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From: Gottschalk, Laura < [email protected] >
Sent: Wednesday, August 18, 2021 5:20 PM
To: Harkins Tull, Elisa < [email protected] >
Cc: Smith, Michael (CBER) < [email protected] >; Naik, Ramachandra
<[email protected] >; Devlin, Carmel M <[email protected] >; Aghajani Memar,
Neda < [email protected] >
Subject: [EXTERNAL] STN 1 25742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) - Comments regarding
inclusion of draft carton and container labels in a single amendment
Dear Ms. Harkins,
Our review of the information provided in your BLA STN 125742/0 for COMIRNATY (COVID -19 Vaccine,
mRNA ), for active immunization to prevent COVID -19 caused by SARS -CoV-2 in individuals 16 years of
age and older, is ongoing.
For the sake of referencing in the Approval Letter, please submit, in a single amendment, all the draft
labels listed in the below a mendments:
• Amendment 46 (Seq 0046, dated 08/13/2021)
o COMIRNATY Vial Label (Kalamazoo)
o COMIRNATY Vial Label (Puurs)
o Diluent Sticker (Hospira)
• Amendment 53 (Seq 0054, dated 08/17/2021)
o COMIRNATY Carton – 25 Vial (Kalamazoo)
o COMIRNATY Carton – 25 Vial (Puu rs)
o COMIRNATY Carton – 195 Vial (Kalamazoo)
o COMIRNATY Carton – 195 Vial (Puurs)
o Diluent Vial (Fresenius Kabi)
o Diluent Vial (Hospira)
o Diluent Carton – 25 Vial (Fresenius Kabi)
o Diluent Carton – 25 Vial (Hospira)
• Unsubmitted
o Diluent stamp (Fresenius Kabi) – revised version
Please submit these labels as soon possible, but no later than 12:00pm, August 19, 2021.
Please acknowledge receipt of these comments and let me know if you have any questions.
Thanks,
Laura
Laura Gotts chalk, PhD
Regulatory Project Manager/Primary Reviewer
FDA-CBER-2021-5683-1150339
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301 -796- 0798
[email protected]
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FDA-CBER-2021-5683-1150340