Pfizer Seeks FDA Approval For COVID-19 Vaccine Booster
Pfizer Inc. (PFE) is seeking an approval from the U.S. Food and Drug Administration for its booster dose of COVID-19 vaccine.
Pfizer and BioNTech SE (BNTX) said that they have initiated a supplemental Biologics License Application or sBLA to the FDA for the approval of a booster (third) dose of their COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older. The companies plan to complete submission of the sBLA by the end of this week.
The FDA on Monday gave full approval to Pfizer/BioNTech’s COVID-19 vaccine for people age 16 and older.
The Pfizer/BioNTech vaccine, marketed as Comirnaty, has been authorized for emergency use in the US since last December for people age 16 and older. In May, the authorization was extended to those 12 and older.
Pfizer and BioNTech said Wednesday that the sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of COMIRNATY between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post-booster.
The companies noted that 99.5% of participants had a four-fold response after the third dose, compared to 98.0% after the second dose. The titers after dose three met the pre-specified 10% non-inferiority margin for the difference in the four-fold seroresponse rates.
The companies intend to submit these data to a peer-reviewed journal, as well as file these data with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.
A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
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