More data needed to make decision on booster injections, US officials say at Pfizer



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This decision could make commercial sense for Pfizer-BioNTech. Since the onset of the pandemic, partner companies have pursued a “market first” strategy for the manufacture and marketing of their vaccine.

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

The strategy has “paid off as generously as anyone could ask,” said Steve Brozak, chairman of WBB Securities, a biotechnology-focused research investment bank.

Last week, Pfizer and BioNTech said that 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 ten times. But antibody levels may not be the best biological measure of the need for booster doses, according to experts, who say it’s no surprise that antibodies rise after taking a third dose.

“The antibody response is not the only measure of immune protection,” said Dr. Leana S. Wen, former Baltimore health commissioner. “Numerous studies suggest that these vaccines also boost B and T cell immunity, so even if there aren’t that many antibodies, that doesn’t mean someone isn’t protected.”

In Israel, the government agreed to provide Pfizer with vaccine data, and Pfizer compared the Israeli data with what its own lab tests show. Some people familiar with the data say it indicates that immunity wanes in those vaccinated after about six to eight months, leading to a growing number of breakthrough infections.

Those attending Monday’s session were a who’s who of government doctors: Dr. Fauci; Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention; Dr Francis Collins, director of the National Institutes of Health; Dr Vivek Murthy, the general surgeon; Dr Rachel Levine, Assistant Secretary for Health; Dr Janet Woodcock, Acting Commissioner of the FDA; Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA; and Dr. David Kessler, a former FDA commissioner who heads, among other things, the Biden administration’s vaccine distribution efforts.

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