The Food and Drug Administration announced new federal guidelines for COVID-19 vaccinations on Wednesday, placing new restrictions on how millions of Americans will access the shots as several states deal with a surge in coronavirus cases in late summer.
Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, outlined the new rules in a social media post Wednesday. The department has officially revoked emergency use authorization, making the vaccines widely available since they first hit the market in late 2020. At the same time, HHS has issued new, non-emergency approvals for four updated vaccines formulated to protect against strains of the virus currently circulating in the US.
“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 it will make it harder for people to defend themselves against a virus that continues to kill more than 100 people 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 about how they access the vaccines for the first time since they became widely available. Here you can read what the specific rules are for different groups.
Seniors: The rules have not changed for anyone aged 65 or over. They can still get all available vaccines from the same places they received them in the past.
Adults and children between 5 and 64 years: The most significant change under the new guidelines is that non-seniors are now divided into high-risk and non-high-risk categories when it comes to how they access the vaccines.
Anyone with an underlying health condition that increases their risk of serious infection or death from COVID can still get the vaccine at a pharmacy, doctor’s office or other vaccination location. The list of conditions that place someone in the high-risk category includes chronic lung disease, heart disease, diabetes, chronic kidney disease, immunocompromising conditions and obesity.
Those who do not have an underlying health condition can now only receive the vaccine after consulting their doctor. Pharmacies and other vaccination locations can no longer provide the injection to someone who is not in the risk group.
Young children: The end of the emergency authorization means only one shot, Moderna’s Spikevax vaccine, is available for children under 5 years old. Spikevax is only approved for children with an underlying health condition. There is no longer a COVID vaccine approved for children under 5 who are not at high risk, although doctors may choose to give the shot “off-label” in some cases.
How have medical experts responded?
Some of the country’s most prominent medical groups have criticized the new vaccine guidelines, saying they create unnecessary barriers to accessing life-saving preventive care.
“The FDA has made a decision that completely contradicts the scientific basis, seriously undermines confidence in science-driven policy, and dangerously limits access to vaccines, depriving millions of Americans of the choice to be protected and increasing the risk of serious 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 vaccination against COVID-19 creates dangerous vulnerability for children and their families.”
Kennedy said that despite the new restrictions, the vaccines are “available to all patients who choose them after consultation with their physicians.”
But critics argue that this may not be entirely true. More than 100 million Americans do not have access to a primary care provider, who they would need to see to get the shot if they are not considered high risk. There is also no guarantee that all doctors will choose to provide the shot “off-label” to healthy patients or that insurance will cover the cost of the vaccine in those cases, the IDSA said. There are also questions about how other vaccination sites will confirm that someone has a high-risk condition that qualifies them for the shot outside the doctor’s office.
What’s happening with COVID right now?
The FDA said it chose to update its vaccine guidance because the threat of the virus has been greatly reduced and COVID has become a “manageable” public health challenge.
It’s true that the worst days of the pandemic are long gone, but the virus still poses a threat, especially to the medically vulnerable. More than 14,000 people have died from COVID-related illnesses so far in 2025, according to data from the Centers for Disease Control and Prevention. COVID cases across the country have risen sharply 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 provide strong protection against the virus.
