ROME – A senior 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 getting 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 the Il Messaggero newspaper in Rome on Tuesday that the EU drug regulator is preparing to make a more definitive statement on the matter in 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 vaccines that have been given.
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“It is becoming increasingly difficult to say that there is no cause-and-effect relationship between the AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets,” said Cavaleri.
Asked about Cavaleri’s comments, the EMA press office said his assessment “has not yet been completed and the review is in progress.” He said he planned 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, stopped using AstraZeneca because of the blood clot. Most EU nations restarted on March 19 – some with age restrictions – after the EMA said the vaccine’s benefits outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended that the vaccine leaflet 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 critical to Europe’s immunization campaign and a pillar in the global strategy to bring vaccines to the poorest countries. The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been approved for use in more than 50 countries and groups, including the 27 EU countries and the World Health Organization. are evaluating the vaccine.
Cavaleri said that although the EMA is prepared to declare a connection, further studies are still needed to understand why and how the phenomenon occurs.
“Certainly the information about the product will be updated, stating that these adverse events are linked to the vaccine. It will be declared very clearly, ”he said.
He said the rare blood clots, including some in the brain, along with a low level of blood platelets that can make people at risk of severe bleeding, “appear to be the key event for further study”. Cavaleri promised more details soon, adding: “In the next few hours, we will say that the link is there, as it happens we have not yet discovered”.
Cavaleri said the biological mechanism of how the vaccine may be causing the rare clots is still unknown and if it is related to how the injection is made, other vaccines with similar technologies also need to be evaluated.
Cavaleri was asked how he could reach this causal conclusion, given the relatively few cases of adverse events.
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“Among those vaccinated, there is a series of brain thrombosis with low platelet levels among young people that is greater than expected. We have to say that, ”he said.
But he emphasized that the risk-benefit analysis remained positive for the AstraZeneca vaccine, even for young women who appear to be most affected by the clots.
“Let’s not forget that young women also end up in intensive care with COVID. Therefore, we need to do a very thorough job to understand whether the risk-benefit analysis remains for all ages,” he said.
He said that EMA is in a difficult situation, due to the different outbreaks of viruses in each of the 27 nations of the EU.
“Certainly, many people would like the EMA to resolve the issue for everyone, but it is not so easy,” he said. “In Italy, there are still about 500 people dying each day, in Norway almost no one. These factors justify a different approach.”
He ruled out preventive therapy to treat the rare blood clots, saying there is still a lot that is unknown about the phenomenon.
Even after the restart on March 19, the Dutch and German governments suspended jabs for people under the age of 60 and some Europeans have avoided shooting.
The chairman of Romania’s national vaccination committee, Valeriu Gheorghita, said on Tuesday that since March, 207,000 people in Romania have canceled their vaccination appointments for AstraZeneca and another 92,000 simply have not attended.
“It is a high percentage, a third of the programmed people who did not attend,” Gheorghita told reporters.
British Prime Minister Boris Johnson refused to be drawn directly to the latest warnings about the vaccine, which was developed at Oxford University, but asked people to look to the board of the Medicines and Health Regulatory Agency independent of the Great Britain.
“Their advice to people is to keep going, get your jab, get your second jab,” he said during a visit Tuesday to an AstraZeneca facility in Macclesfield, in northwest England.
Last week, the MHRA said seven people died in the UK due to blood clots after receiving the AstraZeneca injection. He said it was not clear whether the shots were causing the clot and that he was doing a “rigorous review” of the reports. The agency said it identified 30 cases of blood clot in 18.1 million doses of AstraZeneca administered by March 24.
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Johnson said the rapid launch of vaccines in the UK helped to reverse the situation this year and gave Britain the opportunity to reverse blocking restrictions, just as many other countries in Europe are putting them back in between. outbreak of the virus.