Europe’s Medical Regulator to Rule on AstraZeneca Safety

Europe’s medical regulator, the European Medicines Agency, will announce Thursday its findings on the safety of AstraZeneca’s coronavirus vaccine as more European Union countries suspend its use over fears it might be linked to blood clots. Critics say governments are putting politics over science.The European Medicines Agency’s executive director, Emer Cooke, said Tuesday that for now, the regulator stands behind its conclusion the AstraZeneca vaccine is safe, even as its experts conduct a thorough safety review.The AstraZeneca vaccine has been injected into millions of arms, with just a few reported cases of blood clots—and it’s uncertain if they’re linked to the shot.  “We need to have the facts first,” Cooke said. “We cannot come to a conclusion before we’ve done a thorough scientific analysis. And we owe it to the European citizens to deliver this clear and science-based response.”The medicines agency, or EMA, has also tapped international experts for its review, which will also look at whether certain specific batches could be problematic. Scientists will also look at chances of blood clots with other COVID-19 vaccines beyond AstraZenaca’s.”At present there is no evidence that vaccination has caused these conditions,” said Cooke. “They have not come up in clinical trial and they are not listed as known or expected side events with this vaccine.”  But increasingly, European Union governments are taking no chances. Sweden and Latvia are among the latest to join more than a dozen EU countries to temporarily halt their AztraZeneca rollouts.In France, which suspended the shot Monday, Health Minister Olivier Veran said he hoped the AstraZeneca vaccine campaign will quickly resume — pending a positive EMA ruling. Veran himself received the AstraZeneca inoculation and he told French citizens who have done likewise not to worry.The World Health Organization also recommends AstraZeneca, pending evidence to the contrary. Dozens of countries have authorized its use, although the United States has yet to do so. And AstraZeneca still has EU champions. Belgium, for example, argues suspending the vaccine’s rollout would be irresponsible.That’s also the view of many French medical experts. Dr. Jean-Paul Hamon, honorary president of the French doctor’s federation, told French TV the decision to suspend the vaccine’s use reflected political rather than medical considerations.  “National governments are afraid for safety concerns,” said Simona Guagliardo, an analyst at the Brussels-based European Policy Centre. “But at the same time, I’m not convinced that this is the right way to go about it.””I wonder what could be the damage in the public opinion,” she said. “People are already scared, and I fear that this might scare them off even more.”The vaccine suspensions couldn’t come at a worse time for the EU, with some member states hit by a third wave of the pandemic. Italy is again under lockdown. France and Germany may follow shortly.  And suspending the shot’s use may further delay the EU’s much-criticized vaccine rollout that sees the 27-member bloc lagging behind countries like the United States, Israel, Bahrain and even ex-member Britain—which has jabbed millions in the UK with the AstraZeneca shot. While acknowledging mistakes, EU officials also blame some of the problems on production delays by AstraZeneca itself.
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