may need 2 or more days of operation to establish a stable operating temperature after being set up, and that vaccine should not be stored in the unit until the appropriate temperature has stabilized.

Other language was “weakened” somewhat from the current statement with reference to situations in which a temperature problem can't be resolved, such as when the unit is unplugged or the door left open. The current statement advises that in such instances “a plan should be developed to transfer vaccine to a predesignated alternative emergency storage site.” The new statement simply says that such a transfer “might be necessary.”

The rationale for that change is that in certain environments, it might actually be dangerous for staff to enter. Moreover, external temperature monitoring may reduce the need for staff to enter the environment and open the door, and vaccine stability is enhanced if the door is not opened, noted Dr. Kroger of the CDC's immunization services division.

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome following receipt of MCV4 (Menactra), Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15-19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration between the agency and eight managed care organizations that provide data from 8.8 million members annually, approximately 3% of the U.S. population.

Between April 2006 and February 2009, a total of 642,493 doses of MCV4 were administered in the eight VSD sites.

Among those, five cases of GBS were reported to have occurred in 42 days or less following vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Still the CDC remains vigilant, and is continuing to monitor for GBS reports following receipt of MCV4 vaccine through both VAERS and VSD, she said.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS.

That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, just 100 had sufficient information to determine claim status, and 29 met the primary study end point definition. None had received MCV4—or any other vaccination—within 42 days.

“These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

“The Harvard Pilgrim analysis has been completed. I am fairly certain we will have these data in June, and I hope that this will put to rest the GBS safety issue,” she said in an interview following the meeting.

This has implications because in December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265-6).

The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Calugar said.

Dr. Baker stated that she had no disclosures to make.

“These are some very reassuring data,” Dr. Carol J. Baker said of interim study findings on the subject. ©Parker Clayton Smith

Other Meningococcal Vaccination Issues

The meningococcal working group will present ACIP with information on the duration of protection of MCV4 and the introduction of a second meningococcal conjugate vaccine later this year, Dr. Baker said.

When Sanofi Pasteur's Menactra was recommended in 2005 for use in 11- to 12-year-olds as part of the adolescent vaccination visit, it was assumed that the vaccine would protect for at least 10 years, including the high-risk college years. However, “there were no data then and the 5-year data [now] suggest that 10 years may not be realistic. We hope to have more data in June,” Dr. Baker said in an interview after the meeting.

The current recommendation for revaccination with the meningococcal polysaccharide vaccine is 3-5 years, and a revaccination recommendation may be necessary for MCV4 as well. “Meningococcal conjugate vaccines are unlikely to provide lifelong protection,” she said during the meeting.

Later this year ACIP also is expected to hear immunogenicity data for a new quadrivalent meningococcal conjugate vaccine, Novartis's Menveo, which is expected to be licensed in the summer of 2009. Its composition is different from that of Menactra, and it is not known yet whether or how that might impact duration or degree of protection, Dr. Baker said in the interview.

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome following receipt of MCV4 (Menactra), Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15-19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration between the agency and eight managed care organizations that provide data from 8.8 million members annually, approximately 3% of the U.S. population.

Between April 2006 and February 2009, a total of 642,493 doses of MCV4 were administered in the eight VSD sites.

Among those, five cases of GBS were reported to have occurred in 42 days or less following vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Still the CDC remains vigilant, and is continuing to monitor for GBS reports following receipt of MCV4 vaccine through both VAERS and VSD, she said.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS.

That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, just 100 had sufficient information to determine claim status, and 29 met the primary study end point definition. None had received MCV4—or any other vaccination—within 42 days.

“These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

“The Harvard Pilgrim analysis has been completed. I am fairly certain we will have these data in June, and I hope that this will put to rest the GBS safety issue,” she said in an interview following the meeting.

This has implications because in December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265-6).

The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Calugar said.

Dr. Baker stated that she had no disclosures to make.

