The Trump administration is implementing new restrictions on access to COVID-19 booster shots, introducing additional regulatory challenges for companies creating vaccines aimed at otherwise healthy individuals. According to the Food and Drug Administration (FDA), its current focus is on approving vaccines for adults over 65 and for individuals older than six months who present at least one significant risk factor for severe COVID-19.
In a commentary published in the New England Journal of Medicine (NEJM), FDA officials stated, “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”
This decision coincides with the influence of Robert F. Kennedy, known for his anti-vaccination stance, as he reshapes the US Department of Health and Human Services. Recently, he has been involved in the dismissal of prominent officials at the FDA and other federal health agencies. Public health specialists are expressing doubts regarding the potential effectiveness of the FDA’s revised guidelines on booster shots.
“This is overly restrictive and will deny many people who want to be vaccinated a vaccine.”
Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, expressed her concern in a communication to the New York Times, stating, “This is overly restrictive and will deny many people who want to be vaccinated a vaccine.”
Paul Offit, a vaccine scientist and professor at the Children’s Hospital of Philadelphia, warned, “The only thing this can create is a system where vaccines become less insurable and less available,” according to statements made to The Associated Press.
The FDA has indicated it will require extensive clinical trial data before granting approvals for COVID-19 vaccines aimed at those deemed not at elevated risk. The revision is projected to leave around 100 to 200 million Americans with access to annual vaccinations, which equates to less than 60 percent of the total US population.
Just last week, the FDA authorized the Novavax COVID-19 vaccine exclusively for older adults and individuals with higher disease risks.
The NEJM commentary raised questions about the necessity of booster shots for specific individuals, stating, “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 prior doses of a COVID-19 vaccine will benefit from the seventh dose.”
However, prior studies by the CDC suggest that booster shots are effective in averting mild to moderate COVID-19 cases for up to six months following vaccination, regardless of a person’s risk level. Additionally, being vaccinated can lessen the severity of illness and decrease the likelihood of long COVID, according to the Centers for Disease Control and Prevention.
During the 2024-25 season, the CDC reported a rate of 71.2 COVID-19-related hospitalizations per 100,000 individuals. Notably, hospitals have not been required to communicate COVID-related admissions to HHS since May of the previous year. Vaccines are considered crucial for safeguarding those with compromised immune systems. The FDA’s updated policy raises concerns over whether healthy individuals will be able to access vaccinations to protect themselves or others.
In the commentary, the FDA acknowledged the low uptake of COVID-19 boosters in the United States, with less than 25% of eligible individuals receiving the shot each year. “There may even be a ripple effect: public trust in vaccination in general has declined,” it noted.
Kennedy has a documented background in promoting vaccine-related disinformation, a campaign that has reportedly earned him substantial compensation during the COVID-19 pandemic. “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” wrote Peter Marks, the former director of the FDA’s vaccine regulatory division, in his resignation letter earlier this year.
