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Previously, the FDA had issued an EUA for those over the age of 65 and those at high risk for severe COVID-19 or exposure to the virus.
Pfizer and BioNTech have requested the FDA amend its emergency use authorization (EUA) for a booster dose of their COVID-19 vaccine to include all people 18 years of age and older. This request is based on results from a phase 3 trial with more than 10,000 participants, which showed a relative vaccine efficacy of 95.6% when compared with those who did not receive a booster. The adverse event profile was consistent with other safety data and no new safety concerns were identified.
In September, the FDA issued an EUA for a booster dose of the Pfizer-BioNTech vaccine for people 65 years of age and older, as well as for those 18 through 64 years of age at high risk of severe COVID-19 or with occupational exposure. And in October, the FDA issued an EUA for the vaccine for children five years and up at a dose that is one-third that of the dose for adults.
The companies have shared the data from the phase 3 booster trial with the European Medicines Agency and other regulatory authorities. A booster dose of the vaccine is approved in the European Union and authorized/approved in other countries for individuals 18 years of age and older based on previously submitted safety, tolerability and immunogenicity data.
This COVID-19 vaccine, now called Comirnaty, has contributed $13 billion in direct sales and alliance revenue for Pfizer, according to the company’s third-quarter results.