The US Food and Drug Administration (FDA) today announced that it has granted emergency use authorization for Novavax's updated COVID-19 vaccine.
Approval of the protein-based vaccine comes about a week after the FDA green-lighted the two updated mRNA vaccines—made by Moderna and Pfizer-BioNTech—which target the KP.2 variant. The Novavax vaccine targets JN.1, the parent of KP.2.
Novavax's updated vaccine is authorized for people ages 12 and older.
A third COVID vaccine option
In a statement, Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, said COVID vaccines continue to have a major positive impact on public health and that vaccination continues to be the most effective method for COVID prevention. "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."
Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards.
The company has said the vaccine will be available in prefilled syringes and that it will promptly deliver it as soon as the FDA authorizes the vaccine. Its data suggest the JN.1 monovalent vaccine induces broad neutralization responses against JN.1 lineage viruses, including ones such as KP.2 and KP.3