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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 01-Aug-2012 10:15 AM Initiated by FDA? Yes
Telephone Number: 203-599-6064 x156
2. Information Request
Author: TIMOTHY FRITZ
FluBlok age indication decision.
FDA Participants: Cynthia Nolletti, Lewis Schrager, Rakesh Pandey, Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
We called Dr. Post to inform her that we had reached a decision that, if FluBlok is licensed in this review cycle, the age indication will be for persons 18-49 years of age. Dr. Post asked why we had decided upon this age range. We replied that the efficacy data was supportive for 18-49 year olds. We told Dr. Post that we were actively discussing the parameters for studies needed to extend licensure to persons 50 years of age and older, and that we would provide Protein Sciences Corporation (PSC) with this information as soon as possible.
We asked Dr. Post to submit a revised package insert based on the 18-49 year old age indication within 2-3 weeks, and to submit an updated pediatric plan to include subjects 6-35 months of age. We also asked Dr. Post to submit a protocol to establish a pregnancy registry to be consistent with recommendations we have made to other influenza vaccine manufacturers in light of the Advisory Committee for Immunization Practices recommendation that pregnant women receive influenza vaccination.
Finally, Dr. Post was asked whether pre-immunization serum was collected and banked from subjects in study PSC04 as PSC had previously indicated it might do to establish a correlate of protection. Dr. Post did not remember whether PSC had collected this serum, and asked if we would request that PSC perform an analysis using the pre-immune serum. We replied that would not require PSC to establish a correlate of protection but that such a goal was of interest for all influenza vaccines. We also said that the possibility of PSC establishing a correlate of protection might help us decide on additional studies needed. Dr. Post said that she would provide this information.