The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
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Bayer has signed a collaboration and services agreement with CureVac for the development of CVnCoV, a COVID-19 vaccine currently in late-stage trials.
The first participant has been enrolled in a Phase IIb/III study of CVnCoV, CureVac's mRNA COVID-19 vaccine candidate.
The interim Phase I data suggests CVnCoV can safely induce a neutralising antibody response similar to that of convalescent COVID-19 patients with two 12μg vaccine doses.
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.