“These are some very reassuring data,” Dr. Carol J. Baker said of interim study findings on the subject. ©Parker Clayton Smith

Other Meningococcal Vaccination Issues

The meningococcal working group will present ACIP with information on the duration of protection of MCV4 and the introduction of a second meningococcal conjugate vaccine later this year, Dr. Baker said.

When Sanofi Pasteur's Menactra was recommended in 2005 for use in 11- to 12-year-olds as part of the adolescent vaccination visit, it was assumed that the vaccine would protect for at least 10 years, including the high-risk college years. However, “there were no data then and the 5-year data [now] suggest that 10 years may not be realistic. We hope to have more data in June,” Dr. Baker said in an interview after the meeting.

The current recommendation for revaccination with the meningococcal polysaccharide vaccine is 3-5 years, and a revaccination recommendation may be necessary for MCV4 as well. “Meningococcal conjugate vaccines are unlikely to provide lifelong protection,” she said during the meeting.

Later this year ACIP also is expected to hear immunogenicity data for a new quadrivalent meningococcal conjugate vaccine, Novartis's Menveo, which is expected to be licensed in the summer of 2009. Its composition is different from that of Menactra, and it is not known yet whether or how that might impact duration or degree of protection, Dr. Baker said in the interview.

ATLANTA — The jury is still out regarding a potential link between the quadrivalent meningococcal conjugate vaccine and Guillain-Barré syndrome, but new data from the Centers for Disease Control and Prevention provide some reassurance in favor of the vaccine's safety.

In October 2006, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) that suggested a small increased risk for Guillain-Barré syndrome following receipt of MCV4 (Menactra), Dr. Angela Calugar said at a meeting of the CDC's Advisory Committee on Immunization Practices.

The VAERS data had shown that the observed rate of GBS within 42 days after receipt of MCV4 was not elevated among 11- to 19-year-olds overall (33 observed cases vs. 36 expected from background rates), but the rate of GBS did appear to be elevated among adolescents aged 15-19 (26 vs. 20 cases). However, that difference still did not reach statistical significance, said Dr. Calugar of the CDC's Immunization Safety Office.

Since VAERS is a passive reporting system that is used only to generate a “signal” of a possible problem, the CDC undertook an investigation using the Vaccine Safety Datalink (VSD), a collaboration between the agency and eight managed care organizations that provide data from 8.8 million members annually, approximately 3% of the U.S. population.

Between April 2006 and February 2009, a total of 642,493 doses of MCV4 were administered in the eight VSD sites.

Among those, five cases of GBS were reported to have occurred in 42 days or less following vaccination. Of those, one had onset of symptoms on day 0, and was therefore out of the “risk window.” Another had pre-existing GBS, and two others were found on further investigation to have diagnoses that were not GBS. The fifth case was still pending medical review at the time of Dr. Calugar's presentation.

But even if that case does turn out to be GBS, one case is the expected background number for the population during the study time period, she noted.

Still the CDC remains vigilant, and is continuing to monitor for GBS reports following receipt of MCV4 vaccine through both VAERS and VSD, she said.

Dr. Carol J. Baker, chair of the ACIP meningococcal working group, added that interim data from a study at Harvard Medical School/Harvard Pilgrim Health Care also have thus far failed to find a link between MCV4 and GBS.

That study population included 4.5 million 11- to 18-year-olds, of whom 8% had received MCV4 through May 2007.

Of 240 potential GBS cases identified in claims, just 100 had sufficient information to determine claim status, and 29 met the primary study end point definition. None had received MCV4—or any other vaccination—within 42 days.

“These are very reassuring data,” said Dr. Baker, professor of pediatrics, molecular virology, and microbiology and head of pediatric infectious diseases at Baylor College of Medicine, Houston.

“The Harvard Pilgrim analysis has been completed. I am fairly certain we will have these data in June, and I hope that this will put to rest the GBS safety issue,” she said in an interview following the meeting.

This has implications because in December 2007, the CDC recommended that a history of GBS be considered a “precaution” to administering MCV4 (MMWR 2007;56:1265-6).

The package label, meanwhile, was updated to list such a history as a “contraindication,” Dr. Calugar said.

Dr. Baker stated that she had no disclosures to make.

