Reuters news agency has obtained documents that show that initial 1500 volunteers in late stage trail were administered wrong dose while they were not told about it by the Oxford Astra-Zeneca vaccinators.
The letter signed by the Chief Investigator, Andrew J Pollard, Oxford Professor, of the trail and sent to the trial subjects on June 8 show that the researches wanted to learn the efficacy of vaccine at different doses.
Participants were administered half dose due to the measuring mistake by researchers as per a report by Reuters on December 24. No error was acknowledged in the letter by Pollard but the issue was reported to British medical regulators that asked the researchers to add another test group by administering full dose to them.
Risk of health to trial participants were not suggested to them, according to a report published in Times of India. Reuters news agency had received a letter under the freedom of information request. The letter was shared with three different experts in medical ethics. They all suggested that the trail participants were not given transparent information. According to them, volunteers need to be kept fully informed about any changes made in the plans.
Oxford spokesperson, Steve Pritchard told Reuters, "The half-dose group was unplanned, but we did know in advance that there was discrepancy in the dose measurement and discussed it with the regulators before dosing and when the dosing was revised." He added that they had not stated the dosing error had occurred. However, TOI reported that Pollard didn't respond to a request for a comment.
According to a report, there is a contradiction between what the spokesperson had said and the documents that were produced by the Oxford and its vaccine partner Astra Zeneca PLC. Reuters had reported "Global statistical analyses plan" in December by Oxford Astra-Zeneca, dated November 17. It was later published in The Lancet that called a dose discrepancy 'a potency miscalculation.'
Reuters in their report said that the spokesperson of Astra-Zeneca refused to comment. The Health Research Authority, as per the report said the changes to the design of the study and letter sent to the participants was approved by one of its ethical committees. The Health Research Authority is an agency of British government that approves medical research and ensures it is ethical.
The questions surrounding the efficacy of vaccines including the Oxford Astra-Zeneca vaccine cloud the minds. According to the Reuters report, Oxford showed interim efficacy results in November, it included the results of the trials that were mistakenly administered half dose and a subsequent full dose booster was 90% and " that the rate for those who received two full doses was 62%. Combining data from the two dosing regimens resulted in an efficacy of 70.4%." It is as per a report published in Reuters.
The Medicines and Healthcare products Regulatory Agency (MHRA) is a regulator of UK. While authorizing the vaccine, it accepted the pooled results but didn't approve administering half-dose or full-dose regimen.
Reuters also mentioned "Recent Changes"
The late stage trials began on May 28 and after the researchers realized administering of Half-dose, they alerted the regulatory authority of Britain. The researchers later were requested to add a new group to administer full dose of a two dose vaccine on June 5. After three days, they alerted the trial participants of the changes under the "Participant Information sheet."
Simon Woods, a professor of bio-ethics in New Castle in
an email to Reuters said, "As a letter purporting to explain a) an error
and b) a change of protocol I find this entirely inadequate.” He added, “It
reads like a routine update.”
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