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A massive Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at 12 sites across the U.S. is not being completed due to an adverse reaction in a person in England.
A spokesperson for AstraZeneca, via release aid that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
AstraZeneca followed up with the statement that it started the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.
The spokesperson described the pause as “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. The company is working to expedite the review of the single event to minimize any potential impact on the trial timeline.”
Clinical halts do happen and it’s unclear how long AstraZeneca’s will go on for. The company's experiment and those of all Covid-19 vaccines in development — are being monitored as there is a pressing need for vaccine to tackle the worldwide pandemic. There are currently 9 vaccine potentials in AstraZeneca’s in the first Phase 3 Covid-19 vaccine trial known to have been put on hold.
Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.
AstraZeneca only began its Phase 3 trial in the United States late last month. According to a government registry the U.S. trial is currently taking place at 62 sites across the country, Phase 2/3 trials formerly started in the U.K., Brazil, and South Africa.