The European Union’s drugs regulator reiterated that the benefits of AstraZeneca Plc’s COVID vaccine outweigh the risks as it urgently reviews safety data following the suspension of shots by a growing number of countries.

“A situation like this is not unexpected when you vaccinate millions of people,” Emer Cooke, executive director of the European Medicines Agency, said at a press conference Tuesday as the agency reviews reports of blood clots in some people who received shots. There is “no indication that vaccination has caused these conditions.”

The comments follow dramatic measures by several EU member states to halt the use of Astra’s shot, potentially throwing the region’s already slow inoculation campaign further off track. The bloc’s health ministers are holding a video call on Tuesday, where they’re expected to discuss concerns over side effects.

The EMA’s safety committee has called an extraordinary meeting for Thursday to decide on any further recommendations. Cooke declined to list all the possible conclusions, mentioning an additional warning on the product or possibly more radical action, “if there is a problem that can’t be solved.”

A growing list of countries suspended the use of the AstraZeneca vaccine to examine side effects, while others and the WHO continue with support:
 

Despite repeated reassurances from the EMA, the worries over clotting could further shake public trust in a vaccine many countries were counting on to inoculate large parts of their adult populations.

France, Germany and other countries this week reversed course on the vaccine, suspending its use after initially continuing injections. Concerns initially arose in Austria and Denmark, which suspended AstraZeneca shots last week.

Cooke stressed the need to take the time to evaluate every reported case and come up with an assessment that is science-based.

“This is a serious concern,” she said, that requires “thorough analysis of all the cases that are reported and evaluate whether this is a coincidence or indeed a causal effect.”

What Bloomberg Intelligence says:

“The reports of blood clots are anecdotal and insufficient to draw conclusions. A rare cluster of cases in Germany suggests rising risk, but could be coincidental.”

-- Sam Fazeli, senior pharmaceuticals analyst

The EU has received 14 million doses from AstraZeneca so far, and was expected to receive about 120 million doses in the next six months. Of the Astra doses delivered to the EU, almost 8 million have not been administered.

The European Commission has committed to immunizing 70 per cent of adults by the end of September, but the latest precautions could push back efforts by at least a couple of weeks and potentially longer, according to London-based research firm Airfinity Ltd.

With infection numbers creeping up again in countries like Germany, the risk of further vaccine shortages will increase pressure on politicians who have been punished for a lackluster immunization program. German Chancellor Angela Merkel saw her party slump to its worst ever results in two state elections on Sunday.