Novavax Faces Demand for COVID-19 Vaccine Clinical Trial

The US FDA requests that Novavax finish a new clinical trial for the postponed COVID-19 vaccination. The WSJ reports According to persons familiar with the situation, the Wall Street Journal said Friday that federal regulators had requested that Novavax finish a second clinical trial on its COVID-19 vaccine after previously postponing approval.

The vaccine manufacturer's stock closed at $6.67, down over 6  percent. After-market trading saw the stock drop more than 1 percent.

The article also stated that after officials under Health and Human Services Secretary Robert F. Kennedy Jr. interfered in the approval process, the U.S. Food and Drug Administration requested that the Maryland-based company conduct another research to demonstrate the effectiveness of their vaccine.

According to Novavax, the business has answered the FDA's Post Marketing Commitment (PMC) request and is now awaiting a response. Without providing any other information, the vaccine manufacturer stated that its application is approved and that it anticipates obtaining approval as soon as possible.

According to the publication, Novavax has leverage to bargain for a more affordable, smaller trial that might only cost a few million dollars because of the FDA's requirement for new evidence.

In a CBS interview earlier this month, Kennedy blamed the FDA's failure to approve the shot by the April 1 deadline on the shot's composition, casting doubt on the vaccine's future.

In a move that eased fears about the future of the vaccine and sent its shares skyrocketing, Novavax said on Wednesday that U.S. regulators asked the company to provide more data on its COVID-19 vaccine if it receives final approval.

This coincides with widespread layoffs, including of senior scientists, as part of a significant reorganization under Kennedy that has raised concerns about possible interference with the regulatory evaluation of medications and vaccines. In order to increase usage and better compete with messenger RNA vaccines from competitors Moderna, Pfizer, and BioNTech, the business hopes to transform the emergency authorization for the vaccine from 2022 into a full approval. A substitute for mRNA vaccines from Pfizer-BioNTech and Moderna, which were fully approved in 2021 and 2022, respectively, is provided by Novavax's protein-based technology.