“These are some very reassuring data,” Dr. Carol J. Baker said of interim study findings on the subject. ©Parker Clayton Smith

Other Meningococcal Vaccination Issues

The meningococcal working group will present ACIP with information on the duration of protection of MCV4 and the introduction of a second meningococcal conjugate vaccine later this year, Dr. Baker said.

When Sanofi Pasteur's Menactra was recommended in 2005 for use in 11- to 12-year-olds as part of the adolescent vaccination visit, it was assumed that the vaccine would protect for at least 10 years, including the high-risk college years. However, “there were no data then and the 5-year data [now] suggest that 10 years may not be realistic. We hope to have more data in June,” Dr. Baker said in an interview after the meeting.

The current recommendation for revaccination with the meningococcal polysaccharide vaccine is 3-5 years, and a revaccination recommendation may be necessary for MCV4 as well. “Meningococcal conjugate vaccines are unlikely to provide lifelong protection,” she said during the meeting.

Later this year ACIP also is expected to hear immunogenicity data for a new quadrivalent meningococcal conjugate vaccine, Novartis's Menveo, which is expected to be licensed in the summer of 2009. Its composition is different from that of Menactra, and it is not known yet whether or how that might impact duration or degree of protection, Dr. Baker said in the interview.

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16-26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9-15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and “gender-neutral” vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

The ACIP is expected to recommend the vaccine for use in males aged 11-12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

“There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time,” said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16-23 years and 602 males aged 16-26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. Combining the results of PCR and serology, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that “the vast majority would benefit from the vaccine,” he said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three results were statistically significant.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations due to adverse events were uncommon and were not different between the Gardasil and placebo groups, he reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9-26 years. A decision is expected in mid-October 2009. If the application is approved, ACIP anticipates addressing recommendations for its use in males at its meeting later that month, said Dr. Janet Englund, chair of the ACIP's HPV Vaccine Workgroup.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16-26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9-15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and “gender-neutral” vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

The ACIP is expected to recommend the vaccine for use in males aged 11-12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

“There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time,” said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16-23 years and 602 males aged 16-26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. Combining the results of PCR and serology, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that “the vast majority would benefit from the vaccine,” he said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three results were statistically significant.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations due to adverse events were uncommon and were not different between the Gardasil and placebo groups, he reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9-26 years. A decision is expected in mid-October 2009. If the application is approved, ACIP anticipates addressing recommendations for its use in males at its meeting later that month, said Dr. Janet Englund, chair of the ACIP's HPV Vaccine Workgroup.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — The human papillomavirus vaccine was efficacious in preventing persistent infections and genital warts caused by HPV strains 6, 11, 16, and 18 in a Merck-sponsored study of 4,065 males aged 16-26 years.

The findings were presented by Dr. Richard M. Haupt at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Merck had previously reported immunogenicity and safety data for its HPV vaccine (Gardasil) in younger males aged 9-15 years, but these are the first data on efficacy in males and the first findings in older adolescent and adult males.

The rationale for use of Gardasil in males is twofold. There is intrinsic benefit to males themselves since HPV strain 18 causes penile, anal, and oropharyngeal cancer and HPV 6 and 11 are associated with genital warts. There is also a public health benefit to vaccinating males against HPV since coverage among girls is likely to be incomplete, transition of HPV occurs efficiently between sexual partners, and “gender-neutral” vaccination would be expected to reduce overall viral transmission in the entire population, noted Dr. Haupt of Merck Research Laboratories, Whitehouse Station, N.J.

The ACIP is expected to recommend the vaccine for use in males aged 11-12 at the adolescent visit, just as it is now given to girls. This should simplify implementation, Dr. Doug Campos-Outcalt, of the University of Arizona, Phoenix, said in an interview.

“There are now four vaccines recommended for adolescents. I think there will be a period of time before we get high acceptance rates, but it will help to have other vaccines being offered at the same time,” said Dr. Campos-Outcalt, who serves as the liaison to ACIP from the American Academy of Family Physicians.

