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Vaccines, Blood & Biologics

Record of Telephone Conversation, September 11, 2012 - Flublok


Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Influenza Vaccine
Protein Sciences Corporation
Telecon Date/Time: 11-Sep-2012 03:20 PM        Initiated by FDA? Yes
Telephone Number: 203-599-6064 x156
Communication Categorie(s):
1. Advice
Telecon Summary:
Revision of pediatric plan.
FDA Participants: Timothy Fritz, Cynthia Nolletti
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
We called Dr. Penny Post to discuss Protein Sciences Corporation’s (PSC) pediatric plan submitted on August 31, 2012. We informed Dr. Post that, because PSC was now requesting a waiver for studies in children 6 through 36 months of age in contrast to the deferral PSC had requested for this age group in PSC’s original BLA submission, we would need to present PSC’s revised plan to the FDA Pediatric Review Committee (PeRC). We noted that some information in the pediatric plan appeared contradictory, i.e., that PSC requested a waiver in children 6-35 months of age while at the same time PSC also discussed the possibility of conducting studies in this age group -------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------- We said that we were not advising PSC to not conduct such studies but that PSC should be definitive about its plans for conducting additional studies with the current product under BLA review (FluBlok) in children 6-36 months of age. We further clarified that if PSC wishes to conduct additional studies of FluBlok in this age group, they should request a deferral and propose a specific plan rather than multiple study options. If PSC does not wish to conduct further studies of FluBlok in this age group, they should request a waiver with a rationale and should not propose alternative studies with the current product that might be interpreted by the PeRC as a request for a deferral. We also noted that PSC’s pediatric plan discussed options —b(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. We recommended that PSC remove this information from the pediatric plan as it could also cause confusion for the PeRC. Finally, we asked that PSC submit a revised plan in the next week or two.

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