Oxford-AstraZeneca suspends pediatric investigation pending review by UK regulator

The spokesperson said the study in children has not raised any safety concerns, but it would be interrupted while the UK Medicines and Healthcare products Regulatory Agency, or MHRA, is reviewing rare cases of people who have blood clots while at the same time having low blood levels. to have. platelets.

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

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

Last week, the drug regulatory agency said at least 30 people in the country had had rare types of blood clots after receiving the vaccine, but warned it was too early to know if the injection itself was causing the blood clots.

The head of the MHRA, Dr. June Raine, told CNN on Tuesday that the MHRA was “aware of the University of Oxford’s decision to suspend dosing during the investigation … while the MHRA safety review is underway.”

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

Here's what you need to know about the risk of blood clots and the AstraZeneca vaccine

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

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

The Agency has advised the UK to continue to administer the vaccine in all groups, arguing that such coagulation incidents are very rare and that the benefits still far outweigh the risks, following similar assessments by 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, particularly in Europe, where the AstraZeneca vaccine is widely used. Some countries choose to discontinue the vaccine altogether, while others have limited its use to certain age groups.

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

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

An AstraZeneca spokesperson said in a statement to CNN last week, “Patient safety remains the company’s top priority,” noting recommendations from UK, EU and WHO authorities to continue its use.

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

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

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