U.S. drug watchdog approves new Covid-19 vaccines

(CNN) — The US Food and Drug Administration on Friday authorized an updated version of the protein-based Novavax Covid-19 vaccine for use in people 12 and up. Doses 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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”

Novavax’s vaccine is based on protein technology, which takes longer to manufacture than mRNA vaccines like those made by Pfizer and BioNTech and Moderna. Protein-based vaccines work by getting the body’s immune system to recognize small modified pieces of the virus it’s targeting. In this case, that means pieces of the coronavirus spike protein.

The US Centers for Disease Control and Prevention recommended in June that everyone over 6 months old receive both an updated Covid-19 vaccine and a flu shot this year.

The FDA greenlit updated mRNA-based Moderna and Pfizer shots last week. Those vaccines target the KP.2 strain of the coronavirus, an offshoot of JN.1, which is the target of Novavax’s protein-based shots. The KP.3.1.1 strain, which is also an offshoot of JN.1, is the prevalent version in the US now, according to CDC data.

The Moderna and Pfizer vaccines are already available in some pharmacies. Novavax said its vaccine “will be available in thousands of locations across the country, including retailers, regional grocers, and independent pharmacies.”

Levels of the SARS-CoV-2 virus, which causes Covid-19, measured in wastewater are at “very high” levels nationally, according to CDC data, sparking the highest summer peak in the US since July 2022. Monitoring of viral levels in wastewater can give a picture of how widespread the virus is as testing and other forms of monitoring have fallen off.

CNN’s Jamie Gumbrecht and Meg Tirrell contributed to this report.

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