Booster and Yearly Shot of Pfizer/BioNTech’s COVID-19 Vaccine ‘Likely,’ CEO Says

People vaccinated with Pfizer/BioNTech’s double-dose COVID-19 vaccine will likely need to receive a booster shot within a year of full inoculation, as well as an annual shot, according to Pfizer CEO Albert Bourla.

The Pfizer chief, who spoke Thursday at a CVS Health event, said that he believes a booster shot will be needed around six to 12 months after a patient receives their second dose, as well as an annual vaccine shot, though he cautioned that the follow-up inoculations still need to be confirmed. Mutating viral strains will be pivotal in determining if extra shots are necessary, he said, though he noted that the vaccine appears to completely shield against the troublesome South African variant.

“It is extremely important to suppress the pool of people that can be susceptible to the virus, because they are vaccinated with high efficacy vaccines,” Bourla said. “The pool of people is what defines how many replications the virus will do and that defines if or not and how many variants will appear.”

Though the news raises concern about the logistical implications of requiring booster shots and annual doses for already vaccinated people, including the significant amount of manufacturing power that would entail, Pfizer and BioNTech have been engaged since February in research on a potential booster shot (DID, Feb. 26).

Pfizer recently unveiled data showing that its COVID-19 vaccine, after the second dose, remained highly effective for up to six months (DID, April 5). It’s not currently known how long protection fares beyond that time. The six-month follow-up data puts Pfizer/BioNTech in a position to file a biologics license application and seek full FDA approval, though the companies have not yet given a timeframe for their submission.

David Kessler, a former FDA commissioner and current chief science officer of the Biden administration’s COVID-19 response, also expressed concerns Thursday about viral variants and said a booster shot for vaccines may be needed at some point. Kessler, who testified at a House Select Subcommittee on the Coronavirus Response hearing, was asked by lawmakers if boosters would be needed in the coming months.

“We don’t know everything at this moment. We are studying the durability of the antibody response. It seems strong but there is some waning of that and no doubt the variants ... make these vaccines, in essence, work harder,” Kessler said. “I think that for planning purposes, planning purposes only, because there’s no decision, I think we should expect that we may have to boost.”

“With many vaccines, we understand that at a certain point in time you need to boost, whether that’s nine months, 12 months … we are preparing for that coming.”

Although the Centers for Disease Control and Prevention (CDC) has seen approximately 5,800 cases of “breakthrough” COVID-19 infections out of the millions of Americans that have been fully vaccinated so far, it did not express concern about the small figure. The CDC told FDAnews that only 7 percent of patients with breakthrough cases were hospitalized and only 1 percent died. Nearly 78.5 million people in the U.S. have been fully inoculated as of April 15, according to CDC data.

Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, has previously advised that breakthrough infections should be expected during a mass-scale vaccination initiative. — James Miessler and Jason Scott