LONDON (AP) – The world waited on Thursday for the results of an initial European investigation into whether AstraZeneca’s COVID-19 vaccine is linked to blood clots reported in a small number of recipients of the injection.
Concern about coagulation has led more than a dozen European countries to suspend the use of the vaccine over a period of last week, although the company and international health agencies said there was no indication that the injections caused the clotting and recommended further inoculations.
The European Union’s drug regulator expert committee is due to report its analysis on Thursday, including whether further precautions should be taken regarding the vaccine.
Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blocks.
Although many countries have continued to use the vaccine, there are concerns that the debate could seriously undermine confidence in the injection, which is the key to efforts to vaccinate the world population, especially in the poorest countries.
Even in Europe, where vaccines are available, this has complicated an already slow implementation, at a time when infections are increasing at an alarming rate again 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 he would consider a series of actions, including adding extra warnings to the vaccine.
“We are concerned that there may be an effect on vaccine confidence,” said Executive Director Emer Cooke. “But our job is to make sure that the products we authorize are safe and European citizens can trust us.”
Blood clots have been reported in at least 37 people, and at least four deaths among them have been reported, of the 17 million who received at least one dose of the AstraZeneca vaccine in Europe.
Both the EMA and the World Health Organization said that there is no evidence to suggest that the vaccine is responsible and that the benefits of immunization far outweigh the potentially small risk. The drugmaker also said it found no evidence of an increased risk of blood clots.
On Thursday, ahead of the EMA announcement, Britain’s drug regulatory agency said a detailed analysis of five rare blood clots among the 11 million people who took the AstraZeneca vaccine found that “a causal association with the vaccine has not been established “.
The British agency said it was continuing to investigate and that “as a precautionary measure, we would advise anyone with a headache that lasts more than four days after vaccination, or bruising beyond the vaccination site after a few days, to seek medical attention. “
The advice was similar to that issued by other European regulators earlier this week.
The pause in vaccinations with the injection comes at a time when tens of thousands of new daily cases generate new blocking measures in Italy, increase hospitalizations in France and prompt German authorities to announce that a third wave of COVID-19 has begun.
In Britain, which has shot up vaccinations for its most vulnerable, officials said on Wednesday that the number of people receiving their first dose would be “significantly limited” in April due to reduced vaccine supplies to the country.
Figures from the European Centers for Disease Prevention and Control show this week that there are about 7 million unused doses of AstraZeneca in the 27 EU countries.
The German government defended its decision to stop using the vaccine, saying it was based on expert opinion. Government spokeswoman Ulrike Demmer said on Wednesday that the move could “build confidence” in vaccines.
“Concerns are taken seriously and examined. And as soon as these concerns are cleared up, a vaccine can be used again without hesitation, ”she said.
But some experts expressed concern that the opposite could happen: that very public and dramatic suspensions could fuel already high skepticism about vaccines that were developed in record time.
Germany will rely on the EMA’s decision to know how to proceed, said Ministry of Health spokesman Hanno Kautz. Other countries, including France, have also indicated that they will follow the advice issued on Thursday.
Because clinical tests are done only on tens of thousands of people, extremely rare side effects are often not detected until the vaccines are used in many millions of people, long after they have been licensed.
For example, it took almost a year after the 2009 swine flu pandemic vaccination campaigns began for European authorities to notice an increase in narcolepsy in children and adolescents who received the GlaxoSmithKline vaccine.
“It is okay to investigate any potential signs of problems, but you can do that while immunization continues,” said Michael Head, senior researcher in global health at the University of Southampton. “If we pause the launch of the vaccine whenever there is a possible sign, it will not be a very big launch”.
Head warned that there are costs in going slow: the longer the coronavirus can circulate widely, the more likely it is to mutate into a more deadly version.
“People may be more hesitant to get the AstraZeneca vaccine when immunization is resumed,” he said. “And this is a time when we need to stop the virus from circulating to reduce the chances of new variants appearing.”
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Jordans reported from Berlin.
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