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A CDC Advisory Committee Meeting
No safety issues detected in HPV vaccine pregnancy registry
The analysis of the Gardasil pregnancy registry data has provided "reassuring" results regarding the potential risks of exposure to the vaccine during pregnancy, Dr. Fabio Lievano reported at a meetingof the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Based on more than 2,500 pregnancies reported to Merck and enrolled in the registry over a 6-year period, the overall rates of spontaneous abortion, fetal deaths, and congenital anomalies were "at or below background rates," and no pattern in the type of birth defects has been identified, said Dr. Lievano, executive director of clinical risk management at Merck Research Laboratories. Merck is the manufacturer of the quadrivalent HPV vaccine, which provides coverage against HPV types 6, 11, 16, and 18. The vaccine was approved in the United States in 2006, is marketed as Gardasil, and is administered in a three-dose series.
Gardasil is not recommended for use in pregnancy, and as part of the company’s postmarketing safety commitments for the Food and Drug Administration and European and Canadian regulatory authorities, Merck established a pregnancy registry to monitor outcomes associated with inadvertent pregnancy exposures. Women were enrolled in the pregnancy registry if they were living in the United States, Canada, or France and had received a dose of Gardasil within 1 month of their last menstrual period or at any time during pregnancy.
Between June 1, 2006, and May 31, 2012, 2,802 pregnancies exposed to the vaccine were enrolled in the registry, reported from health care providers and vaccinees. (Enrollment closed on Dec. 31, 2012.) The main outcomes the company monitored were infant outcomes (congenital anomalies) and pregnancy outcomes, which included elective abortions, spontaneous abortions (before 20 weeks’ gestation), fetal deaths (at 20 weeks or later), and live births.
Of the 2,440 prospective pregnancy reports (received before the pregnancy outcome was known), about 91% indicated exposure to the vaccine occurred before the end of the first trimester. Of the total exposed pregnancies, there were 102 (3.6%) elective abortions (including 1 associated with anencephaly and hypoplastic heart) and 105 (3.7%) spontaneous abortions (including 1 triplet pregnancy and 1 with a chromosomal anomaly).
Among the 1,460 newborns, 1,381 (95%) had normal outcomes. Of the remainder, 34 had major congenital anomalies and 45 had minor congenital anomalies.
The rate of spontaneous abortions was 6.7/100 outcomes, Dr. Lievano said, noting that the background rate among clinically recognized pregnancies is 15%. The rate of fetal deaths was 0.8/100 outcomes (live births plus fetal deaths) compared with the background rate of 0.62-1/100.
The overall rate of major congenital anomalies was 2.5/100 live born infants, compared with the background rate of 2.67/100 live born infants. The rate of congenital anomalies appears to be similar to the background rates, and the anomalies reported in the registry have varied in type and etiology, Dr. Lievano said, concluding that the analysis "does not support a causal relationship" between exposure to the vaccine in pregnancy and the birth defects reported in the registry,
Of the 362 retrospective reports of pregnancy exposures in the registry (those with outcomes that were known at the time of enrollment), there were 319 known pregnancy outcomes, which included 61 spontaneous abortions and 8 fetal deaths. Among the retrospective reports, 25 infants had major congenital anomalies, including 13 with an isolated anomaly, 4 with two anomalies each, 3 with multiple anomalies, and 2 with multiple anomalies as part of a chromosomal abnormality, he said.
As of April, the FDA, as well as the European Medicines Agency and Health Canada, consider that the company has met the postmarketing pregnancy registry commitment. The results will be published and will be added to the drug’s label. Merck will continue to update the registry with reports of exposures and will provide periodic safety updates to the regulatory agencies, Dr. Lievano said.
The updated ACIP statement on HPV vaccine, which is being planned, will advise that pregnancy exposures continue to be reported to Merck and to the FDA and CDC’s Vaccine Adverse Event Reporting System (VAERS).
The updated Gardasil pregnancy registry website says that cases of exposure to Gardasil during pregnancy should be reported to Merck at 877-888-4231.
