The executive director of Europe’s drug regulator, the European Medicines Agency, (EMA) said Tuesday it is evaluating Russia's Sputnik V COVID-19 vaccine for possible authorization of use in the European Union.
In comments to European Parliament lawmakers, EMA Executive Director Emer Cooke said the agency is also planning inspections of the manufacturing and clinical sites in Russia to make sure production for the vaccine is adequate.
The vaccine was viewed skeptically by some nations as Russia began distributing it to some European countries before it was evaluated by regulatory agencies – including the EMA and the World Health Organization.
Cooke said it was hoped the shot would be "a valuable vaccine to add to the vaccines that are available from the European population.” She also assured EU lawmakers that the agency was committed to applying the same standards and scrutiny to this review as to any other scientific assessment.
Cooke said the agency was also conducting rolling reviews – or fast-track evaluations – of vaccines made by U.S. manufacturer Novavax and German company Curevac.
She also welcomed the new data on the AstraZeneca vaccine made available from a U.S. trial, saying it is very promising information and shows greater efficacy than expected.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that some experts hoped would help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
U.S. federal health officials said early Tuesday that results may have included “outdated information” and that could mean the company provided an incomplete view of efficacy data.
When asked about that development, Cooke said the company promised to provide the EMA with data and the agency would adjust its assessment, if needed, based on the new information.
