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From: Naik, Ramachandra <[email protected]>
Sent: Friday, April 8, 2022 10:50 AM
To:Mineo, Gosia
Cc:Harkins Tull, Elisa <Elisa.HarkinsTull@pfize r.com>; Collins, Kathleen Mary Catherine
; Devlin, Carmel M <C [email protected]>; Smith, Michael (CBER)
<[email protected]>; Gottschalk, Laura <[email protected]>; MaguireThon,
Meghan <[email protected]>
Subject: STN 125742/45 - Comirnaty sBLA to to extend the indication to ad olescents 12 through 15 years
of age - CBER comment regarding Tris/Sucrose formulation
Dear Ms. Mineo,
We have the following request for additional in formation regarding the sBLA STN 125742/45 submission
for extending licensure of COMIRNATY to adolescents 12 through 15 years of age.
In this sBLA submission, it appears that
only the PBS/Sucrose formulation of COMIRNATY is requested for licensure in adolescents 12 through 15
years of age. Please confirm that you only intend to seek licensure for the 30-microgram dose of
PBS/Sucrose formulation in adolescents 12 through 15 years of age and please provide the rationale for
not including the Tris/Sucrose formulation of the same dosage in the submission.
Please confirm receipt of this email and let me know if you have any questions or need additional
information.
Regards,
Ram
Ramachandra S. Naik, Ph.D.
Biologist (Regulatory) / Primary Reviewer
Center for Biologics Ev aluation and Research
Office of Vaccines Research and ReviewU.S. Food and Drug AdministrationTel: 301-796-2640
ramachandra.naik @fda.hhs.gov
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Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.04.08 10:57:22 -04'00'
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FDA-CBER-2022-5812-0500364