Novavax Asks FDA To Authorize Its Non-MRNA Covid Vaccine
Topline
Novavax on Monday requested the U.S. Meals and Drug Administration to grant emergency use authorization to its Covid-19 vaccine, which depends on conventional protein-based know-how quite than Pfizer and Moderna’s newer mRNA vaccine know-how and has already been authorised by the World Well being Group and European regulators.
Medical assistant Florelyn Adajar injects Rolando Gasmen with a dose of coronavirus vaccine at … [+]
Zachary Snowdon Smith/The Cordova Occasions
Key Details
Novavax CEO Stanley Erck predicted January 10 the FDA might authorize his firm’s vaccine in February (the FDA didn’t instantly reply to a request for remark).
The vaccine was 90.4% efficient at stopping Covid-19 infections and 100% efficient at stopping severe signs in scientific trials, in keeping with a study revealed December 15 within the New England Journal of Medication.
Trials confirmed few severe uncomfortable side effects, and the commonest reactions have been headache, nausea or vomiting, muscle ache, joint stiffness and injection website tenderness or ache.
Key Background
In 2020, Novavax was awarded $1.7 billion from the federal authorities to develop a vaccine utilizing proteins from the coronavirus. Regardless of this, the Maryland-based firm lagged behind Pfizer and Moderna after battling scientific trials and manufacturing, the New York Occasions reported. The corporate submitted its ultimate information packages to the FDA on New 12 months’s Eve, and was unable to request authorization earlier than Monday. The vaccine is utilized in 170 international locations, and the corporate has been contracted to ship about 2 billion doses of the vaccine worldwide, Erck mentioned January 10. Accessible information means that the vaccine is efficient in opposition to the omicron variant.
What To Watch For
Though mRNA vaccines—which construct immunity by inflicting human cells to fabricate a innocent piece of coronavirus protein—have been extensively examined and confirmed safe, some conspiracy theorists declare mRNA vaccines trigger sterility or alter the DNA of vaccine recipients. As a result of protein-based vaccines are extra acquainted, Novavax’s new vaccine could assist scale back hesitancy among the many 24.7% of Individuals who’ve but to obtain a Covid shot.
Huge Quantity
81 million. That’s about how many individuals within the U.S. have but to obtain a single dose of Covid-19 vaccine, in keeping with the Facilities for Illness Management and Prevention.
Tangent
Novavax’s vaccine has gained a cult following on social media websites like Reddit and Twitter as a result of it makes use of protein-based know-how quite than the comparatively new mRNA know-how, Fortune reported.
Essential Quote
“I’ve talked to some unvaccinated of us right here in Canada and the US who acknowledged they’d rethink their place if a extra ‘conventional’ (ie not mRNA or Advert-vectored) vaccine have been obtainable,” virologist Dr. Angela Rasmussen tweeted. “And globally we simply want extra vaccines, interval. Novavax helps on all fronts.”
Additional Studying
“If Authorised, The Novavax Covid-19 Vaccine May Assist Scale back Vaccine Hesitancy In The U.S.” (Forbes)
“WHO Grants Novavax Covid Vaccine Emergency Use Approval As Omicron Fears Deepen” (Forbes)
