COVID-19 vaccine markers Oxford University and AstraZeneca, on Tuesday, 8 December, became the first in the world to publish final-stage clinical trial data in a scientific journal, reported AFP.
Further, according to AFP, the study has been published in The Lancet medical journal and has helped overcome “a key hurdle” in the global race for “safe and effective treatment” for COVID-19.
WHAT DOES THE STUDY SAY?
“ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials,” The Lancet study says.
The study confirms that the vaccine works in an average of 70 percent of cases, according to NDTV.
Further, the study reflected that the vaccine had an efficacy of 63 percent among those it was administered to in two full, and 90 percent among those given a half, and then a full dose.
According to FIT, The Lancet confirmed these findings based on advanced trials of 11,636 people in the UK and Brazil. 131 participants contracted COVID-19, and of these, 30 were in the group that got the vaccine and 101 in the control arm, thus equalling an efficacy rate of 70 per cent.
QUESTIONS AROUND DIFFERENT RESULTS
AstraZenece and Oxford were surrounded by many questions after it was revealed the the half doze had been given in the trials because of a mistake.
Further, there were concerns regarding that the half doze group of 1,367 participants, which yielded better results, did not include adults over 55 years of age.
Dr Shahid Jameel, leading virologist and Director, Trivedi School of Biosciences at Ashoka University, told FIT, “You cannot combine both the results and make it 90 percent efficacy, and 62 percent and together make it 70 percent, I don’t buy this argument. Simply because one, the dosing regime turned out to be different and they were essentially two different trials. And two, because of the different populations so there were two variables.”
Researchers, however, according to AFP, stated that they had provided extra analysis to The Lancet peer reviewers suggesting that the improved results for the half-dose group was not owing to factors such as age.
Pollard further said that once researches became aware of the measurement discrepancy, the same was incorporated into the trial with the nod of the regulators.
“I think it is fair to say it needs more looking into to explain the intriguing result.”Andrew Pollard
AstraZeneca has reportedly said that it would be upon the regulators to chalk out the dosing recommendation.
WERE THERE ANY NEGATIVE EFFECTS?
The Lancet found that 21 days after the first dose – but it is not clear in which trial from which country – there were “ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death.”
There were also 175 severe adverse events that occurred in 168 participants – 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group.
Out of these, three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. One case of the neurological disorder transverse myelitis may be linked to the shot, said The Lancet.
Andrew Pollard, director of the Oxford Vaccine Group, led the study. In a press briefing Pollard said:
“This really can’t be a competition between developers, this has to be a competition against the virus.”
Pollard also said that publishing the study showed that developers were sharing the data “transparently”, and that a range of vaccines would be needed, reported AFP.
(With inputs from AFP and FIT.)
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