The Trump administration has announced annual COVID shots for healthy younger adults and children will no longer be routinely approved under a new policy.
According to the Associated Press, Food and Drug Administration (FDA) officials have laid out new requirements for access to annual COVID shots, that includes offering to people over 65 and only to children and young adults who have a health condition that puts them at risk.
The FDA is recommending that long-term studies be conducted to evaluate the need for healthy individuals to have the shot before they can get approval. The New England Journal of Medicine published a new report noting that the strategy could continue to support annual shots for almost 200 million people.
Dr. Paul Offit, a vaccine expert based at the Children’s Hospital of Philadelphia asked if pharmacists were going to assess who is in a high-risk group.
“The only thing that can come of this will make vaccines less insurable and less available,” Offit said.
President Donald Trump has been making rapid changes to who can access the shots, alongside Health and Human Services (HHS) Secretary John F. Kennedy Jr., who has been critical of the handling of COVID shots and the previous recommendations that children as young as six months should be given them.
The FDA is set to release new guidance, which will be up for public comment before it is finalized.
In the written update, FDA Commissioner Marty Makary and FDA vaccine chief Vinay said the U.S. has been “the most aggressive” in recommending COVID boosters, especially in comparison to countries in Europe.
“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,” they wrote.
Makary and Prasad suggested that companies conduct a six-month study on individuals not considered high risk, randomly assigning them to receive either a vaccine or a placebo. The study would closely monitor outcomes, focusing on severe illness, hospitalization, and mortality.
