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E.U. regulator backs AstraZeneca vaccine


The European Union's drugs regulator reiterated that the benefits of AstraZeneca's coronavirus vaccine outweigh the risks as it urgently reviews safety data after the suspension of shots by a growing number of countries.

The comments were the second from the European Medicines Agency (EMA) in two days, and they come amid reports of blood clots in some people who received shots. Its intervention follows dramatic measures by several E.U. member states to halt the use of AstraZeneca's vaccine, potentially throwing the region's already slow inoculation campaign further off track. The EMA's executive director, Emer Cooke, said she was concerned that the government decisions could undermine public support for vaccines.

"We are worried that there may be an effect on the trust in the vaccines," Cooke said at a news conference Tuesday. The EMA is expected to make a more formal recommendation Thursday. "Our job is to make sure that the products we authorize are safe and can be trusted by European citizens."

E.U. health ministers are holding a video call Tuesday to discuss concerns over side effects. The EMA will comment again Thursday after it's evaluated the latest information. Cooke declined to list all the possible conclusions, mentioning an additional warning on the product or possibly more radical action, "if there is a problem that can't be solved."

She said that "a situation like this is not unexpected when you vaccinate millions of people," and that there's "no indication that vaccination has caused these conditions."

The health scare joins the issues that the European Union is already facing related to vaccinations. It's been involved in a blame game with AstraZeneca over production, and there's tension with the United Kingdom and the United States over accusations of hoarding. Even within the bloc itself, governments are unhappy with how shots are being shared.

On Tuesday, Austrian Chancellor Sebastian Kurz called for a "correction mechanism" of vaccine distribution in the European Union. Speaking in Vienna alongside the prime ministers of Bulgaria, the Czech Republic and Slovenia, he declined to discuss how such a mechanism should work, except saying the guiding principle should be that every member state has the same access to vaccine doses at the same time.

Kurz said the leaders were in talks with European Commission President Ursula Von der Leyen about their proposal.

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The EMA's latest intervention comes a day after France, Germany and other countries reversed course on the vaccine, suspending its use after initially continuing injections. Worries initially arose in Austria and Denmark, which stopped using some AstraZeneca shots last week.

Germany's Health Ministry said seven out of 1.6 million people who received the Astra shot recently experienced clotting in or near their brains. That's higher than the 1 to 1.4 cases that would normally be expected in such a population sample over a similar stretch of time.

On Tuesday, the United Kingdom repeated its view that the AstraZeneca shot, which was developed with the University of Oxford, is "safe and effective."

The EMA's Cooke stressed the need to take the time to evaluate every reported case and come up with an assessment that is science-based.

"This is a serious concern," she said, that requires "thorough analysis of all the cases that are reported and evaluate whether this is a coincidence or indeed a causal effect."

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The European Union has received 14 million doses from AstraZeneca, and it was expected to get about 120 million in the next six months. Of the doses delivered to the European Union, almost 8 million have not been administered.

The European Commission has committed to immunizing 70% of adults by the end of September, but the latest precautions could push back efforts.

With infection numbers creeping up again in countries such as Germany, the risk of further vaccine shortages will increase pressure on politicians who have been punished for a lackluster immunization program. German Chancellor Angela Merkel saw her party slump to its worst ever results in two state elections on Sunday.

Published : March 17, 2021

By : Syndication Washington Post, Bloomberg · Nikos Chrysoloras, Marthe Fourcade