In The News: Updated Covid Vaccines for the Fall May Be in Jeopardy Under Kennedy’s New Rules

NBC News reports the Health and Human Services secretary has introduced a new rule governing vaccine testing. As a result of the rule, experts say updated COVID-19 vaccines for the circulating variant in the fall may be at risk. The change would require new placebo-controlled clinical testing with results from the two groups compared prior to approval.

When originally approved, the COVID-19 vaccines by Pfizer and Moderna conducted placebo-controlled trials. The virus’s subsequent mutations have led vaccine developers to take an approach similar to the annual flu vaccine and attempt to match vaccine to circulating strain. Updated vaccines use the same formula with slight adjustments, which has enabled changes to be made quickly to better target the virus.

The updated shots, however, may be treated as novel vaccines under the rule. An FDA spokesperson released a statement that indicated the new commissioner may consider significant changes to updated vaccines as new products requiring additional evaluation. The statement also indicated the agency did not consider trials from four years ago to be sufficient to allow new versions without new clinical trials, though it exempted flu shots from such consideration.

That move jeopardizes the availability of shots ready for the fall should the FDA committee meet at its scheduled time at the end of May or perhaps in June to recommend the strains for updates. According to experts, if the vaccines were to be regarded as new shots, drug makers would need months to design, enroll and conduct trials prior to having results and then rollout the updated formula.

The new requirements elicited responses of being unethical to give someone a placebo when an approved product could protect people and fears the rule change is part of a broader effort to undermine confidence in vaccines. There was also speculation that the move could lead to unnecessary hospitalizations and deaths.

PIDS member and one of the society’s founders, Stanley Plotkin, is quoted that such a move would make “no sense. What would be reasonable is to compare the old vaccine with the new vaccine to see whether the new vaccine gives better immunologic responses. We have vaccines against Covid, where we have pretty concrete ideas as to what works and what doesn’t work. We know they’re not perfect, but we have vaccines we know work.”