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A Note to Clinicians from NNii – A Summary of Several Key Issues Discussed at the June 20-21 Advisory Committee on Immunization Practices meeting
(For more information on the ACIP, visit www.cdc.gov/nip/acip)



Vaccine Supply

Supply of DTaP : As of 5/24/01, DTaP shortages continued in 11 states, however, providers were able to continue the five-dose series in all areas. With increasing production anticipated by Aventis Pasteur and GlaxoSmithKline (the only two manufacturers of DTaP in the U.S.), indications are that providers will be able to maintain the five-dose schedule for the rest of the year. If there are increasing shortages of DTaP, ACIP recommends that providers prioritize vaccinating children with their three-dose primary series, and that children whose 4th and 5th doses are postponed be given those doses later when the DTaP supply is adequate. (NOTE: On July 10, 2001, Aventis Pasteur notified the CDC that they would be unable to meet their government contract obligations for DTaP and DTaP-Hib vaccine; however, no shortages are anticipated, as GlaxoSmithKline has assured the CDC that they have sufficient vaccine available to meet the expected demand).

Tetanus Toxoid Vaccine Shortage : The Td shortage continues, and the sole supplier, Aventis Pasteur, is expected to take several months to expand its manufacturing capability to meet national needs. The CDC now recommends deferring all routine adult and adolescent tetanus booster vaccinations until 2002 or until the shortage has been resolved. The use of Td for vaccination should continue to follow ACIP recommendations for: - those with severe or contaminated wounds who have not received a tetanus vaccine in the past five years; - those with clean wounds who have not received tetanus vaccine in the last 10 years; - persons planning foreign travel where the risk of diphtheria is high; - those who are pregnant and have not been vaccinated within the preceding 10 years, and; - those who have not completed the primary tetanus series.

ACIP recommendations can be found at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00015794.htm
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4945a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5020a8.htm 

Influenza vaccine : Although delay in the availability of influenza vaccine is anticipated for the 2001-2002 season, it should not be as extensive as for the last season, as more vaccine is in production. By the end of October 2001, it is estimated that 53.5 million doses of vaccine will be available, 64 percent of the total needed. This is twice the amount available at the same time last year. In November and December of 2001, the remaining 30.2 million doses (36 percent) of the total needed for the 2001-2002 influenza season are expected to be available.

Because flu season generally peaks between December and March, the CDC encourages continuing administration of the vaccine late in the season, although immunization of health care workers and those at high risk of influenza complications should take place in September and October.

A draft supplement to the Influenza Information Statement was reviewed at the meeting, and ACIP members suggested that there be more emphasis on, 1) vaccinating health care workers caring for older hospitalized patients, and 2) the vulnerability of long-term care residents, individuals in nursing homes, and health care workers. The Committee also suggested that standing orders for the long-term care elderly be emphasized. The recommendations are outlined in the CDC's National Immunization Program (NIP) Influenza Vaccine Bulletin #2 issued June 21, 2001. It and all other CDC materials regarding influenza will be available at http://www.cdc.gov/nip/Flu/default.htm . 

Update on Adult High-risk Hepatitis B Immunization : From 1981 to 1991, attempts to selectively immunize persons at increased risk of infection was not successful. The current strategy for the elimination of HBV transmission in the U.S. has emphasized routine vaccination of infants, children, and adolescents and selective vaccination of adults at high risk of infection. There was a major decline (76%) in the overall incidence of acute HBV infection in the U.S. from 1982-1998, but since the mid-1990's incidence has remained stable in all adult age groups. One-third of those infected with hepatitis B have no known risk factors for the disease.

Heterosexual activity is the predominant mode of transmission in the U.S., with a trend toward increased incidence in the 30-32 year age groups. An estimated 6 million people in the U.S. are at potential risk for Hepatitis B infection, including 80% of the 2 million incarcerated, approximately 2 million persons receiving treatment for STDs, and 2 million in drug treatment programs. There is no national program which provides access to vaccine for high-risk adults who receive health care in the public sector, and there are many funding barriers for adult Hepatitis B immunization. The committee reviewed a draft 2001 update of the ACIP Recommendations on Hepatitis B Virus Infection: A Comprehensive Strategy to Eliminate Transmission in the United States. It was suggested that a separate section be added with emphasis on eliminating transmission among incarcerated persons. Also, information will be added about the recently licensed Twinrix combination Hepatitis A/B Vaccine. The draft statement will be reviewed and finalized at the October 2001 ACIP meeting.

Vaccine Safety Update

MMR: The IOM report on MMR and autism was presented; the report favors rejection of an association between MMR vaccine and autism. The full report is available at http://www.nap.edu/catalog/10101.html

Thimerosal: The CDC has proposed a complex research study to examine whether there is a relationship between thimerosal-containing vaccines and neurodevelopmental deficits which will be presented to the National Immunization Program and reviewed by the Institute of Medicine.

In 1999, prior to the interim change in the recommendation for use of hepatitis B vaccine in newborns related to thimerosal, about 50% of infants were being vaccinated at birth. Now only about 30% of infants in the US are vaccinated at birth despite the availability of thimerosal-free hepatitis B vaccines and re-institution of the USPHS and AAP recommendation to immunize newborns against hepatitis B (the recommendation can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4835a3.htm). Recommendations regarding the routine immunization of newborns against hepatitis B will be emphasized in the next Recommended Childhood Immunization Schedule, which will be issued in January 2002. Although the ACIP encouraged removal of thimerosal from vaccines, current policy makes it acceptable to continue to use thimerosal-containing vaccines, although all vaccines in the Recommended Childhood Immunization Schedule are now thimerosal-free. For additional information on thimerosal in vaccines, visit the CDC at http://www.cdc.gov/nip/vacsafe/concerns/thimerosal The Institute for Vaccine Safety has a list of all current vaccines and their thimerosal content at http://www.vaccinesafety.edu/thi-table.htm

Vaccine Injury Compensation Program (VICP) : The 7-valent pneumococcal conjugate vaccine has been added to the list of covered vaccines, bringing the total list of covered vaccines to 12. A reduction in the vaccine excise tax from $.75 to $.25 per individual vaccine dose has been suggested, but has not been approved. Influenza vaccine will not be added to the table of compensable injuries unless recommended for universal administration (for the complete table, visit http://bhpr.hrsa.gov/vicp/table.htm.) In addition, due to the Children's Health Act of 2000, enacted October 17, 2000, compensation is allowed even when vaccine associated symptoms don't persist beyond 6 months, if the symptoms also result in inpatient hospitalization and surgical intervention. More information about the Vaccine Injury Compensation Program is available at http://bhpr.hrsa.gov/vicp/, the Children's Health Act of 2000 can be found at http://thomas.loc.gov/cgi-bin/query/z?c106:H.R.4365.ENR:

 
     
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