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AstraZeneca to provide EU with U.S. trial data – EMA’s Cooke

Portugal resumes AstraZeneca vaccination after temporary suspension

(Reuters) – AstraZeneca will provide Europe’s drug regulator with data from a U.S. trial of its COVID-19 vaccine and the watchdog could adjust its assessment of the shot if needed, the head of the European Medicines Agency (EMA) said on Tuesday.

“The trials point to greater efficacy than what we actually observed in the previous trials that we examined,” EMA chief Emer Cooke told members of the European Parliament.

Cooke, however, did not deliberate much on doubts expressed by U.S. federal health officials that AstraZeneca may have used “outdated information” in the data released on Monday.

“The company has promised to provide us with (data) and we will adjust our assessment if there is any new information that needs to be taken into account,” she said.

The AstraZeneca-Oxford vaccine was shown to be 79% effective in preventing symptomatic illness and did not increase risk of blood clots, according to interim data from the late-stage trials in Chile, Peru and United States.

After briefly halting its use due to reports of the clots, many European countries resumed using the shot after the EMA said it was safe. Europe approved the shot earlier this year and the EMA cited efficacy rate of about 60% in its recommendation.

Cooke also said the regulator was in touch with representatives for the Sinopharm vaccine, as part of efforts to access more COVID-19 vaccines as cases surge and current supplies run thin.

Europe currently has four approved COVID-19 vaccines from Pfizer-BioNTech, Moderna, Oxford-AstraZeneca, and J&J’s Janssen.

(Reporting by Pushkala Aripaka in Bengaluru and Josephine Mason in London; Editing by Anil D’Silva)

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