EU agency says shots outweigh clot risk

BRUSSELS — The European Union’s drug regulator insisted Tuesday that there is “no indication” the AstraZeneca vaccine causes blood clots as governments around the world faced the grimmest of dilemmas: push on with a vaccine known to save lives or suspend its use over reports of clotting in some recipients.

The European Medicines Agency urged governments not to halt use of the vaccine at a time when the pandemic is still taking thousands of lives each day. And already there are concerns that even brief suspensions could have disastrous effects on confidence in inoculation campaigns the world over, many of which are already struggling to overcome logistical hurdles and widespread hesitancy about vaccines.

“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 the side effects,” said Emer Cooke, the head of the agency.

Many scientists have argued that even the loss of a few days in vaccinating vulnerable people could be far costlier than the impact of any rare phenomenon.

But a cascading number of countries have taken a different view and locked away shots from the Anglo-Swedish company, awaiting the results of an EMA review, promised Thursday.

Sweden was the latest to do so Tuesday, choosing caution over speed, even as Cooke insisted “that at present there is no indication that vaccination has caused these conditions.”

Highlighting the difficulty of making such decisions at a time when people are voraciously following the ups and downs of every vaccine candidate, Sweden’s state epidemiologist Anders Tegnell said that the risk, if it existed, was rare but the country’s authorities “have felt compelled to pause AstraZeneca’s vaccine” after receiving ever more reports of blood clots.

The AstraZeneca shot has already struggled to gain public trust after troubles with reporting of its data and concerns about its effectiveness in older people. More than half of the 15 million AstraZeneca doses delivered to the EU’s 27 member states are still lying in storage, according to data compiled by the European Center for Disease Prevention and Control.

The current debate could further erode confidence in the vaccine — and that skepticism could even spread to others.

“We are worried that there may be an effect on the trust of the vaccines. But our job is to make sure that the products that we authorize are safe,” Cooke said.

In addition to the EMA, AstraZeneca and the WHO have said there is no evidence the vaccine carries an increased risk of blood clots. There have been 37 reports of blood clots among the more than 17 million people who have received the vaccine across the EU and Britain, the company said.

But the number of countries in the bloc that are sticking with the shot is falling after heavyweights like Germany, Italy, France and Spain all said they were suspending it.

That left Belgium — and a handful of others such as Poland, Romania and Greece — increasingly isolated in their insistence that halting the shots now would cause more harm than the side effects so hotly debated.

“When you know how the virus is making the rounds, it would be very imprudent to stop,” Belgian Health Minister Frank Vandenbroucke told VRT network early Tuesday.