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Home / World

The narrowed approval is a US shift from advice for almost everyone to get Covid boosters

By Rachel Roubein, Lena H. Sun
Washington Post·
27 Aug, 2025 09:55 PM3 mins to read

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Pfizer-BioNTech and Moderna Covid vaccines fill their syringes. US Health and Human Services Secretary Robert F. Kennedy jnr announced FDA limited approval of new vaccines for people at higher-risk. Photo / Getty Images

Pfizer-BioNTech and Moderna Covid vaccines fill their syringes. US Health and Human Services Secretary Robert F. Kennedy jnr announced FDA limited approval of new vaccines for people at higher-risk. Photo / Getty Images

The United States Food and Drug Administration signed off today on coronavirus vaccines for those considered higher risk, narrowing approval for shots once routinely provided to nearly all Americans.

The agency cleared shots manufactured by Pfizer, Moderna and Novavax. Companies were working to reformulate their vaccines to better target new strains of the virus.

The move comes as the country is in the midst of a midsummer wave of Covid cases.

The FDA limited approval of the new vaccines to those at “higher risk”, Health and Human Services Secretary Robert F. Kennedy jnr said in an X post announcing the approvals.

Trump Administration officials previously described those at higher risk as being ages 65 and older or having an underlying condition that increases the risk of severe disease.

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An HHS spokesman pointed to a New England Journal of Medicine article written by top FDA officials in May that listed Covid risk factors, including asthma, smoking, physical inactivity and obesity.

That article accompanied an announcement from the Trump Administration that it would take a new targeted approach to Covid vaccines, rejecting universal recommendations for all Americans aged 6 months and older to receive annual shots.

Health officials under Trump argued there was insufficient data to justify sweeping recommendations and that the US was an outlier.

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“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy said in the X post.

Public health experts and industry groups said before the announcement that narrowed approval would inject uncertainty for Americans not considered high-risk who want to get another coronavirus vaccine.

They said it’s not clear who will ultimately be able to get the shot, whether insurance will cover it and whether they can get vaccinated at their local pharmacy.

It’s possible a vaccine could be provided off-label to groups not covered by FDA approval, but pharmacists and doctors may be hesitant to do so or face regulatory constraints.

The vast majority of Americans get vaccinated for the coronavirus at retail pharmacies.

In nearly 20 states, the authority of pharmacists to offer vaccines is tied to federal immunisation recommendations, according to Brigid Groves, the vice-president of professional affairs at the American Pharmacists Association.

The other states rely on the patient population the FDA approved the vaccine for, making it unclear if healthy Americans younger than 65 will be able to get the shot at a pharmacy.

Pharmacists could decide to give the shot off-label, but it could open them up to liability concerns and potential repercussions against their licence, Groves said.

Access for high-risk children depends on their age: the Moderna vaccine was approved for ages 6 months and older, Pfizer for 5 and older and Novavax for 12 and older.

In some previous years, Americans started to receive coronavirus vaccines at no cost after they were recommended by the Centres for Disease Control and Prevention’s Advisory Committee on Immunisation Practices.

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That committee is expected to meet on September 18 and 19, and the coronavirus vaccine is among the items on the agenda, according to three federal health officials who spoke on the condition of anonymity.

Kennedy previously fired all members of that committee and replaced them with his own picks, most of whom have criticised the coronavirus vaccine policy.

Sign up to Herald Premium Editor’s Picks, delivered straight to your inbox every Friday. Editor-in-Chief Murray Kirkness picks the week’s best features, interviews and investigations. Sign up for Herald Premium here.

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