LONDON (AP) – The world waited on Thursday for the results of an initial European study into whether AstraZeneca’s COVID-19 vaccine is linked to blood clots reported in a small number of recipients of the injection.
Concerns about the clotting have led more than a dozen European countries to stop using the vaccine last week, although the company and international health authorities said there was no evidence that the injections were causing the clotting and recommended that vaccinations continue.
The expert committee of the European Union’s medicines regulator was expected to report its analysis on Thursday, including whether new precautions should be taken regarding the vaccine.
Clots that form in the arms, legs, or elsewhere can break loose and travel to the heart, brain, or lungs and cause strokes, heart attacks, or other deadly blockages.
While many countries have continued to use the vaccine, there is concern that the debate could seriously undermine confidence in the injection, which is essential to efforts to vaccinate the world’s population, especially in poorer countries.
Even in Europe, where there is a choice of vaccines, it has made the already slow rollout difficult at a time when infections are growing again at an alarming rate in many countries.
The head of the European Medicines Agency said this week that the drug regulator’s priority is to confirm that the product is safe and that it would consider a range of measures, including adding additional warnings to the 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.”
Blood clots have been reported in at least 37 people, and at least four of them have died, of the 17 million 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 no evidence to suggest the vaccine was responsible and that the benefits of immunization far outweigh the potentially small risk. The medicine man also said he found no evidence of an increased risk of blood clots.
On Thursday, ahead of the EMA’s announcement, the UK medicines regulator said a detailed study of five rare blood clots among the 11 million people who received the AstraZeneca injection showed that “a causal link to the vaccine had not been established. . “
The UK agency said it was continuing the investigation and that “as a precautionary measure, we would advise anyone with a headache that persists for more than four days after vaccination, or bruises outside the vaccination site after a few days, to seek medical attention.”
The advice was similar to that of other European regulators earlier this week.
The pause in vaccinations using the shot comes as tens of thousands of new daily cases have led to new lockdown measures in Italy, greatly increasing hospital admissions in France and German officials have announced that a third rise in COVID-19 has begun.
In Britain, which has been pre-vaccinated to vaccinate the most vulnerable countries, officials said on Wednesday that the number of people getting their first dose will be “significantly reduced” in April due to a reduction in vaccine supply to the country.
Figures from the European Centers for Disease Prevention and Control this week show that there are about 7 million unused doses of AstraZeneca 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 said on Wednesday that the move could boost confidence in the vaccines.
“Concerns are taken seriously and investigated. And once these concerns are resolved, a vaccine can be reused without hesitation, ”she said.
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.
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 2009 swine flu pandemic vaccination campaigns began, 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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