Pfizer is ready to seek U.S. authorization for a third dose of its coronavirus vaccine, outlining Thursday a top up shot within 12 months could dramatically boost immunity and counter any virus mutant.

Pfizer’s Dr. Mikael Dolsten told the Associated Press early data from the company’s booster study suggests people’s antibody levels rise five- to 10-fold after a third dose, compared to their second dose months earlier.

In April, Pfizer flagged plans to ask the Food and Drug Administration (FDA) for emergency authorization of a third dose, as Breitbart News reported.

“We believe that the third dose will raise the antibody response 10- to 20- fold,” Pfizer CEO Albert Bourla said at the time, likening it to the annual flu shot.

“Every year, you need to go to get your flu vaccine,” Bourla said. “It’s going to be the same with COVID. In a year, you will have to go and get your annual shot for Covid to be protected.”

Dr. Anthony Fauci has already previewed the possibility of coronavirus booster shots, explaining people “very well may need to get booster shots to keep up the level of protection.”

But FDA authorization would be just a first step — it wouldn’t automatically mean Americans get offered boosters, cautioned Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center.

He told AP public health authorities would have to decide if they’re really needed, especially since millions of people have no protection.

“The vaccines were designed to keep us out of the hospital” and continue to do so despite the more contagious delta variant, he said. Giving another dose would be “a huge effort while we are at the moment striving to get people the first dose.”

Hours after Pfizer’s announcement, U.S. health officials issued a statement saying fully vaccinated Americans don’t need a booster yet.

U.S. health agencies “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the FDA and Centers for Disease Control and Prevention said in a joint statement.

That work will include data from the drug companies, “but does not rely on those data exclusively,” and any decision on booster shots would happen only when “the science demonstrates that they are needed,” the agencies said.

Currently only about 48 percent of the U.S. population is fully vaccinated — and some parts of the country have far lower immunization rates, places where the delta variant is surging.

The Associated Press contributed to this story

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