FDA walks back universal Covid-19 booster policy—but is it enough?

I analyse the FDA’s new policy shift and highlight some critical gaps that remain.

The FDA has announced a policy shift on Covid-19 vaccination, stating it will no longer support universal booster approvals without robust clinical evidence of benefit—particularly for healthy individuals under 65.

A new article in the New England Journal of Medicine by Dr Vinay Prasad, incoming director of FDA’s Center for Biologics Evaluation and Research (CBER), and Dr Marty Makary, FDA Commissioner, outlines a new framework aimed at restoring public trust.

L: Marty Makary, FDA commissioner R: Vinay Prasad, Director CBER

The new approach abandons blanket recommendations in favour of risk-based policies and sets a higher bar for future approvals.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and received six previous doses will benefit from the seventh dose,” they wrote.

US is a policy outlier

For the past five years, the US has had one of the world’s most aggressive Covid-19 vaccination policies—recommending annual boosters for everyone aged six months and older, regardless of risk.

Prasad and Makary note that this approach diverged sharply from countries like the UK, Germany, Canada and Australia, which limit boosters to older adults or those at higher risk of severe illness.

While some US officials argued universal guidance would be simpler to implement, Prasad and Makary reject that view, saying the lack of supporting clinical trial data has fuelled public scepticism and reduced uptake.

“Less than 25% of Americans received boosters each year,” they wrote. Among children under 12, uptake fell below 10% in the 2024–25 season, and fewer than one in three healthcare workers opted in.

They warn that such overreach could undermine trust in other vaccines. Declining uptake of MMR (measles, mumps, rubella), they note, is already contributing to rising measles cases and preventable deaths.

A two-tiered model

To chart a new course, the FDA will apply different standards to two broad groups:

• Group 1: High-risk individuals

This includes adults aged 65 and over, and anyone six months or older with one or more risk factors for severe Covid-19.

For these individuals, approvals may continue to rely on immunogenicity data—typically, antibody responses. The CDC’s list of risk factors includes:

By this definition, 100 to 200 million Americans will remain eligible for Covid-19 vaccination.

• Group 2: Healthy people aged 6 months to 64 years

For this group, future approvals will require randomised clinical trials (RCTs) showing benefit—particularly in healthy adults aged 50–64, where global consensus is still evolving.

The FDA recommends using “symptomatic Covid-19” as the primary outcome, with at least a 30% relative risk reduction of high certainty, using saline placebo controls and a minimum of six months’ follow-up.

“These clinical trials will inform future directions for the FDA,” they write, “but more important, they will provide information that is desperately craved by health care providers and the American people.”

Not the flu

Covid-19 booster policies have often mirrored influenza vaccination programs, but Prasad and Makary argue the analogy is flawed.

SARS-CoV-2:

• Mutates differently, possibly reducing the need for frequent updates

• Circulates year-round, allowing more flexible trial timelines

• Triggers strong natural immunity, especially against severe disease

These differences, they argue, support a more targeted and evidence-based vaccine strategy, with updates to the vaccine only when there is clear evidence of significant viral mutation.

Cautious progress—but is the core problem still being ignored?

The FDA is positioning itself as a more measured and transparent regulator.

The decision to abandon blanket booster recommendations and require RCTs for low-risk groups is a welcome course correction. It acknowledges that a one-size-fits-all approach to vaccination is no longer defensible.

However, serious concerns remain.

• Symptomatic Covid-19

When Prasad and Makary question whether a healthy 52-year-old woman—non-obese, previously infected, and already six doses in—needs a seventh shot, it’s a fair point.

But the trials they propose will still rely on symptomatic Covid-19 as the primary endpoint – why not insist on clinically meaningful outcomes like serious illness, hospitalisations or death?

This is the same low threshold used in the original emergency-authorised trials and it was heavily criticised at the time.

• Over 65s

The new policy continues to support booster approvals for those over 65. Yet the pivotal trials on which these approvals were based included very few frail elderly individuals or those with serious comorbidities.

A systematic review of ten published studies found that fewer than 10% of trial participants were over 65, and less than 1% were over 85. As such, RCT evidence for safety and efficacy in the most vulnerable populations remains limited.

