Washington (AP) – Annual Covid-19 vaccinations for healthy young adults and children Acknowledged daily under significant new policy adjustments announced on Tuesday by the Trump administration.
The top officials from the Food and Drug Administration have indicated a continuation of a streamlined method that will establish new criteria for access to Covid vaccines each year, particularly for those at greater risk, including adults over 65, children, and young adults with at least one underlying health condition.
Nonetheless, the FDA’s framework encourages companies to conduct extensive, long-term studies before approving modified vaccines for healthier individuals. With a framework Published in the New England Journal of Medicine on Tuesday, agency officials noted that this approach could enable annual vaccinations for between 100 million and 200 million people.
Possible future changes raise concerns for those who may wish to receive a Covid-19 shot this fall but do not fit neatly into specified categories.
“Will your pharmacist decide if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine specialist at the Children’s Hospital of Philadelphia. “The likely outcome is that the vaccine coverage will continue but it will become unavailable.”
The framework represents the culmination of a series of recent actionsExamining the utilization of Covid vaccines and significant questions regarding the broader availability of vaccines during President Donald Trump’s tenure. This was released just two days before the first convening of the FDA’s external vaccine advisors under the Trump administration.
Last week, the FDA granted full approval to the Novavax Covid-19 vaccine, but significant restrictions apply to its availability, a reflection also seen in Tuesday’s guidance. The approval follows a period in which Trump’s appointees reverted previous FDA scientists’ unrestricted plans.
Pfizer and Moderna, the developers of the most widely administered Covid-19 vaccines, have yet to provide any immediate comments.
For years, federal health officials have indicated that most Americans should anticipate annual updates for the Covid-19 vaccine, similar to flu vaccines. The FDA had previously authorized modified Covid vaccines based on evidence that manufacturers could ensure equivalent immune protection compared to prior versions.
However, the new FDA guidance suggests a shift away from that model Health Secretary Robert F. Kennedy Jr. and filled the FDA and other health organizations with vocal critics of the government’s handling of Community Shots, particularly in regard to recommendations for young, healthy adults and children. The FDA plans to release new guidance in a draft format, allowing for public commentary prior to finalization. According to FDA experts, the publication in medical journals is exceptionally rare and may contravene federal protocols.
Tuesday’s update, authored by FDA Commissioner Marty McCurry and FDA Vaccine Chief Vinay Prasad, critiques the U.S.’s “one-size-fits-all” approach, arguing that the U.S. is “the most aggressive” in advocating for Covid boosters compared to its European counterparts.
“We simply don’t know if a healthy 52-year-old woman with a normal BMI, who has already received three Covid-19 doses along with the previous six vaccines, will gain any benefit from a seventh dose,” they expressed.
Makary and Prasad conducted a study on individuals deemed not at high risk over a six-month period, recommending random assignments to either receive a vaccine or a placebo, while closely monitoring outcomes related to severe illness, hospitalization, or mortality.
Experts acknowledge the legitimate inquiries surrounding the overall advantages of annual Covid vaccinations, or whether they should be recommended solely to those at high risk.
An influential advisory panel from the Centers for Disease Control and Prevention is expected to convene to deliberate on which vaccines will be recommended for specific groups.
The FDA announcement appears to diminish the advisory board’s role, Offit stated. He noted that a CDC study identified that booster doses offer protection against mild to moderate illnesses, even among healthy individuals, for a duration of 4-6 months post-inoculation.
___
The Associated Press School of Health Sciences is supported by the Howard Hughes Medical Institution’s Science and Education Media Group and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
Source: apnews.com