Pfizer requests FDA approval for Omicron-specific booster dose – Consumer Health News

MONDAY, Aug. 22, 2022 (HealthDay News) — Pfizer Inc. announced Monday that it has applied to the U.S. Food and Drug Administration for emergency use approval for an updated booster shot that targets multiple versions of the Omicron variant.

Animal studies show that the new mRNA vaccine produces an immune response against the BA.4 and BA.5 subvariants, with clinical trials expected to begin this month, the company said in a press release announcing the application.

“The agility of the mRNA platform, coupled with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has enabled us to develop, test and manufacture updated, high-quality vaccines that align with strains in circulation at an unprecedented rate,” Pfizer said. Chairman and CEO Albert Bourla.

“Having ramped up production rapidly, we are able to immediately begin distribution of Omicron BA.4/BA.5 bivalent boosters, if approved, to help protect individuals and families as we prepare for power surges. fall and winter potentials,” he said in The Release.

The BA.5 subvariant accounts for nearly 90% of new COVID cases in the United States, according to the United States Centers for Disease Control and Prevention.

The FDA plans to review the data in September. If authorized, the vaccine can be distributed immediately, BNC News reported.

Harvard epidemiologist Bill Hanage said BNC News that the turnaround time for this new vaccine was “remarkably fast”. Vaccines typically take years to develop and distribute, and the latest Omicron subvariants only began to spread widely in the United States in early June.

The new vaccine will be “important” especially for people vulnerable to serious infections, such as the elderly, Hanage said.

The new vaccines should be available before an expected winter surge of COVID cases, White House COVID coordinator Dr. Ashish Jha said last week.

FDA allows Pfizer to submit less vaccine data than for other COVID vaccines because modified vaccines that target emerging strains of COVID can be approved without lengthy clinical trials, BNC News reported.

More information

Visit the US Centers for Disease Control and Prevention to learn more about COVID vaccines.

SOURCES: Pfizer, press release, August 22, 2022; BNC News

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