FDA advisory panel endorses COVID-19 booster shots only for Americans 65 and over or at high risk for severe disease

Coronavirus

WASHINGTON (AP/WAVY/NEXSTAR) — A federal panel of medical experts that voted against Pfizer booster shots for all Americans unanimously supported a third vaccine injection for people at higher risk from the virus.

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The 16-2 vote Friday to reject boosters for all Americans was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious delta variant.

Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on the safety of extra doses.

And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.

However, the FDA advisory panel did endorse COVID-19 booster shots for Americans age 65 and older or at high risk for severe disease. The vote was 18-0.

The panel agreed that, based on the scientific evidence available, the “potential benefits outweigh the known and potential risks of a Pfizer-BioNTech COVID-19 vaccine booster dose administered at least 6 months after completion of the primary series for both population groups.

Virginia Department of Health officials said it’s unlikely they VDH will be authorizing places to dispense any booster shots starting Monday, Sept. 20 because they will not be authorized by the Food and Drug Administration and the Centers for Disease Control and Prevention.

Virginia would only act on approving boosters if the CDC makes a final decision. However, third shots for those who are immunocompromised are now available in the state.

Virginia Vaccine Coordinator Dr. Danny Avula issued a statement after the FDA decisions Friday.

“Today, an advisory committee of the U.S. Food and Drug Administration (FDA) voted in favor of recommending booster doses of the Pfizer-BioNTech COVID-19 vaccine to Virginians 65 years and up and those at high risk for severe COVID-19. This is simply a recommendation at this point, and booster doses will not be available in Virginia until the FDA issues an updated authorization, and the Centers for Disease Control and Prevention (CDC) issues new guidance. The CDC’s Advisory Committee on Immunization Practice is scheduled to meet September 22-23, and we do not expect CDC to release recommendations before late next week at the earliest.

“VDH will continue its planning efforts with pharmacies, providers, hospitals and other partners as well as efforts to establish other vaccination sites to ensure that once the CDC issues guidance, eligible Virginians will be able to access a booster dose. VDH will provide information about accessing a booster dose on vaccinate.virginia.gov when more guidance is available.”

The panel’s support for a third Pfizer shot for elderly and high risk Americans will help salvage part of the White House’s campaign but will still be a huge step back from the sweeping plan proposed by administration a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

Panel members also complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.

Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.

The surprise turn of events could reinforce recent criticism that the Biden administration got out ahead of the science in its push for boosters. President Joe Biden promised early on that his administration would “follow the science,” following disclosures of political meddling in the Trump administration’s coronavirus response.

The FDA advisory panel was the first major hurdle that the Biden administration plan faced. The FDA itself has yet to make its own determination but typically follows the recommendations of its expert panel.

In yet another step to the process, a CDC advisory committee that sets policy for U.S. vaccinations campaigns is set to meet on Wednesday to debate who, exactly, should get boosters and how many months after their second dose should them receive the extra shot.

The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters.

The FDA panel’s overwhelming rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.

And representatives for Pfizer argued that it is important to shore up immunity before protection against severe disease starts to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.

Both Pfizer and the Israeli representatives faced pushback from panelists. Several expressed skepticism about the relevance of Israel’s experience to the U.S. Another concern was whether third doses would exacerbate serious side effects.

Meissner said he is worried about extra doses for younger age groups given the risk of heart inflammation that has been seen in mostly younger men after a second dose. While the condition is very rare, he said, it is not clear if that risk would increase with another dose.

Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to that seen after second doses.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said he was more likely to support approving a third dose for adults over 60 or 65 but “I really have trouble” supporting it for anyone down to age 16.

While an extra shot likely will at least temporarily decrease cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit said.

Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots a month ago, targeting the week of Sept. 20 as an all-but-certain start date. But that was before FDA staff scientists had completed their own assessments of the data.

Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said continuing studies show the shots are working well despite the delta variant.

On Friday, U.S. Surgeon General Dr. Vivek Murthy said that in announcing its booster plan, the Biden administration was not trying to pressure regulators to act but was instead trying to be transparent with the public and be prepared in the event that extra shots won approval.

“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” Murthy said.

The Biden plan has also raised major ethical concerns about impoverished parts of the world still clamoring for vaccine. But the administration has argued that the plan is not an us-or-them choice, noting that the U.S. is supplying large quantities of vaccine to the rest of the globe.

The U.S. has already approved Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.

Some Americans, healthy or not, have managed to get boosters, in some cases simply by showing up and asking for a shot. And some health systems already are offering extra doses to high-risk people.

 To find free vaccines nearby, visit vaccinate.virginia.gov or call 877-VAX-IN-VA (877-829-4682, TTY users call 7-1-1).

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