Pfizer Asks FDA to Approve Omicron-Specific Booster Shot

Pfizer Inc. said Monday that it has asked the U.S. Food and Drug Administration to approve the emergency use of an updated booster shot that targets several versions of the Omicron variant.

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

“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 Pfizer Chairman and CEO Albert Bourla.

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“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,” he said in the release.

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

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

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Harvard epidemiologist Bill Hanage told NBC News that the turnaround time for this new vaccine was “remarkably quick.”

It usually takes years for vaccines to be developed and distributed, and the latest Omicron subvariants only began spreading in the United States widely in early June.

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

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

The FDA is allowing Pfizer to submit less data on the shot than it has for other COVID vaccines, because modified vaccines that target emerging strains of COVID can be approved without lengthy clinical trials, NBC News reported.

What You Need to Know About Vaccines

• CDC recommends COVID-19 primary series vaccines for everyone ages 6 months and older, and COVID-19 boosters for everyone eligible ages 5 years and older.
• Getting a COVID-19 vaccine after you recover from COVID-19 infection provides added protection against COVID-19.
• People who are moderately or severely immunocompromised have different recommendations for COVID-19 vaccines, including boosters.
• The following COVID-19 vaccine and booster recommendations may be updated as CDC continues to monitor the latest data.

Visit the U.S. Centers for Disease Control and Prevention for more on COVID vaccines. booster shot