A Brazilian volunteer who participated in the third phase of the Oxford-AstraZeneca vaccine trials died on Thursday, multiple reports claimed, quoting Brazil’s National Health Agency ANVISA. However, the trials will continue despite the hurdle.
BBC reported that the casualty, presumed to be a 28-year-old medical professional who died of COVID-19 complications, was in the control group. In Phase 3 trials, the trial volunteers are divided into vaccine groups and control groups. Around half of the volunteers are separated into the vaccine group, where they are given the experimental vaccine shot, while the other half are given a harmless meningitis vaccine jab; at the end of the trial, the difference in outcomes between the two groups are examined for placebo effects.
If the volunteer was in the vaccine group—which means he would have received a shot of the experimental vaccine—the trials would have been suspended.
In a statement, Oxford University said: "All significant medical incidents, whether participants are in the control group or the COVID-19 vaccine group, are independently reviewed. The independent review, in addition to the Brazilian regulator, have both recommended that the trial should continue," it said.
AstraZeneca said in a statement: "All required review processes have been followed. All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study."
The Oxford-AstraZeneca vaccine is one of the frontrunners in the global race, now deep into the third and final phase of clinical trials. Earlier, AstraZeneca, who is developing a coronavirus vaccine in association with Oxford university, had paused their trials after a participant fell ill due to a "suspected adverse reaction". The illness was later reported to be a rare but serious spinal inflammatory disorder called transverse myelitis. The trials resumed soon after.
Brazil counts more than 1,53,000 deaths by COVID-19, second only to the United States. The South American nation also confirmed 5.2 million cases of the disease, the third biggest in the world, behind the US and India. In June, Brazil's government announced a deal with Oxford University and pharmaceutical company AstraZeneca to purchase 100 million doses of its potential coronavirus vaccine.
Bolsonaro had overruled his own health minister on Wednesday, rejecting the announced purchase of 46 million doses of China's CoronaVac, a potential vaccine against COVID-19 being tested in Sao Paulo state. "The Brazilian people will not be anyone's guinea pig," Bolsonaro said on his social media channels, adding that the shot made by Chinese pharmaceutical company Sinovac is yet to finish its testing phase which is true of all potential vaccines. "My decision is to not purchase such a vaccine. It is common practice for governments to purchase doses of promising vaccines, to build a stockpile in case they are proven effective. That investment is usually not refundable if the shot fails."
