LONDON (AP) – The world is awaiting the outcome of an initial European inquiry on Thursday into whether AstraZeneca’s COVID-19 vaccine is linked to blood clots reported in small numbers of shot recipients.
Concerns over clotting have led to more than a dozen European countries suspending the use of the vaccine last week, even though the company and international health agencies said there was no indication the shots were causing the clot and recommended that continued vaccinations be done.
The European Union’s expert committee on medicine regulators is expected to report its analysis on Thursday, including whether new precautions should be taken regarding the vaccine.
Clots that form in the arms, legs or elsewhere can break loose and move to the heart, brain or lungs, causing strokes, heart attacks or other fatal blockages.
Although many countries still 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 population, especially in poorer countries.
Even in Europe, where there is a choice of vaccines, it has complicated an already slow rollout at a time when infections are increasing at an alarming rate in many countries.
The head of the European Medicines Agency said this week that the drug regulator’s priority is to confirm that the product is safe and that he will consider a range of actions, including the addition of additional warnings to the 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.”
Blood clots have been reported in at least 37 people, and at least four deaths have been recorded among them, out 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 that the vaccine is responsible and that the benefits of immunization far outweigh the potential low risk. The drugmaker also said he found no evidence of the increased risk for blood clots.
On Thursday, ahead of the announcement of the EMA, the British Agency for Drug Regulation said that an extensive review of five rare blood clots among the 11 million people who received the AstraZeneca shot found that a causal link with the vaccine had not been established. is not. ‘
The British agency said it was continuing the investigation and that we ‘as a precautionary measure would advise anyone with a headache that lasts longer than four days after vaccination, or bruises after vaccination after a few days, to seek medical help. . . ”
The advice was similar to that issued by other European regulators earlier this week.
The interruption of the vaccinations with the shot comes because tens of thousands of new daily cases caused new closure measures in Italy, which increased hospitalizations in France and caused German officials to announce that a third surge of COVID-19 had begun.
In Britain, which has vaccinated the most vulnerable, officials said on Wednesday that the number of people receiving their first dose would be “significantly limited” in April due to a decline in the country’s vaccine supply.
According to figures from the European Centers for Disease Control and Prevention this week, there are approximately 7 million unused doses of AstraZeneca in the EU with 27 countries.
The German government defends its decision to suspend the use of the vaccine, saying it is based on the advice of experts. Government spokeswoman Ulrike Demmer said on Wednesday that the move could boost confidence in the vaccines.
“Concern is taken seriously and investigated. “Once these problems are resolved, a vaccine can be used again without hesitation,” she said.
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.
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 against the swine flu pandemic began in 2009 that European officials noticed an increase in narcolepsy in children and teenagers 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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