Changes are happening around COVID-19 vaccines: Here's what to know
COVID-19 vaccine recommendations could be changing, according to the U.S. Food and Drug Administration.
FDA leaders said on May 20 that clinical trials will be required to approve annual COVID-19 boosters for healthy individuals under the age of 65.
With this move, the FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness, Reuters reported.
Other changes include the FDA’s request that both Pfizer and Moderna update their labels with a warning about the potential for vaccinated males ages 16 to 25 to develop inflammation of the heart muscle or other conditions.
According to past studies conducted by the Centers for Disease Control and Prevention, updated COVID-19 vaccines have been proven to reduce the risk of hospitalization by about one-third among vaccinated adults with weakened immune systems.
But on the flip side, it’s not so simple to say what’s best for those who are healthy, the FDA said, calling for testing to determine whether boosters are needed.
Here’s what you need to know about the proposed changes surrounding vaccines as of spring 2025.
Why are officials planning to limit the vaccine?
FDA Commissioner Marty Makary and U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that while the development of the vaccines in 2020 marked “a major scientific, medical, and regulatory accomplishment,” it’s uncertain how beneficial it is for individuals to get repeated annual COVID-19 vaccines.
The officials pointed out that other countries have restricted the vaccines to older adults and those at high risk for COVID-19, while the U.S. has been operating under a “one-size-fits-all” program allowing everyone over six months old to get the vaccine.
“The U.S. 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 said the FDA should be able to approve boosters for adults 65 years old and up based on testing that measures patient immune response. The vaccine is available for those with one or more health conditions making them more susceptible to COVID-19, including those with asthma, cancer, cystic fibrosis, and other illnesses, per the FDA's publication in the journal.
In order to approve annual boosters for the rest of the population, or those between six months and 64 years old, the FDA will need drug manufacturers to complete randomized, controlled trials.
“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,” Makary and Prasad wrote in the journal. ”This policy will compel much-needed evidence generation.”
Pfizer is evaluating the details of the FDA's plan and having discussions with the agency, a Pfizer spokesperson said in a statement to Paste BN on May 22.
"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 hospitalizations and severe disease, including death," the company said. "The Pfizer-BioNTech COVID-19 vaccines have been administered to over a billion individuals, including adults, adolescents and children, generating robust data demonstrating a favorable safety profile. "
Paste BN has also reached out to Moderna for comment.
Vaccine manufacturers: Trials will delay vaccine availability
As of May 2025, there are three approved vaccines for COVID-19 in the United States:
- Messenger RNA-based shots made by Moderna Inc.
- Messenger RNA-based shots made by Pfizer
- A protein-based vaccine produced by Novavax Inc.
Vaccine manufacturers have said that because COVID vaccines change annually to target specific strains of the virus, the proposed trials could lead to longer wait times for the shots, reported Reuters.
But under new guidelines, Makary and Prasad believe 100 million to 200 million Americans will still have access to vaccines, they wrote.
Dr. David Boulware, an infectious disease specialist at the University of Minnesota, told Reuters that drug manufacturers likely won’t complete the clinical trials to get approval for healthy Americans. He added that the undertaking would require lots of participants and could cost “hundreds of millions of dollars.”
FDA pushes two vaccine manufacturers to affix warning label about heart inflammation
Also changing in regard to vaccines is the FDA’s push in April to add warning labels about the risk of males suffering from myocarditis and pericarditis.
Richard Forshee, acting office director at the FDA's Center for Biologics Evaluation and Research, wrote the announcements on April 17.
Forshee addressed his letters to Moderna for its Spikevax vaccine and Pfizer for its Comirnaty vaccine.
According to Forshee, Moderna’s Spikevax was approved in late January 2022. Since then, data has shown that those who received the vaccine between 2023 and 2024 developed myocarditis and pericarditis in some cases.
Myocarditis is inflammation of the heart muscle, and can reduce the heart's ability to pump blood, according to the Mayo Clinic. Myocarditis can lead to chest pain, shortness of breath, and rapid or irregular heartbeats.
Pericarditis refers to inflammation of the outer heart lining, the Mayo Clinic said.
According to Forshee, researchers looked at commercial health insurance claims data from inpatient and outpatient facilities. They found that myocarditis and pericarditis set in one to seven days after patients received the vaccine.
“The highest estimated incidence was in males 16 through 25 years of age,” or 38 cases per million doses, Forshee said.
The FDA noted that Moderna should replace the current label with one that reads “following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines, the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age.”
Researchers looked at health information for over 300 patients
Forshee suggested a similar change for Pfizer’s Comirnaty vaccine, which was approved in August 2021. Citing a study across 38 U.S. hospitals, Forshee said researchers collected information for cardiovascular outcomes among over 300 patients ages 5 to 29 diagnosed with COVID-19 vaccine-associated myocarditis.
Among the patients, 278 showed symptoms following the second dose of their primary shot, 33 showed symptoms following the first dose of their primary shot, and 20 showed symptoms after receiving their first booster dose.
The researchers also found that among 307 patients who were diagnosed with COVID-19 vaccine-associated myocarditis, 89 reported cardiac symptoms after about 91 days.
Forshee said one of the study’s limitations includes a “potential selection bias” for patients with more severe cases of myocarditis who are more likely to be hospitalized and whose images are available for research purposes, among other factors.
Saleen Martin is a reporter on Paste BN's NOW team. She is from Norfolk, Virginia – the 757. Email her at sdmartin@usatoday.com.