Several days after most EU countries suspended the use of Oxford/AstraZeneca’s vaccine over blood clot concerns, the bloc’s medicines regulator concluded Thursday the vaccine is safe and effective in preventing COVID-19 and its benefits far outweigh the risks — but it could not eliminate a possible link to a rare type of clot.
In the wake of the assessment, countries began to announce the resumption of vaccination, including Italy, Spain, France, Luxembourg, Lithuania, Latvia, Cyprus, the Netherlands and Slovenia.
Emer Cooke, executive director of the European Medicines Agency, said the safety committee PRAC concluded the vaccine is “not associated with an increase in the overall risk of thromboembolic events or blood clots.”
An analysis of a small number of cases of “rare and unusual but very serious clotting disorders” concluded “we still cannot rule out definitively a link between these cases and the vaccine,” she added.
In light of this caution, EMA recommended raising awareness of these possible risks to make sure that they’re included in the product information. It also called for providing information to health care professionals and vaccinated people to help spot and mitigate any possible side effects.
EMA is launching additional investigations to understand more about these rare cases, Cooke added.
It comes after 20 EU countries, starting with Austria, either suspended, entirely or partially, their vaccination program with Oxford/AstraZeneca’s jab — despite statements from the drugmaker, the EMA and the U.K.’s drugs regulator that stood by the safety of the vaccine with regard to blood clots.
Austria, Estonia, Latvia, Lithuania and Luxembourg all suspended use of a specific batch of the vaccine. France, Germany, Italy, Spain, Portugal, Slovenia, Cyprus, Sweden, Norway, Denmark, Bulgaria, Iceland, Ireland, the Netherlands and Luxembourg halted the entire rollout with the jab. Some health experts feared, however, that those decisions will now weaken those countries’ abilities to convince people to accept the jab again.
For her part, Cooke was questioned whether she believed countries’ decision to stop vaccinating people with the Oxford/AstraZeneca jab over the past week has cost lives.
“We just have to continually remind ourselves of what a difficult situation we are in,” she replied. “We have vaccines that are safe and effective, that can help prevent death and hospitalization. We need to use those vaccines.”
As for the rare cases of clotting that the EMA’s safety committee is continuing to investigate, there have been 18 cases reported — all of which the committee evaluated. These included:seven in Germany, three in Italy, two in Norway, one in Spain, three in the U.K. and two in India.
At present, there’s little to suggest a conclusive risk factor, said Sabine Straus, chair of the committee. But she noted the agency is looking at whether gender and age could be linked, since most cases were in younger women.
“At the moment, it’s still rather premature to conclude on a very specific group, because background risk of thrombosis may be different in this group,” she said.
The committee is also looking at whether prior COVID-19 infection, smoking and taking the contraceptive pill could be in any way linked to these cases, she added.
Asked why fewer of these rare cases were reported in the U.K., Straus said that it could be due to the different vaccination strategies in different countries. Many EU countries initially restricted the Oxford/AstraZeneca vaccine to younger adults, whereas the U.K. didn’t, prioritizing older people in its vaccination program with both available jabs.
Overall, “occurrence of thrombosis and embolisms for now is below what we would expect” among the 20 million people who have been vaccinated to date with the Oxford/AstraZeneca vaccine, Straus said.
Separately, in a written statement, Health Commissioner Stella Kyriakides said that the scrutiny was unavoidable, but that the EMA had concluded the shot was safe.
All vaccines had to go through “rigorous and independent safety” analysis, she said. “This has always been non-negotiable for us,” she added. This was to make sure that any problem, “however rare,” is not missed.
Meanwhile, the EMA’s announcement had immediate repercussions in much of Europe.
Explaining the end of the suspension in Italy, Prime Minister Mario Draghi said the country would restart vaccinations with the shot on Friday. “The Italian government is satisfied by the EMA’s decision,” Draghi said.
France, one of Europe’s strongholds of vaccine skepticism, will also resume use of the shot. French Prime Minister Jean Castex, who had promised to use the shot as soon as it received the all-clear from the EMA, confirmed he would be receiving it Friday.
Similar statements were made by the Luxembourgish, Lithuanian, Slovenian and Latvian authorities. In Lithuania, the government announced that residents will be able to choose which jab they receive. Latvia signaled it would announce the resumption of vaccinations with the jab on Friday, as would Cyprus, Reuters reports. Slovenia will also resume administering it the same day, the country’s health minister, Janez Poklukar, announced.
Spain will wait until next week to restart injections with the Oxford/AstraZeneca jab, said El Paìs, reporting that was the decision taken by an emergency meeting of Spain’s health authorities. Over the weekend, experts will meet to decide whether to expand vaccinations to over-55s, as well to decide if any specific “at risk” groups should be excluded.
In Sweden, authorities have also indicated that they will not be resuming vaccinations immediately. “We need a few days to analyze this,” said Johan Carlson, director of the Swedish Public Health Agency, according to news site Nettavisen. Similarly, in Norway, the Institute of Public Health said that it would take some time to review the situation and would provide an update by the end of next week.