FDA approves COVID shots with new restrictions
- The San Juan Daily Star
- Sep 3
- 5 min read
By Christina Jewett and Jacey Fortin
The Food and Drug Administration last week approved updated COVID vaccines for the fall season and limited who can get the shots, the federal government’s most restrictive policy since the vaccines became available.
The agency authorized the vaccines for people who are age 65 and older, who are known to be more vulnerable to severe illness from COVID. Younger people would only be eligible if they had at least one existing medical condition that would put them at risk for severe disease. Healthy children younger than 18 could still receive the shots if a medical provider is consulted.
People seeking the shots will soon face another hurdle. An influential advisory committee to the Centers for Disease Control and Prevention must vote to recommend them. But that panel’s makeup shifted when Health Secretary Robert F. Kennedy Jr. unseated existing members, reduced the panel’s size and added some COVID vaccine opponents.
This would mark the first fall/winter season that COVID shots were not widely recommended to most people and children, pitting federal health officials in the Trump administration against several national medical groups that oppose the restrictions.
In a social media post, Kennedy said the approvals accomplished the goals of keeping vaccines available to people who want them and of demanding that companies conduct placebo-controlled trials. One new, required study would examine “post-COVID-19 vaccination syndrome” in patients, a condition that has been noted in at least one small preliminary medical report, but is still a matter of pitched debate.
“The American people demanded science, safety and common sense,” Kennedy’s post on X said. “This framework delivers all three.”
Many public health experts view the changes as part of Kennedy’s broader campaign against certain vaccines, especially his targeting of mRNA technology, which has been used in the vast majority of shots administered to Americans. They criticized his recent cancellation of $500 million in grants to study flu and COVID vaccines, as a move that would significantly set back the nation’s efforts to develop better therapies and leave the nation reliant on older, slower approaches.
Those efforts have been tempered, to some degree, by the White House, where President Donald Trump remains proud of Operation Warp Speed, which was widely recognized as an impressive feat of science, organization and execution to develop and deliver vaccines that helped bring the pandemic to an end.
“Operation Warp Speed, people say, is one of the greatest achievements ever in politics or in the military — because it was almost a military procedure,” Trump said during a Cabinet meeting Tuesday.
The FDA’s new limited approval covers two vaccines designed with mRNA that were updated to target the LP.8.1 variant, which represents nearly one-third of recent cases. The Moderna vaccine authorization covers those who are 6 months old and older and have medical conditions and all people older than 65. The Pfizer shot was approved for the same group ages 5 and older.
The agency also approved the protein-based Novavax vaccine, which is matched to the omicron strain JN.1, which the mRNA vaccines targeted last year. The company said the shots continue to offer high levels of antibodies.
The FDA revoked emergency authorizations for the vaccines in children, which would make the Pfizer shot unavailable for children younger than 5.
Proponents of limiting eligibility say that younger people are far less susceptible to severe illness. And the rates of vaccine use have dropped in recent years, to about 23% among all adults and to 13% of people younger than 18, according to the CDC.
A decision by the CDC’s panel is expected within a month, and it could greatly influence access to the shots at drugstore sites, which have become the most convenient places to get them. Laws in a number of states, including California, Pennsylvania, Florida and Massachusetts, require that pharmacy staff are only permitted to administer vaccines recommended by the CDC, said Richard Hughes IV, a lawyer who represents vaccine makers.
Along with the new eligibility limits, pharmacists are raising concerns over their role in an era of increasing vaccine restrictions.
“I’m hearing from pharmacists who are fearful they might be in legal jeopardy for providing vaccines,” said Michael Osterholm, a University of Minnesota public health researcher. “We’ve created this environment of fear for vaccine administration, and I’m hearing a lot of that.”
Health insurers have so far made few changes in coverage and have said they expect to continue to support vaccination as a preventive measure, but whether coverage will change because of the new restrictions remains unknown. Medicaid coverage, which includes the Vaccines for Children Program that provides access to low-income and working-class families, generally hews to the CDC recommendations.
Kennedy has upended decades of vaccine policy at the CDC in recent months, replacing infectious disease experts with some members who have vehemently opposed the mRNA COVID vaccines. Kennedy, who spent nearly 20 years working as an anti-vaccine activist before entering government, also has the final say over the panel’s recommendations.
Sara Roszak, senior vice president of health and wellness strategy and policy for the National Association of Chain Drug Stores, a trade group, said her organization was carefully watching the CDC’s next move, given that about 90% of COVID shots were administered in pharmacies in recent years.
A CVS Health spokesperson said it has continued to offer eligible patients COVID vaccines but would review the new federal guidelines. The company also owns the insurer Aetna and said self-funded employers could determine what to cover, depending on state and federal laws. For now, CVS said pregnant women and children would be able to get COVID shots. Walgreens did not respond to a request for comment.
The Blue Cross Blue Shield Association, whose plans cover 1 in 3 Americans, said in a statement that it would monitor the federal guidelines on immunization.
A number of professional groups have already begun to issue advice that diverges from recent changes under Kennedy’s watch. In May, the CDC dropped the recommendation that pregnant women receive the COVID shots, a move that could limit insurance coverage and availability at pharmacies.
The American College of Obstetricians and Gynecologists took a different stance, advising women to get the COVID vaccine to protect themselves and their infants, who cannot be immunized until they are 6 months old. Large studies have found that vaccination reduces the risk of maternal death or stillbirth during pregnancy.
Although data collection has fallen off, reports of COVID deaths have fallen sharply. In July, a month when case counts tend to be low, the CDC reported roughly 170 deaths a week this year. Last year, there were about 550 to 850 deaths a week in July.
Still, lawmakers in several states, including Maryland, Pennsylvania, Massachusetts and Rhode Island, have taken legislative steps to safeguard their ability to provide vaccines regardless of federal policies.
And state health officials in the Northeast and beyond met recently to discuss paths forward in the case of altered federal vaccine policies. Dr. Robbie Goldstein, the Massachusetts health commissioner and an infectious disease specialist, said his team was scouring state laws for references to the CDC committee to ensure that the state could make vaccine policy based on other recommendations, such as ACOG or the American Academy of Pediatrics.
“We are committed to using data and evidence, and we’ve seen that the federal government, in particular Secretary Kennedy, has not supported the use of data and has not been transparent with the data that he’s using to make decisions,” he said.
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