The analysis of the Gardasil pregnancy registry data has provided "reassuring" results regarding the potential risks of exposure to the vaccine during pregnancy, Dr. Fabio Lievano reported at a meetingof the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Based on more than 2,500 pregnancies reported to Merck and enrolled in the registry over a 6-year period, the overall rates of spontaneous abortion, fetal deaths, and congenital anomalies were "at or below background rates," and no pattern in the type of birth defects has been identified, said Dr. Lievano, executive director of clinical risk management at Merck Research Laboratories. Merck is the manufacturer of the quadrivalent HPV vaccine, which provides coverage against HPV types 6, 11, 16, and 18. The vaccine was approved in the United States in 2006, is marketed as Gardasil, and is administered in a three-dose series.
Gardasil is not recommended for use in pregnancy, and as part of the company’s postmarketing safety commitments for the Food and Drug Administration and European and Canadian regulatory authorities, Merck established a pregnancy registry to monitor outcomes associated with inadvertent pregnancy exposures. Women were enrolled in the pregnancy registry if they were living in the United States, Canada, or France and had received a dose of Gardasil within 1 month of their last menstrual period or at any time during pregnancy.
Between June 1, 2006, and May 31, 2012, 2,802 pregnancies exposed to the vaccine were enrolled in the registry, reported from health care providers and vaccinees. (Enrollment closed on Dec. 31, 2012.) The main outcomes the company monitored were infant outcomes (congenital anomalies) and pregnancy outcomes, which included elective abortions, spontaneous abortions (before 20 weeks’ gestation), fetal deaths (at 20 weeks or later), and live births.
Of the 2,440 prospective pregnancy reports (received before the pregnancy outcome was known), about 91% indicated exposure to the vaccine occurred before the end of the first trimester. Of the total exposed pregnancies, there were 102 (3.6%) elective abortions (including 1 associated with anencephaly and hypoplastic heart) and 105 (3.7%) spontaneous abortions (including 1 triplet pregnancy and 1 with a chromosomal anomaly).
Among the 1,460 newborns, 1,381 (95%) had normal outcomes. Of the remainder, 34 had major congenital anomalies and 45 had minor congenital anomalies.
The rate of spontaneous abortions was 6.7/100 outcomes, Dr. Lievano said, noting that the background rate among clinically recognized pregnancies is 15%. The rate of fetal deaths was 0.8/100 outcomes (live births plus fetal deaths) compared with the background rate of 0.62-1/100.
The overall rate of major congenital anomalies was 2.5/100 live born infants, compared with the background rate of 2.67/100 live born infants. The rate of congenital anomalies appears to be similar to the background rates, and the anomalies reported in the registry have varied in type and etiology, Dr. Lievano said, concluding that the analysis "does not support a causal relationship" between exposure to the vaccine in pregnancy and the birth defects reported in the registry,
Of the 362 retrospective reports of pregnancy exposures in the registry (those with outcomes that were known at the time of enrollment), there were 319 known pregnancy outcomes, which included 61 spontaneous abortions and 8 fetal deaths. Among the retrospective reports, 25 infants had major congenital anomalies, including 13 with an isolated anomaly, 4 with two anomalies each, 3 with multiple anomalies, and 2 with multiple anomalies as part of a chromosomal abnormality, he said.
As of April, the FDA, as well as the European Medicines Agency and Health Canada, consider that the company has met the postmarketing pregnancy registry commitment. The results will be published and will be added to the drug’s label. Merck will continue to update the registry with reports of exposures and will provide periodic safety updates to the regulatory agencies, Dr. Lievano said.
The updated ACIP statement on HPV vaccine, which is being planned, will advise that pregnancy exposures continue to be reported to Merck and to the FDA and CDC’s Vaccine Adverse Event Reporting System (VAERS).
The updated Gardasil pregnancy registry website says that cases of exposure to Gardasil during pregnancy should be reported to Merck at 877-888-4231.
The analysis of the Gardasil pregnancy registry data has provided "reassuring" results regarding the potential risks of exposure to the vaccine during pregnancy, Dr. Fabio Lievano reported at a meetingof the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Based on more than 2,500 pregnancies reported to Merck and enrolled in the registry over a 6-year period, the overall rates of spontaneous abortion, fetal deaths, and congenital anomalies were "at or below background rates," and no pattern in the type of birth defects has been identified, said Dr. Lievano, executive director of clinical risk management at Merck Research Laboratories. Merck is the manufacturer of the quadrivalent HPV vaccine, which provides coverage against HPV types 6, 11, 16, and 18. The vaccine was approved in the United States in 2006, is marketed as Gardasil, and is administered in a three-dose series.
