Novavax Inc. on Monday halved its full-year revenue forecast as it does not expect further sales of its COVID-19 shot this year in the United States in the face of a global supply glut and soft demand, sending its shares down 33%.
The United States has administered more than 7,300 doses of Novavax Inc.’s (NVAX.O) COVID-19 shot, which health officials hope will convince more people to opt for vaccinations as it is based on a technology that has been in use for decades.
The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.
The European Medicines Agency on Thursday identified severe allergic reactions as potential side effects of Novavax Inc.’s COVID-19 vaccine.
The vaccine has not yet been authorized for emergency use by the FDA. Advisers to agency last month voted to recommend that the FDA authorize the shot for use in adults.
Novavax Inc. announced today that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus.
U.S. regulators plan to decide by early July on whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday.
Although a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe — Pfizer-BioNTech, Moderna, Johnson & Johnson, AstraZeneca-Oxford — a number of companies are continuing to develop vaccines in hopes they can be used as booster shots.
A look at some of the latest COVID-19 news includes the U.S. Food and Drug Administration’s plans to review changes to Novavax’s manufacturing process before the regulatory agency authorizes the company’s vaccine. Moderna expects to submit data to regulators soon with expectations of the company’s bivalent COVID-19 vaccine—consisting of the original Spikevax vaccine and a newer version, mRNA-1273.214 that contains an Omicron-specific vaccine—becoming available in late summer.