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Novavax Seeks Authorization For COVID Vaccine As US Issues New Travel Warnings

Novavax Seeks Authorization For COVID Vaccine As US Issues New Travel Warnings

After experiencing several setbacks, Novavax said on Monday it has filed for emergency use authorization of its COVID-19 vaccine for U.S. adults, a long-awaited step for the company following months of struggles with development and manufacturing problems. The filing is based on data provided to the U.S. Food and Drug Administration (FDA) last month and results of two late-stage trials in the United States, Mexico, and the UK that showed the protein-based vaccine had an overall efficacy of about 90%, the company said.

Novavax has had to delay its U.S. submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators’ standards.

Chief Executive Officer Stanley Erck said in a statement, “We believe our vaccine offers a differentiated option… that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” an oblique reference to Novavax’s vaccine using a different technology than the mRNA vaccines from Pfizer/BioNTech, Moderna, or Johnson and Johnson.

Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta. Early data published in late December suggests the vaccine is also effective against the fast-spreading Omicron variant, which is now the dominant version of the virus in the United States and most of the world.

 

The news of a potential fourth vaccine comes at the same time the CDC has issued a new advisory against travel to a dozen countries because of high rates of coronavirus infection. Since mid-December, the U.S. government has added more than 60 countries and territories to its list of places to avoid, citing the Omicron coronavirus variant.

The U.S. State Department also raised its travel advisory for Mexico and some of the other nations listed by the CDC to “Level 4: Do Not Travel,”, including Brazil, Singapore, Ecuador, Kosovo, Philippines, and Paraguay. The CDC now lists nearly 130 countries and territories with COVID-19 cases as “Level Four: Very High.” It also added Anguilla, French Guiana, Moldova, Saint Vincent, and the Grenadines to its highest level on Monday.

 

 

 

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