TOPLINE
A Food and Drug Administration advisory committee on Tuesday voted unanimously to endorse Novavax’s protein-based Covid-19 vaccine, bringing the shot one step closer to becoming the fourth FDA-approved coronavirus shot for adults.
KEY FACTS
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21 to 0, with one expert abstaining, to recommend approval of the vaccine.
The FDA is likely to follow the committee’s recommendations, though it does not have to.
The Centers for Disease Control and Prevention then must also choose whether to endorse the vaccine before it can become widely available.
FDA official Peter Marks suggested to the advisory panel Novavax’s shot could offer another option for those who are hesitant to get vaccinated as it is not made from new messenger RNA technology like Pfizer and Moderna’s shots.
KEY BACKGROUND
Novavax’s two-dose primary vaccine was found to be 90% effective at preventing mild, moderate or severe Covid infection in clinical trials. The company scored $1.6 billion in funding from the Trump Administration’s Operation Warp Speed in July 2020, but faced a host of manufacturing hurdles, including difficulty meeting quality standards. The vaccine has already been authorized in several countries, including Indonesia, the Philippines, South Korea, Australia and the United Kingdom. Though some experts have hoped the protein-based coronavirus vaccine could offer another option for more vaccine-hesitant Americans, data suggests vaccine uptake has slowed greatly in the U.S. in recent months: Americans threw out more than 82 million doses from December 2020 to mid-May. The FDA advisory meeting came days after the agency warned of a possible risk of two types of heart inflammation—myocarditis and pericarditis— linked with the Novavax vaccine. Cases of heart inflammation have occurred after patients received Pfizer and Moderna’s Covid vaccines as well. In a statement on Friday, Novavax said it believed there was “insufficient evidence to establish a causal relationship” between its vaccine and the heart inflammation.
FURTHER READING
Novavax Covid vaccine clears key step on path to FDA authorization after committee endorses the shot (CNBC)