The spokesperson stated the trial in youngsters had not raised any security issues, however it will be paused whereas Britain’s Medicines and Healthcare merchandise Regulatory Agency, or MHRA, critiques uncommon instances of people that endure blood clots whereas on the identical time having low ranges of blood platelets.

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

When contacted by NCS, AstraZeneca referred queries to Oxford University.

Last week, the medicines regulator stated no less than 30 individuals within the nation had skilled uncommon forms of blood clots after receiving the vaccine, however warned it was too early to know whether or not the shot itself triggered the clots.

The head of MHRA, Dr. June Raine, advised NCS on Tuesday that the MHRA was “aware of the decision taken by the University of Oxford to pause dosing in the trial…whilst the MHRA safety review is ongoing.”

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

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

MHRA stated in a press release it acquired 22 reviews of cerebral venous sinus thrombosis (CVST), the place clotting kinds within the sinuses that drain blood from the mind, and eight different reviews of thrombosis amongst a complete of 15.8 million individuals who had been given no less than one dose of the vaccine by March 21.

They didn’t say what number of blood clots would possibly in any other case have been anticipated amongst 15.8 million individuals

The company has suggested the UK to proceed administering the vaccine in all teams, arguing that such clotting incidents are very uncommon and that the advantages nonetheless tremendously outweigh the dangers, echoing comparable assessments by the European Medicines Agency (EMA) and the World Health Organization (WHO).

Regulators in different nations have additionally reported blood clots amongst individuals who have acquired the vaccine, significantly in Europe, the place the AstraZeneca vaccine is extensively used. Some nations are selecting to droop the vaccine altogether, whereas others have restricted its use to sure age teams.

Blood clots usually are so frequent that it’s anticipated {that a} sure variety of individuals will get them for numerous causes at any given day of any given week. If somebody has had a vaccine after which develops a blood clot, it does not essentially imply the shot brought on the clot.

After preliminary reviews of clotting final month, AstraZeneca was fast to level out that the incidence of clots total is decrease in individuals who have acquired the shot that within the normal inhabitants.

An AstraZeneca spokesperson stated in a press release to NCS final week: “Patient safety remains the Company’s highest priority,” and pointed to authorities within the UK, EU and the WHO’s suggestions to proceed its use.

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

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



Sources

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