In the randomized, double-blind, placebo-controlled trial, three doses of Gardasil or placebo were given at 0, 2, and 6 months. Mean follow-up for this analysis was 30 months of a planned total of 36. The study population, which came from 18 different countries, included 3,463 heterosexual males aged 16-23 years and 602 males aged 16-26 who have sex with men. Because of problems in enrollment, data collection for the latter group lags behind by about a year, Dr. Haupt noted.

At baseline, 12% of the entire group was polymerase chain reaction-positive to at least one of the four vaccine virus types. By serology, 8% were seropositive to at least one type. Combining the results of PCR and serology, 83% of the group was naive to all four types. Moreover, most who were infected had just one type, suggesting that “the vast majority would benefit from the vaccine,” he said.

Per protocol, efficacy of the vaccine was 90.4% against external genital lesions, 85.6% in preventing persistent infection (from two or more consecutive visits), and 44.7% against DNA detection of a vaccine virus strain in anogenital specimen from one or more visits. All three results were statistically significant.

Safety analysis showed similar findings to those seen in females. Local site reactions were the most common adverse event, occurring in 60% of the 2,020 Gardasil recipients and 54% of the 2,029 placebo recipients. Systemic reactions, serious adverse events, and discontinuations due to adverse events were uncommon and were not different between the Gardasil and placebo groups, he reported.

Merck has filed an application with the Food and Drug Administration for licensure of Gardasil in males aged 9-26 years. A decision is expected in mid-October 2009. If the application is approved, ACIP anticipates addressing recommendations for its use in males at its meeting later that month, said Dr. Janet Englund, chair of the ACIP's HPV Vaccine Workgroup.

Vaccine efficacy was 90.4% against external genital lesions and 85.6% in preventing infection. DR. HAUPT

ATLANTA — Wyeth Pharmaceuticals is in the process of planning the transition from routine childhood immunization with the 7-valent Prevnar to use of a 13-valent pneumococcal conjugate vaccine that is still under investigation.

The Food and Drug Administration has granted fast-track status for PCV13 for the pediatric indication, based on “an unmet medical need.” The company plans to complete the data submission process for PCV13 by the end of this month, at which point the agency will decide about priority review, Peter Paradiso, Ph.D., vice president of new business and scientific affairs at Wyeth Pharmaceuticals, Collegeville, Pa., said at the winter meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“Our goal is that PCV13 will replace PCV7,” he said.

The 13-valent version contains the same amounts of the same seven serotypes that Prevnar has (4, 6B, 9V, 14, 18C, 19F, and 23F) along with six new strains (1, 3, 5, 6A, 7F, and 19A). Each of these polysaccharides in both vaccines is conjugated to the same carrier protein, CRM197, using the same conjugation chemistry. “So, PCV13 uses a technology that has worked successfully with Prevnar,” he noted.

Since the introduction of Prevnar in 2000, the proportion of cases of invasive pneumococcal disease (IPD) caused by the seven vaccine strains has declined dramatically, while the proportion due to other strains—19A in particular—has risen. In 2006, the proportion of IPD cases caused by the seven strains included in Prevnar was 2% in children aged younger than 2 years and 4% in those aged 2-4 years. In contrast, the proportion of IPD cases caused by the 13 serotypes in the new version was 64% and 73%, respectively, with half of the cases due to 19A.

“So, PCV13 uses a technology that has worked successfully with Prevnar,” Peter Paradiso, Ph.D., of Wyeth Pharmaceuticals, said. ©Parker Clayton Smith

Dr. Paradiso summarized previously reported data from a pivotal trial done in Germany in which 603 infants were randomized to receive either PCV7 or PCV13 at 2, 3, and 4 months of age. The 13-valent version was noninferior against each serotype, while provoking a high antibody response rate to each of the six new serotypes. The overall safety profile of PCV13 was comparable with that of PCV7 in a database that includes 4,783 PCV13 recipients in a total study population of 7,240, he said.

Wyeth's transition scheme—which would be subject to approval by both the FDA and the ACIP after PCV13 is licensed—would involve the substitution of PCV13 for PCV7 at any point in the immunization schedule.

