Child trial of vaccine suspended by Oxford University over clot worries

A study of the Oxford / AstraZeneca vaccine conducted by Oxford University in children and adolescents has been reported to have been suspended.

The drug and health product regulator (MHRA) regulators say they are investigating a possible link between the bite and a rare form of blood clot.

An Oxford University spokesperson said in a statement: “Although there are no safety concerns in the pediatric clinical trial, we are awaiting additional information from the MHRA on their review of rare cases of thrombosis / thrombocytopenia reported in adults before further vaccinations are given in the study.

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

It is because regulators from the UK and Europe are evaluating data on the bite and a possible link to a rare form of blood clot.

And the World Health Organization (WHO) has confirmed that it will also convene a group of experts to evaluate the information.

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

Today (April 6), Boris Johnson defended the AstraZeneca Covid-19 vaccine when he visited the pharmaceutical giant’s manufacturing facility in Macclesfield.

“With the Oxford / AstraZeneca vaccine, the best thing to do is look at what the MHRA (Medicines and Health Products Regulator), our independent regulator, says. That’s why we have them, that’s why they are independent,” he said.

“Your advice to people is to keep going out, get your push, get your second push.”

He added, “Best of all, vaccinating our people, getting everyone out, that’s key and that’s what I would advocate, number one.”

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

Marco Cavaleri, head of vaccines at EMA, reportedly suggested a clear link but admitted there was uncertainty about how the vaccine would cause the complication.

When asked about the remarks, Dr. Rogerio Pinto de Sa Gaspar, WHO Director of Regulation and Prequalification: “When we were at this briefing, there was a rejection from the Agency for European Medicine regarding the existence of the link.”

The EMA said its security committee “has not yet reached a conclusion and the review is still ongoing,” but the results are expected to be announced on Wednesday or Thursday.

Dr. Pinto de Sa Gaspar added: “There is currently no association between the vaccine and thrombolytic events with thrombocytopenia.

“There are a number of committees and regulators that deal with data, and new data comes in every day [they are] Evaluation of this data.

“Of course it is currently being evaluated and we are waiting for some feedback from these committees in the coming days and hours.

“The assessment we currently have, and which is being reviewed by the experts, is that the benefit-risk assessment for the vaccine is still largely positive.”

He added: “There is currently no evidence to suggest that the benefit-risk assessment for the vaccine needs to be changed, and we know from data from countries like the UK and others that the benefit is really important in reducing the Mortality of Populations Being Vaccinated. “

Meanwhile, he announced that WHO would convene its Global Advisory Committee on Vaccine Safety to review the data.

“So we are assuming that we will likely have a new final assessment from our experts by the end of Wednesday or Thursday,” he added.

“For the moment, however, we are confident that the risk-benefit assessment for the vaccine is largely positive.”

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

However, the results of the safety committee will be released either on Wednesday or Thursday.

The UK regulator – the Medicines and Health Products Regulator (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) that occurs with low levels of platelets (thrombocytopenia) after vaccination .

It hasn’t confirmed when it will report its results.

A number of countries have stopped the use of the prick among younger people.

The MHRA has identified 30 cases of rare blood clot events from 18.1 million doses of the sting administered through March 24th inclusive.

Among the 30 cases, there were seven deaths.

However, the regulator said the vaccine’s benefits in preventing coronavirus outweigh the risks and urged the public to continue to stand up for the sting.

Dr. June Raine, Managing Director of MHRA said, “People should continue to receive their vaccine when prompted.

“Our thorough and detailed review includes reports of very rare and specific types of low platelet blood clots following the AstraZeneca Covid-19 vaccine.

“A decision on regulatory measures has not yet been taken.”

The 30 cases in the UK include 22 reports of CVST and eight other low platelet thrombosis events.

CVST clots prevent blood from properly draining out of the brain.

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