Shares of Novavax (NVAX) experienced a sharp decline on Thursday, tumbling over 24% to $5.13. This downturn comes in the wake of comments from Robert F. Kennedy Jr. regarding the company's COVID-19 vaccine approval process. The vaccine, which has a single-antigen composition, is currently facing delays in gaining full approval from the Food and Drug Administration (FDA).
The delay is attributed to a shift in focus by health authorities. The Secretary of Health and Human Services noted that the FDA is prioritizing multiple-antigen vaccines over single-antigen types, which they believe have not been effective against respiratory diseases in the past. Consequently, the approval for Novavax's vaccine has been postponed as the agency looks for more comprehensive data.
Earlier reports indicated that the FDA had missed a key decision deadline for Novavax's COVID-19 shot. This delay followed organizational changes, including the departure of the vaccine chief, Peter Marks. Despite the pandemic emergency having ended, the need for continuous vaccine use remains, and Novavax's application now lacks the necessary data for immediate approval.
Other COVID-19 vaccines, such as those from Pfizer (PFE) and its partner BioNTech, as well as Moderna (MRNA, Financial), received full FDA approval in 2021 and 2022, respectively. The recent developments have had a significant impact on Novavax's stock performance, with investors responding negatively to the uncertainty surrounding the vaccine's approval status.
