Children’s AstraZeneca vaccine trial suspended over blood clot concerns

Childrens AstraZeneca vaccine trial suspended over blood clot concerns
Spread the love

A university trial of the AstraZeneca vaccine among children and teens has been paused, it’s been reported.

The University of Oxford said while there are ‘no safety concerns in the paediatric clinical trial’ they want to wait for more information.

This is because regulators at the Medicines and Healthcare products Regulatory Agency (MHRA) say that they are investigating a potential association between the jab and a rare form of blood clot, reports WalesOnline.

A spokesperson from Oxford University said in a statement: “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.

“Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.”

It comes as regulatory bodies from the UK and Europe are assessing data on the jab and a potential association with a rare form of blood clot.

And the World Health Organisation (WHO) has confirmed that it will also convene a panel of experts to assess the information.

The WHO and the European Medicines Agency (EMA) have confirmed they will publish findings later this week.

Earlier yesterday (April 6), Boris Johnson defended the AstraZeneca Covid-19 vaccine as he visited the pharmaceutical giant’s manufacturing plant in Macclesfield.

“On the Oxford/AstraZeneca vaccine, the best thing people should do is look at what the MHRA (Medicines and Healthcare products Regulatory Agency) say, our independent regulator – that’s why we have them, that’s why they are independent,” he said.

“Their advice to people is to keep going out there, get your jab, get your second jab.”

He added: “The best thing of all is to vaccinate our population, get everybody out getting the jab, that’s the key thing and that’s what I would advocate, number one”.

The EMA’s said that its safety committee has “not yet reached a conclusion and the review is currently ongoing” but it is expected to announce findings on Wednesday or Thursday.

Dr Pinto de Sa Gaspar added: “There is no link for the moment between the vaccineand thrombolytic events with thrombocytopenia.

“There are a number of committees and regulatory authorities looking at data and new data is coming every day and [they are] assessing those data.

“Of course it’s under evaluation and we wait for some feedback from those committees in coming days and hours.

“The appraisal that we have for the moment, and this is under consideration by the experts, is that the benefit-risk assessment for the vaccine is still largely positive.”

He added: “For the time being there is no evidence that the benefit-risk assessment for the vaccine needs to be changed and we know from the data coming from countries like the UK and others that the benefits are really important in terms of reduction of the mortality of populations that are being vaccinated.”

Meanwhile he announced that the WHO will convene its Global Advisory Committee on Vaccine Safety to examine the data.

“So we expect that probably by the end of Wednesday or Thursday we might have a fresh conclusive assessment from our experts,” he added.

“But at the present moment we are confident that the benefits risk assessment for the vaccine is largely still positive.”

The EMA has previously said that there is “no evidence” to support restricting the use of the Oxford/AstraZeneca Covid-19 vaccine in any population.

But it will publish the findings from its safety committee either on Wednesday or Thursday.

The British regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is also 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.

It has not confirmed when it will report its findings.

A number of countries have suspended the use of the jab among younger people.

It comes after reports that a senior EMA official told an Italian newspaper there appears to be an association with the vaccine and rare blood clots.

Marco Cavaleri, head of vaccines at the EMA, is said to have suggested a clear link, though admitted there was uncertainty how the vaccine would cause the complication.

When asked about the remarks, Dr Rogerio Pinto de Sa Gaspar, director of regulation and prequalification at the WHO, said: “As we were in this briefing, there was a denial from the European Medicine’s Agency concerning the existence of the link.”