Reuters news agency has obtained documents that show thatinitial 1500 volunteers in late stage trail were administered wrong dose whilethey were not told about it by the Oxford Astra-Zeneca vaccinators.
The letter signed by the Chief Investigator, Andrew JPollard, Oxford Professor, of the trail and sent to the trial subjects on June8 show that the researches wanted to learn the efficacy of vaccine at differentdoses.
Participants were administered half dose due to themeasuring mistake by researchers as per a report by Reuters on December 24. Noerror was acknowledged in the letter by Pollard but the issue was reported toBritish medical regulators that asked the researchers to add another test groupby administering full dose to them.
Risk of health to trial participants were not suggestedto them, according to a report published in Times of India. Reuters news agencyhad received a letter under the freedom of information request. The letter wasshared with three different experts in medical ethics. They all suggested thatthe trail participants were not given transparent information. According tothem, volunteers need to be kept fully informed about any changes made in theplans.
Oxford spokesperson, Steve Pritchard told Reuters,"The half-dose group was unplanned, but we did know in advance that therewas discrepancy in the dose measurement and discussed it with the regulatorsbefore dosing and when the dosing was revised." He added that they had not stated the dosing error hadoccurred. However, TOI reported that Pollard didn't respond to a request for acomment.
According to a report, there is a contradiction betweenwhat the spokesperson had said and the documents that were produced by theOxford and its vaccine partner Astra Zeneca PLC. Reuters had reported"Global statistical analyses plan" in December by OxfordAstra-Zeneca, dated November 17. It was later published in The Lancet thatcalled a dose discrepancy 'a potency miscalculation.'
Reuters in their report said that the spokesperson ofAstra-Zeneca refused to comment. The Health Research Authority, as per thereport said the changes to the design of the study and letter sent to theparticipants was approved by one of its ethical committees. The Health ResearchAuthority is an agency of British government that approves medical research andensures it is ethical.
The questions surrounding the efficacy of vaccinesincluding the Oxford Astra-Zeneca vaccine cloud the minds. According to theReuters report, Oxford showed interim efficacy results in November, it includedthe results of the trials that were mistakenly administered half dose and asubsequent full dose booster was 90% and " that the rate for those whoreceived two full doses was 62%. Combining data from the two dosing regimensresulted 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 thepooled results but didn't approve administering half-dose or full-dose regimen.
Reutersalso mentioned "Recent Changes"
The late stage trials began on May 28 and after theresearchers realized administering of Half-dose, they alerted the regulatoryauthority of Britain. The researchers later were requested to add a new groupto administer full dose of a two dose vaccine on June 5. After three days, theyalerted the trial participants of the changes under the "ParticipantInformation sheet."
Simon Woods, a professor of bio-ethics in New Castle inan email to Reuters said, "As a letter purporting to explain a) an errorand b) a change of protocol I find this entirely inadequate.” He added, “Itreads like a routine update.”