Document text
From: Gottschalk, Laura
Sent: Friday, July 16, 2021 8:16 AM
To: '[email protected]' <[email protected]>
Cc: 'Aghajani Memar, Neda' <[email protected]>; '[email protected]'
<[email protected]>; Naik, Ramachandra <[email protected]>; Smith, Michael
(CBER) <[email protected]>; '[email protected]' <Paul.Rohlfing@ pfizer.com>
Subject: STN 125742/0: IR RE LRP template and DS handling instructions
Dear Ms. Harkins, The review team has the following comments for you regarding your lot release protocols and drug substance handling instructions. Please submit your resp onses to the BLA as soon as possible.
1. The lot release protocols previously submitted in amendments 125742/0.4 (dated May 24, 2021) and 125742/0.10 (dated July 9, 2021) need to be modified to be templates for use for all lots submitted to CBER. Lot release templates should be a preset format that does not state
results.
Please submit a lot release protocol template (no results stated) for the COVID -19 mRNA
Vaccine for CBER review containing only the assays performed and acceptance criteria for the drug pr oduct.
The header on each page of the template should state the following:
cc: 000000 _0/Lic #/FC Page 1 of total # of pages
Lot Number:
License Name of Product:
Please note; upon CBER review of the lot release protocol template, additional information may
be requested.
2. We received three different lots of drug substance (DS) on July 09, 2021 to conduct testing at CBER. You provided one tube of frozen DS for each lot. Please provide instructions for thawing and any other conditions that we need to consider in making aliquots. Also, please state how many freeze -thaw cycles are acceptable. We would appreciate this response as soon as possible,
but no later than July 20, 2021.
Please confirm receipt of this message and let us know if you have any questions. Best,
Laura
Laura Gottschalk, PhD
Regulatory Project Manager/Primary Reviewer
Center for Biologics Evaluation and Research
Office of Vaccines Research and Review
FDA-CBER-2021-5683-1150184
U.S. Food and Drug Administration
Tel: 301-796-0798
laura.gottschalk@fda hhs.gov
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FDA-CBER-2021-5683-1150185