Rome (AP) – A senior European Medicines Agency official said in an interview on Tuesday that there was a causal link between the AstraZeneca coronavirus vaccine and the rare blood clot, but that it was still unclear what the link was between the benefits of the vaccine. Risks of getting COVID-19
Marco Cavaleri, head of the Amsterdam-based agency’s health threats and vaccines strategy, told Rome’s Il Messaggero newspaper that the EU drug regulator was going to make a clearer statement this week.
Based on the evidence to date, Cavalier said there was a clear link between the AstraZeneca vaccine and the “dozens of rare blood clots” that have been reported in tens of millions of vaccine injections worldwide.
Dozens of countries, including Germany, stopped using AstraZeneca last month due to a blood clot problem. The EMA said the benefits of the vaccine outweighed the risks of people not being vaccinated against COVID-19, some with age restrictions. The EMA then recommended updating the vaccine leaflet to inform physicians and patients about rare thrombi.
“It is becoming increasingly difficult to establish that there is no causal link between the very rare cases of AstraZeneca vaccines,” Cavalieri was quoted as saying. ,
He said he appreciated the need for a clear European proposal on vaccine safety for certain age groups, but said he did not expect the EMA to provide it now.
“Certainly the product information will be updated to confirm that these adverse events are related to the vaccine. “It will be announced very clearly,” he was quoted as saying.
Further suspicions about the AstraZeneca vaccine will be a reversal of the shot, which is crucial to Europe’s immunization campaign in the global vaccine strategy for poor countries. The AstraZeneca vaccine is cheaper և easier to use than Pfizer և Moderna’s competitor vaccines և approved for use in groups ավելի in more than 50 countries, including 27 EU countries համաշխարհային World Health Organization. US authorities are still in the process of evaluating the vaccine.
Many EU countries, including Italy, resumed use of the AstraZeneca vaccine on March 19.
Cavalieri said that before the EMA was ready to announce the link, further research was needed to understand why and how it occurs.
He said the rare thrombi, including those in part of the brain, were associated with low blood platelet counts, which could be a “potential follow-up event” for people at high risk for bleeding. Cavalier promised to add more details soon. “In the coming hours we will say that there is a link, how it happened, we have not found out yet.”
Cavalieri says the vaccine’s biological mechanism for rare thrombi is still unknown, and if it is related to the method of shooting, it may be necessary to evaluate other vaccines with similar technologies.
Asked about Cavalieri’s comments, the EMA press office said that its assessment “has not yet been concluded, the review is currently ongoing.” It says it is planning a press conference when the review is over, possibly on Wednesday or Thursday.
Cavalieri was asked how he could come to such a causal conclusion given the relatively small number of adverse events.
“There is a number of cerebral thrombosis among the vaccinated, with low platelet counts in young people, which is higher than we expected. This is what we have to say, “he was quoted as saying.
But he stressed that the risk-benefit analysis remains positive for AstraZeneca piercing, even for young women who appear to have suffered more from blood clots.
“Let’s not forget that young women also find themselves in intensive care with COVID. “So we have to do a lot of thorough work to understand whether the risk-benefit analysis remains for all ages,” he said.
He said the EMA was in a difficult position given the different outbreaks of the virus in each of the 27 EU countries.
“Of course, many would like the EMA to solve the problem for everyone, but it is not so easy,” he said. “Let’s not forget that the weight of COVID varies from country to country. About 500 people die every day in Italy, almost no one in Norway. These factors justify a different approach. “
He ruled out preventative therapy for rare thrombosis, saying it was still unknown.
Follow AP epidemic coverage https://apnews.com/hub/coronavirus-pandemic և https://apnews.com/hub/coronavirus-vaccine