Many will welcome less pressure to vaccinate for COVID. This is especially true of people in healthcare. 

Importantly, the new policy will likely reveal at last the answers to two hotly-contested claims about COVID vaccines. It may 1) trigger greater COVID severity and case numbers, as vaccine proponents claim; or 2) lead to fewer blood clot, myocarditis, and pregnancy problems, as vaccine opponents claim.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/117178

Fall COVID Shots Approved, With New Restrictions

— Three vaccines broadly approved for people 65 and older, but with limits for younger groups

August 27, 2025

The FDA approved 2025-2026 COVID vaccines from Pfizer (Comirnaty), Moderna (Spikevax, mNexspike), and Novavax (Nuvaxovid), the companies announced on Wednesday. But the agency removed one of the vaccines available for the youngest kids and added limits that will make it difficult for millions of Americans to access the shots.

The mRNA vaccines Comirnaty and Spikevax are approved for all adults 65 and older but limited to people ages 5 to 64 years with at least one condition that puts them at high risk for severe COVID-19. Moderna's Spikevax vaccine is also approved for kids 6 months to 4 years with a high-risk condition. Moderna's lower-dose mRNA vaccine mNexspike and Novavax's protein-based non-mRNA vaccine are approved only for individuals 12 to 64 years with a high-risk condition, and all adults 65 and up.

The three vaccines target the LP.8.1 strain of Omicron, following the advice of the agency's vaccine advisors. Pfizer and Moderna said they expect the vaccines to ship immediately and should be available "in the coming days."

FDA revoked prior emergency use authorizations for the COVID vaccines, which for the Pfizer product previously included a lower-dose shot for children ages 6 months to 4 years.

"The emergency use authorizations for COVID vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," said HHS Secretary Robert F. Kennedy Jr. in a post on X on Wednesday.

The FDA in May announced their plans to limit COVID vaccines to higher-risk groups, bypassing recommendations from the CDC's Advisory Committee on Immunization Practices (ACIP). Since that time, the FDA has also approved prior versions of Moderna and Novavax vaccines for higher-risk groups.

A recent sweeping review by the Vaccine Integrity Project suggested no new evidence that would prompt the recent changes to fall COVID vaccine recommendations made by HHS. The American Academy of Pediatrics (AAP) also broke with government vaccine recommendations this month, announcing that it strongly recommends COVID-19 shots for children ages 6 months to under 2 years. Shots also are advised for older children if parents want their kids vaccinated, the AAP said.

That differs from the latest guidance under Kennedy, which doesn't recommend the shots for healthy children of any age, but says kids may get the shots in consultation with physicians.

In his post Wednesday, Kennedy said the shots will be "available for all patients who choose them after consulting with their doctors."

Coverage Questions and Access Issues Are Unresolved subhead

Infectious Diseases Society of America (IDSA) President Tina Tan, MD, said the science "strongly supports" vaccination of more than the FDA's newly limited populations.

"By narrowing its approval, 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," she said in a statement.

Coverage Questions and Access Issues Are Unresolved

In a statement, AAP President Susan J. Kressly, MD, called the new proposal to limit the availability of COVID vaccines in children and young adults "deeply troubling."

"Today's unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children," she said.

AAP "remains focused on increasing access to vaccines for all children, in all communities," said Kressly. "As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing."

And Americans are likely to confront a number of logistical hurdles.

Insurers typically base their vaccine coverage decisions on ACIP's recommendations, but some say they will also look to medical professional groups, including the American Medical Association.

Earlier this year, Kennedy ousted the prior ACIP members and replaced its members with a number of doctors and researchers who have repeatedly questioned the safety of commonly used vaccines and ingredients. The panel is expected to meet in September, but no specific date has been set and no agenda released.

Depending on ACIP's advice, Americans under age 65 could be expected to provide documentation of a serious medical condition before they can get a shot. Complicating the rollout is the fact that pharmacists -- who administer most COVID-19 shots -- typically aren't expected to collect that kind of information. And laws governing their ability to administer routine vaccinations vary by state, where pharmacists are licensed.

Many states limit vaccinations by pharmacists to those recommended by ACIP.

"Physicians can still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science," Tan said. "However, pharmacists' ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access."

Access could also be complicated for healthy adults and children who are interested in getting a shot for extra protection.

If the latest vaccines aren't covered by their insurance, those patients could be required to pay $150 or more out of pocket if they want one.

The Associated Press contributed to this report.

Terrence Rudd is a staff writer at MedPage Today, covering the infectious diseases beat. He has been a medical writer and editor for more than 30 years.