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European Union regulators have delayed a decision to approve Novavax Inc.’s protein-based Covid-19 vaccine tailored for recent variants.
It’s another setback for the Gaithersburg biotech, which didn’t get U.S. approval for its initial Covid vaccine until mid-2022 and has trailed behind Pfizer and Moderna, both makers of mRNA-based shots, in getting domestic approvals for its updated shots.
The Food and Drug Administration and Centers for Disease Control and Prevention gave the green light to Novavax’s updated vaccine in early October and it arrived in CVS and Rite Aid stores about three weeks after rival shots, but demand across the U.S. for recently tailored vaccines has been weak.
The Covid vaccine is Novavax’s lone product on the market. The company has raised doubts about its ability to stay in business unless it’s able to widely distribute its vaccine in the U.S. and abroad. Novavax has taken on a series of cost-cutting measures to stay afloat.
In a statement, Novavax (NASDAQ: NVAX) said it continues to work with the European Medicines Agency as it reviews the company’s updated vaccine and that it has responded to additional questions from the agency and is awaiting feedback. It also said it expects to meet its full supply commitment for doses to European countries that have requested it.
The Financial Times reported that the European Medicines Agency has questions about the potency of Novavax’s latest shot and it’s looking to ensure the vaccine keeps its same characteristics across several production facilities.
Novavax’s share price dropped 7.85% in early Monday trading on the news, but has since rebounded slightly and was trading $6.72 midday Tuesday. Its share price is down 9.8% in the last five days of trading and is down more than 31% year to date.
