FDA VACCINE APPROVAL

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has federal oversight over regulating and approving vaccines in the United States.

Currently, FDA approval has granted U.S. licenses for only three flu vaccines. Two of these are for injectiable vaccines: Chiron’s Fluvirin^®, and Aventis Pasteur’s Fluzone^®. The other is for Maryland-based MedImmune’s live, intransal vaccine, FluMist^®

After Chiron’s Fluvirin^® production facility was reported contaminated, and the U.K. suspended all of this flu vaccine, much of which was destined for the U.S., Health and Human Services Secretary Tommy Thompson announced that FDA inspectors were federal exploring whether to approve two additional flu vaccines manfuactured by GlaxoSmithKline in Germany, and ID Biomedical Corp. in Canada.

If one of these manufacturers has problems with quality control and sterility, production, or essential components like egg supplies and other components, then an entire flu season’s source of vaccines can suddenly be put in jeopardy.

FDA officials and vaccine makers remain keenly aware of this delicate balance.

At a February 2003 meeting of the CBER’s Vaccines and Related Biological Products Committee, Dr. Roland A. Levandowski of the FDA’s Division of Viral Products expressed concern about the potentially drastic effect that vaccine production problems could have upon the public’s need to guard against invluenza:

      “A new concern that we have this year in terms of this vaccine use in the fall is that we now have only two manufacturers of inactivated vaccine supplying the United States. Those two manufacturers are Aventis Pasteur and Evans PowderJect. You probably have seen press releases to know this, but Wyeth announced at the end of the 2002 influenza vaccine production campaign that it would no longer produce inactivated influenza virus vaccines.

      Although the current manufacturers have given us assurance of their intent to fill the gap that's left by Wyeth's departure, we can be certain that any shock to the system is more likely to be evident for all of us in terms of what happens.

      When there are multiple manufacturers, it's possible that if one manufacturer experiences a temporary problem, then others can pick up the slack and help out. That's been true often in the past. However, if one of the two remaining current manufacturers experiences a problem, the probability is now a lot greater that there will be a delay or a shortage of vaccine during the vaccine preparation period.” (Emphasis added)