1,500 Oxford Vaccine Trial Volunteers Given Wrong Dose, Kept In Dark About Error
About 1,500 of the initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca COVID-19 vaccine were given the wrong dose, but weren¡¯t informed that a mistake had been made after the blunder was discovered, documents obtained by Reuters reveal.
A letter obtained by the Reuters News agency has revealed that the volunteers were given half-dose due to a measuring mistake by Oxford researchers.?
Bid to turn error into opportunity?
According to the report, the error was instead 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 Pollard letter didn¡¯t acknowledge any error. Nor did it 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.
Oxford spokesperson denied any error
There is no suggestion there was any risk to the health of trial participants.
However, the spokesperson for Oxford?contradicted the revelations made in the letter, saying no mistake was committed.?
As quoted by Reuters, Steve Pritchard, a spokesman for Oxford said, "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."
"We have not stated that a dosing error occurred," Pritchard added.The recent revelation has raised several concerns against the British-developed vaccine which is being rolled out across the UK and has been touted as a low-cost weapon against the coronavirus outbreak.
Paucity of data about its efficacy in older people??
The vaccine recently has received authorization for use in a growing number of countries, includingthe European Union and India. The UK became the first country to approve it, and began rolling out the vaccine on January 4.
The jab has come under scrutiny because of the dosing error in the Oxford trial and a paucity of data about its efficacy in older people who are most vulnerable to the virus.
Reuters shared the letter ¨C which it obtained from the university through a Freedom of Information request ¨C with three different experts in medical ethics. The ethicists all said it indicates the researchers may not have been transparent with trial participants. Volunteers in clinical trials are supposed to be kept fully informed about any changes.
