The Food and Drug Administration announced new federal guidance for COVID-19 vaccinations on Wednesday that put new restrictions on how millions of Americans will be able to access the shots as several states deal with a late-summer surge in coronavirus cases.
Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, outlined the new rules in a post on social media Wednesday. The department officially revoked the emergency use authorization that has allowed the vaccines to be widely available since they first came onto the market in late 2020. At the same time, HHS issued new, nonemergency approvals for four updated vaccines that are formulated to protect against strains of the virus that are currently circulating in the U.S.
“The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy wrote.
Some public health experts strongly disagreed with the move, arguing that it will make it harder for people to defend themselves against a virus that is still causing more than 100 deaths in the U.S. every week.
Who can get the vaccines now?
The most important takeaway from the new guidelines is that most people who want a COVID vaccine can still get one. But there are important new protocols that mean different groups of Americans will have different rules for how they can access the vaccines for the first time since they became widely available. Here’s what the specific rules are for various groups.
Seniors: For anyone who’s 65 or older, the rules haven’t changed. They can still get any of the available vaccines from the same places they have gotten them in the past.
Adults and children between the ages of 5 and 64: The most significant change under the new guidelines is that nonseniors are now separated into high-risk and non-high-risk categories when it comes to how they can access the vaccines.
Anyone with an underlying health condition that increases their risk of severe infection or death from COVID can still get the vaccine from a pharmacy, doctor’s office or other vaccine site. The list of conditions that put someone into the high-risk category includes chronic lung disease, heart conditions, diabetes, chronic kidney disease, immunocompromising conditions and obesity.
Those who do not have an underlying health condition can now only get the vaccine after consulting with their doctor. Pharmacies and other vaccination sites can no longer provide the shot to someone who isn’t in the high-risk pool.
Young children: The end of the emergency authorization means that only one shot, Moderna’s Spikevax vaccine, is available to children under the age of 5. Spikevax is only approved for children with an underlying health condition. There is no longer a COVID vaccine authorized for non-high-risk children under 5 years old, though doctors may choose to provide the shot “off label” in some cases.
How have medical experts reacted?
Some of the most prominent medical groups in the country have criticized the new vaccine guidelines for creating what they consider to be unnecessary barriers to accessing lifesaving preventative care.
“FDA has made a decision that completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID,” the Infectious Diseases Society of America (IDSA) wrote in a statement Wednesday.
The president of the American Academy of Pediatrics called the new rules “deeply troubling” and argued that “any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families.”
Kennedy said that, despite the new restrictions, the vaccines “are available for all patients who choose them after consulting with their doctors.”
But critics argue that may not be entirely true. More than 100 million Americans don’t have access to a primary health provider, who they would need to see in order to get the shot if they’re not considered high risk. It’s also not guaranteed that all doctors will choose to provide the shot “off label” to healthy patients or that insurance will cover the costs of the vaccine in those cases, the IDSA said. There are also questions about how other vaccination sites will confirm that someone does have a high-risk condition that qualifies them to receive the shot outside of a doctor’s office.
What’s happening right now with COVID?
The FDA said it chose to update its vaccine guidelines because the threat of the virus has been greatly reduced and COVID has become a “manageable” public health challenge.
It is true that the worst days of the pandemic are long over, but the virus still poses a threat, particularly to the medically vulnerable. More than 14,000 people have died of COVID-related illnesses so far in 2025, according to data from the Centers for Disease Control and Prevention. The number of COVID cases across the country has spiked in recent weeks, driven by the new “stratus” variant of the virus.
Experts from the FDA and other health organizations continue to maintain that the vaccines offer strong protection from the virus.
