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suspension of AstraZeneca vaccine trials in children

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The University of Oxford said Tuesday to wait for additional information from the British regulator before resuming trials on children of its vaccine developed with the AstraZeneca laboratory. Blood clots in patients who received the serum have been reported.

The University of Oxford announced Tuesday, April 6 that it was suspending trials on children of the Covid-19 vaccine that it developed with the Anglo-Swedish laboratory AstraZeneca, pending the opinion of the regulator British.

“While there are no concerns regarding the safety of the pediatric clinical trial, we await further information from the MHRA,” the UK regulator, “on the rare cases of thrombosis which have been reported in adults, before proceeding with new vaccinations in the trial, “the British university said in a statement. “Parents and children should continue to attend scheduled visits and can contact the sites where the trial is being held if they have any questions,” the university added.

The MHRA is investigating reports of blood clots in patients who have received the AstraZeneca vaccine. Seven fatal cases have been identified in the United Kingdom out of a total of 30 identified cases, the regulator said on Saturday, while more than 18 million doses of the AstraZeneca vaccine were administered in the country.

Risk / benefit balance

MHRA official June Raine has since asserted that people should “continue to be vaccinated when instructed to do so.” “Our in-depth and detailed examination is underway regarding reports of very rare and specific types of blood clots with low platelet counts following AstraZeneca’s Covid-19 vaccine,” she continued, adding that “no decision has not yet been taken on possible regulatory action “.

A World Health Organization (WHO) official Rogerio Pinto de Sa Gaspar said on Tuesday that the risk / benefit balance continued to weigh “largely” in favor of the use of AstraZeneca’s anti-Covid vaccine.

Earlier today, an official from the European Medicines Agency (EMA) mentioned the existence of a “link” between the AstraZeneca vaccine and the cases of thrombosis observed after its administration, in an interview with the Italian daily Il Messaggero. The European agency in the process specified that its security committee “has not yet reached a conclusion and (that) the examination is currently underway”.

Suspicions

For several weeks, suspicions have appeared on possible serious side effects, but rare, after the observation in people vaccinated with AstraZeneca of cases of atypical thrombosis.

As a precaution, several countries have decided to no longer administer this vaccine below a certain age, such as France, Germany and Canada. Norway and Denmark have even suspended its use for now.

For its part, AstraZeneca assured in March that there was “no evidence of aggravated risk”, and assured Saturday that “patient safety” was its “main priority”.

With AFP

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