Safety concerns: AstraZeneca vaccine trials in children have been suspended
DUBLIN: The Oxford/AstraZeneca COVID-19 vaccine trial in children has been suspended due to safety concerns.
The University of Oxford said the vaccines will be administered only after further information is obtained from the Medicines and Healthcare products Regulatory Agency (MHRA). Meanwhile, the University confirmed that no safety issues were raised during children’s clinical trial.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” the University of Oxford said in a statement.
“Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions,” it added.
Sage adviser Professor Calum Semple urged people to continue taking the Oxford / AstraZeneca doses, saying the decision was made out of “exceptional caution”.
Meanwhile, regulatory agencies from the UK, Europe and the World Health Organization (WHO) are also evaluating the risk of blood clots, which are rare in adults. The World Health Organization and the European Medicines Agency (EMA) have confirmed that their findings will be published this week.
The EMA said that its safety committee has not yet reached a conclusion. The agency said the review is currently ongoing and the results are expected to be announced soon.
The World Health Organization (WHO) has confirmed that an expert panel has been appointed to evaluate the data and publish the findings as soon as possible. Dr Rogerio Pinto de Sa Gaspar, director of regulation and prequalification at the WHO, said the data would be examined by the WHO’s Global Advisory Committee on Vaccine Safety.
As of March 24, 18.1 million doses of AstraZeneca jab had been administered, according to the MHRA. Thirty cases of blood clots were confirmed, with seven deaths among them.
British Prime Minister Boris Johnson has called on the public to trust the regulator on vaccine safety. He also visited the AstraZeneca manufacturing plant in Macclesfield. “On the Oxford/AstraZeneca vaccine, the best thing people should do is look at what the MHRA [Medicines and Healthcare products Regulatory Agency] say, our independent regulator. Their advice to people is to keep going out there, get your jab, get your second jab,” he said.
Incidents of blood clots in Ireland as well
The Health Products Regulatory Authority of Ireland (HPRA) said there were 10 cases of blood clots in the legs or lungs following administration of the AstraZeneca vaccine. The HPRA stated that it had received 22 similar reports for mRNA vaccines (Pfizer and Moderna).
These figures are included in the latest report on side effects from the COVID-19 vaccine published on March 25. The HPRA said none of these reports described specific types of blood clots.
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