The University of Oxford has suspended AstraZeneca COVID-19 vaccinations in a small clinical trial for children, while the U.K.’s medicines regulator examines reports of rare blood clotting in vaccinated adults.
An Oxford spokesperson said “there are no safety concerns in the pediatric clinical trial,” in a statement sent to Fox News.
“Whilst there are no safety concerns in the pediatric clinical trial, we await additional information from the MHRA [Medicines and Healthcare products Regulatory Agency] on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” the statement reads. “Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.”
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The MHRA told Fox News on Tuesday the review was ongoing and it hadn’t made any regulatory decisions yet.
“We are aware of the decision taken by the University of Oxford to pause dosing in the trial of the Oxford University/AstraZeneca COVID-19 vaccine trial in children whilst the MHRA safety review is ongoing,” Dr. June Raine, head of MHRA, said in a statement. “Participant safety in any clinical trial is our top priority, and no safety concerns have been reported with this trial.”
The University of Oxford announced in February it launched a trial to study the safety and efficacy of the AstraZeneca COVID-19 vaccine in children as young as 6. The study, which Oxford University had said was the first of its kind, involves 300 volunteers, 240 of which would receive the vaccine while the 60 others would receive a meningitis shot.
The university said the 60 who will receive the meningitis shot will serve as the control, and that the jab is safe in children but also is expected to produce similar reactions such as a sore arm.
The news comes just as a top official at the European Medicines Agency said there is a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that it’s unclear what the connection is and the benefits of taking the vaccine still outweigh the risks of getting COVID-19.
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Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, told Rome’s Il Messaggero newspaper on Tuesday that the EU medicines regulator is preparing to make a more definitive statement on the topic this week.
Based on the evidence to date, Cavaleri said there’s a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide amid the tens of millions of vaccine jabs that have been given out.
Fox News’ Alexandria Hein and the Associated Press contributed to this report.