LONDON (AP) – The world is awaiting the results of a first European investigation into whether there is evidence that the AstraZeneca coronavirus vaccine was behind unusual blood clots reported in some recipients of the shot.
Concerns about coagulation led to more than a dozen European countries suspending vaccines with the shot, although the company and international health agencies said there were no indications that the vaccine would cause clotting and recommended continue inoculations. The European Union Drug Regulator’s Committee of Experts is expected to explain the analysis later this Thursday, including whether new precautions should be taken in relation to the vaccine.
While many countries have continued to use the vaccine, there are concerns that the debate may call into question the shot, which is key in efforts to vaccinate the world’s population, especially in the poorest countries. Even in Europe, where countries can choose vaccines, it has complicated an already slow deployment at a time when infections are rising again in many countries.
The head of the European Medicines Agency said this week that the priority of the drug regulator was to confirm that the vaccine is safe and that he would consider a number of actions, including the need to add additional warnings to the AstraZeneca vaccine.
“We are concerned that there may be an effect on vaccine confidence,” said CEO Emer Cooke. “But our job is to make sure the products we authorize are safe and that 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 have said there is no current evidence to indicate that the vaccine was responsible and that the benefits of vaccination far outweighed the potentially small risk. The drug maker said that after a careful review of its COVID-19 vaccination data, it found no evidence of an increased risk of blood clots in any age or sex group in any country.
The pause in shot vaccinations comes as Britain expects significant delays in vaccine delivery and tens of thousands of new cases daily have led to new blockade measures in Italy, led to an increase in hospitalizations in France and have led German officials to announce that one of COVID-19 has begun.
Figures from this week’s European Centers for Disease Prevention and Control show that there are approximately 7 million unused AstraZeneca vaccines across the EU in 27 countries.
The German government defended its decision to suspend the use of the vaccine, saying it was based on expert advice.
Government spokeswoman Ulrike Demmer told reporters in Berlin on Wednesday that she understood some might be concerned about the measure, but it should be seen as a sign that “confidence in our control mechanisms is justified”.
“That’s why this step could also strengthen confidence” in vaccines, he said. “Concerns are being taken seriously and examined. And as soon as these concerns are clarified, a vaccine can be used again without hesitation. ”
But some experts have expressed concern that the opposite could happen: that very public and dramatic suspensions could already fuel a high level of skepticism about vaccines that were developed in record time.
Germany will rely on the EMA’s decision to proceed, Health Ministry spokesman Hanno Kautz said. Other countries, including France, have also indicated they will follow advice issued on Thursday.
Whenever vaccines are widely developed, scientists expect serious health problems and deaths to be reported, simply because tens of millions of people are being shot. Determining whether the vaccine is to blame or not can be difficult, especially because vaccination campaigns currently focus on vulnerable people who may have other health problems.
But as there are no long-term data on any of the COVID-19 vaccines, any potential signs of a problem need to be thoroughly investigated.
Because clinical trials are only performed on tens of thousands of people, extremely rare side effects are often not detected until vaccines are used in many millions of people, long after they have been authorized. For example, it took almost a year after vaccination campaigns began after the 2009 swine flu pandemic for European officials to notice an increase in narcolepsy in children and adolescents who received the GlaxoSmithKline vaccine.
“It’s okay to investigate possible signs of problems, but you can do it while you continue vaccination,” said Michael Head, a senior researcher in global health at the University of Southampton. “If we pause the launch of the vaccine whenever there is a possible signal, it won’t be very important.”
Head warned that there are costs to go slowly: the longer the coronavirus is allowed to circulate widely, the more likely it is to mutate into a more deadly version.
“People may have more hesitation in getting an AstraZeneca vaccine when vaccination is resumed,” he said. “And it’s at a time when we need to stop the circulation of the virus to reduce the chances of other variants appearing.”
___
Jordans reported from Berlin.
___
Follow AP pandemic coverage at: https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccineand https://apnews.com/UnderstandingtheOutbreak.