Home https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ World https://server7.kproxy.com/servlet/redirect.srv/sruj/smyrwpoii/p2/ Oxford-AstraZeneca suspends pediatric trial pending review by UK regulator

Oxford-AstraZeneca suspends pediatric trial pending review by UK regulator



The spokesman said the trial of children had not raised any safety concerns but would be put on hold while the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, reviews rare cases of people suffering from blood clots while having low blood levels. . platelets.

“Parents and children should continue to attend all scheduled visits and can contact the courts if they have any questions,” the spokesman said.

When AstraZeneca was contacted by CNN, inquiries referred to Oxford University.

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

The head of the MHRA, Dr. June Raine, told CNN on Tuesday that the MHRA was “aware of the decision taken by the University of Oxford to halt dosing in the trial … while the MHRA safety review is underway.”

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

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

The MHRA said in a statement that it received 22 reports of cerebral venous sinus thrombosis (CVST), in which coagulation 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 had received at least a dose of the vaccine before 21 March.

They did not say how many blood clots could otherwise be expected among 15.8 million people

The Agency has advised the United Kingdom to continue administering the vaccine in all groups, claiming that such coagulation events are very rare and that the benefits still outweigh the risks and repeat similar assessments by the European Medicines Agency (EMA) and the World Health Organization (WHO).

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

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

Following initial reports of coagulation last month, AstraZeneca was quick to point out that the incidence of blood clots is generally lower in people who have received the shot in the general population.

A spokesman for AstraZeneca said in a statement to CNN last week: “Patient safety remains the company’s top priority,” pointing to UK, EU and WHO recommendations for continued use.

“The vaccine’s benefit risk profile was confirmed in the EMA’s monthly safety update,” the spokesman said.

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


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