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The U.S. FDA cleared a third dose of Pfizer’s Covid-19 vaccine, seen here, for some people with weakened immune systems last week.
Patrick T. Fallon / AFP via Getty Images
Pfizer
and his partner
BioNTech
submitted initial data to the United States Food and Drug Administration to support authorization of a third booster dose of their Covid-19 vaccine, the couple said on Monday
The data comes from the first part of a three-part study of booster doses in people who received their first two doses in a previous trial. The company previously presented data from this trial which showed that the antibody responses elicited by the blood of people who received three doses of the vaccine were stronger than those of people who received two doses.
The company claims that the highest levels of neutralizing antibodies were seen against both the original version of the virus and the Delta variant.
Pfizer shares (ticker: PFE) were flat Monday at noon. BioNTech’s U.S. Certificate of Deposit (BNTX) fell 10.3%, continuing a decline that began before the announcement.
The announcement comes days after the FDA cleared a third dose of Pfizer and
Modern‘s
vaccines (mRNA) for certain people with weakened immune systems. Although regulators pushed back in early June when Pfizer and BioNTech said they planned to submit data to the FDA in support of a booster dose, health officials have acknowledged in recent days that recalls may be inevitable. .
At a White House press briefing on Thursday, Dr Anthony Fauci, chief medical adviser to President Biden, said reminders would eventually be needed. “We think sooner or later you’ll need a durability booster for protection,” Fauci said. “If the data shows us that in fact we have to do it, we’ll be very ready to do it and do it quickly.”
The World Health Organization has called on rich countries not to offer short-term boosters, given the large populations of fully unvaccinated people living in poorer countries.
In its Monday press release, Pfizer said it believes a third booster dose provides additional protection. “The data we’ve seen to date suggests that a third dose of our vaccine causes antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Albert Bourla, CEO of Pfizer.
The companies said they expect more data from the three-part recall trial soon and will submit it when it’s ready.
“These initial data indicate that we can preserve and even exceed the high levels of protection against wild type virus and relevant variants by using a third dose of our vaccine,” said the CEO of BioNTech. “A booster vaccine could help reduce the rates of infection and disease in people who have already been vaccinated and better control the spread of variants of the virus in the coming season. “
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