Pfizer and BioNTech seek FDA emergency use authorization for updated COVID-19 vaccine booster

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Pfizer and BioNTech have asked the U.S. Food and Drug Administration to green-light emergency use authorization for an updated COVID-19 vaccine booster shot.

According to a press release, the companies are seeking an EUA for “a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.”

“The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant,” the press release said. “Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.”

The booster is set to roll out immediately once the green light is given.

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“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Pfizer chairman and CEO Albert Bourla said, according to the release. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”

Prominent figures, including Bourla, have tested positive for COVID-19 after having already received four vaccine shots.

“After isolating all week, I am happy to report that I have now tested negative in 2 consecutive tests. Although I was fortunate to only experience mild symptoms that resolved within a few days, I am grateful for the support and well wishes expressed by so many,” Bourla tweeted on Friday.

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