Winning: FDA Panel Rejects Pfizer Booster Shots In 16-3 Vote

Winning: FDA Panel Rejects Pfizer Booster Shots In 16-3 Vote

The Food and Drug Administration’s advisory panel on Friday rejected the Biden administration’s plan to offer booster shots of the Pfizer-BioNTech Covid vaccine to those age 16 and older. The FDA’s Vaccines and Related Biological Products Advisory Committee delivered the Biden proposal a stinging defeat of 16-3. However, the vote was non-binding and a final FDA vote is forthcoming.

“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 safety of extra doses,” the Associated Press reported. “And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.”

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” Michael Kurilla, a committee member with the National Institutes of Health, said.

However, after the FDA panel’s initial vote, it unanimously recommended booster shots for Americans over 65 and for those who are at high risk.

The Food and Drug Administration advisory panel did not recommend COVID-19 vaccine booster shots.
Xinhua News Agency via Getty Images

The FDA is reportedly in “full revolt” against the Biden administration’s repeated attempts at political pressure.

The advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.

The vote Friday, 16-3, 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 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.

The Biden administration’s embattled plan to dispense COVID-19 booster shots to most Americans faced its first major hurdle Friday as a government advisory panel vigorously debated whether to endorse extra doses of the Pfizer vaccine.

“Biden White House intended on rolling out booster shots in 3 days,” Jordan Schachtel noted. “Today, FDA overwhelmingly voted to shut that down. 1st clear revolt from bureaucracy during this admin. Sparked by 2 top officials retiring & denouncing boosters in Lancet paper. Interesting developments for sure.”

“It’s a legit revolt. The White House is not happy. Here’s the strategy to roll out boosters, right from their COVID plan,” Schachtel added.

Indeed, the FDA has been pivotal in offering a modicum of pushback to an administration that appears not to have any ethical boundaries.

“Two top scientists who recently announced their retirements from the US drug watchdog have criticised the policy of giving most people Covid-19 booster vaccinations, just days before the Biden administration plans to start doing so,” the Financial Times reported. “Philip Krause and Marion Gruber, who resigned from the Food and Drug Administration two weeks ago, are among the authors of a scathing critique of widespread booster shots, which was published in The Lancet on Monday.”

“The article, which argues that the scientific evidence does not yet justify giving most people third shots of messenger RNA vaccines, offers an insight into the internal tensions in the Biden administration that were ignited by the White House’s sudden decision to back the booster plan,” FT notes. “The piece warns: ‘Current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe disease remains high’.”

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.

The panel, made up of outside experts who advise the Food and Drug Administration, weighed a less than clear-cut case: 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 FDA experts were scheduled to vote on one basic question: Does the evidence show that a Pfizer booster would be safe and effective for people 16 and older? In the event of a yes vote, the FDA is expected to quickly approve boosters for Pfizer’s shot.

The FDA panel said more data is needed before it can recommend a third dose for people 16 and older.
Bloomberg via Getty Images

But that is just one step in the process. The more thorny question of who should get the shots and when will be debated on Wednesday by advisers to the Centers for Disease Control and Prevention. The CDC generally adopts the recommendations of the group, which sets policy for U.S. vaccination campaigns.

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.

At Friday’s meeting, the FDA panelists heard 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. Also complicating the committee’s decision: No one yet knows the antibody level below which infection is likely and boosters are needed.

“That would be a great way for us to monitor if we really needed booster shots,” said Dr. James Hildreth, president of Meharry Medical College.

FDA vaccine reviewer Dr. Philip Krause raised a host of questions about the reliability of one of the key studies Pfizer said showed that immunity is waning.

Another concern was whether third doses would exacerbate serious side effects.

Dr. Cody Meissner of Tufts Medical Center 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.

While the Biden administration has said that its priority is to get people vaccinated in the first place, the deepening crisis has given urgency to efforts to shore up Americans’ protection against the virus by giving them booster shots.

Joe 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. It said boosters would be dispensed eight months after the second dose of the Pfizer and Moderna vaccines.

The advisory panel found the Pfizer vaccine is still highly protective against the spread of the Delta variant — and denied recommending the boosters because they aren’t needed at this time.
Bloomberg via Getty Images

But that was before FDA staff scientists had completed their own assessments of the data. Some experts questioned whether Biden was breaking his own pledge to “follow the science” on COVID-19 by getting out ahead of government scientists.

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.

It will be interesting to observe the Biden administration’s reaction to the FDA’s rebuke: Will it follow the so-called “science” even if it isn’t politically expedient, or will it follow its political agenda? Anyone who has been following this administration since its inception knows the answer.


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