Earlier this week, the Food & Drug Administration (FDA) — under the auspices of the Department of Health and Human Services (HHS) — announced that it will be drastically pulling back on recommending seasonal vaccination for COVID-19. Until now, annual vaccination was recommended for all Americans six months and older to be better protected from COVID-19 variants.
Now, in a paper published in The New England Journal of Medicine, FDA director Martin Makary and the agency’s top vaccines regulator Vinay Prasad wrote that future recommendations for routine annual vaccination will be limited to adults over the age of 65 and for younger Americans with at least one condition that puts them at risk for severe Covid (e.g. people with asthma, diabetes, obesity, among other conditions).
This could limit availability, which some health experts feel could have negative effects, especially moving into the colder months, when COVID infections become more numerous.
“Although the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment,” the paper reads, “the benefit of repeat dosing — particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both — is uncertain. The American people, along with many health care providers, remain unconvinced.”
While the agency expects to find favorable risk-benefit findings for seniors and those with high-risk factors, for all other groups not perceived to be at risk, the FDA will likely require randomized, controlled trial data.
“Due to cost, timeline constraints, and variant evolution, full-scale randomized controlled trials (RCTs) are unlikely for updated seasonal COVID-19 vaccines,” says Dr. Steven Goldberg, the Chief Medical Officer of HealthTrackRx, told Scary Mommy in a statement.
This could lead to vaccines for seasonal variants being less available and less likely to be covered by insurance.
In a statement, the American Academy of Pediatrics (AAP) has “serious concerns” about what this might mean for vaccine availability. Sean T. O’Leary, chair of the AAP Committee on Infectious Diseases, said the plan “ignores all the work that’s already been done looking at the effectiveness and safety of this (vaccine).”
“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” he said in a statement, which adds that data from the Centers of Disease Control and Prevention (CDC) show that 41% of children hospitalized for Covid did not have an underlying condition.
Goldberg echoed this concern, and while he does acknowledge that the vaccine would likely still be available to those willing to pay out of pocket at pharmacies and through private providers, he cautions that this could exacerbate disparities in access, particularly if vaccine availability becomes tied to federal purchasing or payer coverage decisions.
“A more restrictive vaccination framework could decrease population-level immunity, facilitating increased viral transmission and indirect risk to vulnerable individuals,” he says. “Public confusion over eligibility and a lack of consistent coverage could undermine vaccine confidence and uptake. Clear communication and equitable distribution strategies must accompany any policy shift.”
Questions also remain as to who would determine eligibility for the vaccine. Could a pharmacist determine whether someone had an underlying condition? Would it be up to insurance companies? Such regulations remain unclear.
“The way we license and recommend vaccines in the U.S. is really a model for much of the world, and to circumvent that process in this manner is deeply concerning,” said O’Leary, continuing, “When everyone has access to immunizations, our communities and our children are healthier.”
Dr. Goldberg observes that to be successful, any policy shift “necessitates rigorous communication, robust data monitoring, and proactive planning to ensure the protection of high-risk groups and the maintenance of public trust.”
