FDA announces COVID-19 vaccine restrictions for seniors over 65 and high-risk groups
The FDA announced a new policy limiting COVID-19 vaccine approval to adults over 65 and those at high risk for severe illness, aiming to refine the approach to annual vaccinations while still covering millions with preexisting conditions.
The U.S. Food and Drug Administration (FDA) released a significant update to its COVID-19 vaccination policy, limiting vaccine approval to adults 65 and above and those at increased risk of severe disease. The update tightens the previous broad eligibility and toward the development of a more targeted and efficient annual immunization program. Despite the cutoff, tens of millions of Americans with chronic illnesses will continue to be covered under the new policy.
FDA officials emphasized that this shift is predicated on evolving scientific understanding and the need for more targeted vaccine use. They emphasized that future vaccine updates, especially those specially designed for novel variants of the coronavirus, should be backed by thorough, controlled trials rather than simply formula changes. This is a departure from the previous "one size fits all" approach to COVID-19 vaccination.
FDA announces COVID-19 restrictions for seniors
The FDA on Tuesday announced that COVID-19 vaccines are now only approved for individuals 65 years and older or those at high risk for severe illness.
This change is meant to facilitate easier implementation of the strategy for annual coronavirus vaccinations, though 100 million to 200 million people with certain health conditions will still qualify, according to FDA officials in a New England Journal of Medicine editorial.
The U.S. Centers for Disease Control and Prevention (CDC) includes numerous conditions that carry higher risk, and roughly 75% of Americans six months and older have at least one of them.
FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, who wrote the editorial, said that the uniform vaccine strategy may be too outdated to work. They suggested conducting rigorous, controlled studies prior to updating vaccines for new strains, a process that before only needed slight tweaks to the same formula.
Prasad took the unusual place of Dr. Peter Marks, who has resigned in March, condemning the spread of misinformation by vaccine critic Robert F. Kennedy Jr., the Secretary of Health and Human Services, whose department oversees the FDA.
