EU drug regulator clears AstraZeneca COVID-19 vaccine for all adults
The European Union’s drug regulator on Friday cleared AstraZeneca’s COVID-19 vaccine for all adults.
The European Medicines Agency recommended that the European Commission grant conditional marketing authorization for the vaccine, which was co-developed by the University of Oxford, for use in people aged 18 and older.
The vaccine is the third that the agency has recommended for approval; it previously recommended Pfizer and BioNTech’s vaccine, as well as a vaccine from Moderna.
“Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalizations,” AstraZeneca CEO Pascal Soriot said in a statement.
“We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans,” he said.
The agency said clinical data it reviewed showed the vaccine was safe and effective for people 18 years and older.
Most trial participants were between 18 and 55 years old, and the agency said there aren’t enough results in participants over the age of 55. However, the agency predicted that “the vaccine can be used in older adults.”
AstraZeneca’s vaccine is given in two doses about four to 12 weeks apart.
The recommendation comes after the EU and AstraZeneca feuded this week over AstraZeneca reportedly delaying the delivery of vaccine doses. The company cut the number of doses it would deliver to 31 million after originally agreeing to 80 million.
The move angered EU officials, who threatened export controls on vaccines made in the region.
It also comes as Johnson & Johnson reported on Friday that its new single-dose vaccine is 66 percent effective.
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