LONDON (AP) – The world was awaiting the results on Thursday of a first European investigation into whether AstraZeneca’s COVID-19 vaccine is related to blood clots reported in a small number of prey recipients.
Concerns about coagulation caused more than a dozen European countries to suspend vaccine use last week, although the company and international health agencies said there were no indications that the shots caused clotting and recommended continuing to inoculate.
The European Union Drug Regulator’s Committee of Experts was expected to report on the analysis on Thursday, including whether new precautions should be taken about the vaccine.
Clots that form in the arms, legs, or anywhere else can be released and travel to the heart, brain, or lungs, causing strokes, heart attacks, or other deadly blockages.
While many countries have continued to use the vaccine, there are concerns that the debate could seriously undermine confidence in the shot, which is key to efforts to vaccinate the world’s population, especially in the poorest countries.
Even in Europe, where there is a selection of vaccines, it has complicated an already slow deployment at a time when infections are rising again at an alarming rate in many countries.
The head of the European Medicines Agency said this week that the priority of the drug regulator is to confirm that the product is safe and that it would consider several actions, including the addition of additional alerts to the 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.”
Blood clots have been reported in at least 37 people and at least four deaths have been reported 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 evidence that the vaccine was responsible and that the benefits of vaccination far outweighed the potentially small risk. The drug maker also said it found no evidence of an increased risk of blood clots.
On Thursday, ahead of the EMA announcement, the British drug regulatory agency said that in a detailed review of five rare blood clots among the 11 million people who received AstraZeneca’s shot it was found that “no causal association with the vaccine has 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 who has bruises beyond the site of vaccination after vaccination. a few days, to seek medical attention. “
The advice was similar to that published by other European regulators earlier this week.
The pause in vaccinations by shooting comes as tens of thousands of new cases a day have led to new blockade measures in Italy, increased hospitalizations in France and led German officials to announce that a third has begun. increase in COVID-19.
In Britain, which has made progress in vaccinating the most vulnerable, officials said on Wednesday that the number of people receiving their first dose will be “significantly limited” in April due to the reduced supply of vaccines in the country.
Figures from this week’s European Centers for Disease Prevention and Control show that there are approximately 7 million unused doses of AstraZeneca in the EU in 27 countries.
The German government defended its decision to suspend the use of the vaccine, saying it was based on the advice of an expert. Government spokeswoman Ulrike Demmer said Wednesday the measure could “strengthen confidence” in vaccines.
“Concerns are being taken seriously and examined. And as soon as these concerns are clarified, a vaccine can be used again without hesitation, ”he said.
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.
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 was almost a year after vaccination campaigns against the 2009 swine flu pandemic began 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.”
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Jordans reported from Berlin.
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