Novavax announced that it's COVID-19 vaccine could get full approval from the U.S. Food and Drug Administration (FDA) soon.
The update sent Novavax’s stock up above 21% in early trading. In addition, it assisted calm feats that the decision had been postponed by the Trump Administration, according to The Associated Press.
Novavax COVID-19 vaccine can be used under emergency use only
Novavax produces the only protein-based COVID-19 vaccine which is currently accessible in the U.S. It is only approved under emergency use.
Notably, this vaccine varies from the mRNA vaccines from Pfizer and Moderna, which already have complete FDA approval for specific age groups.
FDA asked Novavax to gather more clinical data from individuals who got its shot, the statement reads.
The company further stated that it is “engaging with the FDA expeditiously” in hopes to get full approval “as soon as possible.”
The vaccine was likely to get FDA approval by April 1; however, acting FDA Commissioner Dr. Sara Brenner asked the agency to halt it.
This raised several concerns regarding the U.S. Health Secretary Robert F. Kennedy Jr., a longtime vaccine sceptic, has caused the delay.
The COVID vaccines utilised in the U.S. train the human body to identify the tell-tale spike protein on the SARS-CoV-2 virus.
Unlike the Pfizer and Moderna vaccines that depend on a genetic code to stimulate immunity, Novavax's vaccine combines lab-produced copies of the spike protein along with an agent that strengthens immunity.
