ROMEI – A top official at the European Medicines Agency says that there is a causal link between the AstraZeneca coronavirus vaccine and rare blood clots, but that it is unclear what the connection is and the benefits of its vaccination outweigh the risks of To get COVID-19.
Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam agency, told Roman newspaper Il Messaggero on Tuesday that the EU medicine regulator is preparing to make a more definitive statement on the subject this week.
Based on the evidence so far, Cavaleri said there is a clear link between the AstraZeneca vaccine and the dozens of rare blood clots reported worldwide amid the tens of millions of vaccines distributed.
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“It is becoming increasingly difficult to confirm that there is no cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with low platelet counts,” Cavaleri said.
Asked about Cavaleri’s comments, the EMA press office said that the evaluation had not yet come to a conclusion and that the investigation was currently underway. “He said he was planning a press conference as soon as the review was completed, possibly Wednesday or Thursday.
AstraZeneca did not immediately respond to a request for comment.
Last month, more than a dozen countries, including Germany, suspended their use of AstraZeneca due to the blood clot issue. Most EU countries restarted on March 19 – some with age restrictions – after the EMA said the benefits of the vaccine outweighed the risks of not vaccinating people against COVID-19. At the time, the EMA recommended that the vaccination of the vaccine be updated to tell people about the rare blood clots.
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Any further doubts about the vaccine against AstraZeneca would be a setback for the shot, which is critical to the European vaccination campaign and an important role in the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than competing Pfizer and Moderna vaccines and has been approved for use in more than 50 countries and groups, including the EU of 27 countries and the World Health Organization. US authorities are still evaluating the vaccine.
Cavaleri said although the EMA was prepared to explain a link, further study is still needed to understand why and how the phenomenon occurs.
“The information about the product will definitely be updated and confirm that these side effects are linked to the vaccine. This will be explained in a very clear way,” he said.
He said the rare blood clots, including some in the brain, coupled with a low level of platelets that can cause people with severe bleeding, ‘appear to be the most important event to further study.’ Cavaleri soon promised more details and added: “In the coming hours we will say that the link is there, how we have not noticed it yet, how it is happening.”
Cavaleri said the biological mechanism for the way the vaccine can cause the rare blood clots is still unknown. If it is linked to the way the shot is made, other vaccines with similar technologies should also be evaluated.
Cavaleri was asked how he could come to such a causal conclusion, given the relatively few cases of adverse events.
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“Among those vaccinated, there is a number of cerebral thrombosis with a low level of platelets among young people that is higher than we would expect. We have to say that,” he said.
But he stresses that the risk-benefit analysis remains positive for the AstraZeneca sting, even for young women who appear to be more affected by the blood clots.
“Let us not forget that young women also end up in intensive care in COVID. So we have to do very careful work to understand whether the risk-benefit analysis remains for all ages,” he said.
He said the EMA was in a difficult situation, given the different outbreaks of viruses in each of the 27 EU countries.
“A lot of people definitely want the EMA to solve the question for everyone, but it’s not that easy,” he said. “In Italy there are still about 500 people dying a day, in Norway there are almost none. These factors justify a different approach.”
He ruled out preventative therapy to address the rare blood clots and said there was still too much unknown about the phenomenon.
Even after the restart of 19 March, the Dutch and German governments suspended jabs for people under 60 and some Europeans shy away from the shot.
The president of Romania’s national vaccination committee, Valeriu Gheorghita, said on Tuesday that since March, 207,000 people in Romania had canceled their AstraZeneca vaccine appointments and that another 92,000 had simply not turned up.
“This is a high percentage, a third of the people who did not show up,” Gheorghita told reporters.
British Prime Minister Boris Johnson did not want to be directly involved in the latest warnings about the vaccine being developed at the University of Oxford, but urged people to take the advice of the British Independent Agency for Medicine and Health Care.
“Their advice to people is to keep going out, get a jab, get a second jab,” he said during a visit to an AstraZeneca plant in Macclesfield, northwest of Tuesday, during a visit. England, said.
Last week, the MHRA said seven people had died in the UK from blood clots after getting the AstraZeneca jab. It said it was not clear if the shots were causing the blood clot and that it was doing a “careful review” of the reports. The agency said it had identified 30 blood clotting cases from 18.1 million doses of AstraZeneca given on March 24.
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Johnson said the rapid explosion of vaccines in the UK could help reverse the situation this year and give Britain the opportunity to impose restrictions, just as many other European countries are putting it back amid an increase in the virus. .