Europe Restarts AstraZeneca Vaccines After Safety Endorsement
(Bloomberg) -- European countries including Germany and France will restart using AstraZeneca Plc’s Covid-19 vaccine after the European Union’s drug regulator endorsed it as safe and said it isn’t linked to an increase in the risk of blood clots.
The fresh guidance from the European Medicines Agency follows suspensions by governments that added to the hurdles facing the EU’s inoculation campaign. Italy, Spain, Bulgaria, Portugal and Slovenia are among countries that will also resume dispensing Astra’s dose, though Sweden is keeping it on hold as it continues its own review.
Governments are desperately trying to accelerate vaccinations as variants of the coronavirus spread and authorities are forced to reintroduce restrictions. Italy is already back in lockdown, and France on Thursday announced tougher Paris-area restrictions.
In their assessment on Thursday, EMA officials were very clear that the benefits of the vaccine in protecting against the coronavirus clearly outweigh any risks. But they also cautioned that they can’t entirely rule out a link with some rare cases of blood clotting. The EMA is recommending that a warning is added to make sure the public is better informed.
“If it was me, I would be vaccinated tomorrow,” said Emer Cooke, the EMA’s executive director. “But I would want to know that if anything happened to me after vaccination what I should do about it, and that’s what we’re saying today.”
Amid concern that the suspensions could fuel vaccine hesitancy, French Prime Minister Jean Castex said he’ll get his first AstraZaneca jab Friday to help restore public confidence.
Ann Taylor, Astra’s chief medical officer, welcomed the EMA decision and said safety is “paramount.”
“The company has robust processes in place for the collection, analysis and reporting of adverse events,” she said.
The warning label could fuel uncertainty that has swirled around the Astra vaccine since the trial phase, when a dosing mistake and different intervals between the two shots created confusion over its efficacy. That was compounded by a lack of data on its effectiveness in the elderly, which initially prompted many European countries to limit its use to younger people -- a position they mostly reversed before the suspensions.
The EMA said there have been seven cases of blood clots in multiple vessels, and 18 cases of a type of cerebral vein clotting that’s hard to treat, out of about 20 million inoculations. While the numbers are “rare,” it will do additional studies on these risks.
Asked if governments should restart vaccinations with the Astra shot, which requires two doses, Cooke was very clear.
“This pandemic is costing lives,” she said. “We have vaccines that are safe and effective, that can help prevent death and hospitalization. We need need to use those vaccines.”
Earlier on Thursday, the U.K.’s drugs regulator also said the benefits outweigh the risks and people “should still go and get their Covid-19 vaccine when asked to do so.”
The crisis over vaccine side effects is just one of many playing out in the effort to inoculate populations. The EU has already been in a long-running battle with AstraZeneca over supplies and the pace of deliveries, and this week it ramped up tensions with the U.K. by threatening to restrict vaccine exports to its former member.
The EU has administered 12 doses per 100 people so far, less than a third of the U.K., according to Bloomberg’s Coronavirus Vaccine Tracker.
The Astra vaccine is one of four approved in the EU. The bloc expects 360 million deliveries from all providers in the second quarter, almost four times as many as this quarter.
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