Pfizer to ask permission to give booster shot; FDA, CDC say it’s not necessary

Pfizer plans to ask the Food and Drug Administration for emergency authorization of a third dose of its COVID-19 vaccine, the company’s chief scientific officer told The Associated Press on Thursday.

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According to Mikael Dolsten, the company will seek the authorization after studies showed people’s antibody levels jump five to 10 times after a third dose of the vaccine.

Dolsten, pointing to early data from the company’s booster study, said that a third shot within a year after being fully vaccinated could dramatically boost immunity and possibly fight such virus variants as the delta variant, which is the prominent version of the virus in the United States.

“We continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination,” a statement from Pfizer and its partner BioNTech released Thursday read.

“While protection against severe disease remained high across the full 6 months, the observed decline in efficacy against symptomatic disease over time and the continued emergence of variants are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection.”

While the company is seeking permission to give a third shot, the FDA and the Centers for Disease Control and Prevention issued a joint statement Thursday saying that those who are fully vaccinated do not need a booster COVID-19 shot.

“Americans who have been fully vaccinated do not need a booster shot at this time,” read the statement. “FDA, CDC and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”

The statement went on to say, “We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

A peer-reviewed report published Thursday in the journal Nature showed that two doses of the Pfizer vaccine generate a neutralizing response to the Delta variant in 95% of people in the study. The results, researchers say, show the need to be fully vaccinated to get protection from COVID-19 and its variants.

According to researchers, a single shot of a two-dose vaccine “barely” offers any protection against the variant.

Another report released this week, written by scientists in the United States and published Wednesday in the New England Journal of Medicine, showed similar results.

Variants are mutations a virus undergoes to protect itself and to continue to replicate.

The delta variant is thought to be more contagious than the original COVID-19 virus. However, various studies have shown that vaccines manufactured by Pfizer, Moderna and Johnson & Johnson are effective against the variant.

Should someone who is fully vaccinated contract the Delta variant, they would be far less likely to suffer severe symptoms, become hospitalized or die from the infection, researchers say.

Pfizer will be asking the FDA in August to authorize the administration of a third dose of its vaccine.

Moderna has not yet revealed any plan to petition the FDA to allow for a third dose of its vaccine.

Should the FDA authorize a third dose for Pfizer, who gets it and how it is administered would still have to be determined.

William Schaffner, a vaccine expert at Vanderbilt University Medical Center, told the AP that a decision would have to be made as to whether a third dose would be given, when millions of people still 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.”

About 48% of the U.S. population are fully vaccinated against the COVID-19 virus.

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