Pfizer to press its case to U.S. officials Monday on need for Covid vaccine booster shots

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Pfizer is meeting with federal health officials Monday to press its case for Covid-19 vaccine booster shots as the pharmaceutical company prepares to seek U.S. authorization for a third shot, the company confirmed.

The meeting comes amid a public dispute between the drugmaker and U.S. officials on if and when Americans will need additional doses of the Covid vaccines. Pfizer said Thursday it is starting to see waning immunity from its two-dose vaccine, developed with German partner BioNTech, and now plans to seek authorization for a booster dose.

But shortly after Pfizer’s announcement, the Centers for Disease Control and Prevention and the Food and Drug Administration released a joint statement rebuking the company’s comments, saying Americans who have been fully vaccinated against Covid do not need booster shots at this time.

The debate over booster shots comes as the public becomes increasingly concerned about the highly transmissible delta variant — already the dominant form of the disease in the U.S. — and whether current regimens of the authorized vaccines will provide enough protection.

Those invited to the meeting include White House chief medical advisor Dr. Anthony Fauci, Dr. Francis Collins, director of the National Institutes of Health, CDC Director Dr. Rochelle Walensky and acting FDA Commissioner Dr. Janet Woodcock, according to The Washington Post.

The White House and the Department of Health and Human Services declined to comment.

“It is very unusual, and it is frustrating,” Dr. Paul Offit, who advises the FDA on Covid vaccines, said about the meeting Monday. “Pfizer is a pharmaceutical company. They are not a public health agency. It is not theirs to determine how this vaccine gets distributed regarding booster doses. That’s dependent on the epidemiological work that’s being done by the CDC.”

Offit said there is currently no data to suggest most Americans need booster doses yet. When officials begin seeing an increase in the percentage of fully vaccinated people going to the hospital or dying, then it may be time for the booster shots, he said.

“Right now, that percent is less than 1%,” he said. “Maybe over a year it’s 5% and then a year after that it’s 10% to 20%” of hospitalizations and deaths are among fully vaccinated people.

Pfizer has cited data from Israel that shows its vaccine remains highly effective against severe disease and death but that its effectiveness is declining against mild cases.

Last week, Israeli officials reported a decrease in the effectiveness of the Pfizer-BioNTech vaccine in preventing infections and symptomatic illness but said it remained highly effective in preventing serious illness.

Dr. Isaac Bogoch, an infectious disease professor at the University of Toronto, called Israel’s report on vaccine effectiveness “flawed” as it was based on only an observational study from a single source.

People want to say “delta is invading vaccines,” he said. “That’s not the case. This is rapidly becoming the disease of the unvaccinated. We need to learn to distinguish between infection and disease.”

He said the vaccines in the U.S. provide “excellent protection against” variants, including delta.

“There may be a need for boosters in select populations, like immunocompromised individuals, and we should be open-minded to the need for boosters in the general population moving forward. But there currently does not appear to be a need right now,” he said.

Source: Business -

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