FDA may greenlight updated COVID-19 vaccines this week

INDIANA- The U.S. Food and Drug Administration may greenlight updated COVID-19 vaccines this week.

A spokesperson for the FDA said the agency can’t comment on the timing of product applications but noted that it “anticipates taking timely action to authorize or approve updated COVID-19 vaccines to make vaccines available this fall.”

The mRNA vaccines from Moderna and Pfizer/BioNTech will target the leading variants in circulation as the country experiences its largest summer wave in two years.

Representatives for Pfizer and Moderna told CNN that the companies had ample supply of their updated Covid vaccines and would be ready to ship doses upon approval. Moderna’s spokesman expects the vaccine to be available within days of FDA signoff.

The US is amid a significant COVID-19 wave, with viral activity levels in wastewater the highest they’ve been for a summer surge since July 2022, according to the US Centers for Disease Control and Prevention’s wastewater dashboard.

Measures of severe disease, including rates of hospitalization and death, have been rising, according to the CDC, but they’re nowhere near levels seen in previous years.

Waves of the virus are driven by both waning immunity and new variants, experts say. The prevalent strain in the US now is KP.3.1.1, according to CDC data, accoounting for 37% of cases over the past two weeks – triple its level a month ago.

KP.3.1.1 and KP.2 – the strain included in the updated mRNA vaccines – are both offshoots of JN.1, the target of Novavax’s shot, and all are versions of the Omicron variant.

The CDC recommended that everyone over six months old receive updated COVID-19 and flu vaccines this year because protection provided by the shots appears to wane over time.

Information: CNN.