The U.S. FDA authorized a third dose of Pfizer's Covid-19 vaccine, seen here, for some people with compromised immune systems last week.
Patrick T. Fallon/AFP via Getty ImagesPfizer and its partner BioNTech have submitted initial data to the U.S. Food and Drug Administration in support of authorization for a third booster dose of their Covid-19 vaccine, the pair said Monday
The data comes from the first part of a three-part study on booster doses in people who received their first two doses as part of an earlier trial. The company has previously presented data from this trial that showed antibody responses elicited from the blood of people who had received three doses of the vaccine were stronger than from people who had received two doses.
The company says the higher neutralizing antibody levels were seen both against the original version of the virus and the Delta variant.
Shares of Pfizer (ticker: PFE) were flat in midday trading Monday. BioNTech’s (BNTX) American depositary receipt was down 10.3%, continuing a drop that began before the announcement.
The announcement comes days after the FDA authorized a third dose of Pfizer and Moderna’s (MRNA) vaccines for certain people with compromised immune systems. Though regulators pushed back in early June when Pfizer and BioNTech said they planned on submitting data to the FDA in support of a booster dose, health authorities have acknowledged in recent days that boosters may be an inevitability.
At a White House press briefing Thursday, Dr. Anthony Fauci, President Biden’s chief medical advisor, said that boosters would eventually be necessary. “We believe, sooner or later, you will need a booster for durability of protection,” Fauci said. “If the data shows us that in fact we do need to do that, we’ll be very ready to do it and do it expeditiously.”
The World Health Organization has asked wealthy nations not to offer booster shots in the near term, given the vast populations of entirely unvaccinated people living in poorer nations.
In their press release on Monday, Pfizer said they believed that a third booster dose offered additional protection. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Pfizer CEO Albert Bourla.
The companies said that they expect more data from the three-part booster trial soon, and will submit it when it’s ready.
“This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine,” said BioNTech’s CEO. “A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.”
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