Novavax Faces Setback, European Authority Delays Decision On Variant-Tailored COVID-19 Vaccine

Novavax Inc NVAX faces a setback as the European Medicines Agency (EMA) delays a decision on its variant-tailored COVID-19 vaccine. 

This delay comes at a challenging time for the US-listed biotech, grappling with declining demand for COVID-19 vaccines.

The EMA was set to approve the updated jab, but instead, they've requested more information, raising concerns about the vaccine's characteristics.

The EMA's questions center around the vaccine's potency and ensuring consistency across different production sites. The EMA is expected to provide its approval within four weeks. 

"As part of the ongoing review process, [the EMA] has additional questions, which we are answering expeditiously," Novavax told the Financial Times.

Earlier this month, the FDA approved Novavax's updated COVID-19 vaccine, targeting the omicron subvariant XBB.1.5 in individuals aged 12 and older. 

Novavax's COVID-19 vaccine, a protein-based vaccine, is considered safe and highly effective. Initially, it was seen as a solution for those wary of mRNA vaccines, but demand has waned with the dominance of BioNTech SE BNTX / Pfizer Inc PFE and Moderna Inc MRNA in the European market.

Related: Pfizer Cuts Annual Revenue Guidance By $9B Amid COVID-19 Vaccine Sales Slump, BioNTech Warns €900M Write-Offs

While the impact of EMA approval on Novavax's revenues remains uncertain due to market saturation, the company intends to supply doses to European countries with advanced purchase agreements in place.

Price Action: NVAX shares are down 4.26% at $6.75 during the premarket session on the last check Monday.