FDA Authorizes Updated Novavax Covid-19 Vaccine for Use in People Age 12 and Older
The U.S. Food and Drug Administration (FDA) has officially authorized an updated version of the protein-based Novavax Covid-19 vaccine for individuals aged 12 and older. Health officials anticipate that doses of this vaccine could be available by the end of next week.
“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” stated Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He emphasized, “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. 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.”
The Novavax vaccine utilizes protein technology, which is known to take longer to produce compared to mRNA vaccines like those developed by Pfizer and BioNTech, as well as Moderna. This type of vaccine initiates an immune response by prompting the body to recognize small, modified pieces of the virus it is designed to target, specifically pieces of the coronavirus spike protein.
In a related recommendation from June, the U.S. Centers for Disease Control and Prevention (CDC) advised that everyone over the age of 6 months receive both an updated Covid-19 vaccine and a flu shot this year.
Last week, the FDA also gave the green light to updated mRNA-based vaccines from Moderna and Pfizer, which specifically target the KP.2 strain of the coronavirus. In contrast, Novavax’s protein-based shots target a different strain, the JN.1 variant. According to CDC data, the prevalent strain in the U.S. at this time is the KP.3.1.1, another offshoot of JN.1.
Pharmacies across the U.S. have already started offering the Moderna and Pfizer vaccines. Novavax has announced that its vaccine “will be available in thousands of locations across the country, including retailers, regional grocers, and independent pharmacies.”
Recent data from the CDC indicates that levels of the SARS-CoV-2 virus, which causes Covid-19, detected in wastewater are currently at “very high” levels nationwide. This surge marks the highest summer peak in the U.S. since July 2022. Monitoring viral levels in wastewater serves as a crucial indicator of the virus’s spread, particularly as testing rates and other monitoring efforts have decreased.
This report was contributed to by CNN’s Jamie Gumbrecht and Meg Tirrell.
