AstraZeneca: the University of Oxford stops its trials on children

Pending an opinion from the British regulator after the reports of cases of thrombosis occurring after the injections of the doses at AstraZeneca, the University of Oxford prefers to suspend the clinical trial in progress on children.

The University of Oxford announced on Tuesday April 6 that it was interrupting trials on children of the vaccine against the coronavirus, which it developed with the Anglo-Swedish laboratory AstraZeneca, pending the opinion of the British regulator . “While there are no concerns regarding the safety of the pediatric clinical trial, we are awaiting further information from the MHRA, the UK regulator, on the rare cases of thrombosis that have been reported in adults, before proceeding. carry out new vaccinations in the trial “, explained the British university in a statement. Parents and children should continue to attend scheduled visits and can contact trial sites if they have any questions.“, added the university.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is reviewing all reports of blood clots in patients who have received British Swedish serum. To date, 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 have been administered in the country. UK Medicines and Health Products Regulatory Agency chief executive June Raine has since said people need to “Continue to get 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, specifying that “no decision has yet been made on possible regulatory actionHowever, an official of the World Health Organization (WHO), Rogerio Pinto de Sa Gaspar, explained on Tuesday that the benefit / risk balance continued to tilt greatly in favor of the use of the AstraZeneca vaccine, since renamed Vaxzevria Earlier in the day on April 6, an official from the European Medicines Agency (EMA) said that a link has been established between the British Swedish vaccine and cases of thrombosis.

For many weeks, suspicions have remained about possible serious side effects, even if they are rare. As a precaution, several countries such as Germany, Canada and France have taken the initiative to limit its use by imposing an age limit (prohibited below 60 years). Other countries like Norway and Denmark have suspended injections of the British-Swedish vaccine for now. For its part, AstraZeneca claimed in March that there was “no evidence of increased risk“, And assured on Saturday that “Patient safety” was “his main priority”