On Tuesday, AstraZeneca said it had paused global trials of its coronavirus vaccine because of unexplained illness in one of the volunteers.
It’s a standard precaution in vaccine trials that are meant to make sure experimental vaccines don’t cause serious reactions among participants.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow the review of safety data,” AstraZeneca said in a statement sent to CNN.point 466 |
“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.point 169 | ”point 172 | 1
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.point 377 |
We are working to expedite the review of the single event to minimize any potential impact on the trial timeline.point 94 | We are committed to the safety of our participants and the highest standards of conduct in our trials,” the statement added.point 200 | point 200 | 1
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 reads.point 340 |
It was signed by the CEOs of AstraZeneca, BioNTech GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.point 117 | point 117 | 1
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” they added.
The AstraZeneca vaccine is one of three coronavirus vaccines in late-stage, Phase 3 trials in the United States. A Data and Safety Monitoring Board (DSMB) usually monitors trials for adverse events and can order a pause or halt a trial, but AstraZeneca did not say who had stopped the trial.