Because data have shown that a single dose of PCV13 will induce an immune response to the six new serotypes in more than 90% of children aged 12 months and older, any child who received the primary three-dose series with PCV7 could simply receive PCV13 as a booster after they reach the age of 12 months. For children 12 months and older who already received the complete series with PCV7 including the booster, one additional dose of PCV13 would be needed for protection against the six new strains. Infants aged 6 months or younger who received one or two doses of PCV7 would complete the primary series and the booster using PCV13.

In January, Wyeth initiated a study in the Yukon-Kuskokwim Delta region of Alaska to test the safety and effectiveness of this scheme in children younger than 5 years old, he said.

The company will first seek an indication for the use of PCV13 in children younger than 5 years old. After that, it hopes to bring it to adults over age 50, and ultimately to the entire population. “Our goal is to fill in the gaps and make this vaccine available for all age groups,” Dr. Paradiso said.

In response to an audience member's query as to whether PCV13 would cost more than PCV7, Dr. Paradiso replied, “I honestly don't know the answer to that question. Obviously, that's something you'll hear about as we get closer [to implementation].

ATLANTA — Wyeth Pharmaceuticals is in the process of planning the transition from routine childhood immunization with the 7-valent Prevnar to use of a 13-valent pneumococcal conjugate vaccine that is still under investigation.

The Food and Drug Administration has granted fast-track status for PCV13 for the pediatric indication, based on “an unmet medical need.” The company plans to complete the data submission process for PCV13 by the end of this month, at which point the agency will decide about priority review, Peter Paradiso, Ph.D., vice president of new business and scientific affairs at Wyeth Pharmaceuticals, Collegeville, Pa., said at the winter meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“Our goal is that PCV13 will replace PCV7,” he said.

The 13-valent version contains the same amounts of the same seven serotypes that Prevnar has (4, 6B, 9V, 14, 18C, 19F, and 23F) along with six new strains (1, 3, 5, 6A, 7F, and 19A). Each of these polysaccharides in both vaccines is conjugated to the same carrier protein, CRM197, using the same conjugation chemistry. “So, PCV13 uses a technology that has worked successfully with Prevnar,” he noted.

Since the introduction of Prevnar in 2000, the proportion of cases of invasive pneumococcal disease (IPD) caused by the seven vaccine strains has declined dramatically, while the proportion due to other strains—19A in particular—has risen. In 2006, the proportion of IPD cases caused by the seven strains included in Prevnar was 2% in children aged younger than 2 years and 4% in those aged 2-4 years. In contrast, the proportion of IPD cases caused by the 13 serotypes in the new version was 64% and 73%, respectively, with half of the cases due to 19A.

“So, PCV13 uses a technology that has worked successfully with Prevnar,” Peter Paradiso, Ph.D., of Wyeth Pharmaceuticals, said. ©Parker Clayton Smith

Dr. Paradiso summarized previously reported data from a pivotal trial done in Germany in which 603 infants were randomized to receive either PCV7 or PCV13 at 2, 3, and 4 months of age. The 13-valent version was noninferior against each serotype, while provoking a high antibody response rate to each of the six new serotypes. The overall safety profile of PCV13 was comparable with that of PCV7 in a database that includes 4,783 PCV13 recipients in a total study population of 7,240, he said.

Wyeth's transition scheme—which would be subject to approval by both the FDA and the ACIP after PCV13 is licensed—would involve the substitution of PCV13 for PCV7 at any point in the immunization schedule.

Because data have shown that a single dose of PCV13 will induce an immune response to the six new serotypes in more than 90% of children aged 12 months and older, any child who received the primary three-dose series with PCV7 could simply receive PCV13 as a booster after they reach the age of 12 months. For children 12 months and older who already received the complete series with PCV7 including the booster, one additional dose of PCV13 would be needed for protection against the six new strains. Infants aged 6 months or younger who received one or two doses of PCV7 would complete the primary series and the booster using PCV13.

