The US Food and Drug Administration (FDA) has overhauled its Covid-19 vaccine approval process, a move that could restrict future shots to older Americans and those at higher risk of severe infection. According to Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary, the agency will now require more stringent evidence from vaccine manufacturers to approve updated Covid-19 shots.
Under the new guidelines, updated vaccines will likely be available this fall for adults 65 and older and those with underlying conditions that put them at higher risk of severe Covid-19 infection. However, healthy adults and children may no longer be eligible for the shots. This change aligns the US with guidelines in the UK, Canada, and Australia.
The FDA’s decision is based on the fact that nearly three-quarters of Americans aged six months and older have at least one underlying medical condition. Novavax CEO John Jacobs acknowledged the shifting landscape, noting that their target population aligns with those most likely to seek seasonal COVID-19 vaccination, according to CDC data.
According to Prasad and Makary, there is insufficient data to conclude that regular Covid-19 injections provide clinically substantial advantages to healthy children and adults. They call for more placebo-controlled trials, particularly in those aged 50 to 64, before prescribing injections for other groups
Manufacturers of vaccines, such as Pfizer, Moderna and Novavax, may face challenges due to the new regulations since they may have to carry out costly and time-consuming randomized controlled studies. Pfizer and Novavax have not responded to the new framework, but Moderna has stated that it is committed to collaborating with the FDA to supply the required data.
Just days before the policy change, the FDA approved Novavax’s COVID-19 vaccine, although the decision came six weeks past its anticipated timeline. Approval was restricted to individuals 65 and older and those aged 12 and up with existing health conditions.
The FDA’s decision has significant implications for millions of healthy adults and children who may lose access to updated vaccines under the new criteria. As the agency considers the results of future studies, the future of Covid-19 vaccination in the US may look very different.
Source: CNN
