SNY - Novavax Seeks FDA Nod for Updated COVID-19 Vaccine | Benzinga
Novavax (NASDAQ: NVAX) submitted an application to the FDA, seeking to amend its Emergency Use Authorization (EUA) and update its protein-based COVID-19 vaccine for the upcoming fall season.
While this updated vaccine has been formulated to target the JN.1 variant, management claims that the vaccine has also been shown to be effective against the current circulating strains, including KP.2 and KP.3.
Subject to necessary permissions from the FDA and CDC, Novavax intends to market this updated COVID-19 vaccine in pre-filled syringes by mid-August. If authorized/approved, it will be the only protein-based non-mRNA COVID-19 vaccine in the United States.
Novavax's filing is based on guidance from the FDA issued last week, which advised COVID-19 vaccine manufacturers Moderna (NASDAQ: MRNA), Novavax and Pfizer (NYSE: PFE) to update their respective COVID-19 vaccines to target the KP.2 strain if it is feasible. This guidance is an update on the FDA's prior advice issued at the beginning of this month that recommended updating the COVID-19 vaccines to target the JN.1 strain.
The FDA's prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country ...