Gardasil is not recommended for use in pregnancy, and as part of the company’s postmarketing safety commitments for the Food and Drug Administration and European and Canadian regulatory authorities, Merck established a pregnancy registry to monitor outcomes associated with inadvertent pregnancy exposures. Women were enrolled in the pregnancy registry if they were living in the United States, Canada, or France and had received a dose of Gardasil within 1 month of their last menstrual period or at any time during pregnancy.
Between June 1, 2006, and May 31, 2012, 2,802 pregnancies exposed to the vaccine were enrolled in the registry, reported from health care providers and vaccinees. (Enrollment closed on Dec. 31, 2012.) The main outcomes the company monitored were infant outcomes (congenital anomalies) and pregnancy outcomes, which included elective abortions, spontaneous abortions (before 20 weeks’ gestation), fetal deaths (at 20 weeks or later), and live births.
Of the 2,440 prospective pregnancy reports (received before the pregnancy outcome was known), about 91% indicated exposure to the vaccine occurred before the end of the first trimester. Of the total exposed pregnancies, there were 102 (3.6%) elective abortions (including 1 associated with anencephaly and hypoplastic heart) and 105 (3.7%) spontaneous abortions (including 1 triplet pregnancy and 1 with a chromosomal anomaly).
Among the 1,460 newborns, 1,381 (95%) had normal outcomes. Of the remainder, 34 had major congenital anomalies and 45 had minor congenital anomalies.
The rate of spontaneous abortions was 6.7/100 outcomes, Dr. Lievano said, noting that the background rate among clinically recognized pregnancies is 15%. The rate of fetal deaths was 0.8/100 outcomes (live births plus fetal deaths) compared with the background rate of 0.62-1/100.
The overall rate of major congenital anomalies was 2.5/100 live born infants, compared with the background rate of 2.67/100 live born infants. The rate of congenital anomalies appears to be similar to the background rates, and the anomalies reported in the registry have varied in type and etiology, Dr. Lievano said, concluding that the analysis "does not support a causal relationship" between exposure to the vaccine in pregnancy and the birth defects reported in the registry,
Of the 362 retrospective reports of pregnancy exposures in the registry (those with outcomes that were known at the time of enrollment), there were 319 known pregnancy outcomes, which included 61 spontaneous abortions and 8 fetal deaths. Among the retrospective reports, 25 infants had major congenital anomalies, including 13 with an isolated anomaly, 4 with two anomalies each, 3 with multiple anomalies, and 2 with multiple anomalies as part of a chromosomal abnormality, he said.
As of April, the FDA, as well as the European Medicines Agency and Health Canada, consider that the company has met the postmarketing pregnancy registry commitment. The results will be published and will be added to the drug’s label. Merck will continue to update the registry with reports of exposures and will provide periodic safety updates to the regulatory agencies, Dr. Lievano said.
The updated ACIP statement on HPV vaccine, which is being planned, will advise that pregnancy exposures continue to be reported to Merck and to the FDA and CDC’s Vaccine Adverse Event Reporting System (VAERS).
The updated Gardasil pregnancy registry website says that cases of exposure to Gardasil during pregnancy should be reported to Merck at 877-888-4231.
FROM A CDC ADVISORY COMMITTEE MEETING
CDC panel recommends egg-free influenza vaccine
The recently licensed recombinant egg-free influenza vaccine is recommended for influenza vaccination in adults aged 18-49 years with egg allergy of any severity for the 2013-2014 influenza season, by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a meeting June 20, the committee voted 13-0 to recommend the vaccine, a trivalent recombinant hemagglutinin vaccine marketed as FluBlok, for this population.
FluBlok, manufactured by Protein Sciences, was licensed by the Food and Drug Administration in January 2013 for annual influenza vaccination for the same population. It is the first recombinant hemagglutinin protein influenza vaccine, and is manufactured without the use of influenza virus or chicken eggs, so it does not contain any egg protein.
ACIP "recommends that individuals with a severe egg allergy consult with a physician about their allergic conditions prior to vaccination if FluBlok is not available," according to a CDC statement.
