FDA may change Covid-19 booster rules from 2025: What it means for you

The US Food and Drug Administration may limit Covid-19 boosters shots to high-risk groups from 2025; Pfizer reviewing proposal as agency seeks new trials, clearer risk labels for younger males

The US Food and Drug Administration (FDA) is considering a significant revision to its Covid-19 vaccination strategy. On Tuesday, agency officials indicated that annual booster shots for healthy individuals under 65 would only be approved if supported by robust clinical trial data. 

If the proposal is adopted, updated Covid-19 vaccines may primarily be offered to older adults and those at elevated risk of severe illness, according to Reuters.

 

Heart risk warning proposed for young men

The FDA is also seeking to include additional safety information on vaccine labels. Specifically, the agency has asked manufacturers Pfizer and Moderna to add warnings about a rare risk of heart inflammation in males aged 16 to 25 following vaccination.

 

 

More data needed on Covid-19 vaccine efficacy for the healthy

Citing earlier findings from the US Centers for Disease Control and Prevention (CDC), FDA officials noted that new Covid-19 vaccines have shown a 33 per cent reduction in hospitalisation risk among immunocompromised individuals. However, their effectiveness in otherwise healthy people remains uncertain — prompting calls for more extensive testing.

 

To boost or not to boost?  COVID-19 vaccinations remain at the forefront of public conversation and this FDA is committed to bringing you answers. Join us as we dive deeper into how science—and solid evidence—will guide the path forward. pic.twitter.com/KI0aA3lsRk

— U.S. FDA (@US_FDA) May 21, 2025

  Experts question the need for routine boosters

In a commentary published in the New England Journal of Medicine, FDA Commissioner Marty Makary and vaccine adviser Vinay Prasad expressed skepticism about the need for yearly boosters for all Americans. 

They pointed out that while many countries have adopted targeted vaccination strategies focusing on vulnerable populations, the US has maintained a broader approach — offering vaccines to nearly everyone over six months old. 

"The US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age-and-risk-based recommendations," they wrote. "We reject this view." 

Makary and Prasad proposed that future booster approvals be streamlined only for high-risk groups such as people over 65 or individuals with medical conditions like asthma, cancer, or cystic fibrosis. 

"We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” the doctors added. “This policy will compel much-needed evidence generation."

 

Pfizer reacts to FDA’s recommendation

Pharmaceutical giant Pfizer, a leading producer of Covid-19 vaccines, is currently reviewing the FDA’s proposed changes.

In a statement to the daily USA TODAY on Thursday, the company said, “We stand by the science behind the Pfizer-BioNTech Covid-19 vaccine and continue to believe that broad vaccination programmes are an essential tool for helping to prevent Covid-19-associated hospitalisations and severe disease, including death.”   

 

Kerala reports 182 Covid-19 cases in May

Kerala has recorded 182 Covid-19 cases so far in May, prompting the state health department to reinforce safety guidelines, including face mask usage — particularly for vulnerable populations. Following a meeting with the state Rapid Response Team (RRT) in Thiruvananthapuram, Health Minister Veena George warned of a possible increase in cases, citing similar surges in Southeast Asia. 

“The public must remain vigilant. Cases are rising in other countries, and we need to be prepared,” George said. Kottayam led with 57 cases, followed by Ernakulam (34) and Thiruvananthapuram (30). The state’s overall Covid tally for May crossed 250 earlier this week. 

 

Covid-19 cases: Highly transmissible variants under watch

Kerala health minister mentioned that Omicron sub-variants JN.1, LF.7, and NB 1.8, prevalent in Southeast Asia, are being closely monitored. These strains, while more contagious, currently appear to cause mild illness. Yale Medicine has identified JN.1 as a sublineage of BA.2.86 (‘Pirola’) with a mutation that may help it evade immune defences, although its full impact is still under evaluation.

 

Covid-19 cases on a rise: States step up precautionary measures

Across India, states are reinforcing Covid protocols. Uttar Pradesh has asked districts to prepare Covid wards and ensure oxygen availability. Odisha has urged citizens to follow preventive measures and report symptoms. Tamil Nadu is monitoring the situation through its Integrated Health Information Platform. 

“Any infections will be promptly reported,” said TS Selvavinayagam, director of public health in Tamil Nadu. 

As of May 19, India had 257 active cases — mostly mild. Karnataka recorded 30 cases this month, with no alarming trends, according to Health Commissioner Sivakumar KB Maharashtra has reported two Covid-related deaths, Kerala one, while Mumbai saw around 95 cases.

 

[With agency inputs]