CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV saltlakecitysun.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from saltlakecitysun.com Daily Mail and Mail on Sunday newspapers.
CureVac has initiated a rolling review with the European Medicines Agency (EMA), working towards authorization for its mRNA COVID-19 vaccine in the European Union.
The candidate is currently in Phase 3 trials in Europe and Latin America, and the rolling review with the EMA is its first submission for authorization globally.
Phase 1 interim data, announced in November, showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection, according to the company.
DGAP-News: CureVac / Key word(s): Study
CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV
12.02.2021 / 11:04
CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV
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- Submission of CVnCoV pre-clinical data package marks start of the rolling process
TÜBINGEN, Germany/ BOSTON, USA - February 12, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company s mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing. The process was initiated when the first data package consisting of CVnCoV pre-clinical data was submitted to EMA and passed the technical validation.
CureVac startet rollierendes Zulassungsverfahren () aktiencheck.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from aktiencheck.de Daily Mail and Mail on Sunday newspapers.