The clinical trials showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine compared with people given control injections, the European Medicines Agency (EMA) said in a statement.
EMA recommended granting a conditional marketing authorization for the vaccine to prevent coronavirus disease in people from 18 years of age.
“EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety, and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorization be granted by the European Commission,” the statement said, adding that this will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls, and obligations to underpin EU-wide vaccination campaigns.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguarding the health of EU citizens.”