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AstraZeneca Puts Leading COVID-19 Vaccine Trial On Hold

After unexplained illness in volunteer

The pharmaceutical company AstraZeneca halted large, late-stage global trials of its coronavirus vaccine on Tuesday, because of a serious suspected adverse reaction in a participant. It is not yet known whether the reaction was directly caused by the company’s vaccine or was coincidental.

The pause will allow AstraZeneca to conduct a safety review and investigate whether the vaccine caused the illness. How long the hold will last is unclear.

« This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials » , a company´s statement added. « In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials. »

Drug companies are racing to complete a coronavirus vaccine that could bring an end to a pandemic that has already claimed more than 890,000 lives globally. AstraZeneca is a front-runner, with late-stage clinical trials underway around the world, and has said it hoped to have a vaccine ready before the end of the year. If the cause of the reaction turns out to be related to the vaccine, those efforts could be derailed.

Late-stage vaccine testing remains crucial, as large trials can turn up rare but serious side effects that would surface only if many thousands of people received a vaccine.

Earlier Tuesday, AstraZeneca joined eight other companies in signing a pledge, promising they would not seek premature government approval for any coronavirus vaccine. They promised they would wait until they had adequate data showing any potential vaccine worked safely.
« We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles, » the statement read. It was signed by the CEOs of AstraZeneca, BioNTech GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.

 

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