Brandon Guerrero, 34, from Compton, receives both a flu and a COVVI-19 vaccine at the CVS in Huntington Park on August 28, 2024.
Christina House | Los Angeles Times | Getty images
Food and Drug Administration Tuesday has described new regulatory advice for future Boosters in the COVVI-19 vaccine, establishing stricter approval standards for healthy Americans.
The FDA has recommended various standards of proof of approval on the risk of patients to become seriously ill from COVVID, according to an article published Tuesday in the New England Journal of Medicine. The authors of the newspaper are the commissioner of the FDA, Marty Makary and Vinay Prasad, a frank critic of the pharmaceutical industry which was appointed to direct the division of the agency which supervises the vaccines.
The new guidelines are involved as Secretary for Health and Social Services Robert F. Kennedy Jr., a leading vaccination skeptic, revisits the country’s health agencies.
For adults aged 65 and over, and for people as young as 6 months who have certain underlying health conditions, the FDA said that it would accept immunogenicity data – which shows that a vaccine triggers a fairly strong response of antibodies – as sufficient to determine that the advantages suddenly prevail.
But for healthy people between 6 months and 64 years old who have no risk factors, the agency plans to require higher evidence of vaccines from randomized controlled trials. These studies must show real clinical results, such as fewer infections or hospitalizations, before the FDA offers complete approval of a gunshot.
When approving a vaccine coded for high-risk people, the FDA will encourage manufacturers to conduct randomized and controlled clinical trials in healthy adults as part of their post-marketing commitment.
Previously, the FDA was based more on immunogenicity data when evaluating the photos of Booster Covid – which are adapted to new circulating strains of the virus – for the approval of all Americans each year. This approach reflected the influenza vaccine model, where annual deformation updates are approved on the basis of immune response data, not complete clinical trials.
“The new COVVI-19 philosophy of the FDA represents a balance of regulatory flexibility and a commitment to the standard sciences,” said the agency in the newspaper. “The FDA will approve vaccines for high -risk people and, at the same time, will require robust and standard data on low -risk people.”
Makary and Prasad will contact the new executive during a virtual town hall on Tuesday at 1 p.m. he.
