Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. The same data had been submitted to the FDA and will be filed with other regulatory authorities in the upcoming weeks.
The submitted variation 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 booster (third) dose of COMIRNATY elicited significantly higher SARS-CoV-2 neutralizing antibody titers against the wild-type strain compared to the levels observed after the two-dose primary series. Phase 1 data also were submitted, showing a similar pattern of booster responses against the wild-type, Beta and Delta variants.
The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY.
Pfizer and BioNTech intend to submit these data to a peer-reviewed journal.
COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Source link: World Pharma News
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