EU Regulator Backs Astra Vaccine as Safety Review Ramps Up
The European Union’s drugs regulator reiterated that the benefits of AstraZeneca Plc’s Covid vaccine outweigh the risks.
(Bloomberg) -- European Union countries were warned on Tuesday that the slow pace of vaccinations, as well as moves to block the use of some doses, could put the recovery effort at risk and increase the likelihood of prolonged lockdowns.
The European Commission on Tuesday pushed back against member states’ attempts to dodge any blame over the EU’s lackluster vaccination rollout, which has been plagued by slow regulatory approvals and delivery disruptions by AstraZeneca Plc. The bloc’s health chief, Stella Kyriakides, told EU ministers in a call that out of the 70 million doses delivered to member states so far, only 51 million have been administered.
“Vaccines don’t save lives, vaccination does, and we must use every single precious dose available to us,” Kyriakides told a crunch call of health ministers, according to two officials familiar with the exchange.
The Commission has committed to immunizing 70% of adults by the end of September, but the performance of most EU governments in administering the limited number of shots available doesn’t bode well for when supplies are expected to increase in the coming months.
Vaccine Trust
The U.S. has so far administered three times as many doses as the EU when adjusted for population. The lag could keep Europe’s economies in recession-inducing restrictions for longer and delay an anticipated rebound from the steepest recession on record.
Adding another layer of complexity, several EU member states decided to suspend vaccinations with Astra shots over fears of life-threatening clotting incidents among recipients. The decision took place against the advice of the bloc’s drugs regulator, which on Tuesday reiterated that the benefits of the vaccine outweigh any potential risks.
In Tuesday’s ministerial call, the European Medicines Agency said it would give definitive guidance Thursday after examining all available evidence, according to one of the officials familiar with the discussion, who asked not to be identified because the talks were private.
“We are worried that there may be an effect on the trust in the vaccines,” EMA executive director Emer Cooke said at a hastily convened press conference on Tuesday. There’s “no indication that vaccination has caused these conditions,” Cooke told reporters in Brussels.
Unfair Distribution
The dispute has inflamed tensions within the bloc itself, with some governments saying they are unhappy with how shots are being shared.
On Tuesday, Austrian Chancellor Sebastian Kurz called for a “correction mechanism” of vaccine distribution in the EU to avoid political tensions. Speaking in Vienna alongside the prime ministers of the Czech Republic, Bulgaria and Slovenia, he declined to be drawn on how such a mechanism should work, except saying that 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 already in talks with Commission President Ursula Von der Leyen about their proposal.
Despite the vaccination setbacks, the Commission on Wednesday will unveil its strategy to gradually lift coronavirus lockdowns. The coordinated easing will be based on a tier “system reflecting the epidemiological situation in each member state,” according to a draft of the proposals seen by Bloomberg.
Reopening Strategy
The system, due to be proposed by the European Centre for Disease Prevention and Control, will simulate how much latitude each government has to lighten the measures “without risking a reversal in the spread of the virus.” Any easing will be conditional on close monitoring of the virus for mutations, which could render it resistant to existing vaccines.
The Commission will also publish on Wednesday a legislative proposal for a digital pass certifying that holders have been vaccinated, tested negative or recovered from the virus. The aim is to allow the gradual resumption of travel, and the easing of the current ban for incoming visits from outside the bloc, amid pressure from tourism-dependent economies to not risk another lost summer season.
In her comments to ministers on Tuesday, Kyriakides warned there is still a long way to go until a return normalcy, according to the two officials familiar with the discussion. Measures such as social distancing will have to remain in place to protect health care systems from a new surge in infections.
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