Novavax’s shot, which targets the JN.1 variant, has been authorized.
The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.
Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.
FDA officials said that animal testing data supported the decision.
“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.
The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid (mRNA) technology earlier in the month.
Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.
“The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.
Novavax President and CEO John C. Jacobs said in a statement that the company’s vaccine showed “robust cross-reactivity against JN.1 lineage viruses” in animals.
JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention.
The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks that ended on Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August.
The Pfizer and Moderna vaccines target KP.3.
