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U.S. Officials Push Back on Pfizer’s Request for Booster Shot Approval

“Americans who have been fully vaccinated do not need a booster shot at this time,” the statement said, adding, “We are prepared for booster doses if and when the science demonstrates that they are needed.”

The move may make good business sense for Pfizer-BioNTech. Since the onset of the pandemic, the partner companies have pursued a “get to market first” strategy in manufacturing and marketing their vaccine.

The companies did not take federal money or participate in Operation Warp Speed, former President Donald J. Trump’s fast-track vaccine initiative. They were not only the first to win Food and Drug Administration authorization for their coronavirus vaccine, the first to use novel mRNA technology, but also the first to gain authorization for their vaccine’s use in adolescents.

The strategy has “paid off as handsomely as anyone could ask for,” said Steve Brozak, the president of WBB Securities, a research investment bank focused on biotechnology.

Last week, Pfizer and BioNTech said a booster given six months after the second dose of the vaccine increased the potency of antibodies against the original virus and the Beta variant by five- to tenfold. But antibody levels may not be the best biological measurement of the need for booster doses, according to experts, who say it is no surprise that antibodies would increase after taking a third dose.

“Antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, a former health commissioner for Baltimore. “There have been multiple studies that suggest these vaccines also stimulate B cell and T cell immunity, so even if there isn’t as much antibody, that doesn’t mean someone isn’t protected.”

In Israel, the government agreed to provide Pfizer with data on its vaccine recipients, and Pfizer has been matching the Israeli data with its own laboratory tests on antibody responses. Some people familiar with the data say that taken together, the two data sets indicate that immunity is waning among the vaccinated after roughly six to eight months, leading to a growing number of breakthrough infections.

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