The FDA Approves FluMist
On June 17, 2003, the Food and Drug Administration (FDA) issued a license to Medimmune Inc. to produce FluMist, a live attenuated influenza vaccine administered intranasally. To view the package insert for this product, go to http://www.fda.gov/cber/label/inflmed061703LB.pdf
The Advisory Committee on Immunization Practices (ACIP) will publish recommendations for this new vaccine in the Morbidity and Mortality Weekly Report (MMWR) before the 2003-04 influenza vaccination season begins. For additional information on the approval of FluMist, please see Flu News on the CDC-NIP web site at http://www.cdc.gov/nip/flu/News.htm#flumist
Updated Projection for This Year's Influenza Vaccine Supply
The three influenza vaccine manufacturers licensed to produce vaccine for the U.S. market, Aventis Pasteur, Powderject Vaccines (which produces the Evans Vaccines brand), and Medimmune, project an aggregate total of 86.5-93 million doses for 2003. This recent projection remains from 2 to 8.5 million doses below last year's total production but exceeds the estimated 79 million doses that were sold to individuals in 2002.
The AMA Strongly Supports Influenza Vaccination Efforts
In a recent article published in the AMA/Federation News, AMA Executive Vice President and CEO Michael D. Maves, MD, affirmed the AMA's position on influenza vaccination. While addressing attendees at the National Influenza Vaccine Summit in Chicago on May 20, 2003, Maves remarked, "We are committed to working with all of you to support mechanisms to increase influenza vaccine supply and vaccine demand among physicians, other providers, and the public to reach the goals of Health People 2010."
Review the entire article for additional highlights at http://www.ama-assn.org/ama/pub/article/2403-7702.html
This Season, Possible Relaxation of ACIP's Tiered Approach to Vaccination
On June 18, 2003, the ACIP voted to relax the tiered approach to vaccination if, by late summer, vaccine production is proceeding satisfactorily.
If the National Immunization Program (NIP), in consultation with the FDA and the influenza vaccine manufacturers, decides to relax the tiered approach for 2003, an announcement will be published in the MMWR and in a subsequent issue of this bulletin. The CDC and FDA staff will collaborate to draft a process by which such a decision can be made this year.
The Vaccines for Children (VFC) Program Expands to Cover Influenza Vaccine
The ACIP continues to encourage influenza vaccination for children 6-23 months of age and for household contacts and out-of-home caregivers of children under 2 years of age. The Vaccines for Children (VFC) program has expanded to cover VFC-eligible children in these groups during the 2003-2004 flu season.