LONDON (AP) – The world is awaiting the results of an initial 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 coagulation have prompted more than a dozen European countries to suspend vaccination with the injection, although the company and international health agencies said there was no indication that the vaccine caused the clotting and recommended further inoculations. The European Union’s drug regulator expert committee is due to give an explanation of its analysis on Thursday, including whether further precautions should be taken regarding the vaccine.
Although many countries have continued to use the vaccine, there are concerns that the debate may cast doubt on the vaccine, which is the key to efforts to vaccinate the world’s population, especially in the poorest countries. Even in Europe, where countries have vaccine options, this has complicated an already slow implementation, at a time when infections are increasing again 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 he would consider a series of actions, including whether extra warnings needed to be added to the AstraZeneca 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.”
There have been reports of blood clots in 37 people among the 17 million who have received at least one dose of the AstraZeneca vaccine in Europe. Both the EMA and the World Health Organization said that there is no current evidence to suggest that the vaccine is responsible and that the benefits of immunization far outweigh the potentially small risk. The manufacturer said that after a careful review of its COVID-19 immunization data, it found no evidence of an increased risk of blood clots in any age group or sex in any country.
The pause in vaccinations with the injection comes at a time when Britain expects long delays in vaccine deliveries and tens of thousands of new daily cases have led to new blocking measures in Italy, caused an increase in hospitalizations in France and led to the German authorities to announce a third increase. of COVID-19 has been started.
Figures from the European Centers for Disease Prevention and Control show this week that there are about 7 million unused AstraZeneca vaccines 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 told reporters in Berlin on Wednesday that she understood that some might be concerned about the change, but it should be seen as a sign that “confidence in our control mechanisms is justified”.
“That’s why this step can also build confidence” in vaccines, she said. “Concerns are taken seriously and examined. And once these concerns are cleared up, a vaccine can be used again without hesitation. “
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.
Whenever vaccines are widely distributed, scientists expect some serious health problems and deaths to be reported, simply because tens of millions of people are receiving the vaccines. Determining whether or not the vaccine is to blame can be difficult, especially since vaccination campaigns are currently focused on vulnerable people who may have other health problems.
But, as there is no long-term data on any of the COVID-19 vaccines, any potential signs of a problem should be investigated thoroughly.
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 vaccination campaigns began after the 2009 swine flu pandemic 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.”
___
Jordans reported from Berlin.
___
Follow AP’s pandemic coverage at: https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccineand https://apnews.com/UnderstandingtheOutbreak.