Novavax Applies For FDA Authorization Of Its Protein-Based Covid Shot
The Food and Drug Administration will next review the company's data. Already in use in 170 other countries, Novavax's covid vaccine is protein-based, rather than mRNA-based, and could give unvaccinated people who have been hesitant another option.
CBS News:
Novavax Could Offer Unvaccinated Americans A New Option, If Regulators Agree
Following a long-awaited submission of data to the Food and Drug Administration last month, Novavax announced Monday that it had formally filed a request for emergency use authorization of its protein-based COVID-19 vaccine in the United States. If greenlighted by the FDA, Novavax's shots could be the first COVID-19 doses available in the U.S. based on a kind of "protein subunit" technology that has been used for decades in other routine vaccinations. Officials say having this option could help persuade some remaining vaccine holdouts to get the shots, as well as boost the Biden administration's international vaccine donation goals. (Tin, 1/31)
WTOP:
Gaithersburg’s Novavax Officially Files For FDA Vaccine Approval
Gaithersburg, Maryland-based Novavax, which began developing its protein-based COVID-19 vaccine candidate almost two years ago, has officially filed for approval with the U.S. Food and Drug Administration for its use in the U.S. The final FDA filing Monday comes months after Novavax had originally intended, and, while it may seem the company is late to the vaccine game, it sees its vaccine filling a void, particularly internationally. It does not require sub-zero storage, making it potentially more accessible to developing countries and remote areas. (Clabaugh, 1/31)
NBC News:
Covid Vaccine: Novavax Asks FDA To Authorize For Adults
The Novavax vaccine is already available for use in at least 170 countries, but if cleared for emergency use in the United States, it would provide an alternative to the popular mRNA-based shots from Pfizer-BioNTech and Moderna. For certain groups of people — particularly young men — the mRNA vaccines carry a slightly elevated risk of a heart condition called myocarditis. Novavax's vaccine has not been linked to myocarditis. (Lovelace Jr., 1/31)
CNN:
Novavax Seeks FDA Emergency Use Authorization Of Its Coronavirus Vaccine
The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), and has a shelf life of about nine months, according to the company. Stanley Erck, Novavax's president and chief executive officer, told CNN in November that if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship. (Howard, 1/31)
