Pfizer Requests FDA Authorization For Omicron COVID Booster

Pfizer Requests FDA Authorization For Omicron COVID Booster

Pfizer and BioNTech have requested that the Food and Drug Administration (FDA) grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant.

The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.

“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,” said Albert Bourla, Chairman and CEO of Pfizer. “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.”

Ugur Sahin, CEO and co-founder of BioNTech, noted that the updated vaccines would quickly target the most dominant current strain of the coronavirus.

“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” Sahin said in the statement. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”

The updated vaccine contains mRNA of the original SARS-CoV-2 spike protein found in the current vaccine together with mRNA spike protein for the Omicron BA.4/BA.5 variant.

The FDA previously authorized the Pfizer/BioNTech vaccine for active immunization in adults to prevent COVID in 2019 under the Emergency Use Authorization (EUA). Later versions have been approved for younger individuals, including a recent three-dose series available to children as young as six months old.

While COVID case numbers have decreased recently across the nation, officials are recording more than 5,500 hospitalizations per day, according to the Centers for Disease Control and Prevention (CDC). On Sunday, more than 93,000 positive COVID tests were reported nationwide.

The most recent data provided by the CDC reveals that the BA.5 variant is responsible for 88.9% of all new cases between August 14 and August 20. The BA.4 variant included an additional 4.3% of new cases.

Several well-known Americans have tested positive despite being fully vaccinated and receiving booster shots. Both President Joe Biden and First Lady Jill Biden tested positive in recent weeks.

The first lady tested positive on August 16, leading to added precautions for the president.

“The President tested negative for COVID this morning on an antigen test,” the White House press secretary tweeted at the time. “Consistent with CDC guidance because he is a close contact of the First Lady, he will mask for 10 days when indoors and in close proximity to others. We will also increase the President’s testing cadence and report those results.”

Vice President Kamala Harris and Second Gentleman Douglas Emhoff also tested positive for the coronavirus earlier this year. Other leading officials, including House Speaker Nancy Pelosi (D-CA), have also tested positive despite being vaccinated.

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