• Immunobridging data

Continued reliance on immunogenicity data for over 65s and high-risk groups is another concern. Antibody titres are not reliable indicators of protection.

Prasad and Makary know this.

In January 2023, they both co-signed a Citizen Petition to the FDA stating, “This immunobridging surrogate endpoint has not been validated to predict clinical efficacy.”

They urged the FDA to update vaccine labelling accordingly, as required under 21 CFR 201.57. So why do they now accept immunogenicity data as sufficient for high-risk groups?

Even Peter Marks - the previous head of CBER - admitted that antibody levels were weak “correlates of protection” during an FDA advisory meeting in April 2022.

He reiterated that view later that year in JAMA, writing:

“Unless correlates of protection that are strongly associated with duration of protection against Covid-19 can be identified... large randomised clinical trials… will be required to ascertain the effectiveness of these new vaccines.”

• Immunocompromised

The authors also support vaccination for the immunocompromised. As a haematologist-oncologist, Prasad emphasises the importance of protecting people with weakened immune systems.

But there are no RCTs demonstrating safety and efficacy in this group as they were excluded from the original trials.

Once again, assumptions are being made without adequate evidence.

• Pregnancy

Pregnancy is another qualifying risk factor for Covid-19 vaccination. Yet Makary himself has criticised the early recommendation for pregnant women.

On the Sensible Medicine podcast, he said: “They just recommended it for pregnant women with zero data.”

Pfizer’s pregnancy trial, launched in February 2021, aimed to enrol 4,000 women. By year’s end, just 349 had enrolled. Pfizer later stated that recruitment collapsed because health authorities had already issued broad recommendations to pregnant women.

When the results were eventually posted on clinicaltrials.gov, the trial was underpowered, inconclusive, and had missing data.

• High risk people

The current list of qualifying risk factors includes depression, smoking, obesity, and physical inactivity—conditions so prevalent that most of the U.S. population now qualifies for continued boosters.

Is this truly a departure from the previous universal approach?

It also raises practical questions: if uptake remains low, will manufacturers even bother to invest in RCTs for low-risk groups?

• The elephant in the room - safety

There’s the larger issue—vaccine safety. And here, the FDA’s position remains opaque.

Multiple independent labs have shown that residual DNA in the vaccines far exceeds safety limits. Student researchers in FDA’s own lab found residual DNA levels exceeded safety limits by up to 470 times.

Yet the FDA continues to ignore this evidence.

Makary’s own special assistant at the FDA, Dr Tracy Beth Høeg, has previously raised concerns about DNA contamination. Still, the agency remains silent.

A Citizen Petition has also been filed, alleging the mRNA vaccines were “wrongfully and illegally” approved after the FDA allowed manufacturers to bypass Environmental Assessments under 21 CFR Part 25—a critical safeguard for biologics and gene therapies – thereby denying the public informed consent.

Again, no response from the FDA.

Is this a secret strategy?

Perhaps this shift in policy signals the start of a longer reform process.

Or perhaps the agency is simply stalling—waiting for more data before making tougher decisions.

Makary and Prasad’s own 2023 Citizen Petition highlighted the surge in reports to VAERS following the rollout of Covid-19 vaccines, demonstrating clear awareness of the safety concerns.

VAERS as at Jan 2023

So is this part of a deliberate strategy—an incremental step forward to avoid political backlash? Or is the agency paralysed, unable to walk back a technology it championed too quickly?

Either way, the cost of inaction is real.

Florida Surgeon General Dr Joseph Ladapo was among the first public health officials to call for a halt to these vaccines due to the unknown cancer risks of this novel platform. Others have since followed.

Many have framed the FDA’s new direction as bold.

But a truly bold move would mean acknowledging that the mRNA platform was rushed into widespread use, that manufacturing flaws remain unresolved, and that this technology—while innovative—was not ready for mass deployment.

This latest move is a step in the right direction, but it stops short of confronting the core safety concerns.

We should not wait for “more safety data.” The licensure of Covid-19 mRNA vaccines should be suspended until those issues are properly addressed.

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