A UK trial testing the COVID-19 vaccine developed by AstraZeneca and the University of Oxford on kids and youngsters has been paused pending extra information from a probe by the UK’s medicines regulator on doable hyperlinks with uncommon blood clotting points in adults.
University of Oxford’s Prof. Andrew Pollard mentioned that there have been “no safety concerns” within the trial of 300 volunteers aged 6-17 years, however that it’s going to look forward to additional information to be launched from the Medicines and Healthcare Products Regulatory Agency (MHRA)—the UK medication watchdog—earlier than giving any additional vaccinations.
The trial started in February to evaluate whether or not the shot produces a robust immune response in these within the age group.
The pause got here shortly after Marco Cavaleri, a senior official for the European Medicines Agency (EMA) suggested that there’s a hyperlink between AstraZeneca’s COVID-19 vaccine and really uncommon blood clots within the mind, often called cerebral venous sinus thrombosis (CVST). The doable causes are nonetheless unknown, the chair of the vaccine analysis crew on the EMA informed Italian every day Il Messaggero.
“It is increasingly difficult to state that there is no cause-and-effect relationship between vaccination with AstraZeneca and very rare cases of unusual blood clots,” he mentioned. Cavaleri didn’t present proof to again up his feedback.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” Pollard mentioned, BBC News reported.
AstraZeneca has repeatedly denied a hyperlink between its vaccine and a better threat of clots, citing earlier research.
The World Health Organization, who has backed the vaccine, mentioned it’s working with different regulators in intently inspecting the newest information. The U.N. company mentioned it isn’t more likely to change its evaluation that the vaccine’s advantages outweigh potential dangers.
Currently, nations together with Germany, France, Spain, Italy and the Netherlands have restricted use of the vaccine to the older inhabitants, whereas some have banned it outright.
The United Kingdom has seen 30 obvious circumstances and 7 deaths of the uncommon blood clots from greater than 18 million doses of AstraZeneca’s vaccine.
Dr. Peter Arlett, the European Union medical regulator’s head of security monitoring, mentioned that the determine was “more than we would expect to see,” however that the conventional background price of the uncommon blood clots is unsure.
The EMA is predicted to launch its findings on Wednesday or Thursday. It informed BBC News its security committee had “not yet reached a conclusion and the review is currently ongoing.”
The Epoch Times has reached out to AstraZeneca for remark.
Reuters contributed to this report.
From The Epoch Times