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Pfizer and BioNTech file sBLA with FDA for Comirnaty as booster dose for 16 years and up in COVID-19

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Published:26th Aug 2021
Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to the FDA for the approval of a booster (third) dose of Comirnaty (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.

The companies intend to complete submission of the sBLA by the end of this week.

The sBLA includes data from a Phase III 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 booster (third) dose of Comirnaty elicited robust neutralizing antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection through one-month post-dose-three. SARS-CoV-2 50% neutralizing titers after the third dose were 3.3 times the titers after the second dose. The post-dose-three neutralizing titers met the prespecified 1.5-fold non-inferiority criterion for success and were statistically superior. Moreover, 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.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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