125742 S12 M1 13jul2021 response

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Pfizer Bla Submission

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COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 13Jul 2021FDA queries –Preservative Exception or Alternative
PFIZER CONFIDENTIAL
Page 1QUERY 1
COMIRNATY is supplied in a multiple -dose vial that does not contain a preservative.  Our 
review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID -
19 mRNA Vaccine), for active immunization to prevent COVID -19 caused by  SARS-CoV-2 
in individuals 16 y ears of age and older, is ongoing.  Please note that 21 CFR 610.15(a)
requires that “Products in multiple -dose containers shall contain a preservative,…” The 
regulations in 610.15(d) permit the approval of an exception or alternative to this 
requirement.  Requests for such exceptions or alternatives must be in writing.  You r 
submission does not include a request for an exception or alternative to the requirement of a 
preservative.  Therefore, please submit a request and a justification for an exception or 
alternative to the requirement under 21 CFR 610.15(a) that products in multiple-dose vials 
include a preservative.
RESPONSE 1
The Sponsor acknowledges this request to submit a request and justification for an exception 
or alternative to the requirement under 21 CFR 610.15(a) that products in multiple-dose 
vials include a preservative.  The formal request for an exception is provided in 1.12.5 
Request for Exception to the 21 CFR 610.15(a) Requirement for a Preservative.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
1.12.5Requestfor Exception to the 21 CFR 610.15(a) Requirement for a Preservative , new
Previously submitted supporting documentation
None
090177e19791eb5c\Approved\Approved On: 15-Jul-2021 19:51 (GMT)
FDA-CBER-2021-5683-0651235