Latest study data for CVnCoV published 

Cure­Vac N.V. (Nas­daq: CVAC), a bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing a new class of trans­for­ma­tive mes­sen­ger ribonu­cle­ic acid (mRNA)-based drugs in clin­i­cal tri­als, today announced the pub­li­ca­tion of the first data from its piv­otal Phase 2b/3 HERALD study of CVn­CoV, its first-gen­er­a­tion COVID-19 vac­cine can­di­date, on The Lancet pre-print serv­er. The HERALD tri­al enrolls approx­i­mate­ly 40,000 sub­jects in 10 coun­tries in Latin Amer­i­ca and Europe in pre­de­fined age groups between 18 and 60 years and over 60 years. In the final analy­sis, COVID-19 cas­es were detect­ed based on 15 dif­fer­ent viral variants.

As pre­vi­ous­ly announced, the data are based on 228 con­firmed COVID-19 cas­es that occurred at least two weeks after the sec­ond vac­ci­na­tion. CVn­CoV demon­strat­ed 48% over­all effi­ca­cy against COVID-19 dis­ease of any sever­i­ty, includ­ing sin­gle mild and non-res­pi­ra­to­ry symp­toms. In par­tic­i­pants in the 18- to 60-year age group, CVn­CoV showed sig­nif­i­cant pro­tec­tive effi­ca­cy, with 53% effi­ca­cy against dis­ease of any sever­i­ty across all 15 iden­ti­fied viral vari­ants; a 77% pro­tec­tive effect against mod­er­ate and severe dis­ease was also cal­cu­lat­ed for this age group. In the same age group, CVn­CoV also pro­vid­ed a 100% pro­tec­tive effect against hos­pi­tal­iza­tion or death.

The com­pa­ny is in close con­tact with the Euro­pean Med­i­cines Agency (EMA) with the inten­tion of seek­ing reg­u­la­to­ry approval to make the vac­cine avail­able to the large pop­u­la­tion for which it has been shown to be high­ly pro­tec­tive. Com­pre­hen­sive clin­i­cal data pack­ages con­tin­ue to be sub­mit­ted to the EMA as part of the rolling reg­u­la­to­ry process, which began in Feb­ru­ary 2021. Com­ple­tion of data sub­mis­sion is expect­ed towards the end of the third quar­ter. With the lack of effec­tive vac­cines still a chal­lenge in many parts of the world, the COVID-19 vac­cine can­di­date CVn­CoV, which has been test­ed in clin­i­cal tri­als in a vari­ant-dom­i­nat­ed envi­ron­ment, has the poten­tial to con­tribute to the fight against the coro­n­avirus pan­dem­ic in an envi­ron­ment char­ac­ter­ized by an increas­ing num­ber of viral variants.