Pfizer CEO Albert Bourla said Monday that the Food and Drug Administration’s full approval of the company’s Covid-19 vaccine should help ease hesitancy and persuade more people to get the shots.

“For those people that were a little bit reluctant because they wanted to see a full approval, now they have the full confirmation of one of the most respected agencies in the world, the FDA, that the … vaccine is effective and safe,” Bourla said in an interview with NBC News’ Lester Holt. “I expect that these people that were reluctant because of that will now go and get their shots.”

In a wide-ranging interview on the day the FDA granted full approval to the company’s two-dose vaccine for people ages 16 and older, Bourla also mentioned the need for booster shots, how Pfizer is developing a vaccine against the delta variant of the coronavirus and the company’s commitment to get vaccines to poorer countries.

“We realize that through real-world data that after several months there is a need for the booster,” Bourla said. “The booster will be needed because of the combination of the delta variant … and the fact that the immunity after six months starts waning. So a booster dose is a must.”

While some public health experts say booster shots against Covid-19 will probably be warranted at some point, it may be too early to start promoting them for all people without fully understanding how effective they have been.

Still, federal health officials last week announced that starting Sept. 20, all Americans will be eligible for third doses eight months after their second doses. Currently, only people with compromised immune systems are able to get extra shots.

Asked whether Pfizer will eventually have to develop a new and better vaccine, Bourla said scientists are constantly tinkering with new vaccines and are making a vaccine for the highly transmissible delta variant.

“We are making, right now, a specialized vaccine for delta,” he said. Bourla said the delta variant-specific vaccine will almost certainly not be needed, however, because “the booster shot of the current vaccine is very, very, very effective.”

Data from Pfizer and Israel show the booster’s effectiveness, Bourla said. He said nearly half of the 3 billion vaccine doses produced this year — about 40 percent — “will go to middle- and low-income countries.”

The FDA’s acting commissioner, Dr. Janet Woodcock, said in a statement Monday: “The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic. While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA’s decision might pave the way for more vaccination mandates, because many businesses were waiting for full approval before they required employees to be vaccinated.

“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Richard Besser said in a statement. Besser, president and CEO of the Robert Wood Johnson Foundation, is a former acting director of the Centers for Disease Control and Prevention. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

Monday’s approval does not cover people ages 12 through 15, but that group can still get the Pfizer vaccine through emergency use authorization.

No Covid vaccines have been authorized or approved for use in children under 12. Those approvals are expected this fall or winter.

Pfizer’s vaccine is one of three in use in the U.S. and the first to receive full approval. Moderna has also applied for full approval, also known as a Biologics Licensing Application. Johnson & Johnson has not yet applied for full approval, and its vaccine remains in use under emergency authorization.

 

NBC NEWS

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By PharmaTimes

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