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Oxford University said on Tuesday it had stopped giving doses of the COVID-19 vaccine it had developed with AstraZeneca to minors, awaiting more information on rare problems with blood clotting (thrombosis) in adults who have received it.
The decision coincides with statements by the European Medicines Agency (EMA) after one of its spokespersons confirm a “link” between the AstraZeneca vaccine and the thromboses recorded in people who received this vaccine.
“Now we can say, it is clear that there is a link with the vaccine, which causes this reaction. However, we still do not know why (…) In summary, in the next few hours we will say that there is a link, but we have not yet understood why it happens“Said Marco Cavaleri, head of vaccine strategy at EMA.
The Oxford-led pediatric trial began in mid-February and aims to test the vaccine in more than 200 young people aged 6 to 17.
An Oxford spokesperson quoted by The Wall Street Journal said Tuesday that so far a safety concern did not arise in the trial itself, but there are general concerns about rare clotting problems in vaccinated adults. In fact, the issue prompted further regulatory reviews in the UK and Europe to investigate any potential link to the vaccine.
“While there are no concerns about the safety of the pediatric clinical trial, we are awaiting further information from the MHRA (the UK regulatory agency)”, explained the university.
Indeed, Oxford awaits further information from the British watchdog., the Medicines and Health Products Regulatory Agency, before continuing the pediatric trial.
This interruption of studies with minors is the Ultimate setback for Oxford-AstraZeneca injection, which is currently questioning its effectiveness and possible side effects, even though tens of millions of doses have already been administered after approval in more than 70 countries.
The pediatric study, funded by the UK’s National Institute for Health Research and AstraZeneca, aimed to recruit 300 volunteers in Oxford, London and two other UK sites, 200 of whom would receive the vaccine and the rest a placebo, a- he declared. Oxford
The vaccine Oxford-AstraZeneca, a mainstay of the UK mass inoculation campaign, is cleared for widespread use in the country in adults over 18 years of age.
There have been concerns about possible serious, but rare, side effects in people vaccinated with AstraZeneca for several weeks. These would be cases of atypical thrombosis, some of them caused death. However, agency experts argue that among the elderly the benefit of the vaccine outweighs the risk, given the need to be immune to COVID-19.
In the UK, there are 30 cases and 7 deaths out of a total of 18.1 million doses administered through March 24.
With information from EFE
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