Covid-19 vaccine rules may change from 2025: What you should know

The US Food and Drug Administration (FDA) is planning to make big changes to COVID-19 vaccine recommendations. On May 20, FDA officials said that in the future, annual COVID-19 booster shots for healthy people under 65 would be approved only if drug companies carry out detailed clinical trials.

If implemented, the updated vaccines might be available to older adults only and people who are at high risk of getting seriously sick from COVID-19, according to Reuters.

The FDA also wants Pfizer and Moderna to add warnings to their vaccine labels to explain the small risk that males, aged 16 to 25, could develop heart inflammation after vaccination.

According to previous studies by the Centres for Disease Control and Prevention (CDC), the new COVID-19 vaccines have reduced the risk of hospitalisation to around 33% in those with compromised immune systems. However, the benefits in healthy individuals are still not quite clear. Therefore, according to the FDA, more testing is required.

FDA OFFICIALS SAY BOOSTERS MAY NOT BE NEEDED FOR ALL

FDA Commissioner Dr. Marty Makary and vaccine official Dr. Vinay Prasad wrote in the New England Journal of Medicine that while the original development of COVID-19 vaccines in 2020 was a huge achievement, it’s not clear whether healthy people still need yearly boosters.

They explained that many countries have limited vaccine access to older adults or people with health problems. However, the US still lets nearly everyone over six months old get a shot.

"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 the FDA would allow boosters without conducting full trials for adults above 65 and people 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 wrote. “This policy will compel much-needed evidence generation."

PFIZER RESPONDS TO FDA’S PLAN

Pfizer, one of the major vaccine makers, is still reviewing the FDA’s proposal.

"We stand by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19-associated hospitalisations and severe disease, including death," Pfizer said in a statement to USA TODAY on May 22.