FDA questions common practice of getting covid, flu vaccines together

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on administering multiple vaccines at the same time.

Vinay Prasad, the FDA’s top vaccine regulator, recently announced that his team will require new clinical trials before allowing pharmaceutical companies to claim that coadministering multiple respiratory virus vaccines is safe and effective — a plan that was dismissed by outside experts as unnecessary and potentially counterproductive.

The shift under Prasad, which he described as part of a new “evidence-based philosophy,” could have implications that go beyond the fall respiratory vaccination season and potentially reverse long-standing guidance that encourages Americans to get multiple vaccines at the same time.

He wrote in a memo last week that FDA officials “cannot affirm” the safety and efficacy of administering multiple vaccines for the coronavirus, flu and other conditions such as RSV at the same time. In recent years, federal agencies embraced multiple shots in one visit as a way to increase protection against respiratory viruses with no serious downsides.

Andrew Nixon, a spokesman for the Department of Health and Human Services, said the FDA will soon announce a new framework on Prasad’s changes.

Pfizer had been negotiating with the FDA as it sought federal approval for its updated coronavirus shots, and Prasad’s new stance put millions of manufactured doses at risk, according to two people familiar with the matter who spoke on the condition of anonymity to detail sensitive discussions. Pfizer last week issued a letter to physicians that withdrew its prescribing information for providers saying they could administer its coronavirus vaccine with other shots, noting that the language was not FDA approved. Similar language had been previously cleared with other FDA reviewers.

The FDA’s memo does not prevent pharmacies and doctors from providing coronavirus and flu vaccines in the same visit, medical experts said. But they worried that the scrutiny and rhetoric coming from top medical regulators would discourage a practice that can increase vaccination rates.

“For many, this inconvenience of having to return for a second visit just to get the other vaccine will deter them from getting that other vaccine,” said L.J. Tan, chief policy officer for Immunize.org, an immunization advocacy organization. “Access to vaccination suffers.”

Under HHS Secretary Robert F. Kennedy Jr., federal health agencies have upended how they approach coronavirus vaccination. The FDA narrowed approval last week of updated coronavirus shots to high-risk groups, including those 65 and older and people with underlying conditions that elevate their risk of severe disease. California, Oregon and Washington state announced plans Wednesday to form a “health alliance” to coordinate vaccine recommendations based on advice from national medical organizations because they said federal actions have raised concerns “about the politicization of science,” according to a joint statement.

The Biden administration embraced doubling flu and coronavirus shots as a strategy to boost coverage earlier in the coronavirus pandemic.

“This is why God gave us two arms — one for the flu shot and the other one for the covid shot,” Ashish Jha, then the nation’s coronavirus coordinator, told reporters in September 2022.

But Prasad, who became prominent as a critic of the mainstream public health pandemic strategy, denigrated this strategy as lacking evidence and cited Jha’s comments as an example of why Donald Trump returned to the White House.

“Ashish Jha should remember that God gave people two arms,” Prasad wrote on X in November 2024, one week after the presidential election. “One to vote for Donald Trump, and the other one to give thumbs up to RFK Jr. His Non-Evidence-Based, pro-corporate conduct as White House covid czar is the reason the backlash exists.”

Studies support the safety of getting both the flu and coronavirus vaccines at the same time, according to federal documents and outside experts. One CDC study showed that people who received a flu vaccine and coronavirus vaccine at the same time were slightly more likely to have reactions including fatigue, headache and muscle ache than people who got only a coronavirus vaccine, but those reactions were mostly mild and went away quickly.

According to data posted on the CDC website as of Aug. 18, flu, coronavirus and RSV vaccines “may be coadministered (given at the same visit)” and there is no minimum wait period between shots.

Dan Jernigan — who used to oversee vaccine safety at the CDC and resigned last week to protest what he described as efforts by Kennedy to politicize the vaccine recommendation process — said the federal government has not identified serious issues with coadministering coronavirus and flu shots. If there were serious side effects, Jernigan said, evidence would have emerged by now from the Vaccine Adverse Event Reporting System that closely monitors coronavirus vaccines.

In 2021, the World Health Organization concluded based on preliminary data that coadministration does not interfere with the effectiveness of either the coronavirus or influenza vaccine; that the amount of reactogenicity, or side effects, is acceptable; and that coadministration is tolerable for those who choose to get the vaccines at the same time.

Since then, more research has been conducted backing the WHO’s findings, said Tan of Immunize.org, who also co-wrote a March paper extensively reviewing studies of coadministering flu and coronavirus vaccines.

Prasad detailed the Trump administration’s latest vaccine shift in a memo outlining his decision to limit approval of Pfizer’s coronavirus shot to high-risk groups. He wrote that administering several vaccines at the same time “offers the theoretical benefit” of boosting vaccination rates for the respiratory virus season. But, he wrote, there were potential downsides, arguing that doing so could decrease the shots’ effectiveness and complicate vaccine safety data.

He did not cite new studies supporting the change but rather asserted that the design and scale of past studies have been insufficient.

Prasad called for companies to conduct randomized controlled trials on administering the coronavirus, RSV and flu shots.

“The burden of proof is not on manufacturers to be able to do something that clearly has been done millions of times safely,” Jha, the covid czar under Biden, said in an interview. “The burden of proof is on people who are calling this into question, given the long-standing track record we have of coadministration of vaccines.”

Jesse Goodman, a Georgetown University professor of medicine who previously served as the FDA’s top vaccine regulator, said such studies would be costly and burdensome — and are “unlikely to provide important new information.”

Pfizer declined to comment. But the company issued a letter to health care providers saying that certain batches of its coronavirus vaccine contain “unapproved prescribing information inside the cartons,” indicating that the company had been seeking to add the coadministration of the shot to the label.

Prasad’s move could lay the groundwork for the federal government to change its recommendations around vaccines for the respiratory virus season, several medical experts said.

A policy shift about coadministration could come from the FDA or CDC’s vaccine advisory panel, the Advisory Committee on Immunization Practices. Kennedy recently purged the members of the influential panel and replaced them with his own picks, several of whom have criticized coronavirus vaccine policy.

The FDA’s latest initiative could also have ramifications for how health care providers administer other vaccines. Infants and young children often receive multiple vaccines during a single visit to a physician’s office, which medical experts have long deemed safe and have encouraged as a tactic to increase immunization rates.

But Kennedy and his allies have questioned whether administering multiple vaccines at a single visit can be harmful. They have also taken aim at the CDC’s recommended schedule for childhood vaccines, which calls for administering multiple vaccines at key milestones, such as a child’s birthday.

“Pediatric care is built on the fact that infants and young children safely receive multiple vaccines in a single visit, a practice backed by decades of strong evidence,” said David Higgins, a pediatrician and preventive medicine specialist at the University of Colorado Anschutz Medical Campus. “Requiring separate visits could delay timely protection, increase the burden on families and ultimately leave children more vulnerable to preventable diseases.”