EU official backs AstraZeneca shot
Drug regulator says there’s ‘no indication’ the COVID vaccine causes blood clots.
Regulator says vaccine is safe despite reports of blood clots.
BRUSSELS — The European Union’s drug regulator said Tuesday that there is “no indication” AstraZeneca’s COVID-19 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 effect on confidence on inoculation campaigns the world over, many of which are already struggling to overcome logistical hurdles and widespread hesitancy about experimental 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 effect of any rare phenomenon.
But a cascading number of countries have taken a different view and locked away shots from the AngloSwedish company, awaiting the results of a review by the medicine agency, promised Thursday.
Sweden was the latest to do so Tuesday, choosing caution over speed, even as Cooke said “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 chief epidemiologist, Anders Tegnell, said that the risk, if it existed, was rare but that the country’s authorities “have felt compelled to pause AstraZeneca’s vaccine” after receiving more reports of blood clots.
Europe has the luxury to be able to pick from several vaccines, but the decision on whether to suspend use of the AstraZeneca vaccine is still not an easy one on a continent where the virus has killed more than half a million people and is surging again and the vaccination campaign has repeatedly stumbled.
The choice may be even more fraught elsewhere because many countries are relying heavily on the AstraZeneca vaccine, which is cheaper and easier to handle than some other shots. The vaccine has played a huge role in the global initiative to ensure vaccines get to poorer countries.
For instance, when Congo decided to hold off on the vaccine, it put its entire campaign on pause before it even began because it has not received other vaccines.
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 European Union’s 27 member states are still 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 other vaccines.
“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.
He noted that thousands of people across the EU develop blood clots every year for a variety of reasons and that there were no reports of increased clotting incidents in the clinical studies of the AstraZeneca vaccine. Still, experts would undertake a “very rigorous analysis” and make a recommendation Thursday.
The difficulty of the decision was clear in Thailand, the first country outside Europe to suspend use of the AstraZeneca vaccine, only to reverse course on Tuesday, when its prime minister received a dose.
“There are people who have concerns,” Prime Minister Prayuth Chan-ocha said after getting the shot. “But we must believe doctors, believe in our medical professionals.”
Many other countries in Asia have likewise shrugged off concerns, but Indonesia, a nation of more than a quarter-billion people, halted use of the shot this week, saying it would wait for a World Health Organization report on the issue.
In addition to the European Medicines Agency, 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.
Casert and Jordans write for the Associated Press.