ROME – A top official at the European Medicines Agency says that there is a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that it is unclear what the connection is and the benefits of taking the vaccine still outweigh the risks of getting COVID-19.
Marco Cavaleri, head of health threats and vaccine strategy at Amsterdam-based agency, told Roma newspaper Il Messaggero on Tuesday that the European Medicines Agency is preparing to make a more final statement on the subject this week.
Based on the evidence to date, Cavaleri said there is a clear link between the AstraZeneca vaccine and the dozens of rare blood clots reported worldwide among the tens of millions of vaccine jabs handed out.
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“It is becoming increasingly difficult to confirm that there is no causal link between AstraZeneca vaccines and the very rare cases of blood clots associated with low platelet counts,”
Asked about Cavalieri’s comments, the EMA’s press office said that its evaluation “has not yet reached a conclusion and that the review is currently under way.” It said it planned a press conference as soon as the review is 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 over the blood clot problem. Most EU nations restarted on March 19 – some with age restrictions – after the EMA said the benefits of the vaccine outweigh the risk of not inoculating people against COVID-19. At the time, the EMA recommended that the vaccine package leaflet be updated to tell people about the rare blood clots.
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Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is crucial to Europe’s immunization campaign and a cornerstone of the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than competing vaccines from Pfizer and Moderna and is approved for use in over 50 countries and groups, including by the 27-nation EU and the World Health Organization. US authorities are still evaluating the vaccine.
Cavaleri said that while the EMA was ready to declare a link, further investigation was still needed to understand why and how the phenomenon occurs.
“Certainly the information on the product will be updated and confirm that these side effects are linked to the vaccine. They will be stated in a very clear way,” he was quoted as saying.
He said the rare blood clots, including some in the brain, combined with a low level of platelets that could put people at risk for severe bleeding, “seem to be the most important event to study further.” Cavaleri soon promised more details, adding: “In the coming hours we will say that the link is there, how this happens, we still have not figured out.”
Cavaleri said the biological mechanism for how the vaccine can cause the rare blood clots was still unknown, and if it was linked to how the shot was made, it may also be necessary to evaluate other vaccines with similar technologies.
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 are a number of cerebral thromboses with a low level of platelets among young people that are higher than we would have expected. This we must say,” he was quoted as saying.
However, he stressed that the risk-benefit analysis remained positive for AstraZeneca jab, 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 with COVID. So we have to do very careful work to understand if the risk-benefit analysis remains at all ages,” he was quoted as saying.
He said the EMA was in a difficult situation given the various virus outbreaks in each of the EU’s 27 nations.
“Certainly, a lot of people want the EMA to solve the issue for everyone, but it’s not that easy,” he said. “In Italy, about 500 people still die a day, in Norway almost none. These factors justify a different approach.”
He ruled out a preventative treatment to tackle the rare blood clots, saying there is still too much unknown about the phenomenon.
Even after the resumption on March 19, the Dutch and German governments suspended jabs for people under the age of 60, and some individual Europeans have been 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 a further 92,000 simply did not show up.
“That’s a high percentage, a third of the planned people who did not come,” Gheorghita told reporters.
British Prime Minister Boris Johnson refused to be drawn directly into the latest warnings about the vaccine, which was developed at Oxford University, but urged people to look at the advice of Britain’s independent Medicines and Healthcare Regulatory Agency.
“Their advice to people is to keep going out there, get your jab, get your second jab,” he said during a visit Tuesday at an AstraZeneca facility in Macclesfield, northwest England.
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 conducted a “rigorous review” of the reports. The agency said it had identified 30 blood clots out of 18.1 million AstraZeneca doses given on March 24.
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Johnson said the rapid rollout of vaccines in the UK has helped turn the situation around this year and given the UK the opportunity to revoke restrictions as many other European countries are putting them up again in a new wave of the virus.