‘Safe and effective’: EU drug regulator backs AstraZeneca vaccine

The European Union drug regulator has said it has come to a “clear scientific conclusion” that the AstraZeneca-Oxford vaccine is “safe and effective” after several, mostly European, countries suspended its use following reports of blood clots among some recipients.

Speaking during a news briefing on Thursday, Emer Cooke, head of the European Medicines Agency (EMA), said the AstraZeneca vaccine “is not associated with an increase in the overall risk of thromboembolic events or blood clots,” stressing once again that the jab’s benefits outweigh possible risks.

But Cooke said the agency “cannot rule out definitively a link” between rare types of blood clots and the jab.

The EMA said it will update its its guidance to include an explanation for the patient about the potential risks and in information for healthcare professionals, she said.

Cooke also reiterated the 60 percent efficacy of the AstraZeneca jab shown in clinical trials. “And in fact, the real-world evidence suggests that the effectiveness could be even higher than that,” she added.

At least 16 countries temporarily suspended the use of the jab, developed with Oxford University, after reports of dozens of cases of blood clots, including several fatalities.

Denmark, Norway and Iceland were among the first countries to halt the vaccine rollout following the death of a Danish woman who had developed blood clots after receiving a shot.

Several other countries, including France and Germany, followed suit in suspending the use of the vaccine pending the result of the EMA investigation.

Following the EMA announcement, officials in Italy, France, Germany, Spain, Portugal, the Netherlands and Bulgaria said those countries would resume administering AstraZeneca’s vaccine, as early as Friday in some cases.

Ireland expects to announce on Friday its decision on whether to resume the roll-out, Deputy Chief Medical Officer Ronan Glynn told journalists.

The temporary suspensions of rollouts across the EU dealt another blow to the bloc’s inoculation drive, which has been beset by supply issues. On Wednesday, the EU Commission chief Ursula Von der Layen said AstraZeneca has “under-produced and under-delivered”.

The company said last week it aimed to deliver to the EU 100 million doses of its vaccine by the end of June, instead of 300 million envisaged under the EU contract, citing production problems and export restrictions.

Furthermore the block is battling the resurgence of the virus, with the daily number of infections rising in several countries.

In the past week, COVID-19 infections have begun to rise steadily, from 200 per million in mid-February to 270 per million last weekend. That level is still a long way off from the EU record of 490 per million in November, but a worrying trend nonetheless.