In a shocking revelation, documents have shown nearly 1,500 initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca COVID-19 vaccine in London were given wrong doses. The volunteers, however, were not informed about the blunder, even after it came to the knowledge of the authorities. A letter accessed by Reuters states participants were given about a half-dose due to a measuring mistake by Oxford researchers.
The dosing mishap was presented to the trial participants in a letter dated June 8 as an opportunity for University of Oxford researchers to learn how well the vaccine works at different doses. The letter was signed by the trial’s chief investigator, Oxford professor Andrew J. Pollard, and sent to the trial subjects.
The letter, however, did not acknowledge any error, neither did the letter disclose that researchers had reported the issue to British medical regulators, who then told Oxford to add another test group to receive the full dose, in line with the trial’s original plan.
The letter did not suggest any risk to the health of trial participants.
“The half-dose group was unplanned, but we did know in advance that there was a discrepancy in the dose measurements and discussed this with the regulators before dosing and when the dosing was revised,” Reuters quoted Steve Pritchard, a spokesman for Oxford.
Pritchard also said, “We have not stated that a dosing error occurred.”
The Health Research Authority, a British government agency responsible for approving medical research and ensuring it is ethical, said in a statement that changes to the study design and the letter sent to participants were approved by one of its ethics committees.
The Oxford/AstraZeneca vaccine recently has received authorization for use in a growing number of countries.
The UK became the first country to approve it and began rolling out the vaccine on January 4.
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