In January, Wyeth initiated a study in the Yukon-Kuskokwim Delta region of Alaska to test the safety and effectiveness of this scheme in children younger than 5 years old, he said.

The company will first seek an indication for the use of PCV13 in children younger than 5 years old. After that, it hopes to bring it to adults over age 50, and ultimately to the entire population. “Our goal is to fill in the gaps and make this vaccine available for all age groups,” Dr. Paradiso said.

In response to an audience member's query as to whether PCV13 would cost more than PCV7, Dr. Paradiso replied, “I honestly don't know the answer to that question. Obviously, that's something you'll hear about as we get closer [to implementation].

ATLANTA — Wyeth Pharmaceuticals is in the process of planning the transition from routine childhood immunization with the 7-valent Prevnar to use of a 13-valent pneumococcal conjugate vaccine that is still under investigation.

The Food and Drug Administration has granted fast-track status for PCV13 for the pediatric indication, based on “an unmet medical need.” The company plans to complete the data submission process for PCV13 by the end of this month, at which point the agency will decide about priority review, Peter Paradiso, Ph.D., vice president of new business and scientific affairs at Wyeth Pharmaceuticals, Collegeville, Pa., said at the winter meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

“Our goal is that PCV13 will replace PCV7,” he said.

The 13-valent version contains the same amounts of the same seven serotypes that Prevnar has (4, 6B, 9V, 14, 18C, 19F, and 23F) along with six new strains (1, 3, 5, 6A, 7F, and 19A). Each of these polysaccharides in both vaccines is conjugated to the same carrier protein, CRM197, using the same conjugation chemistry. “So, PCV13 uses a technology that has worked successfully with Prevnar,” he noted.

Since the introduction of Prevnar in 2000, the proportion of cases of invasive pneumococcal disease (IPD) caused by the seven vaccine strains has declined dramatically, while the proportion due to other strains—19A in particular—has risen. In 2006, the proportion of IPD cases caused by the seven strains included in Prevnar was 2% in children aged younger than 2 years and 4% in those aged 2-4 years. In contrast, the proportion of IPD cases caused by the 13 serotypes in the new version was 64% and 73%, respectively, with half of the cases due to 19A.

“So, PCV13 uses a technology that has worked successfully with Prevnar,” Peter Paradiso, Ph.D., of Wyeth Pharmaceuticals, said. ©Parker Clayton Smith

Dr. Paradiso summarized previously reported data from a pivotal trial done in Germany in which 603 infants were randomized to receive either PCV7 or PCV13 at 2, 3, and 4 months of age. The 13-valent version was noninferior against each serotype, while provoking a high antibody response rate to each of the six new serotypes. The overall safety profile of PCV13 was comparable with that of PCV7 in a database that includes 4,783 PCV13 recipients in a total study population of 7,240, he said.

Wyeth's transition scheme—which would be subject to approval by both the FDA and the ACIP after PCV13 is licensed—would involve the substitution of PCV13 for PCV7 at any point in the immunization schedule.

Because data have shown that a single dose of PCV13 will induce an immune response to the six new serotypes in more than 90% of children aged 12 months and older, any child who received the primary three-dose series with PCV7 could simply receive PCV13 as a booster after they reach the age of 12 months. For children 12 months and older who already received the complete series with PCV7 including the booster, one additional dose of PCV13 would be needed for protection against the six new strains. Infants aged 6 months or younger who received one or two doses of PCV7 would complete the primary series and the booster using PCV13.

In January, Wyeth initiated a study in the Yukon-Kuskokwim Delta region of Alaska to test the safety and effectiveness of this scheme in children younger than 5 years old, he said.

The company will first seek an indication for the use of PCV13 in children younger than 5 years old. After that, it hopes to bring it to adults over age 50, and ultimately to the entire population. “Our goal is to fill in the gaps and make this vaccine available for all age groups,” Dr. Paradiso said.

In response to an audience member's query as to whether PCV13 would cost more than PCV7, Dr. Paradiso replied, “I honestly don't know the answer to that question. Obviously, that's something you'll hear about as we get closer [to implementation].