Federal regulators announced Tuesday a new regulatory policy for Covid-19 approvals designed to limit vaccine approvals to older Americans and those at serious risk from the virus.
The FDA’s new policy will make seasonal Covid-19 vaccines available to the elderly and those with health conditions that put them at a greater risk of infection, but not for young adults and children who otherwise face little risk of suffering from debilitating Covid-19 symptoms.
Food and Drug Administration Commissioner Dr. Marty Makary and Center for Biologics Evaluation and Research director Dr. Vinay Prasad unveiled the policy in a new paper published by the New England Journal of Medicine.
“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes,” Makary and Prasad wrote.
“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”
Makary and Prasad argue the FDA’s new policy brings the U.S. in line with its peers in Canada, Europe, and Australia in recommending Covid-19 boosters for only the most vulnerable patients. The public health officials asserted that the Covid-19 vaccine is a major scientific accomplishment, but the benefits of repeat boosters for low-risk patient groups are unclear.
Less than a quarter of Americans have received annual Covid-19 boosters, including less than 10 percent of children under 12 years old. Only a third of health care workers have gotten the yearly shot and 50 percent of adults over 75 have taken the boosters.
In making the case for their new policy, Makary and Prasad pointed out the declining public trust in vaccines, including those, like the measles shot, that have been around for decades and have proven extraordinarily effective.
“The American people were skeptical, and some of them took that skepticism to every single vaccine, which has led to some big problems,” Prasad told the Free Press, which first reported the new policy. “This is a restoration of that trust. It’s bringing us back to evidence.”
Makary and Prasad both work under Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic who has strongly criticized Covid-19 vaccine mandates.
The FDA’s new policy will allow for timely approvals for the people who need boosters the most, while allowing public health officials the time to better generate evidence of their effectiveness, Makary and Prasad say. The Centers for Disease Control estimates that most Americans have at least one condition putting them at heightened risk of severe disease. Obesity, diabetes, chronic lung disease, sickle cell disease, and weakened immune systems are among the numerous conditions the CDC considers risk factors.