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FDA schedules April 6 meeting to devise next steps on COVID-19 boosters

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The Food and Drug Administration said Monday it will hold an advisory meeting in early April to debate who should get additional COVID-19 booster shots in the coming months and whether the vaccines need to be tailored to specific variants as the U.S. debates the best use of a quiet stretch in the pandemic to avoid future shocks.

Regulators are kickstarting debate around a fourth shot as Americans brace for a potential surge from the BA.2 variant that socked Europe. There are fears the country will be caught flat-footed as it closes state-run testing sites and tries simply to weather pandemic spikes without widespread restrictions and mandates.

Nearly 100 million Americans opted for a third vaccine dose and have been left to wonder if and when they may need a fourth injection to restore waning immunity during the pivot to an endemic phase in which the virus lingers in the background of everyday life.

Case counts of 30,000 per day are at their lowest point since July, before the delta wave, prompting debate about complacency and ways to maintain defenses against the virus.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) won’t discuss a specific application from any company or hold votes during the April 6 session.

But the FDA signaled it wants to start answering questions about the next steps in an open forum.

“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat,” he said. “Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”

Vaccine makers say they are prepared to make an omicron-specific vaccine if needed, though scientists say the existing shots have been able to offer broad protection against severe disease from known variants.

Pfizer and BioNTech recently requested FDA authorization for the fourth shot of its vaccine for persons 65 and older. They cited data from Israel that found persons who received another booster at least four months after the third shot were two times less likely to get infected and four times less likely to face severe illness.

Days later, Moderna upped the ante by requesting authorization for another booster for adults of all ages, fueling the debate around who needs a booster and when.

“The facts on boosters/fourth shots remain murky. FDA is saying it needs to review all data and it does,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.

The Centers for Disease Control and Prevention says 65% of the U.S. population, or 217 million people, received a primary vaccination series, defined as two doses of the Pfizer or Moderna vaccines or one shot of the Johnson & Johnson vaccine.

About 45% of the fully vaccinated opted to receive an initial booster shot.

President Biden spent the past several months begging Americans to take advantage of booster shots that are free and widely available, though some Americans do not seem convinced additional shots are necessary to stave off a bad outcome.

Those resisting any vaccination at all are dug in and persons who detest mandates around the shots are protesting in a trucker convoy around the nation’s capital.

On the flip side, some governors have pressed regulators to let them give fourth shots to the elderly and vulnerable persons as the nation decides to navigate its way through future waves without resorting to widespread restrictions.

At the same time, many governors are closing state-run testing sites, citing a lack of demand.

New Hampshire closed its state-run sites last week, South Carolina is closing its own through March, and Utah has been unwinding mass testing since February, according to a tally from The New York Times.

Some Massachusetts lawmakers told Gov. Charlie Baker, a Republican, to reconsider his decision to close a large number of PCR testing sites by the end of the month.

“The Stop the Spread site has proven invaluable in the battle to identify community outbreaks and take steps to curb higher education transmission rates and prevent spread to the wider community,” lawmakers wrote a recent letter to the Department of Public Health.

The Daily Hampshire Gazette reports officials in Amherst and elsewhere are particularly worried about losing services on college campuses and would like them to continue until June 1.

“The discontinuation of this program comes at a critical time as the population is transitioning from mask mandates to navigating risk reduction,” they wrote. “At the end of this week, approximately 30,000 students and other members of our community will be returning to Amherst from spring break. It is crucial to understand the direction of the disease in regards to case transmission, as well as new variants that may have different virulence or fitness.”

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