FDA Review of Novavax COVID Vaccine Raises Doubts about Broader Shot Approval

On Monday, the Food and Drug Administration (FDA) asked Novavax to run a new clinical trial of its vaccine after the agency granted full approval, and it's believed the shot will be approved. The Novavax vaccine, in its clinical trial, has shown effectiveness in over 30,000 people; however, it is still being sold under emergency use authorization in the US.

 Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, commented, “I don’t think, because there’s a strain change, that this is a new product.”

 Andrew Nixon, a Health and Human Services spokesmen, stated, “It’s now been years since Covid has presented the therapy it once did, and the urgency to rush approval of boosters without normal oversight no longer exists.” For decades with flu vaccines, the FDA had been treating as the same treat during the annual COVID-19 strain and not as new products, but similarly the existing ones that are simply adjusted against the latest strains, commended by Dr Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

 He also said that companies should perform tests on small numbers of people to show that these updated vaccines produce levels of antibodies that are protective and mention for safety. He suggested the policy might not apply to the flu shot that has been tried and tested for more than 80 years.

 The FDA is required to follow procedures during the issue of requirements for approval under federal law. If any of the procedures are skipped by the agency or forces additional requirements for political reasons, they could be sued by drugmakers or even patients if they have any allergic reactions or some other reasons.