Novavax seeks FDA emergency use authorization of its coronavirus vaccine
The request is based on data that includes the results of two large clinical trials that demonstrated an overall efficacy of about 90% and a “reassuring safety profile,” according to the company.
Novavax’s vaccine — administered as two doses, three weeks apart — is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach for vaccine development that some people may be more familiar or comfortable with, compared with the mRNA vaccines made by Moderna and Pfizer/BioNTech.
“In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines,” Erck said in November. “And to provide a booster.”
When the genetic sequence for the coronavirus was first published, Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells — specifically, cells from the fall armyworm — with that virus, prompting them to produce the coronavirus spike protein.
These virus-like nanoparticles were harvested to make Novavax’s vaccine.
The FDA has authorized vaccines made by Pfizer, Moderna and Johnson & Johnson for emergency use in the United States. The Pfizer vaccine is now approved for use in people 16 and older, and the Moderna vaccine is approved for adults 18 and older.
Novavax has applied for authorization in several other countries, including the United Kingdom, Canada and New Zealand.
