CureVac’s COVID-19 Vaccine Heads to Phase 2b/3 Trial

Supported by promising phase 1 data, CureVac announced Monday that it has enrolled the first participant in the pivotal phase 2b/3 study of its messenger-RNA based coronavirus vaccine, CVnCoV.

The randomized trial of the two-dose vaccine is expected to enroll more than 35,000 participants aged 18 and up at sites throughout Europe and Latin America. Participants will also be monitored in a yearlong study following the trial’s conclusion that will collect additional data to help assess the vaccine’s duration of effectiveness.

“We are hopeful that this trial will continue to demonstrate the impact of mRNA technology,” said CureVac CEO Franz-Werner Haas.

The company announced positive phase 1 trial results in November that demonstrated its candidate elicited immune responses and was well-tolerated. No adverse events were observed and the reactions were similar to those seen in recovered COVID-19 patients, CureVac said (DID, Nov. 3).

Like Pfizer and Moderna’s highly effective vaccines, CVnCoV is a two-dose vaccine based on mRNA technology. But unlike Pfizer’s shot, which must be shipped at extremely cold temperatures, CureVac’s vaccine can remain stable for at least three months at 41 F (Fahrenheit), similar to Moderna’s vaccine. Those temperature requirements are likely to make distribution significantly easier in the event it proves itself in the late-stage trial and receives regulatory authorization. — James Miessler