Blitz Bureau
The U.S. Food and Drug Administration (FDA) has authorised 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 authorisation to the Maryland-based company for the product. FDA officials said that animal testing data supported the decision.
‘Meets standards’
“Today’s authorisation provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorisation,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an August 30 statement.
The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology (mRNA) 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.
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 ending August 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.
FDA officials initially advised manufacturers to target JN.1 but later recommended they target KP.3. Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the mRNA shots. Company officials told FDA advisers that they were planning to continue manufacturing a JN.1-based vaccine.
