Document text
From: Naik, Ramachandra
Sent: Friday, August 20, 2021 2:08 PM
To: Boyce, Donna < [email protected] >
Cc: Malarkey, Mary < [email protected] >; Gruber, Marion < [email protected] >;
Harkins Tull, Elisa < [email protected] >; Rohlfing, Paul < [email protected] >; Aghajani
Memar, Neda <[email protected] >; Smith, Michael (CBER)
<[email protected] >; Gottschalk, Laura < [email protected] >
Subject: RE: Lot Numbers for the COVID Launch Lots [BLA STN 125742/0 - COMIRNATY]
De
ar Donna,
Thank you for the information!
Please note that we do not consider these EUA -labeled “lots in the field” to comply with the BLA at this
time since lot release activities have yet to be agreed upon and performed. We will work with you to
develop a lot re lease approach after the initial BLA approval occurs. Please ensure that these “lots in
the field” are not listed in the cvdvaccine -us.com/resources website included in the Dear HCP Letter
(submitted in draft as amendment 64 to the BLA on August 19, 2021) . We will provide comments on the
Dear HCP Letter in a separate communication.
Please confirm receipt of this message 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 Evaluation and Research
Office of Vaccines Research and Review
U.S. Food and Drug Administration
Tel: 301- 796-2640
ramachandra.naik @fda.hhs.gov
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From: Boyce, Donna < [email protected] >
Sent: Thursday, August 19, 2021 6:49 PM
To: Malarkey, Mary < [email protected] >; Naik, Ramachandra
FDA-CBER-2021-5683-1150333
<[email protected] >; Gruber, Marion < [email protected] >
Cc: Harkins Tull, Elisa < [email protected] >; R ohlfing, Paul < [email protected] >;
Aghajani Memar, Neda < [email protected] >
Subject: RE: [EXTERNAL] Lot Numbers for the COVID Launch Lots
CAUTION: This email originated from outside of the organization. Do no t click links or open attachments unless you
recognize the sender and know the content is safe.
Dear All,
Attached please find the list of lots in the field that comply with the BLA. We do not have visibility to the consumption/inventory of these lots so cannot say how many doses per lots remain.
Also, we have not shipped any doses from the 7 “launch lots.” These are planned for shipment in Sept. Therefore, the million dose remain in our control.
Please contact m e with any questions.
Kind regards,
Donna
From: Malarkey, Mary <[email protected] >
Sent: Thursday, August 19, 2021 5:37 PM
To: Boyce, Donna < Donna.Boyc e@p f izer.com >; Naik, Ramachandra < [email protected] >;
Gruber, Marion < [email protected] >
Cc: Harkins Tull, Elisa < [email protected] >; R ohlfing, Paul < [email protected] >;
Aghajani Memar, Neda < [email protected] >
Subject: RE: [EXTERNAL] Lot Numbers for the COVID Launch Lots
Dea
r Donna
Thanks so much for this! I think we have these lots in house now. I probably wasn’t clear to Peter that
we were still waiting to get the other lots in the field that would be considered BLA compliant. It
would be very helpful to get a list of those and some idea of magnitude. I presume the seven lots have
diminished from the million doses at this point.
We will also have comments on the Dear HCP.
Thanks again
Mary
From: Boyce, Donna < [email protected] >
Sent: Thursday, August 19, 2021 5:33 PM
To: Naik, Ramachandra < [email protected] >
Cc: Malarkey, Mary < [email protected] >; H arkins Tull, Elisa < [email protected] >;
Rohlfing, Paul < [email protected] >; A ghajani Memar, Neda < [email protected] >
Subject: [EXTERNAL] Lot Numbers for the COVID Launch Lots
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150334
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you
recognize the sender and know the content is safe.
Dear Ram,
I understand from Peter Marks that the CBER review team is looking for the lot numbers of the launch lots.
These are the seven Lot Numbers:
1. FD7220
2. FE3592
3. FF2587
4. FF2588
5. FF2590
6. FF2593
7. FF8841
Please contact me with any questions.
Kind regards
Donna
FDA-CBER-2021-5683-1150335