The results are the “first full peer-reviewed efficacy results,” Lancet said. (Archive)
Paris:
Oxford University and AstraZeneca became the first Covid-19 vaccine manufacturers to publish the results of end-stage clinical trials in a scientific journal on Tuesday, clearing a key hurdle in the global race to produce safe and effective drugs. for the new coronavirus.
The study, published in the respected medical journal Lancet, confirmed that the vaccine works in an average of 70 percent of cases.
It comes during a series of positive events that have raised hopes that the launch of vaccines could help start to curb a pandemic that has killed more than 1.5 million people and affected societies around the world.
Britain on Tuesday became the first country in the Western world to start immunizations, using a rival vaccine developed by Pfizer-BioNTech after approving it for general use last week.
Andrew Pollard, director of the Oxford Vaccine Group, said the publication in The Lancet showed that developers were “sharing data in a transparent way.”
He said a variety of vaccines would be needed to control the pandemic, “otherwise we will still be in this position six months from now.”
“This really can’t be a competition between developers, it has to be a competition against the virus,” he told a news conference.
The study showed that the vaccine was 62 percent effective for those who received two full doses, and 90 percent effective for those who received half and then the full dose.
AstraZeneca and Oxford faced questions last month about their analysis, which looks at data from a total of 23,000 people in separate trials with different protocols, after publishing an overview of the results.
These focused on the smaller group that received a half initial dose due to error.
Tuesday’s study confirmed that this group of 1,367 participants did not include adults 55 and older.
The authors said they provided additional analysis to the Lancet peer reviewers suggesting that the better results for the half-dose group were not due to other factors such as age.
But they said more research would be needed.
AstraZeneca said it would be up to regulators to decide, based on the data, whether people would receive two full doses or half doses followed by a full dose.
“I think it’s fair to say that more research is needed to explain the intriguing result,” Pollard said.
It confirmed that the use of a lower starting dose was “unplanned” and the result of a discrepancy in measurement, but once the researchers realized it, it entered the trial with the agreement of regulators.
“Dilemma”
The results are likely to present a “dilemma” for regulators, said Simon Clarke, associate professor of cell microbiology at the University of Reading.
He said that while the half-dose regimen showed better protection against the disease and also in reducing asymptomatic transmission, the group was “relatively small.”
“Furthermore, it did not contain any older participants (55 and older) and it is possible that if regulators allowed the vaccine to be used in this way, the highest risk group might not be protected.”
Overall, the authors analyzed data from phase 3 (end-stage) clinical trials in Great Britain and Brazil, involving 11,636 people, along with safety data from a total of 23,745 trial participants in Great Britain, Brazil, and South Africa.
There were 131 cases of symptomatic COVID-19 illness more than 14 days after the second dose of the vaccine in these 11,636 people; 30 of them were in the group that received a vaccine of either dose and 101 in the control group.
The study said that so far no hospitalizations or serious illnesses had been reported in the Covid-19 vaccine group.
(Except for the headline, this story has not been edited by NDTV staff and is posted from a syndicated feed.)
.
