February 1, 2021 -- The European Medicines Agency (EMA) has recommended the issuance of a conditional marketing authorization (CMA) for AstraZeneca's COVID-19 vaccine in the European Union (EU) for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The authorization follows a positive opinion given by the EMA's Committee for Medicinal Products for Human Use (CHMP) based on data from the rolling review of an analysis from a phase III clinical trial led by the University of Oxford. The analysis included analysis of 23,745 participants ages 18 years and older, accruing 232 symptomatic COVID-19 infections from the U.K. and Brazil phase III trials conducted by the University of Oxford.
The CHMP recommends two doses of the AstraZeneca COVID-19 vaccine, AZD1222, to be administered four-12 weeks apart. The vaccine is based on a replication-deficient chimpanzee adeno-associated viral vector and contains genetic material of the SARS-CoV-2 spike protein. The safety of the vaccine has been confirmed in global clinical trials with over 20,000 participants and confirmed in results published in peer-reviewed journals.
The company anticipates that the EU will approve a CMA shortly and immediately begin immunization across member states.
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