Another COVID-19 vaccine might soon be approved for use in the United States, an alternative that one infectious disease expert boasted as being “more traditional” than the rest.
Novavax submitted its candidate coronavirus vaccine, NVX-CoV2373, to the Food and Drug Administration on Monday for emergency use authorization for individuals 18 years or older, according to a statement.
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The company reported that its protein-based COVID-19 vaccine has an overall efficacy of about 90% and a “reassuring safety profile.” It requires two doses administered 21 days apart.
“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Novavax President and CEO Stanley Erck.
The company conducted two phase-three clinical trials, which had approximately 30,000 participants in the United States and Mexico, and another in the United Kingdom with nearly 15,000 participants. The company found only a low number of “serious and severe adverse” side effects among trial groups, according to the statement. The most common side effects reported during the trials included headaches, nausea, vomiting, injection-site tenderness, and others.
If approved, Novavax will provide an alternative to Pfizer and Moderna’s mRNA vaccines, as well as the one-shot jab offered by Johnson & Johnson. Both Pfizer and Moderna’s mRNA methods, as well as Johnson & Johnson’s viral vector method, instruct human cells how to create the part of the coronavirus called the spike protein that triggers an immune response, according to the Mayo Clinic. The Novavax vaccine uses the “protein subunit” method, directly injecting a defanged version of spike protein to trigger an immune response without having the body create it, thus skipping a step intrinsic to the other available vaccines.
“The Novavax vaccine has no genetic material, only proteins,” Diana Florescu, who led the phase-three trial at the University of Nebraska, said in June. “The vaccine technology is more traditional, and it’s very similar to a protein-based influenza vaccine.”
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The company also said it is evaluating the “safety and effectiveness” of a booster dose of the vaccine and studying it in children age 12-17, according to the statement.