FluBlok
The recently licensed recombinant egg-free influenza vaccine is recommended for influenza vaccination in adults aged 18-49 years with egg allergy of any severity for the 2013-2014 influenza season, by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a meeting June 20, the committee voted 13-0 to recommend the vaccine, a trivalent recombinant hemagglutinin vaccine marketed as FluBlok, for this population.
FluBlok, manufactured by Protein Sciences, was licensed by the Food and Drug Administration in January 2013 for annual influenza vaccination for the same population. It is the first recombinant hemagglutinin protein influenza vaccine, and is manufactured without the use of influenza virus or chicken eggs, so it does not contain any egg protein.
ACIP "recommends that individuals with a severe egg allergy consult with a physician about their allergic conditions prior to vaccination if FluBlok is not available," according to a CDC statement.
The recently licensed recombinant egg-free influenza vaccine is recommended for influenza vaccination in adults aged 18-49 years with egg allergy of any severity for the 2013-2014 influenza season, by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a meeting June 20, the committee voted 13-0 to recommend the vaccine, a trivalent recombinant hemagglutinin vaccine marketed as FluBlok, for this population.
FluBlok, manufactured by Protein Sciences, was licensed by the Food and Drug Administration in January 2013 for annual influenza vaccination for the same population. It is the first recombinant hemagglutinin protein influenza vaccine, and is manufactured without the use of influenza virus or chicken eggs, so it does not contain any egg protein.
ACIP "recommends that individuals with a severe egg allergy consult with a physician about their allergic conditions prior to vaccination if FluBlok is not available," according to a CDC statement.
FluBlok
FluBlok
FROM A CDC ADVISORY COMMITTEE MEETING
Encephalitis travel vaccine recommendation expanded to children
ATLANTA – Vaccination against Japanese encephalitis should be recommended for children aged 2 months to 16 years as a travel vaccine in certain situations, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 13-0 vote, the committee supported the proposed recommendation of ACIP’s Japanese encephalitis (JE) vaccine workgroup to extend the current ACIP recommendation for JE vaccine in adults aged 17 years and older to children aged 2 months to 16 years, targeting people traveling at increased risk, based on their itineraries and activities. Until May, no vaccine for JE was available for children in the United States.
The 2009 recommendation for the JE vaccine in adults states the following:
• The JE vaccine is recommended for travelers who plan to spend 1 month or more in a JE-endemic area during the JE virus transmission season.
• The vaccine "should be considered" for short-term travelers (under 1 month) to endemic areas, if they are planning to travel outside of urban areas and have an increased risk of exposure to the JE virus (such as spending a "substantial time outdoors in rural or agricultural areas," or "participating in extensive outdoor activities").
• The vaccine also should be considered for travelers to an area with an ongoing JE outbreak, and travelers to endemic areas "who are uncertain of specific destinations, activities, or duration of travel."
• The vaccine is not recommended for short-term travelers who will be staying in urban areas only, or at times that are "outside of a well-defined JE virus transmission season."
The JE virus, a mosquito-borne flavivirus closely related to dengue and West Nile viruses, is endemic in China, Japan, and other parts of Asia, with the highest risk of in rural, agricultural areas.
Although the risk for most travelers to Asia is low, that risk varies depending on the destination, the duration and season of the visit, and activities, according to Dr. Marc Fischer of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), a member of ACIP’s JE vaccine workgroup. No cases of JE have been reported for travelers who only visited urban areas for short periods.
But JE is a severe disease with substantial morbidity and mortality, with no specific treatment available, and "the work group placed a high value on preventing this life-threatening disease," he said. Another consideration was the availability of a safe and effective vaccine, which provides high levels of seroprotection in children after 2 doses.
The vaccine that is available for adults – an inactivated cell culture derived JE vaccine (JE-VC) licensed by the Food and Drug Administration for adults aged 17 years and older – was also licensed for use in children aged 2 months to 16 years in May 2013. The vaccine is marketed as Ixiaro by Intercell Biomed, a Scottish company, and is distributed in the United States by Novartis. It is indicated for active immunization to prevent disease caused by JE virus and is administered as a two-dose primary series, 28 days apart.
