The request is based on data that includes the results of two large clinical studies that showed a total effect of around 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 parts of the coronavirus to stimulate immunity, a more traditional approach to vaccine development that some people may be more familiar with or comfortable with, compared to mRNA. the vaccines made by Moderna and Pfizer / BioNTech.
“In the United States, I think the primary market in 2022 will be to deliver a vaccine, our usual two-dose regimen, to many people who have been hesitant to get other vaccines,” Erck said in November. “And to give a booster.”
When the genetic sequence of the coronavirus was first published, Novavax researchers 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 autumn armyworm – with that virus, which caused them to produce the nail protein from the coronavirus.
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 years and older, and the Moderna vaccine is approved for adults 18 years and older.
Novavax has applied for authorization in several other countries, including the United Kingdom, Canada and New Zealand.