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Oxford-AstraZeneca suspends pediatric trial awaiting review by UK regulator


The spokesperson said the trial in children had raised no safety concerns but would be put on hold while the UK Medicines and Health Products Regulatory Agency, or MHRA, examines rare cases of people suffering from blood clots while having low blood levels. platelets.

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

When contacted by CNN, AstraZeneca referred the queries to the University of Oxford.

Last week, the drug regulator said at least 30 people in the country suffered from rare types of blood clots after receiving the vaccine, but warned that it was too early to know if the injection itself. even had triggered the clots.

MHRA chief Dr June Raine told CNN on Tuesday that the MHRA was “aware of the decision by the University of Oxford to suspend dosing in the trial … as the review MHRA security is underway. “

“The safety of participants in any clinical trial is our top priority, and no safety concerns have been reported with this trial,” she added.

MHRA said in a statement that it has received 22 reports of cerebral venous sinus thrombosis (CVST), where clotting forms in the sinuses that drain blood from the brain, and eight other reports of thrombosis out of a total of 15.8 million. people who received at least one dose of the vaccine before March 21.

They did not say how many blood clots might otherwise have been expected in 15.8 million people.

The agency advised the UK to continue administering the vaccine in all groups, arguing that such incidents of coagulation are very rare and that the benefits always far outweigh the risks, echoing similar assessments of the European Medicines Agency (EMA) and the World Health Organization (WHO).

Regulators in other countries have also reported blood clots in people who have received the vaccine, especially in Europe, where the AstraZeneca vaccine is widely used. Some countries choose to withhold the vaccine altogether, while others have limited its use to certain age groups.

Blood clots in general are so common that a number of people are expected to get them for various reasons on any given day of a given week. If someone has received a vaccine and then develops a blood clot, it does not necessarily mean that the injection caused the clot.

After the first reports of clotting last month, AstraZeneca was quick to point out that the incidence of clots overall is lower in people who received the vaccine than in the general population.

A spokesperson for AstraZeneca said in a statement to CNN last week: “Patient safety remains the top priority of society,” and stressed UK, EU and WHO recommendations to continue to use it.

“The benefit-risk profile of the vaccine has been reaffirmed in the EMA’s monthly safety update,” the spokesperson said.

CNN’s Angela Dewan and Richard Allen Greene contributed to this report.

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