In 'Anti-Science Move,' FDA Expected to Broadly Restrict Access to Covid Vaccines

Public health experts on Tuesday warned Tuesday that forthcoming Food and Drug Administration guidance on the Covid-19 vaccine would "cause confusion" and result in fewer people getting inoculated against the virus that killed 350,000 people in the U.S. before the shots became available.

Dr. Vinay Prasad, head of the agency's vaccine division, and Dr. Martin Makary, the FDA commissioner, wrote in the New England Journal of Medicine that the vaccine "booster" doses that have been available for the last several years to anyone aged six months and older carry "uncertain" benefits for much of the population.

The officials said the next round of shots will be available only for adults over 65 and those with certain medical conditions.

They said that before a new round of updated vaccines are made available in the fall, the FDA "anticipates the need" for new clinical trials for many patients under 65. Participants in the trial would be given either the new shots or a placebo and followed by vaccine manufacturers for at least six months to determine if the vaccines continued to provide them with protection from Covid.

Both Prasad and Makary were vocal skeptics of vaccine mandates and other public health measures during the coronavirus pandemic, and Health and Human Services Secretary Robert F. Kennedy, Jr.—who oversees the FDA—has spread baseless misinformation about the Covid shots and other vaccines.

Kennedy said in 2021 that the shots were the "deadliest ever made"; the Centers for Disease Control and Prevention (CDC) has found the vaccines reduce people's risk of developing serious illness, long-term symptoms, and hospitalization.

Dr. Daniel Griffin, a physician in New York, told The New York Times that the FDA's plan will ultimately "very slowly [reduce] vaccination in the country."

"I think that changes like this will lead to more unnecessary deaths," said Griffin.

Makary and Prasad made their announcement days before scientific advisers to the FDA are set to decide on the composition of the Covid vaccines that will be offered this fall.

Dr. Lucky Tran, director of science communication and media relations at Columbia University Irving Medical Center, emphasized that many Americans have conditions that raise the risk of severe illness when they get Covid—including asthma, pregnancy, diabetes, obesity, and some mental health conditions.

"However, limiting Covid vaccines to people with specific conditions only causes confusions and decreases uptake," said Tran. "Most are unaware they have a condition that puts them at risk, so many who would want to get vaccinated may not try because they think they don't qualify."

About 74% of people in the U.S. have at least one condition that puts them at higher risk for severe disease, according to the CDC.

For people without medical conditions who are under age 65, it was unclear Wednesday whether they will be able to get vaccinated in the fall—and if shots are available to them, whether insurers will cover the costs.

William Schaffner, an infectious disease physician who is on the CDC's vaccine advisory panel—which recommends who should get FDA-approved vaccines—told The Washington Post that the panel could include in this year's recommendations that healthy people under 65 can still get a shot to protect themselves.

"They could add that line... and it would allow those people very focused on prevention who would like to get the vaccine and have it paid for by their insurance," Schaffner told the Post.

But Prasad said the FDA could still limit access because the agency "can only approve products if it concludes, based on the available scientific evidence, the benefit-to-harm balance is favorable."

Pediatricians expressed concern for children's safety if vaccines become unavailable to them; the CDC reported 150 pediatric deaths from Covid over the 12-month period that ended last August.

"I think there is strong data to suggest Covid should be part of routine childhood vaccinations," Amesh Adalja, an infectious disease physician, told STAT News. "We vaccinate kids for things that have less morbidity and mortality than Covid, like chickenpox for example."

Tran denounced the anticipated guidance as "an anti-science move that will kill more Americans."

"The FDA is being led by people who have consistently spread misinformation about Covid and vaccines," said Tran. "Their record indicates that they cannot be trusted to implement evidence-based guidance for vaccines, and their policies will kill people and make them sicker."