France, Italy to restart AstraZeneca COVID vaccine shots upon regulators’ OK

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At least two European Union countries plan to start using AstraZeneca’s coronavirus vaccine again if regulators give the green light this week.

France and Italy agreed to “promptly” resume their rollout of the British drugmaker’s shot if the European Medicines Agency formally confirms that it’s safe to use amid concerns about people who received it developing blood clots, officials said.

After reviewing the blood clot cases Tuesday, the drug regulator stood by its assessment that the AstraZeneca vaccine’s benefits outweigh its risks. An EMA committee is slated to issue formal conclusions and possible recommendations about the concerns at a Thursday meeting.

Italian prime minister Mario Draghi’s office called the EMA’s statement “encouraging” after he discussed the AstraZeneca vaccine on a Tuesday phone call with French President Emmanuel Macron.

“In the event of a positive conclusion of the EMA analysis, the two leaders are ready to promptly restart the administration of the AstraZeneca vaccine,” Draghi’s office said in a statement.

Italy and France are among more than a dozen countries that have halted the use of AstraZeneca’s vaccine amid concerns about blood clots popping up in a handful of vaccinated people, some of whom died.

But the EMA, AstraZeneca, and the World Health Organization have all indicated there is no evidence that the vaccine caused the blood clots.

“While the investigation is ongoing, we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risk of these side effects,” EMA executive director Emer Cooke said during a Tuesday briefing.

The agency is evaluating data from the blood clot cases that have occurred among vaccinated Europeans, which have occurred at a rate no higher than that of the general population, EMA officials said.

The results of that evaluation will be discussed at the Thursday meeting and made public thereafter, Cooke said.

“Trust in the safety and efficacy of the vaccines that we have authorized is paramount for us,” she said. “And our job is to make sure that we can maintain trust in these vaccines based on a proper scientific evaluation.”

AstraZeneca’s US-listed shares were down 0.7 percent at $49.70 in premarket trading as of 8:05 a.m. Wednesday.

With Post Wires

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