The previously available JE vaccine, an inactivated mouse brain–derived JE vaccine, manufactured in Japan and licensed in the United States for people aged 1 year and older in 1992, is no longer available.
Between 1973 and 2012, there were 65 cases of travel-associated JE cases in the United States reported to the CDC or in the literature, including 6 (9%) of cases in children under age 17 years. Of the 65 cases, 13 (20%) were fatal, and of those who survived, 28 (43% of the total cases) had sequelae, Dr. Fisher said. Thailand was the "probable country of acquisition in most (32%) of these cases, followed by China (14%) Indonesia (14%), the Philippines (11%), Japan (6%) and Vietnam (5%), he said. In the remaining 18%, the probable country of acquisition was unknown.
Although the vaccine is expensive (about $200 a dose) and the risk of JE is not high, Dr. Fisher cited U.S. survey data indicating that parents would be willing to pay a high price for a vaccine to prevent a serious outcome.
Several members of the panel observed that the JE-VC vaccine is not likely to be provided in most general clinical practices, and that it would more likely be found in a travel medicine clinic. Cost was another issue cited, because travel vaccines are usually not covered by medical insurers.
There are 15 members in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; 13 members were present at this meeting.
ATLANTA – Vaccination against Japanese encephalitis should be recommended for children aged 2 months to 16 years as a travel vaccine in certain situations, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 13-0 vote, the committee supported the proposed recommendation of ACIP’s Japanese encephalitis (JE) vaccine workgroup to extend the current ACIP recommendation for JE vaccine in adults aged 17 years and older to children aged 2 months to 16 years, targeting people traveling at increased risk, based on their itineraries and activities. Until May, no vaccine for JE was available for children in the United States.
The 2009 recommendation for the JE vaccine in adults states the following:
• The JE vaccine is recommended for travelers who plan to spend 1 month or more in a JE-endemic area during the JE virus transmission season.
• The vaccine "should be considered" for short-term travelers (under 1 month) to endemic areas, if they are planning to travel outside of urban areas and have an increased risk of exposure to the JE virus (such as spending a "substantial time outdoors in rural or agricultural areas," or "participating in extensive outdoor activities").
• The vaccine also should be considered for travelers to an area with an ongoing JE outbreak, and travelers to endemic areas "who are uncertain of specific destinations, activities, or duration of travel."
• The vaccine is not recommended for short-term travelers who will be staying in urban areas only, or at times that are "outside of a well-defined JE virus transmission season."
The JE virus, a mosquito-borne flavivirus closely related to dengue and West Nile viruses, is endemic in China, Japan, and other parts of Asia, with the highest risk of in rural, agricultural areas.
Although the risk for most travelers to Asia is low, that risk varies depending on the destination, the duration and season of the visit, and activities, according to Dr. Marc Fischer of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), a member of ACIP’s JE vaccine workgroup. No cases of JE have been reported for travelers who only visited urban areas for short periods.
But JE is a severe disease with substantial morbidity and mortality, with no specific treatment available, and "the work group placed a high value on preventing this life-threatening disease," he said. Another consideration was the availability of a safe and effective vaccine, which provides high levels of seroprotection in children after 2 doses.
The vaccine that is available for adults – an inactivated cell culture derived JE vaccine (JE-VC) licensed by the Food and Drug Administration for adults aged 17 years and older – was also licensed for use in children aged 2 months to 16 years in May 2013. The vaccine is marketed as Ixiaro by Intercell Biomed, a Scottish company, and is distributed in the United States by Novartis. It is indicated for active immunization to prevent disease caused by JE virus and is administered as a two-dose primary series, 28 days apart.
The previously available JE vaccine, an inactivated mouse brain–derived JE vaccine, manufactured in Japan and licensed in the United States for people aged 1 year and older in 1992, is no longer available.
Between 1973 and 2012, there were 65 cases of travel-associated JE cases in the United States reported to the CDC or in the literature, including 6 (9%) of cases in children under age 17 years. Of the 65 cases, 13 (20%) were fatal, and of those who survived, 28 (43% of the total cases) had sequelae, Dr. Fisher said. Thailand was the "probable country of acquisition in most (32%) of these cases, followed by China (14%) Indonesia (14%), the Philippines (11%), Japan (6%) and Vietnam (5%), he said. In the remaining 18%, the probable country of acquisition was unknown.
