LONDON (AP) – The world is awaiting the results of an initial European investigation into whether there is evidence that the AstraZeneca coronavirus vaccine was behind unusual blood clots reported by some recipients of the shot.
Concerns about the clot have led to more than a dozen European countries suspending vaccinations with the shot, although the company and international health agencies have said there is no indication the vaccine is causing the clot and recommends continuing with vaccinations. The expert committee of the European Medicines Regulator is expected to provide an outline of the analysis later on Thursday, including whether new precautions should be taken regarding the vaccine.
Although many countries still use the vaccine, there are concerns that the debate could challenge the shot, which is key to efforts to vaccinate the world population, especially in poorer countries. Even in Europe, where countries have a choice of vaccines, it has complicated an already slow rollout at a time when infections are on the rise again in many countries.
The head of the European Medicines Agency said this week that the drug regulator has the priority of confirming that the vaccine is safe and that he will consider a range of actions, including if additional warnings should be added to the AstraZeneca vaccine.
“We are concerned that there may be an effect on the confidence of the vaccines,” said Emer Cooke, chief executive officer. “But our job is to make sure that the products we approve are safe and that we can be trusted by European citizens.”
There are reports of blood clots in 37 people among the 17 million who received at least one dose of the AstraZeneca vaccine in Europe. Both the EMA and the World Health Organization said there was no current evidence to suggest that the vaccine was responsible and that the benefits of immunization far outweighed the potential low risk. The drugmaker said the COVID-19 vaccination data after careful review did not find evidence of an increased risk of blood clots in any age group or gender in any country.
The interruption of vaccinations using the shot comes as Britain expects major delays in the delivery of vaccines, and tens of thousands of new daily cases have led to new closure measures in Italy, increasing hospitalizations in France, and German officials have announced that ‘ a third boom of COVID-19 begins.
According to figures from European Centers for Disease Prevention and Control this week, there are around 7 million unused AstraZeneca vaccines in the EU with 27 countries.
The German government defends its decision to suspend the use of the vaccine, saying it is based on expert advice.
Government spokeswoman Ulrike Demmer told reporters in Berlin on Wednesday that she understood that some people might be concerned about the move, but that it should be seen as a sign that “confidence in our governance mechanisms is justified.”
“Therefore, this step can also boost confidence in the vaccines,” she said. “Concern is taken seriously and investigated. Once these problems are resolved, a vaccine can be used again without hesitation. ‘
But some experts have expressed concern that the opposite could happen: that public and dramatic suspensions could already lead to widespread skepticism about vaccines being developed in record time.
Germany’s Ministry of Health spokesman Hanno Kautz will rely on the EMA decision on how to proceed. Other countries, including France, have also indicated they will follow the advice issued on Thursday.
If vaccines are widely distributed, scientists expect serious health issues and deaths to be reported simply because tens of millions of people receive the shots. It can be difficult to determine if the vaccine is to blame, especially since vaccination campaigns are currently focusing on vulnerable people who have other health problems.
But because there is no long-term data on any of the COVID-19 vaccines, any possible signal of problems should be thoroughly investigated.
Because clinical trials are only performed on tens of thousands of people, extremely rare side effects are often not detected until many millions of people have been vaccinated long after they have been licensed. For example, it took almost a year after vaccinations began after 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 okay to investigate potential signals of problems, but you can do it while you continue the vaccination,” said Michael Head, a senior research fellow in global health at the University of Southampton. “If we interrupt the explosion of the vaccine every time there is a possible signal, it will not be much.”
Chief warned that there are costs involved in going slow: the longer the coronavirus is allowed to spread widely, the more likely it is to turn into a more deadly version.
“People may be more reluctant to take a vaccine against AstraZeneca when vaccination resumes,” he said. “And this is at a time when we need to stop the virus circulating to reduce the chance of further variants.”
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Jordans reports from Berlin.
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