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Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA.

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Published:28th Dec 2021
Pfizer Inc. and BioNTech SE announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase III clinical trial in 2,228 individuals 12 through 15 years of age to the European Medicines Agency (EMA) to further support the favorable safety and efficacy profile of Comirnaty (COVID-19 mRNA vaccine) in this age group.

In the trial, a two-dose series of Comirnaty (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days through over four months after the second dose. Among 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, all cases of COVID-19 were in the placebo group (n=1,129) and no cases were in the Pfizer-BioNTech vaccine group (n=1,131). The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose.

Pfizer and BioNTech have also submitted these data to the FDA. The data will be filed with other regulatory authorities in the coming weeks. Pfizer and BioNTech plan to submit data from the full Phase III trial for scientific peer-review publication.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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