LONDON (AP) – The world awaits the results of a first European investigation into whether there is any evidence that the AstraZeneca coronavirus vaccine was behind unusual blood clots reported in some recipients of the injection.
Concerns about the clot prompted more than a dozen European countries to stop injecting vaccinations, although the company and international health authorities said there was no evidence that the vaccine was causing the clotting and advised them to proceed with inoculations. The expert committee of the European Union’s drug regulator is expected to comment on its analysis later Thursday, including whether new precautions should be taken regarding the vaccine.
While many countries have continued to use the vaccine, there are concerns that the debate could cast doubt on the shot, which is essential to efforts to vaccinate the world’s population, especially in poorer countries. Even in Europe, where countries have a choice of vaccines, it has made the already slow rollout difficult at a time when infections are on the rise in many countries.
The head of the European Medicines Agency said this week that the drug regulator’s priority was to confirm that the vaccine is safe and that it would consider a range of measures, including whether additional warnings should be added to the AstraZeneca vaccine.
“We are concerned there may be an effect on the confidence of the vaccines,” said Executive Director Emer Cooke. “But our job is to make sure that the products we approve are safe and that we can be trusted by European citizens.”
There have been reports of blood clots in 37 of the 17 million people who have received at least one dose of the AstraZeneca vaccine in Europe. Both the EMA and the World Health Organization have said there is currently no evidence to suggest the vaccine was responsible and that the benefits of immunization far outweigh the potentially small risk. The drug manufacturer said after careful review of its COVID-19 immunization data, it found no evidence of an increased risk of blood clots in any age group or gender in any country.
The pause in vaccinations using the shot comes as Britain expects major delays in vaccine deliveries and tens of thousands of new daily cases have led to new lockdown measures in Italy, soaring hospital admissions in France and prompting German officials to announce that a third rise of COVID-19 has begun.
Figures from the European Centers for Disease Prevention and Control this week show that there are about 7 million unused AstraZeneca vaccines in the EU of 27 countries.
The German government defended its decision to suspend use of the vaccine, saying it was based on expert advice.
Government spokeswoman Ulrike Demmer told reporters in Berlin on Wednesday that she understood that some may have been concerned about the move, but it should be seen as a sign that “trust in our controls is warranted.”
“Therefore, this move could also boost confidence in the vaccines,” she said. “Concerns are taken seriously and investigated. And once these concerns are allayed, a vaccine can be reused without hesitation. “
But some experts have expressed concern that the opposite could happen: that the very public and dramatic suspensions could fuel the already high skepticism about vaccines developed in record time.
Germany will rely on the EMA’s decision to move forward, said Health Ministry spokesman Hanno Kautz. Other countries, including France, have also indicated that they will follow Thursday’s advice.
Every time vaccines are rolled out on a large scale, scientists expect some serious health problems and deaths to be reported simply because tens of millions of people get the injections. Determining if the vaccine is to blame can be difficult, especially since vaccination campaigns are currently targeting vulnerable people who may have other health conditions.
But because there is no long-term data on the COVID-19 vaccines, any possible sign of trouble needs to be thoroughly investigated.
Because clinical trials are only conducted on tens of thousands of people, extremely rare side effects are often not discovered until vaccines are used in many millions of people long after they have been licensed. For example, it took nearly a year after the vaccination campaigns began following the 2009 swine flu pandemic, for European officials to notice an increase in narcolepsy in children and teens who received the GlaxoSmithKline vaccine.
“It’s good to examine all possible signs of trouble, but you can do that while continuing with immunization,” said Michael Head, a senior research fellow in global health at the University of Southampton. “If we pause the rollout of the vaccine whenever there is a possible signal, it won’t really be a rollout.”
Head warned there is a cost to go slow: the longer the coronavirus is allowed to circulate widely, the more likely it is to mutate into a more deadly version.
“People may be more hesitant to take an AstraZeneca vaccine when immunization resumes,” he said. “And this is at a time when we need to stop the circulation of the virus to reduce the chance of new variants.”
Jordans reported from Berlin.
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