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FDA Advisory Panel Set to Meet on Booster Shots

HealthDay News
by By Ernie Mundell and Robin Foster HealthDay Reporters
Updated: Sep 2nd 2021

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THURSDAY, Sept. 2, 2021 (HealthDay News) -- The U.S. Food and Drug Administration will hold a key advisory panel meeting on coronavirus booster shots on Sept. 17, a mere three days before the Biden administration plans to begin offering third shots for Americans.

While the public session could add clarity to what some feel has been a confusing decision-making process, it also could fuel more controversy over the administration's plan.

Panel member Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, has questioned whether boosters are needed at this time because data indicates the vaccines still work well against severe COVID-19. But administration officials have stressed that protection is waning.

Though the stated purpose of the meeting is to review booster data on the Pfizer vaccine, it will likely to deal with broader questions about booster shots, the Washington Post reported: Those include who should get booster shots and when, and what is this country's obligation to other countries who are scrambling for first and second doses of the vaccines.

The panel's recommendations are not binding. But a split between the FDA's expert panel and agency officials could make it more difficult for the agency to approve boosters.

If the committee concludes boosters are needed, it could strengthen the agency's hand in approving a third Pfizer shot and later doing the same for boosters by Moderna and Johnson & Johnson, the Post said. The two-shot Pfizer regimen received full FDA approval last week, while the Moderna and Johnson & Johnson vaccines are still given under an emergency use authorization.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told the Post that "a transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines."

Outside experts praised the scheduling of the meeting, saying it shows the agency is trying to stick to the normal procedures on vaccines, despite the urgency caused by the highly transmissible Delta variant. The Biden administration announced Aug. 18 that boosters would be available the week of Sept. 20 to most people fully vaccinated eight months earlier, pending clearance from the FDA and the U.S. Centers for Disease Control and Prevention. But critics said that typically the FDA and the CDC, and their advisers, would review data before decisions were announced.

"It's a good sign that the FDA is trying to adhere to a regular process," said Jason Schwartz, an associate professor of health policy and the history of medicine at the Yale School of Public Health. But he told the Post that the meeting could be "awkward," with the administration receiving criticism for "a really messy sequence of events."

That argument was amplified Tuesday when news broke that two top vaccine officials would retire this fall. Marion Gruber, who leads the Office of Vaccines Research and Review, will step down at the end of October. Philip Krause, Gruber's deputy, is expected to leave the agency in November. The two have decades of experience in vaccines and have helped steer the agency's efforts through a demanding period with the pandemic.

People familiar with the decisions told the Post that Gruber has been talking about retiring for some time, but that Krause's decision was more of a surprise. They said both officials were frustrated by what they saw as an encroachment by the White House on the agency's ability to analyze data and make independent decisions. But they also said they did not know whether that was the reason for the retirements, the Post added.

U.S. COVID vaccination rates climb in August

Nearly 14 million Americans got their first dose of a coronavirus vaccine in August, a steep rise from July, White House officials said this week.

The statistic is a sign that vaccine skepticism may be waning, as the highly contagious Delta variant continues to fuel case surges across the United States.

"We've accelerated the pace of first shots. In August, we got over 14 million. That's almost 4 million more first shots in August compared to the prior month, July," White House COVID-19 response coordinator Jeff Zients said during a news conference Tuesday.

"Back in mid-July, we were averaging 500,000 vaccinations per day. Today, we're averaging 900,000," Zients added. "That's an 80 percent increase in the number of shots we're getting into arms each and every day."

"We remain laser-focused on getting more shots in arms, and we continue to build momentum," he stressed.

One important tool in that mission? Zients said vaccine mandates are helping drive immunization numbers up, and he championed those already in place for federal workers, and at some colleges and companies.

"Tens of millions of Americans are now covered by vaccination requirements. And these requirements are already working to get more people vaccinated," he said.

A new poll suggests Zients is right: It showed that a stubborn core of vaccine-hesitant Americans is slowly warming to the vaccines.

Only 20 percent of American adults now say they won't get immunized, the lowest number ever, the Axios/Ipsos poll found, and there has been a sharp increase in past two weeks of the number of parents who plan to get their younger kids vaccinated as soon as it's allowed.

68% of parents said they either have already vaccinated their children or are likely to do so as soon as the vaccines are approved for their child's age group. That's the highest share ever seen in the survey, and a 12-point spike from 56% just two weeks ago.

One in three unvaccinated Americans in the survey said full approval of the vaccines would make them likely to get shots. But 43% said employer vaccine mandates would make them likely to do so, up from 33% a month ago.

"Schools, organizations, companies, governments implementing mandates are forcing people to deal with them," Cliff Young, president of Ipsos U.S. Public Affairs, said in a news release on the poll. "That's what going on."

Nearly 62 percent of people in the United States aged 12 and older have had at least one dose of coronavirus vaccine, according to data from the U.S. Centers for Disease Control and Prevention. But other developed nations such as Canada, Germany and the United Kingdom still have higher vaccination rates, according to recent data from Johns Hopkins University, the Post reported.

Meanwhile, about 70 percent of all adults in the European Union are now fully vaccinated, the bloc announced on Tuesday, reaching a target it set at the start of the year, the Post reported.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.


SOURCES: Washington Post; The New York Times




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