The U.S. Food and Drug Administration (FDA) is on the verge of approving updated Covid-19 vaccines as soon as this week, according to two sources familiar with the matter. This potential approval comes at a critical time, as the U.S. is experiencing its largest summer wave of Covid-19 in two years.
Expected Vaccine Approvals
The FDA is anticipated to grant approval for updated mRNA vaccines from Moderna and Pfizer/BioNTech, which target the recently circulating KP.2 strain of the virus. Sources, who requested anonymity due to the confidential nature of the timing, indicated that approval for Novavax’s updated vaccine, which addresses the JN.1 strain, remains uncertain at this point. This would mark an earlier authorization compared to last year’s vaccine, which was approved by the FDA on September 11.
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, emphasized the importance of getting vaccinated amid the current surge. “Now is the time to get a dose with this surge,” Osterholm stated in a News interview. He also mentioned that he had received last season’s vaccine to boost his immunity while awaiting the new vaccines. Health officials recommend waiting four months between doses, and Osterholm plans to follow this guideline.
CDC Recommendations and Vaccine Availability
In June, the U.S. Centers for Disease Control and Prevention (CDC) recommended that everyone aged six months and older receive both an updated Covid-19 vaccine and a flu shot this year. Pfizer and Moderna have confirmed that they have sufficient supplies of their updated Covid-19 vaccines and are prepared to distribute them immediately upon FDA approval. Moderna expects its vaccine to be available in stores shortly after the FDA’s green light.
Novavax’s vaccine, which utilizes protein technology, takes longer to manufacture than mRNA vaccines. The company anticipates having its updated vaccine in warehouses by the end of the month and ready for distribution upon authorization. However, Novavax has not yet responded to requests for additional comments.
Current Covid-19 Situation
The CDC reports that SARS-CoV-2 levels, which cause Covid-19, are at “very high” levels nationwide, leading to the highest summer peak since July 2022. Monitoring wastewater has revealed the extent of viral spread, especially as testing and other monitoring efforts have declined. Although severe disease measures, including hospitalizations and deaths, are rising, they are still significantly lower than in previous years.
The current wave is attributed to both waning immunity and new variants. The prevalent strain in the U.S. is KP.3.1.1, which now accounts for 37% of cases, up from a month ago. KP.3.1.1 and KP.2—targeted by the updated mRNA vaccines—are both derivatives of the JN.1 strain, which Novavax’s vaccine aims to address. All these strains are variants of Omicron.
Looking Ahead
The anticipated approval of these updated Covid-19 vaccines is a crucial step in managing the ongoing pandemic and addressing the surge in cases. As the U.S. continues to navigate through high levels of Covid-19, timely access to effective vaccines will play a key role in controlling the spread of the virus and protecting public health.
