CureVac, GSK load into starting block in omicron booster race

With competitors laps ahead on the track, CureVac and GSK are loading into the starting block for the COVID-19 booster race. The companies announced Thursday morning that a phase 1 trial for their mRNA booster vaccine targeting the omicron variant is getting underway.

The candidate, called CV0501, is meant to be administered as a booster dose following previous COVID-19 vaccination. GSK used CureVac’s “second-generation mRNA backbone” to develop the vaccine, according to a press release.

CureVac will test CV0501 at sites in the U.S., the U.K., Australia and the Philippines in up to 180 healthy, COVID-19 vaccinated adults. The participants will receive a single booster dose at first, with larger doses possible as safety is confirmed.

The company also kicked off a phase 1 test for a so-called "second-generation" COVID-19 shot called CV2CoV in March that will go after the original coronavirus that caused the respiratory disease and the global pandemic. The company said this double-pronged clinical approach will help narrow down the best candidate to advance into later-stage testing.

Data from the two studies will be reported together, although CureVac did not say when. 

CV2CoV is CureVac’s second attempt at an mRNA vaccine after the companies’ first candidate failed.

Both Pfizer-BioNTech and Moderna have omicron boosters already on order with countries around the world. In the U.S., the White House expects updated shots to be available in about three weeks if they pass muster at the FDA and the Centers for Disease Control and Prevention. 

CV0501 and CV2CoV are part of GSK and CureVac’s larger infectious diseases collaboration, which features trials for the unmodified seasonal influenza candidate CVSQIV and the modified candidate FLU SV mRNA. The pact was originally signed back in July 2020. COVID-19 was added to the deal in February 2021, and the agreement was amended again earlier this year to include modified mRNA technologies in addition to unmodified mRNA.