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EU Drug Regulator Approves AstraZeneca Vaccine for Emergency Use


FILE - An employee in personal protective equipment (PPE) removes vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune, India, Nov. 30, 2020.
FILE - An employee in personal protective equipment (PPE) removes vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune, India, Nov. 30, 2020.

European Union regulators on Friday approved the AstraZeneca COVID-19 vaccine, the third vaccine approved for use on the European continent.

Amid criticism the bloc is not moving fast enough to vaccinate its population, the European Medicines Agency’s (EMA) expert committee unanimously recommended the vaccine for adults, despite concerns of inadequate data proving its effectiveness for people over 55.

Addressing reporters from agency headquarters in Amsterdam, EMA chief Emer Cooke told reporters the agency had approved the drug for conditional or emergency use because clinical studies found the vaccine to be about 60% effective at fighting the coronavirus — lower than the two previously approved vaccines from Pfizer-BioNTech and Moderna, which show efficacy in the 90% range.

Many EU health officials had been anticipating approval of the AstraZeneca vaccine because it is less expensive and does not require deep-freeze storage like the Pfizer-BioNTech drug.

Earlier Friday, German Health Minister Jens Spahn indicated the vaccine would be approved, but not recommended for patients older than 65, as the clinical studies lacked data regarding its efficacy for patients in that age range.

But Emer said EMA’s experts determined, based on the immune results seen in patients between the ages of 18 and 55 years, older adults are expected get the same protection from the vaccine.

The AstraZeneca vaccine had already been approved for use in Britain and a number of other countries. The U.S. Food and Drug Administration is still considering the drug company’s application for emergency use.

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