Food and Drug Administration
Center for Biologics Evaluation and Research
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 23, 2009
Hilton Hotel, Gaithersburg, MD
|Committee Members||FDA Participants|
|Dr. John Modlin, Chair||Dr. Norman Baylor|
|Dr. Lisa Jackson||Dr. Jerry Weir|
|Dr. Jack Stapleton||Dr. Wellington Sun|
|Dr. Vicky Debold *||Dr. Hector Izurieta|
|Dr. Jose Romero|
|Dr. Pablo Sanchez|
|Dr. Frank DeStefano|
|Dr. Peter Gilbert|
|Dr. Margaret Rennels **|
|Temporary Voting Members||Speakers|
|Dr. Theodore Eickhoff||Dr. Anthony Fiore|
|Dr. Bruce Gellin||Dr. Robin Robinson|
|Dr. Roland Levandowski||Dr. Nancy Cox|
|Dr. Pamela McInnes||Dr. Alexander Klimov|
|Dr. Melinda Wharton|
|Designated Federal Official|
Christine Walsh, R.N.
|Committee Management Specialist|
These summary minutes for the July 23, 2009 Meeting of the Vaccines and Related Biological products Advisory Committee were approved on June 24, 2010.
I certify that I participated in the July 23, 2009 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
|Christine Walsh, R.N.|
Designated Federal Official
|John Modlin, M.D.|
* Consumer Representative
** Industry Representative
The Chair, Dr. John Modlin called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 8:00 a.m. ET on July 23, 2009. The committee discussed FDA’s approach to licensure of vaccines against the 2009 H1N1 virus and considerations for their use.
An Open Public Hearing was announced for each topic. Several public comments were made.
Following is a summary of the discussion. Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the Vaccines and Related Biological Products Advisory Committee 2009 Meeting Materials page.
Proceedings were adjourned at approximately 4:05 p.m. ET on July 23, 2009.
After administrative remarks, Dr. Norman Baylor, FDA opened up the meeting with an introduction to the day’s agenda. Presentations were given by FDA, CDC, NIH, HHS, and vaccine manufacturer’s including Novartis, Sanofi Pasteur, CSL Ltd., MedImmune, and GlaxoSmithKline. After an Open Public Hearing session where several members of the public participated, a discussion was held by the committee dealing with the specific discussion points provided by the FDA.
- The committee supported FDA’s approach to licensure of vaccines against the 2009 H1N1 influenza virus as a strain change supplement to each seasonal vaccine manufacturers’ license.
- During the discussion of whether individuals should receive one or two doses of vaccine 21 days apart several perspectives were raised: historical data with H1N1 containing vaccines which would suggest that primed individuals will respond to one dose, the availability of data from clinical studies to inform a decision may not be available until after a recommendation regarding number of doses is made, and the logistics of communication of a vaccination regimen.
- Regarding considerations for immunizing special populations such as children <6 months of age and pregnant women members expressed the view that immunizing pregnant women and older siblings was critical to protecting young infants. Available data suggest that infants <6m do not respond well to influenza vaccines immunization and that future studies with adjuvanted vaccines may support immunization in this age group.
- Regarding considerations for use of adjuvanted vaccines Dr. Baylor explained that such adjuvanted vaccines would only be used under an Emergency use Authorization (EUA). The committee noted that the benefits of an adjuvant may not be apparent for the H1N1 vaccines compared to, for example, an H5N1 vaccine to which the population is naïve. The committee discussed the elements which should be weighed in a decision to use adjuvanted vaccines such as the available safety data with such vaccines, the severity of H1N1 disease, vaccine supply and public acceptance.
- The committee discussed the agency’s plans for post-licensure safety monitoring within the US and the potential for sharing of global safety information. The committee supported the evaluation of post-licensure effectiveness and acknowledged the limitations of various cohorts of vaccinated individuals in such assessment.
- The committee discussed the need for diagnostic tests to distinguish pandemic influenza strains from other circulating strains and non-influenza causes of respiratory illness. The committee noted the importance of accurate diagnoses particularly when there are a number of strains circulating.
The meeting adjourned at 4:05pm.