Submission Type: BLA
Submission ID: 125419/0
Product: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Applicant: ID Biomedical Corporation of Quebec
Telecon Date/Time: 22-Jan-2013 12:00 PM Initiated by FDA?Yes
Telephone Number: 857-207-4197
Communication Category: 1. Information Request
Author: Jeremy Wally
Telecon Summary: Follow-Up Discussion of Shipping Issues
FDA Participants: Carmen Collazo-Custodio, Randa Melham, Kirk Prutzman, Jeremy Wally
Non-FDA Participants: Angela Haag, Caroline Munger, Elyse Lavoie, Jeroen Janssens, LaDonna Nugent, Melanie Raymond, Michael Schwartz, Nathalie Renaud, Ozzie Berger, Robert Brobst, Sandra Gilbert, Sonia Proulx
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
A telecon was requested by CBER and the following issues were discussed:
- CBER noted that in the sponsor’s response to question 4 of CBER’s information request of August 6, 2012 and follow-up telecon of August 10, 2012, contained within amendment STN 125419/0.8 of September 10, 2012, the sponsor submitted approximately 14 shipping validation reports and that it is unclear to CBER which of these validations is relevant to the planned shipping conditions for the adjuvant and antigen.The sponsor clarified that all material is shipped at 2-8°C, and that the adjuvant is formulated, filled and boxed and then shipped to their facility in Canada where it is then co-packaged with the antigen and this final package is then shipped to the US distribution centers.CBER then asked about the product stored at the US stockpile and the sponsor replied that concentrated antigen in (b)(4) and adjuvant in vials is stored in --(b)(4)--.
- CBER asked the sponsor to clarify why shipping validations at -(b)(4)- were submitted if all material is shipped at 2-8°C as stated above.The sponsor responded that these validations were performed to cover a variety of products and that they routinely use temperature monitoring for all shipments.CBER requested that the sponsor submit summary explanations/assessments of inclusion of these validation reports to the BLA and the sponsor agreed.
- CBER asked the sponsor if they have provided reports of ground shipping and the sponsor responded that they are relying on the ground shipper’s validation to support the proposed shipping procedure.CBER asked the sponsor to submit to the BLA information regarding this shipper.
- CBER asked the sponsor to submit to the BLA data and reports for the shipping of commercial H1N1 vaccine lots during the 2009 pandemic, and the sponsor noted that they had shipped approximately (b)(4) lots and would be unsure of how to select the data to be submitted.CBER asked the sponsor to submit data on the first lots shipped in the months of November, December and February, and the sponsor agreed.
- CBER asked the sponsor to submit to the BLA flow-charts detailing the packaging, labeling, shipping and inspection procedures after filling for the adjuvant, antigen and co-packaged final product, and the sponsor agreed.
- CBER asked the sponsor when the information requested above would be submitted to the BLA and the sponsor tentatively agreed to submission of an amendment to the BLA by February 1st, with a possible earlier email to facilitate the review process.