Pfizer seeks U.S. authorization for a third dose of their coronavirus vaccine, immunity boost, and combat any virus mutant.
Pfizer’s Dr. Mikael Dolsten told the AP the company’s booster study suggests antibody levels rise fivefold to tenfold after a third dose.
The data have not been published nor peer-reviewed. The vaccine makers said they expected to submit their findings to the Food and Drug Administration in the coming weeks, a step toward gaining authorization for booster shots.
As Breitbart News reported in April, Pfizer flagged plans to ask for emergency authorization by the Food and Drug Administration for the third dose.
“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. Fauci has already previewed the possibility of booster shots for coronavirus; he explained that people “very well may need to get booster shots to keep up the level of protection.”
Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, cautioned FDA authorization would be just a first step – it would not mean Americans get offered boosters.
He told AP public health authorities would have to decide if they’re 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.”
The news comes as US regulators said Americans who have been fully vaccinated do not need a booster Covid-19 shot at this time.
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.
Drug company data will be included in that work but does not rely on those data exclusively,” only when “the science demonstrates that they are needed,” the agencies said.
The U.S. population is only about 48 percent fully vaccinated – while some parts of the country have far lower immunization rates, the delta variant surges there.