The agency is not recommending future boosters pending additional study data.
The Food and Drug Administration (FDA) recently announced a new policy limiting annual COVID-19 vaccine eligibility to individuals over 65 and those with high-risk health conditions. The change, published by FDA Commissioner Dr. Martin Makary and vaccine division chief Dr. Vinay Prasad in the New England Journal of Medicine, will require more clinical data before authorizing additional booster doses for healthy people aged 6 months to 64 years.
“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,” read the new framework, published by Drs. Makary and Prasad.
This shift aligns U.S. vaccine policy more closely with countries such as Canada, Germany, and the UK, which recommend COVID-19 boosters primarily for older adults and vulnerable populations. The announcement came just before the Centers for Disease Control (CDC) and Prevention’s expert panel meeting to discuss fall booster recommendations. FDA leaders also urged vaccine manufacturers to monitor recipients for at least six months post-vaccination to better understand long-term effects and effectiveness among lower-risk individuals.
As the Lord Leads, Pray with Us…
- For Secretary Robert F. Kennedy, Jr. to be led by the Lord as he heads the Department of Health and Human Services.
- For Commissioner Makary to receive God’s wisdom as he oversees the FDA.
- For U.S. health officials as they seek additional data from COVID-19 vaccination studies.
Sources: NY Post, Washington Examiner, MSN