HHS Announces Restrictions, New Framework for COVID-19 Vaccines

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On May 20, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad an editorial outlining FDA’s new approach for approving COVID-19 vaccines. To date, FDA has approved seasonal COVID boosters for all Americans over six months of age based on smaller studies of the body’s immune response, like it has with influenza vaccines. Makary and Prasad argue that this one-size-fits-all framework is outdated, citing limited evidence of the benefit of COVID boosters for healthy individuals (despite strong evidence—even from the —suggesting that boosters reduce the risk of severe disease and Long COVID in this population), more targeted recommendations in peer countries, and a decline in COVID vaccine uptake. Moving forward, FDA says it will approve seasonal COVID boosters for adults over the age of 65 and those six months and older with one or more risk factors that increase a person’s risk of severe disease. Manufacturers seeking approval for healthy individuals over six months of age must run a large, randomized control trial and meet certain clinical endpoints. FDA estimates that 100 to 200 million Americans remainligible for annual boosters under this framework. 

One week later, on May 27, HHS Secretary Kennedy in a video, alongside Commissioner Makary and the Director of the NIH, that he “couldn’t be more pleased to announce” that the CDC will no longer recommend the COVID-19 vaccine for healthy children and healthy pregnant women, claiming that there is not enough evidence to support the repeat booster strategy in children. CDC officials were blindsided by the news. Notably, Kennedy did not provide an explanation for pulling the recommendation for pregnant women, despite “pregnancy and recent pregnancy” being listed as qualifying risk factors in FDA’s new COVID vaccine framework.

CDC did later issue formal changes to its immunization schedules; however, the agency did not go as far to limit COVID vaccines for healthy children and pregnant women. Instead, CDC that healthy children six months and older may receive the COVID vaccine following shared clinical decision-making between their health care provider and the patient or their parent or guardian. And while CDC removed the recommendation for , they did not preclude pregnant women from receiving the vaccine. This issue has caused confusion for insurers, which are required by the ACA to cover, without cost sharing, vaccines recommended by CDC’s Advisory Committee on Immunization Practices (ACIP).

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