Although the vaccine is expensive (about $200 a dose) and the risk of JE is not high, Dr. Fisher cited U.S. survey data indicating that parents would be willing to pay a high price for a vaccine to prevent a serious outcome.
Several members of the panel observed that the JE-VC vaccine is not likely to be provided in most general clinical practices, and that it would more likely be found in a travel medicine clinic. Cost was another issue cited, because travel vaccines are usually not covered by medical insurers.
There are 15 members in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; 13 members were present at this meeting.
ATLANTA – Vaccination against Japanese encephalitis should be recommended for children aged 2 months to 16 years as a travel vaccine in certain situations, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
In a unanimous 13-0 vote, the committee supported the proposed recommendation of ACIP’s Japanese encephalitis (JE) vaccine workgroup to extend the current ACIP recommendation for JE vaccine in adults aged 17 years and older to children aged 2 months to 16 years, targeting people traveling at increased risk, based on their itineraries and activities. Until May, no vaccine for JE was available for children in the United States.
The 2009 recommendation for the JE vaccine in adults states the following:
• The JE vaccine is recommended for travelers who plan to spend 1 month or more in a JE-endemic area during the JE virus transmission season.
• The vaccine "should be considered" for short-term travelers (under 1 month) to endemic areas, if they are planning to travel outside of urban areas and have an increased risk of exposure to the JE virus (such as spending a "substantial time outdoors in rural or agricultural areas," or "participating in extensive outdoor activities").
• The vaccine also should be considered for travelers to an area with an ongoing JE outbreak, and travelers to endemic areas "who are uncertain of specific destinations, activities, or duration of travel."
• The vaccine is not recommended for short-term travelers who will be staying in urban areas only, or at times that are "outside of a well-defined JE virus transmission season."
The JE virus, a mosquito-borne flavivirus closely related to dengue and West Nile viruses, is endemic in China, Japan, and other parts of Asia, with the highest risk of in rural, agricultural areas.
Although the risk for most travelers to Asia is low, that risk varies depending on the destination, the duration and season of the visit, and activities, according to Dr. Marc Fischer of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), a member of ACIP’s JE vaccine workgroup. No cases of JE have been reported for travelers who only visited urban areas for short periods.
But JE is a severe disease with substantial morbidity and mortality, with no specific treatment available, and "the work group placed a high value on preventing this life-threatening disease," he said. Another consideration was the availability of a safe and effective vaccine, which provides high levels of seroprotection in children after 2 doses.
The vaccine that is available for adults – an inactivated cell culture derived JE vaccine (JE-VC) licensed by the Food and Drug Administration for adults aged 17 years and older – was also licensed for use in children aged 2 months to 16 years in May 2013. The vaccine is marketed as Ixiaro by Intercell Biomed, a Scottish company, and is distributed in the United States by Novartis. It is indicated for active immunization to prevent disease caused by JE virus and is administered as a two-dose primary series, 28 days apart.
The previously available JE vaccine, an inactivated mouse brain–derived JE vaccine, manufactured in Japan and licensed in the United States for people aged 1 year and older in 1992, is no longer available.
Between 1973 and 2012, there were 65 cases of travel-associated JE cases in the United States reported to the CDC or in the literature, including 6 (9%) of cases in children under age 17 years. Of the 65 cases, 13 (20%) were fatal, and of those who survived, 28 (43% of the total cases) had sequelae, Dr. Fisher said. Thailand was the "probable country of acquisition in most (32%) of these cases, followed by China (14%) Indonesia (14%), the Philippines (11%), Japan (6%) and Vietnam (5%), he said. In the remaining 18%, the probable country of acquisition was unknown.
Although the vaccine is expensive (about $200 a dose) and the risk of JE is not high, Dr. Fisher cited U.S. survey data indicating that parents would be willing to pay a high price for a vaccine to prevent a serious outcome.
Several members of the panel observed that the JE-VC vaccine is not likely to be provided in most general clinical practices, and that it would more likely be found in a travel medicine clinic. Cost was another issue cited, because travel vaccines are usually not covered by medical insurers.
There are 15 members in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population; 13 members were present at this meeting.
FROM AN ACIP MEETING
