Pfizer Fails to Convince FDA on Immediate Need for COVID Booster Shots | The Defender | Children’s Health Defense News & Views

Pfizer met with U.S. regulators Monday evening to press its case for quick authorization of COVID booster vaccines but health officials, who remained unconvinced, called for more data.

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After meeting with Pfizer executives Monday, U.S. regulators said they are still not ready to recommend COVID vaccine booster shots.

“Nothing has really changed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting.

Pfizer executives met privately with U.S. senior scientists and regulators Monday evening to press their case for quick authorization of COVID booster vaccines amid pushback from federal health agencies who last week said the extra doses are not needed.

Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.

During the 1-hour online virtual meeting, Pfizer’s chief scientific officer briefed top doctors in the federal government, including: Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Dr. Francis Collins, director of the National Institutes of Health; U.S. Surgeon General Dr. Vivek Murthy; Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA); Assistant Secretary for Health Dr. Rachel Levine; and Dr. David Kessler, chief science officer of the Biden administration’s COVID response team.

The meeting was largely seen as a courtesy after Pfizer’s announcement last week that it would seek Emergency Use Authorization for its booster shot led to unusual pushback from the FDA and CDC.

The two agencies responded to Pfizer’s news in a joint statement, issued last week by the U.S. Department of Health and Human Services (HHS), in which they said fully vaccinated Americans don’t need boosters right now and the science is lacking.

“The CDC and the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci told CNN Monday. “That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions,” Fauci said.

Officials said any recommendations about booster shots are likely to be scaled, even within age groups. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait, The New York Times reported.

Then there is the issue of what kind of booster will be needed: a third dose of the original vaccine, or a shot tailored to the Delta variant.

“It was an interesting meeting,” Fauci said. “They shared their data. There wasn’t anything resembling a decision. This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Pfizer called the meeting “productive”:

“We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow.”

Pfizer said it would be publishing “more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible.”

According to The New York Times, HHS, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” the agency said.

An HHS spokesperson told CNN the CDC and FDA take laboratory data, clinical trial data, cohort data — which can include data from specific pharmaceutical companies, but do “not rely on those data exclusively.”

The administration is prepared for booster doses if the science demonstrates they are needed, the spokesperson added, and will continue to review any new data as it becomes available.

Prior to Monday’s meeting, Dr. Scott Gottlieb, former FDA commissioner and current board member at Pfizer, told CBS News updated efficacy numbers from the Israeli Ministry of Health led Pfizer to seek Emergency Use Authorization for a booster dose of its COVID vaccine.

Israel’s health ministry said in a statement last week it had seen the efficacy of Pfizer’s vaccine drop from more than 90% to about 64% as the Delta variant spread.

As a result, Israel started administering a third dose of Pfizer’s COVID vaccine to immunocompromised people and heart transplant patients — despite the vaccine’s link to heart inflammation.

WHO says Pfizer should focus on improving access to vaccine, not boosters

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