Tuesday, April 13, 2021
Home Health Study of Astra vaccinations in children is paused, Oxford says

Study of Astra vaccinations in children is paused, Oxford says


The vaccine researchers are awaiting the results of a review by the Medicines and Healthcare Products Regulatory Agency, the U.K.’s drug watchdog, the university said in an emailed statement. No safety issues have arisen in the children’s trial, Oxford said.

The action comes as the European Union’s medicines regulator prepares to provide an updated assessment of the shot’s safety at about 4 p.m. Amsterdam time. A number of reports of ocassional brain blood clots in younger adults have led some countries, including several in the EU, to suspend use of the vaccine in certain age groups. Germany halted its use in people younger than 60 last week.

Drug regulators in the UK and EU have said that a connection between the clots and the vaccine is possible but unclear, and that the benefits continue to outweigh the risks. The European Medicines Agency’s planned update may indicate a potential link between the drugmaker’s shot and the blood clots, Italian newspaper Il Messaggero reported Tuesday, quoting Marco Cavaleri, chair of the EMA’s vaccine evaluation team.

US trial planned

Cavaleri’s comments were personal and preliminary, the drug regulator said by email..

Amid concerns about the AstraZeneca vaccine, the UK began rolling out a shot from Moderna Inc. on Wednesday, ahead of the expected timetable. Britain is also immunizing people with a vaccine from Pfizer Inc. and BioNTech SE.

AstraZeneca shares fell 0.7% Wednesday at 10:37 a.m. in London.

The UK’s regulator said Saturday that it had identified 30 cases of a rare combination of blood clots and low platelets in people in Britain who had received the Astra shot through March 24, of whom seven died.

The Oxford trial plans to enroll 300 children and adolescents aged 6 to 17, the university said when it began the study in February. As many as 240 participants will receive the coronavirus vaccine and the remainder a meningitis shot. Initial data from the trial is expected by the summer, Oxford said at the time.

Astra is planning to start a larger US trial for children, similar to those run by Pfizer and Moderna, in the coming months.

Parents and children continue to attend all scheduled visits and can contact the trial sites if they have any questions, the university said in the statement. The Wall Street Journal reported the pause in the study earlier.

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This story has been published from a wire agency feed without modifications to the text.





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