Topline
Novavax on Monday asked the U.S. Food and Drug Administration to grant emergency use authorization to its Covid-19 vaccine, which relies on traditional protein-based technology rather than Pfizer and Moderna’s newer mRNA vaccine technology and has already been approved by the World Health Organization and European regulators.
Key Facts
Novavax CEO Stanley Erck predicted January 10 the FDA could authorize his company’s vaccine in February, though the FDA said it could not foresee how long its evaluation of the data would take.
The vaccine was 90.4% effective at preventing Covid-19 infections and 100% effective at preventing serious symptoms in clinical trials, according to a study published December 15 in the New England Journal of Medicine.
Trials showed few serious side effects, and the most common reactions were headache, nausea or vomiting, muscle ache, joint stiffness and injection site tenderness or pain.
Key Background
In 2020, Novavax was awarded $1.7 billion from the federal government to develop a vaccine using proteins from the coronavirus. Despite this, the Maryland-based company lagged behind Pfizer and Moderna after struggling with clinical trials and manufacturing, the New York Times reported. The company submitted its final data packages to the FDA on New Year’s Eve, and was unable to request authorization before Monday. The vaccine is used in 170 countries, and the company has been contracted to deliver about 2 billion doses of the vaccine worldwide, Erck said January 10. Available data suggests that the vaccine is effective against the omicron variant.
What To Watch For
Although mRNA vaccines—which build immunity by causing human cells to manufacture a harmless piece of coronavirus protein—have been extensively tested and proven safe, some conspiracy theorists claim mRNA vaccines cause sterility or alter the DNA of vaccine recipients. Because protein-based vaccines are more familiar, Novavax’s new vaccine may help reduce hesitancy among the 24.7% of Americans who have yet to receive a Covid shot.
Big Number
81 million. That’s about how many people in the U.S. have yet to receive a single dose of Covid-19 vaccine, according to the Centers for Disease Control and Prevention.
Tangent
Novavax’s vaccine has gained a cult following on social media sites like Reddit and Twitter because it uses protein-based technology rather than the relatively new mRNA technology, Fortune reported.
Crucial Quote
“I’ve talked to some unvaccinated folks here in Canada and the US who stated they’d reconsider their position if a more ‘traditional’ (ie not mRNA or Ad-vectored) vaccine were available,” virologist Dr. Angela Rasmussen tweeted. “And globally we just need more vaccines, period. Novavax helps on all fronts.”
Further Reading
“If Approved, The Novavax Covid-19 Vaccine Could Help Reduce Vaccine Hesitancy In The U.S.” (Forbes)
“WHO Grants Novavax Covid Vaccine Emergency Use Approval As Omicron Fears Deepen” (Forbes)
