Germany, France Halt AstraZeneca Vaccine That Regulator Says Is Safe
(Bloomberg) -- Europe’s biggest countries, including Germany and France, suspended use of AstraZeneca Plc’s Covid-19 vaccine amid a growing health scare that’s creating yet another delay for the European Union’s inoculation campaign.
Governments across the continent halted the distribution of the shots following reports of serious blood clotting, even as the EU drugs regulator reiterated its support for the vaccine.
The suspensions mark a U-turn for some countries that had previously said inoculations should continue while the issue was investigated. Italy, Spain and Portugal also suspended use of the shot.
EU health ministers are due to hold a video conference on Tuesday, where the latest concerns will probably dominate proceedings. In its statement on Monday, Germany cited additional cases of serious thrombotic events in recent days as the reason for the temporary suspension.
As Europe tries to sort the vaccination issue, it’s also dealing with rising coronavirus cases that are forcing some governments to reimpose restrictions on activity. Most of Italy returned to lockdown on Monday.
The European Medicines Agency said the benefits of the Astra vaccine continue to outweigh the risks. It’s working closely with the company and health officials, including the drug regulator in the U.K., based on its experience with about 11 million of the shots.
The agency previously said that inoculations should continue while the clotting is investigated, and only 30 people have had issues out of about 5 million vaccinated. The EMA’s safety committee is scheduled to further review the information Tuesday and has called an extraordinary meeting on Thursday to take any further actions needed, according to a statement.
“Many thousands of people develop blood clots annually in the EU for different reasons,” the agency said. “The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.”
Austria -- the first country to observe the suspicious clotting -- is continuing to use the shot. The national vaccine panel met Monday evening and decided that the existing data didn’t support stopping use. The panel will meet again Tuesday after the EM’s safety committee review.
In Asia, Indonesia also temporarily halted the distribution of AstraZeneca’s vaccine for its inoculation program on Monday.
The response to the Astra issue has until now been far different in the U.K., where authorities have moved to reassure the public. Prime Minister Boris Johnson’s official spokesman Jamie Davies said Monday that the shot remains “both safe and effective,” a view echoed by Scotland’s first minister, Nicola Sturgeon.
For the EU, the latest suspensions are yet another blow to a vaccination campaign that’s been embarrassingly slow and politically damaging to governments. In Germany, Chancellor Angela Merkel’s Christian Democratic Union suffered a rout in regional elections over the weekend that’s being partly blamed on the government’s handling of the pandemic.
Despite the efforts of some medical officials to reassure the public about the safety of the Astra shot, concerns are growing. In Sicily, some 7,000 people canceled their vaccination appointments after an Astra batch was seized by the authorities, while 4,000 called off appointments in Tuscany, according to local media.
The number of blood clots reported among 17 million people in the EU and the U.K. who have received the shot is lower than the hundreds of cases that would be expected in the general population, AstraZeneca said.
“The safety of all is our first priority,” the company said in a statement. “We are working with national health authorities and European officials and look forward to their assessment later this week.”
German Health Minister Jens Spahn said the country’s agency that oversees vaccine safety changed its opinion on Monday, and cited seven instances of serious clotting that had occurred out of some 1.6 million doses administered. That agency, the Paul Ehrlich Institute, issued a statement highlighting a “striking” accumulation of “very rare” clotting in the brain.
“This all concerns a very low risk, but if it proves to be related to the vaccine, then it would be an above-average risk,” Spahn said.
AstraZeneca’s vaccine is one of four that have been approved in the EU, alongside those from Pfizer Inc. and BioNTech SE, Moderna Inc., and Johnson & Johnson. With supplies from J&J yet to arrive and doses of Moderna limited, that means the bulk of immunizations in many countries will now be conducted with the Pfizer-BioNTech shot.
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