Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
July 1, 1999
Dear Vaccine Manufacturer:
The Center for Biologics Evaluation and Research (CBER) is evaluating the continued use of thimerosal in biologic products under the Food and Drug Administration Modernization Act (FDAMA) of 1997, Section 413, "FDA Study of Mercury Compounds in Drugs and Food."
As part of this evaluation, we are now requesting that all manufacturers of thimerosal-containing vaccines provide information to CBER regarding their plans for thimerosal as a preservative in U.S. licensed vaccines, addressing each product separately.
If you intend to remove thimerosal from your product(s), please discuss the following:
- proposed studies to assess the effect of removing thimerosal on sterility, potency, stability, and immunogenicity of the product;
- feasibility of eliminating or reducing the amount of thimerosal, using alternative preservatives, or reformulating the product solely for single dose containers;
- anticipated manufacturing changes as a result of removing thimerosal, if any;
- approximate time-line necessary to evaluate and implement removal.
- If you intend to continue using thimerosal in your product (s), please provide an explanation as to why you have made this decision.
Please note that FDA regulations do not require use of preservatives in biological products formulated for single-dose containers. CBER encourages discussions with manufacturers as to what additional data, if any, would be required to effect such a change.
We request that you submit the information requested above within 45 days to the attention of Ms. Valerie Vashio, HFM-475. Please contact Norman W. Baylor, Ph. D. at 301-827-0655 if you have questions or would like to schedule a meeting with CBER regarding the above request.
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William Egan, Ph.D.
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research