This Week Could Bring FDA Approval of Fall COVID-19 Vaccines

TUESDAY, Aug. 20, 2024 (HealthDay News) — Updated COVID-19 vaccines may receive approval from the U.S. Food and Drug Administration this week.

Two sources familiar with the issue told CNN that updated mRNA vaccines from Moderna and Pfizer that target the KP.2 variant could be greenlit as early as this week. The news agency said the sources declined to be named because information around the timing of approval has not yet been made public. It is not clear whether approval for the Novavax non-mRNA shot, targeted to the JN.1 strain, would be approved simultaneously.

If approval does come this week, that would be a few weeks ahead of the timing for last fall”s shots, which were approved on Sept. 11.

The news comes as Americans are suffering through a summer surge of COVID-19 cases — the highest seen since the summer of 2022, based on wastewater levels of virus tracked by the U.S. Centers for Disease Control and Prevention.

According to CDC data, the prevalent COVID-19 variant is now KP.3.1.1, thought to make up 37 percent of cases over the past two weeks. Still, experts note that although levels of severe disease have been rising, they remain much lower than those seen during the early years of the pandemic. KP.3.1.1 and KP.2, which are both covered in the updated shots, are offshoots of JN.1. All are members of the omicron family.

Both Moderna and Pfizer have said they have ample supplies of their updated COVID-19 vaccines on hand, ready for shipment to stores soon after FDA approval. The Novavax vaccine may take a bit longer to reach consumers, because its protein-based shot takes longer to manufacture than mRNA vaccines do.

In June, the CDC recommended that every American older than 6 months of age receive an updated COVID-19 shot along with the flu shot this year.

CNN Article