The US Food and Drug Administration is on the verge of approving updated Covid-19 vaccines targeting newer strains of the virus, as the country faces its largest summer surge in two years, sources familiar with the matter said.
According to the sources, the FDA is expected to authorize updated mRNA vaccines from Moderna and Pfizer/BioNTech that target the KP.2 strain of the virus. It remains uncertain whether the agency will also approve Novavax’s updated shot, which targets the JN.1 strain.
This approval would come several weeks earlier than last year’s vaccine, which was given the green light on September 11.
“Now is the time to get a dose with this surge,” Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, advised.
In June, the US Centers for Disease Control and Prevention recommended that everyone over 6 months old receive both an updated Covid-19 vaccine and a flu shot this year.
Representatives for Pfizer and Moderna confirmed that they have an abundant supply of their updated Covid vaccines and will be prepared to distribute doses once approved. Moderna even expects its vaccine to be available in stores within days of FDA approval.
Novavax’s vaccine, based on protein technology, is expected to be available for distribution this month once authorized. However, a spokesperson for Novavax did not respond to a request for comment.
The FDA stated that they anticipate taking timely action to authorize or approve updated COVID-19 vaccines to make them available this fall.
Wastewater measurements have indicated very high levels of the SARS-CoV-2 virus, leading to the highest summer peak in the US since July 2022. Surveillance of viral levels in wastewater provides insight into the widespread virus circulation.
Rates of hospitalization and death due to severe Covid-19 are rising, but they are not as high as in previous years.
Experts attribute the waves of the virus to waning immunity and new variants, with the prevalent strain in the US being KP.3.1.1, accounting for 37% of cases in the past two weeks.
KP.3.1.1 and KP.2 are both variants of the Omicron strain, similar to the target of Novavax’s vaccine, JN.1.
CNN’s Brenda Goodman contributed to this report.
