FDA Authorizes Novavax Covid Vaccine, A Fourth Option For US
Instead of relying on mRNA technology, Novavax is the nation's first protein-based covid-19 vaccine. The two-dose shot should be available “in the next few weeks," according to the Department of Health and Human Services, but first needs clearance from the CDC.
The Washington Post:
FDA Authorizes Novavax Coronavirus Vaccine, Adding To Pandemic Arsenal
U.S. regulators Wednesday authorized the nation’s fourth coronavirus vaccine, a shot developed by Novavax, a Maryland biotechnology company that has been a straggler in the vaccine race. For a relatively small niche of people who want to be vaccinated, but can’t or won’t take existing vaccines, Wednesday’s decision by the Food and Drug Administration has been impatiently awaited. Some people are allergic to an ingredient in messenger RNA vaccines or simply prefer the more traditional technology at the core of Novavax’s shot, which is the United States’ first protein-based vaccine. (Johnson, 7/13)
NBC News:
FDA Authorizes Novavax's Covid Vaccine
The FDA’s signoff isn’t the last step: The decision will now to go the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on how the shots should be used. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on July 19. (Lovelace Jr., 7/13)
Politico:
Novavax Covid-19 Vaccine Wins FDA Authorization
In a trial of more than 26,000 adults in the U.S. and Mexico, two doses of the Novavax Covid vaccine were more than 90 percent effective at preventing symptomatic disease. For adults 65 and older, effectiveness was more than 78 percent. There were no serious side effects or safety concerns, including for the approximately 21,000 adults who were followed for more than two months after their second shot. (Foley and Lim, 7/13)
The New York Times:
Novavax’s Latecomer Covid-19 Vaccine Gets U.S. Authorization
Novavax’s vaccine, given in doses spread three weeks apart, works differently from mRNA vaccines. It provokes an immune response with nanoparticles made up of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been widely used around the world for decades. (Robbins and Zimmer, 7/14)
