LONDON (PA) – The world is waiting for the results of an initial European investigation into whether the AstraZeneca COVID-19 vaccine is linked to blood clots reported in a small number of recipients of the shot.
Coagulation concerns have led more than a dozen European countries to suspend vaccine use last week, even though the company and international health agencies said there was no indication the shots had caused clotting and recommended continued inoculations.
The Committee of Experts of the European Union Drug Regulator was expected to report the analysis on Thursday, including whether new precautions should be taken with regard to the vaccine.
Clots that form in the arms, legs or elsewhere can be released and move 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 shooting, which is key to vaccinating the world’s population, especially in poorer countries.
Even in Europe, where there is a variety of vaccines, this has complicated an already slow launch at a time when infections are growing again at an alarming rate in many countries.
The head of the European Medicines Agency said this week that the priority of the medicines regulator is to confirm the safety of the product and that he will consider a number of actions, including the addition of additional warnings to the vaccine.
“We are concerned that there could be an effect on vaccine confidence,” said CEO Emer Cooke. “But our job is to make sure that the products we authorize are safe and that we can be trusted by European citizens.”
Blood clots have been reported in at least 37 people and at least four deaths have been reported, of the 17 million who received at least one dose of AstraZeneca vaccine in Europe.
Both the EMA and the World Health Organization have said there is no evidence to suggest that the vaccine is responsible and that the benefits of immunization far outweigh the potential low risk. The drug manufacturer also said he found no evidence of an increased risk of blood clots.
On Thursday, ahead of the EMA announcement, the British drug regulatory agency said a detailed analysis of five rare blood clots among the 11 million people who received the AstraZeneca shot found that “no causal association with the vaccine had been established”.
The British agency said it was continuing to investigate and that “as a precaution, we will 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 vaccination break with the coup is taking place as tens of thousands of new cases every day have led to new blockades in Italy, increased hospitalization in France and led German officials to announce that a third increase in COVID-19 has begun.
In the UK, which ran ahead in vaccinating the most vulnerable, officials said on Wednesday that the number of people receiving their first dose would be “significantly constrained” in April due to a reduction in vaccine supply to the country.
Figures from this week’s European Centers for Disease Prevention and Control show that there are around 7 million unused doses of AstraZeneca in the EU, with 27 nations.
The German government has defended its decision to suspend the use of the vaccine, saying it is based on expert advice. Government spokesman Ulrike Demmer said on Wednesday that the measure could “strengthen confidence” in vaccines.
“Concerns are taken seriously and examined. And as soon as these concerns are clarified, a vaccine can be used again without hesitation, “she said.
But some experts have expressed concern that the opposite could happen: the fact that very public and dramatic suspensions could already fuel high skepticism about vaccines that have been 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 that they will follow the advice issued on Thursday.
Because clinical trials are only performed in 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 licensed.
For example, it took almost a year after the 2009 swine flu pandemic vaccination campaigns began for European officials to see an increase in narcolepsy in children and adolescents who received the GlaxoSmithKline vaccine.
“It’s okay to investigate any potential signs of problems, but you can do this while you continue your immunization,” said Michael Head, a senior researcher in global health at the University of Southampton. “If we stop launching the vaccine every time there is a possible signal, it won’t be too much of a launch.”
Head warned that there are costs to go slowly: the more widely allowed the coronavirus circulates, the more likely it is to move to a more deadly version.
People may be more hesitant to get an AstraZeneca vaccine when immunization resumes, he said. “And this is happening at a time when we need to stop the circulation of the virus to reduce the chances of additional variants.”
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Jordanians reported from Berlin.
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