Makary: FDA Won’t Approve COVID Boosters Without ‘Some Good Data’

U.S. | Science & Health

9 hours ago

Originally posted by: Children's Health Defense

The head of the U.S. Food and Drug Administration (FDA) on Tuesday said the agency is still considering whether to approve COVID-19 vaccines for this winter, citing a lack of data on booster shots.

In an interview this week with the editor-in-chief of MedPage Today, Dr. Marty Makary said, “Look, 85% of healthcare workers declined the latest Covid booster vaccine last fall. Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a 7th Covid jab this fall? Or should we make evidence-based recommendations based on a meaningful study showing a clinical benefit today?”

The FDA has received “a bunch of applications” from COVID-19 vaccine manufacturers for their 2025 booster products, Makary, who formerly served as editor-in-chief of MedPage Today, told CBS News. He said:

“We’re taking a look. I can’t comment on any particular application. … I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

The FDA has now asked several COVID-19 vaccine makers, including Novavax, to do clinical studies “so we can educate the population and have information to work with,” Makary told CBS News.

Pfizer and Moderna did not immediately respond when The Defender asked if they have been asked to complete a clinical trial for their 2025-2026 COVID-19 booster. Novavax declined to comment on the topic.

Makary said, “It’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them.”

Makary’s comments come a week after internal sources told Politico that U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. is advocating to remove the COVID-19 shot from the Centers for Disease Control and Prevention’s (CDC) list of recommended vaccines for children, arguing there is little scientific evidence that the shot provides a benefit to babies and young children.

The CDC currently recommends that everyone 6 months and up get an annual COVID-19 shot.

Makary’s approach to COVID-19 vaccine approvals marks a change from how the FDA was run during the Biden administration, when the agency routinely approved COVID-19 boosters each year, CBS News reported.

Under the Biden administration, the FDA sometimes approved COVID-19 shots with little or no data showing benefit. For example, the FDA in October 2022 amended the emergency use authorizations for the Pfizer and Moderna COVID-19 Omicron boosters for children as young as 5, despite having no direct data on the safety or effectiveness of the shots in children.

The CDC may soon narrow its COVID-19 vaccination recommendations. At its latest meeting earlier this month, the agency’s independent vaccine advisory committee discussed switching from a universal to a risk-based approach for its COVID-19 recommendations.

A risk-based approach might mean changes to the CDC’s current recommendation that all kids 6 months and up get vaccinated for COVID-19, as kids are considered at low risk of severe illness from the virus. The committee is expected to vote on the issue in June.

‘I’d rather have a sound decision a few days after the target date than have another Vioxx’

Makary faced criticism earlier this week when the FDA told Novavax it must do a clinical trial for its new COVID-19 booster before the agency approves the new shot.

According to The Associated Press, it’s unlikely Novavax could complete the trial before fall.

NBC News, under the headline “FDA appears to be slow-walking vaccine approvals,” claimed the FDA had missed an April 1 deadline for approving the shot.

Makary pushed back against that claim, telling MedPage that the FDA has “target dates,” rather than “deadlines,” for approval decisions.

FDA scientists sometimes say that certain targets will or won’t be met, depending on how complex a product application may be, Makary said. “I’d rather have a sound decision a few days after the target date than have another Vioxx that potentially killed 38,000 Americans.”

In 1999, the FDA approved Vioxx, a painkiller sold by Merck, even though Merck’s internal scientists knew the drug could cause deadly heart attacks and strokes. The FDA later issued a public health advisory about the drug. In 2004, Merck withdrew it from the market.

According to Makary, a big part of his job is “rebuilding public trust.”

COVID-19 vaccination rates would likely be higher if there were a study showing that COVID-19 boosters helped keep people out of the hospital, he said.

Makary said his special assistant, Dr. Tracy Beth Høeg, is one of the FDA staff reviewing datasets in Novavax’s application. Høeg and colleagues in 2022 published a peer-reviewed study that showed teenage boys faced greater risk than benefit from getting two doses of an mRNA COVID-19 vaccine.

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‘It’s like a judge issuing a verdict and then having lawyers make their arguments’

It could cost Novavax “tens of millions of dollars” to do a new randomized trial for its COVID-19 booster, according to The Wall Street Journal.

“But my job,” Makary told MedPage, “is upholding gold standard science and rebuilding public trust, not to save pharma companies tens of millions of dollars.”

Makary pointed out in an April 26 X post that the product Novavax wants to bring to market this winter isn’t the same product it brought to market in 2021. “New products require new clinical studies,” he said.

Moreover, the study Novavax conducted in 2020 to 2021 for its COVID-19 shot excluded people with natural immunity to COVID-19, he told MedPage. “Today, there is broad population immunity, and the big question is does it provide a benefit?”

Makary added, “Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question.”

The move drew criticism from former FDA officials Phil Krause and Luciana Borio, who argued in a commentary that the FDA “should stick to its normal processes.”

However, according to Makary, in recent years, the FDA’s processes failed to adequately gather data before making a decision. For instance, on March 29, 2022, Makary wrote a scathing series of X posts criticizing the FDA for authorizing a fourth COVID-19 shot without sufficient data.

Rather than calling for more data, the FDA authorized the shot by bypassing a vote of the agency’s external experts, and later convening the experts to “discuss” the shot afterward.

“It’s like a judge issuing a verdict and then having lawyers make their arguments,” Makary wrote.

The Defender asked the FDA how soon it estimates issuing decisions on the COVID-19 booster applications, but did not receive a response by the deadline.

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