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Shares of Novavax jumped more than 13% on Tuesday after the biotech company said its new Covid vaccine generated a broad immune response against the now-dominant Eris variant and another fast-spreading strain of the virus in small animal trials. But the trial results suggest that the shot may still be effective against newer Covid variants gaining a greater foothold in the U.S. That includes Eris and XBB.1.16.6, both of which are also descendants of omicron. "We have a lot of confidence in our updated Covid vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall," Filip Dubovsky, Novavax's president of research and development, said in a release. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. XBB.1.16.6 is also beginning to surge, accounting for 8% of all cases nationwide as of Saturday, the CDC said.
Persons: Novavax, Filip Dubovsky Organizations: Pfizer, Moderna, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S, hospitalizations
The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.
Jan 26 (Reuters) - Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States. The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants. The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. Reporting by Leroy Leo in Bengaluru Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.
CNN —Novavax’s Covid-19 vaccine is now available in the United States for use as a first booster dose for people 18 and older. The company said its booster is for adults for whom a Pfizer/BioNTech or Moderna updated booster vaccine is not accessible or clinically appropriate, and for adults who elect to receive the Novavax vaccine because they would otherwise not get a booster dose of a Covid-19 vaccine. “The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” Novavax President and CEO Stanley Erck said in a news release Wednesday. Novavax executives have long suggested that their Covid-19 vaccine could be used as a booster dose, even for people who got another vaccine type as their primary series. The most common side effects reported with the Novavax booster were pain or tenderness at the injection site, fatigue, muscle pain and headache.
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