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From: Smith, Michael (CBER)
Sent: Thursday, August 5, 2021 3:13 PM
To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda
<[email protected]>; Devlin, Carmel M <[email protected]>; Rohlfing, Paul
<[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottscha lk, Laura
<[email protected]>
Subject: STN 125742.0: Diluent questions
Elisa,
The review team has the below questions regarding the diluent.
1. The BLA includes 4 pictures of the saline diluent that will be provided but
shipped separately from the vaccine vials. Additional, information regarding the diluent does not appear to be included in the BLA. Based on the
pictures provided, the saline diluent is provided in “2mL single dose” and “10mL single dose” vials.
a. With respect to the 2mL single dose vial of saline, we assume that the
end user will extract 1.8mL to reconstitute a single vial of vaccine. Please confirm and provide the instructions provided with the
diluent.
b. With respect to the 10mL single dose vial, please submit any instructi ons
provided to healthcare providers.
2. Also, please clarify if providers can reconstitute 2 or more vials of vaccine with saline from a 10mL single dose vial.
3. Lastly, please provide the container/closure information for each of these vials and informat ion regarding the number of permissible punctures of the
vial stopper.
4. If the requested information above is provided in the BLA, please provide the section(s).
FDA-CBER-2021-5683-1150217
If possible, please email a response by 11:00 AM Monday, August 9, 2021, and
follow -up w ith a submission to the BLA.
Regards,
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications
Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150218