Annual COVID-19 shots for healthy young adults and children in the United States will no longer be approved on a regular basis under the major new vaccine policy shift announced by the Trump administration on Tuesday.
The Food and Drug Administration's top officials say they will continue to use a streamlined approach that will set new requirements for annual renewals for Covid Shots and make vaccines available to adults over the age of 65, children and young adults with at least one health problem.
However, the FDA framework encourages businesses to conduct large-scale, long-term research before approving a tweaked vaccine for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach could make annual vaccinations available to between 100 million and 200 million adults.
Future changes are still asking questions about people who may still want a fall Covid-19 shot, but are clearly not part of the category.
“Are your pharmacist going to determine if you're in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia. “The only thing that can come is to keep the vaccine undercover and it's no longer available.”
Get weekly health news
Receive the latest medical news and health information provided every Sunday.
The framework featured in The New England Journal of Medicine is the culmination of a series of recent steps that raise key questions about the broader availability of vaccines under President Donald Trump.
For years, federal health officials have told most Americans to expect an annual update to the Covid-19 vaccine, as well as annual flu shots. Like the flu vaccine, the FDA has previously approved updated Covidshots when it provided evidence that manufacturers would cause as much immune protection as the previous year's version.
Trend now
New searches for missing ns kids will be reviewed carefully,” RCMP says
Three children died, 19, arrested for drunk driving in Toronto, 19
However, the new FDA guidance appears to be the end of that approach, under Health Secretary Robert F. Kennedy, who has met the FDA and other health agencies with outspoken critics about government covid shots, particularly recommendations for young healthy adults and children.
Written by FDA Commissioner Marty McCurry and FDA vaccine chief Vinai Prasad, Tuesday's update criticised the US's “all-all” approach, saying the US is “the most aggressive” when it comes to recommending Covid boosters when compared to European countries.
“We simply don't know if a healthy 52-year-old woman with a normal BMI who has had three Covid-19 doses and received the previous six Covid-19 vaccines will benefit from the seventh dose,” they write.
External experts say there are legitimate questions about how much everyone still benefits from the annual Covid vaccination, or whether it should be recommended to people at high risk. An influential panel of advisors at the Centers for Disease Control and Prevention will discuss the questions next month.
The FDA framework, released Tuesday, appears to take away the advisory board's job, Offitt said. He added that a CDC study revealed that booster doses provide protection against mild to moderate illnesses even in healthy people for 4-6 months of shots.
More Video Details
& Copy 2025 Canada Report