Healthcare groups denounce limited COVID shot approvals 

Healthcare groups are condemning the FDA’s decision to issue narrow approvals for COVID-19 vaccines, saying the move will limit access for millions of Americans and raise the risk of severe outcomes ahead of respiratory virus season. 

On Aug. 27, the FDA approved updated vaccines targeting newer strains of the virus from Pfizer, Moderna and Novavax. All were approved for individuals 65 and older. However, regulators limited their use among younger adults and children to individuals with at least one condition that puts them at high risk for severe disease. 

In past years, COVID shots were broadly recommended for everyone 6 months and older. Medical and public health experts have said the FDA’s move will cause confusion and create new access hurdles, which could limit uptake of the vaccine and lead to strain on the nation’s healthcare system in the months ahead. 

HHS Secretary Robert F. Kennedy Jr. in a post on X said vaccines will be available “for all patients who choose them after consulting with their doctors.” However, it is unclear what type of evidence healthy patients seeking a shot may need to provide in order to receive the vaccine.

“This makes things much more complicated, and when things get complicated we see vaccine uptake go down,” Andy Pekosz, PhD, a professor of molecular microbiology and immunology at Johns Hopkins University Bloomberg School of Public Health in Baltimore, told the Associated Press. 

Here are how two healthcare industry groups responded to the narrowed approvals:

Susan Kressly, MD, president of the American Academy of Pediatrics, called the changes “deeply troubling.” 

“The American Academy of Pediatrics remains focused on increasing access to vaccines for all children, in all communities,” Dr. Kressly said in a statement. “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 developing.” 

The AAP recommends all children 6 months to 2 years old receive an annual COVID vaccination, Dr. Kressly said. The AAP also recommends kids ages 2-18 in certain risk groups receive the vaccine. The group issued those recommendations Aug. 19, breaking with updated CDC recommendations published in May that advised “shared clinical decision-making” between patients and providers. 

“Any parent who wants their child vaccinated should have access to this vaccine; 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. Parents and pediatricians, together, make the best decisions to protect children’s long-term health. We urge the Administration to allow these choices to remain with medical experts and families.”

The Infectious Diseases Society of America reaffirmed its support for COVID-19 vaccination as a critical local tool to prevent severe illness, hospitalization and death and said the narrow approvals increase the risk of more severe outcomes this fall and winter. 

“The scientific evidence continues to strongly support broad vaccination far beyond the limited populations outlined in the Food and Drug Administration’s new label,” Tina Tan, MD, president of IDSA, said in a statement. “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.”

IDSA said it is working with other medical groups to finalize its own vaccination guidelines that apply to both healthy and immunocompromised adults. It expects to release those recommendations in September. The group also urged insurers to continue covering the vaccines “consistent with multiple medical society recommendations and scientific evidence.”

“Physicians can still provide COVID vaccines off-label, and IDSA strongly encourages doctors to continue recommending and administering vaccination to their patients based on the best available science,” Dr. 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.”

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