The Trump administration announced a major shift in COVID-19 vaccine policy on Tuesday, revealing that annual shots will no longer be automatically authorized for healthy children and younger adults.
New guidelines released by the Food and Drug Administration outline that future COVID vaccine updates will still be streamlined for older adults, specifically those 65 and above, as well as younger people with medical conditions that elevate their risk.
However, the FDA is now calling on pharmaceutical companies to undertake more comprehensive, long-term clinical trials before vaccines aimed at the general population of healthy individuals can gain approval. In a new article in the New England Journal of Medicine, officials estimated that the revised strategy could still allow for 100 to 200 million adults to get updated shots each year.
This regulatory shift leaves uncertainty for people who might wish to get the shot in the fall but do not fit neatly into the high-risk categories.
“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”
The new framework, detailed in the medical journal, reflects a culmination of the FDA’s recent reevaluation of how COVID vaccines are used and distributed under the leadership of President Donald Trump.
Since the early days of the pandemic, federal officials have encouraged the public to view COVID shots like the annual flu vaccine — with updated formulas expected each year. Until now, the FDA has accepted manufacturer data showing that revised vaccines match the performance of earlier versions in terms of immune response.
But with Health Secretary Robert F. Kennedy now overseeing key agencies, that strategy is being phased out. Kennedy has brought in figures who have been critical of how the government promoted widespread COVID vaccinations, especially for younger and healthier demographics.
In the article released Tuesday, FDA Commissioner Marty Makary and vaccine policy director Vinay Prasad argued that the U.S. approach has been overly broad. They noted that America has gone further than many countries in urging booster doses for wide swaths of the population.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” they wrote.
Public health experts acknowledge that the benefit of annual COVID boosters for everyone remains debatable, particularly when it comes to individuals who are not at elevated risk. The CDC’s vaccine advisory committee is expected to discuss this very issue next month.
Offit expressed concern that Tuesday’s announcement from the FDA essentially overrides the CDC panel’s role. He noted that recent CDC findings show that booster shots can reduce mild to moderate illness for several months even among those who are generally healthy.
{Matzav.com}