ROME – A senior official at the European Medicines Agency says there is a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that the connection is unclear and the benefits of taking the vaccine still outweigh the risks. of contracting COVID-19.
Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, told Rome’s Il Messaggero newspaper on Tuesday that the EU’s drug regulator is preparing to make a more definitive statement on the issue. this week.
Based on the evidence to date, Cavaleri said there is a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide amid the tens of millions of vaccine injections that have been administered.
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“It is becoming increasingly difficult to say that there is no cause and effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with low platelets,” Cavaleri said.
When asked about Cavaleri’s comments, the EMA press office said its assessment “has not yet reached a conclusion and the review is ongoing.” He said he planned a press conference as soon as the review is finalized, possibly on Wednesday or Thursday.
AstraZeneca did not immediately respond to a request for comment.
Last month, more than a dozen countries, including Germany, suspended the use of AstraZeneca due to the problem of blood clots. Most EU nations rebooted on March 19, some with age restrictions, after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended that the vaccine brochure be updated to inform people about rare clots.
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Any other doubts about the AstraZeneca vaccine would be a setback for the injection, which is central to Europe’s immunization campaign and a lynchpin in the global strategy to bring vaccines to the poorest countries. The AstraZeneca vaccine is cheaper and easier to use than rival Pfizer and Moderna vaccines and has been approved for use in more than 50 countries and groups, including all 27 EU countries and the World Health Organization. US authorities are still in the process of evaluating the vaccine.
Cavaleri said that while the EMA was prepared to declare a link, more studies are still needed to understand why and how the phenomenon occurs.
“Certainly the information on the product will be updated, stating that these adverse events are linked to the vaccine. It will be stated very clearly,” he was quoted as saying.
He said that rare blood clots, including some in the brain, along with low blood platelets that can put people at risk for serious bleeding, “appear to be the key event to study further.” Cavaleri promised more details soon, adding: “In the next few hours, we will say that the link is there, how does this happen, we have not discovered it yet.”
Cavaleri said the biological mechanism for how the vaccine might be causing the rare clots is still unknown and that if it was related to the way the injection is done, other vaccines with similar technologies may need to be evaluated as well.
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 thromboses with a low platelet level among young people that is higher than we would have expected. This we have to say,” he said.
But he emphasized that the risk-benefit analysis remained positive for the AstraZeneca jab, even for young women who appear to be more affected by clots.
“Let’s not forget that young women also end up in intensive care with COVID. So we have to do a very meticulous job to understand whether the risk-benefit analysis holds up for all ages,” she said.
He said the EMA was in a difficult situation, given the different virus outbreaks in each of the 27 EU nations.
“Certainly many people would like EMA to solve the question for everyone, but it is not that easy,” he said. “In Italy around 500 people still die a day, in Norway hardly anyone. These factors justify a different approach.”
He ruled out preventive therapy to address the rare blood clots, saying too much is still unknown about the phenomenon.
Even after the March 19 reboot, the Dutch and German governments suspended jabs for people under 60 and some Europeans have been avoiding the shot.
The chairman of Romania’s national vaccination committee, Valeriu Gheorghita, said Tuesday that since March 207,000 people in Romania canceled their appointments for the AstraZeneca vaccine and another 92,000 simply did not show up.
“It is a high percentage, a third of the people scheduled who did not show up,” Gheorghita told reporters.
British Prime Minister Boris Johnson refused to be swayed directly by the latest warnings about the vaccine, which was developed at the University of Oxford, but urged people to consult the advice of the Great Britain Medicines and Health Regulatory Agency. Brittany.
“His advice to the people is to go ahead, get your jab, get your second jab,” he said during a visit Tuesday to an AstraZeneca facility in Macclesfield, north-west England.
Last week, the MHRA said that seven people had died in the UK due to blood clots after receiving the AstraZeneca injection. He said it was unclear whether the injections were causing the clot and that he was conducting a “rigorous review” of the reports. The agency said it had identified 30 cases of blood clots from 18.1 million doses of AstraZeneca administered as of March 24.
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Johnson said the rapid launch of vaccines in the UK has helped turn things around this year and given Britain a chance to reverse the lockdown restrictions just as many other countries in Europe are putting them back in the middle. from another wave of the virus.