Following the detection of a possible link with the Oxford-AstraZeneca COVID-19 jab and rare blood clots in adults in the UK, the university has decided to halt the trial which was being carried out in children. The trial which started in February 2021 was assessing whether the vaccine helped produce a strong immune response in those aged between 6 to 17.
The suspension of the trial was announced after a European Medicines Agency (EMA) official, said there appeared to be a link with the vaccine and rare blood clots. However, there were no safety concerns with the trial itself, but its scientists were waiting for further information, said researchers.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the Medicines and Healthcare Products Regulatory Agency (MHRA) on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” said Prof. Andrew Pollard, Director of the Oxford Vaccine Group.
Meanwhile, the EMA said its safety committee had “not yet reached a conclusion and the review is currently ongoing”. The MHRA said the benefits of the jab continue to outweigh any risk. Even if the vaccine was the cause, and this is still not proven, the numbers suggest around one death in every 2.5 million people vaccinated in the UK.
For everyone over the age of 75 infected there is one death per eight COVID-19 infections while for those in their 40s it is one death per 1,000. So the risk-benefit ratio is clearly in favour of vaccination – if you assume you are going to be infected at some point, said the agency.
The MHRA has said it identified 30 cases of rare blood clot events out of 18.1 million doses of the jab administered up to and including 24 March. There have been seven deaths among the 30 cases.
The authorities are trying to collect more information about who has been suffering from these rare blood clots, their age and about whether or not they had any underlying health conditions, to understand what had happened. This will help narrow down the scale of any potential risks.
The MHRA is investigating reports of a very rare and specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST), occurring together with low levels of platelets (thrombocytopenia) following vaccination.
A number of countries have suspended the use of the Oxford-AstraZeneca jab among younger people, including in Germany, which has paused it for people aged below 60, and Canada, where the jab is not being given to those under 55.
“Our thorough and detailed review is ongoing into reports of very rare and specific types of blood clots with low platelets following the the administration of the COVID-19 vaccine by AstraZeneca.No decision has yet been made on any regulatory action.” said Dr June Raine, chief executive of MHRA.
Adam Finn, Professor of paediatrics at Britain’s University of Bristol, said the trial of the jab on children was paused as a “precautionary measure” while they wait for clearer information, rather than because any problems had occurred.