USA TODAY International Edition

FDA panel to consider COVID- 19 boosters

Necessity for third shot divides health experts

- Karen Weintraub and Elizabeth Weise USA TODAY Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competitio­n in Healthcare. The Masimo Foundation does not provide edito

A federal advisory committee will decide today whether third shots of COVID- 19 vaccines are safe and protective against infections.

At root is whether the extra shots are “luxuries” or an essential part of providing complete protection against the virus, presidenti­al adviser Dr. Anthony Fauci said this week.

He and other federal officials, including President Joe Biden, believe it is time to begin offering third shots to compensate for what appears to be fading protection.

Others, particular­ly the director general of the World Health Organizati­on, argue that Americans would benefit far more by getting initial shots to the unvaccinat­ed around the world.

The Food and Drug Administra­tion advisory committee will consider informatio­n from Pfizer and its German partner BioNTech in deciding whether to allow the companies to provide third vaccine doses to people 16 and older.

In a rare open letter on the eve of an FDA committee meeting, CEO Albert Bourla said both lab data and real- world evidence from Israel showed boosters can play an important role in addressing the pandemic.

“A booster of the same dose and the same vaccine can achieve this marked enhancemen­t of protection,” Bourla wrote in the letter, published on Pfizer’s website Thursday morning.

FDA officials, however, appeared skeptical about the need for third shots for everyone at this point.

In briefing informatio­n provided to the committee and posted online Wednesday, the FDA emphasized studies supporting the need for boosters are not conclusive and were not conducted in the United States, which may see different results than other countries.

“Overall, data indicate that currently US- licensed or authorized COVID- 19 vaccines still afford protection against severe COVID- 19 disease and death in the United States,” the FDA report concluded.

In the United States, “still well over 90% of people” who are hospitaliz­ed with COVID- 19 have not been vaccinated, though vaccinated people have begun to catch milder forms of the disease, CDC Director Dr. Rochelle Walensky said in a White House briefing last week.

It’s not clear whether the committee members, all experts in aspects of vaccine developmen­t and immunology, will support these booster doses six months after initial doses.

Even if they do decide that third doses are safe and effective, it will be up to the Centers for Disease Control and Prevention and its own advisory committee – scheduled to meet Wednesday and Thursday – to decide who should receive the boosters and on what schedule.

The agencies are considerin­g only the Pfizer- BioNTech vaccine at the moment, which is the only fully approved shot, though they are expected to soon review the Moderna vaccine as well.

Fauci, speaking to a class of undergradu­ates Wednesday morning at the Massachuse­tts Institute of Technology, said he thinks it will turn out that people need three doses of the Moderna or Pfizer- BioNTech vaccines in order to get adequate long- term protection against COVID- 19. Other diseases, such as hepatitis B, also require a three- dose vaccine regimen for full protection.

“We started with two doses because we needed to get the vaccine out there quickly to save millions of lives, which it already has done,” he told the students. “But when we ultimately get down to looking at this, as the dust settles, it is my opinion and now many of my colleagues’ that the proper complete regimen would be a three- dose regimen as opposed to a two- dose regimen.”

Data from Israel, which Fauci cited, suggests that vaccine protection begins to fade over time, beginning at around six months, with vaccinated people becoming first more prone to mild disease, and then to increasing­ly severe disease.

Israel, where most people received the Pfizer- BioNTech shots, was one of the first countries to launch wide- scale vaccinatio­n against COVID- 19 and so has some of the best data about how well those vaccines are holding up over time.

Israeli public health officials are expected to attend Friday’s meeting of the Vaccines and Related Biological Products Advisory Committee to explain their findings in detail.

Other public health and vaccine experts are less persuaded by the available data.

“I’m convinced that protection against symptomati­c infection wanes,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelph­ia. But he’s “less convinced about waning of protection against severe disease.”

The purpose of vaccines is not to prevent every single symptom of infection, but to protect people against the most severe outcomes, said Dr. Anna Durbin, who studies experiment­al vaccines at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

“Right now,” she said on a Wednesday call with media, “the indication is that we don’t need an additional booster.”

There’s no doubt that boosters are effective. “Will it improve your immune response? Will we see higher titers of antibody? Yes. Do the safety data look good? Yes. Does that mean we need boosters? No.”

She added, “and we shouldn’t be giving a valuable resource just because we can,” noting it won’t be possible to stop COVID- 19 from coming into the United States unless the virus is stopped around the world.

In his letter, Pfizer CEO Bourla said a decision about boosters should be based on science, not concerns about equitable distributi­on. The introducti­on of boosters won’t alter how many doses each country receives, he said.

“No commitment­s already made by Pfizer to a country will change if boosters are approved,” he said. “We will honor each and every one.”

His letter also noted booster doses were effective against the extremely contagious delta variant, which now accounts for nearly all the COVID- 19 infections in the U. S. Studies show adding a third dose – the same vaccine at the same dose of the first two shots – boosts protection against all variants of the virus.

Fauci told the students he’s relieved the original vaccine provides protection against a wide range of variants; otherwise, he said, “you’d be playing whacka- mole with every new variant.”

 ?? MALCOLM DENEMARK/ USA TODAY NETWORK ?? Cindy Yee of Titusville, Fla., gets a COVID- 19 test from a nurse at the Faith Temple Christian Center in Rockledge.
MALCOLM DENEMARK/ USA TODAY NETWORK Cindy Yee of Titusville, Fla., gets a COVID- 19 test from a nurse at the Faith Temple Christian Center in Rockledge.

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