FDA panel rejects mass booster plan — undermining Biden's hopes

FDA panel rejects mass booster plan — undermining Biden's hopes
President Joe Biden, joined by Counselor to the President and White House COVID-19 Response Coordinator Jeff Zients, receives a briefing from Director of the NIH Dr. Francis Collins and Chief Medical Adviser to the President and Director of the National Institutes of Allergy and Infectious Diseases Dr. Anthony Fauci Thursday, Feb. 11, 2021, at the Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health in Bethesda, Maryland. (Official White House Photo by Adam Schultz)

It looks like most Americans won't be rolling up their sleeves for a third COVID-19 vaccine shot this year — at least those under the age of 65.

On Friday, a federal advisory committee of 18 people voted against the Biden administration's mass booster plan to offer third Pfizer vaccine shots to everyone over the age of 16. Two members of the committee voted in favor of the plan to offer mass booster shots, while the remainder of the committee voted no. If a majority of the committee voted yes, boosters would have been offered to people 16 and over who received their last dose nearly eight months ago.

Then, in a rare second vote, the panel voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer's vaccine in people 65 and older and those at high risk of severe COVID-19 six months after full vaccination.

The first vote that rejected the Biden administration's plan came as a surprise. The rejection of the booster plan ultimately hinged on a lack of adequate data that showed a third shot would slow transmission among people who get infected despite vaccination, and data suggesting that the antibodies from a third shot wouldn't wane over time as well. The panel questioned the accuracy of comparing data from Israel to the situation in the U.S., and questioned whether a third dose would increase the rare risk of heart inflammation that has been seen in mostly younger men after the second dose.

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

Many members of the committee, assembled by the Food and Drug Administration, also expressed doubts about the effectiveness of a mass booster plan compared to one that would target specific groups — like people over the age of 65.

The FDA has yet to make its own decision on the recommendation, but their recommendation generally follows what's decided among the expert panel like the one that met today. Today's vote was the first step in the process for the FDA to officially approve boosters. A CDC advisory committee is scheduled to meet next week, as another step of the process, to debate who should get boosters and how many months after their second dose they should receive them.

In August, the U.S. Department of Health and Human Services (HHS) announced they were putting a plan together for booster shots. In the announcement, public health officials stated starting the week of September 20, 2021, people who were fully vaccinated and about eight months away from their last second shot would be eligible for a third.

"At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster," the statement read. "We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them."

As this so-called booster roll-out date neared, the initial plan appeared to be in flux. Since Moderna, maker of one of three approved COVID-19 vaccines in the US, hasn't provided adequate data on boosters, the Pfizer vaccine was the only possibility for a third shot to get into arms this month. While the Biden administration appeared to be confidently moving forward with approving a third Pfizer shot for everyone over the age of 16, a bit of a backlash and debate in the scientific community surfaced.

In particular, there have been a series of clashing reviews and arguments among scientists on whether or not boosters are really needed. A study published in The New England Journal of Medicine argued that those who received a third Pfizer shot in Israel were far less likely to get a severe case of COVID-19 than those who received two shots. However, a group of scientists wrote in The Lancet that there's not enough evidence to suggest boosters are needed at this time.

Two of the authors of the paper are scientists at the Food and Drug Administration. According to the New York Times, Dr. Philip Krause and Dr. Marion Gruber is poised to leave this fall, in part because they were upset over the initial booster announcement.

As Salon previously reported, boosters are already controversial in part because mass distribution of them would decrease the supply of available vaccines that could be distributed in more needy nations with less vaccine access. Previously, the World Health Organization (WHO) called for a moratorium on booster shots in affluent countries throughout September. Yet Israel, Germany, and the UK had already approved COVID-19 booster shots for the elderly and those with underlying conditions.

"Even while hundreds of millions of people are still waiting for their first dose, some rich countries are moving towards booster doses," said WHO Director-General Tedros Adhanom Ghebreyesus. "So far more than 4 billion vaccine doses have been administered globally. More than 80% have gone to high and upper middle income countries, even though they account for less than half of the world's population."

In the U.S., many have been obtaining booster shots illicitly, in many cases lying about their vaccine status to pharmacists or traveling to neighboring states where their vaccine information is not on state records.

Some feared the Biden administration's push for boosters was politically motivated.

"Weeks ago, the administration decided that the public needs cake and deserves cake, and so shall have cake," John Moore, a virologist at Weill Cornell Medicine, told the New York Times. "Now, the public expects cake and would be very annoyed if its cake was taken away at this point."

According to AP News, Sharon Alroy-Preis of Israel's Ministry of Health previously said a third shot improves protection against COVID-19 by tenfold in people ages 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.

Currently, in the U.S., a third vaccine dose is approved for certain immunocompromised people.

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