4 min read.Updated: 08 Dec 2020, 09:54 PM IST Edited By Aparna Banerjea ( with inputs from Agencies )
Oxford-AstraZeneca's results are the 'first full peer-reviewed efficacy results' published for a Covid-19 vaccine, the Lancet said
In its initial data, the partners said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%
What comes as a positive news for the world, Oxford University and AstraZeneca became the first Covid-19 vaccine makers to publish final-stage clinical trial results in a scientific journal Tuesday, clearing a key hurdle in the global race to develop safe and effective drugs for the novel coronavirus.
The study published in the respected Lancet medical journal confirmed that the Covid-19 vaccine, codenamed ChAdOx1 nCoV-19, works in an average 70% of cases, with efficacy of 62% for those given two full doses, and of 90% in those given a half then a full dose.
The results are the "first full peer-reviewed efficacy results" published for a Covid-19 vaccine, the Lancet said.
"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 scientific journal stated in its analysis.
Researchers claim the vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given the half dose. However, independent experts have said the second group was too small — 2,741 people — to judge the possible value of that approach and that more testing is needed.
This news comes during a flurry of positive developments that have raised hopes the roll-out of vaccines can help begin to restrain a pandemic that has killed more than 1.5 million people and stricken societies worldwide.
Britain on Tuesday became the first country in the Western world to start immunisations, using a rival vaccine developed by Pfizer-BioNTech after approving it for general use last week.
Astrazeneca's CEO Pascal Soriot said,"We have begun submitting data to regulatory authorities around the world for early approval."
Initial data from Astra and Oxford last month appeared positive but raised concern over how much protection the shot would offer after the trials produced two different results from two dosing regimens. The partners said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%.
It later emerged the lower dose was the result of a manufacturing discrepancy and only tested in a younger group. Astra CEO Pascal Soriot said in an interview last month the company would set up an additional, probably global, trial to verify the 90% result. The company said Tuesday it’s still deciding whether to hold an additional study.
The results, based on advanced trials of 11,636 people in the U.K. and Brazil, were reviewed after 131 participants contracted Covid-19. Of those, 30 were in the group that received the vaccine and 101 in the control arm, equating to an efficacy rate of 70%, according to The Lancet data.
While the vast majority of 175 severe adverse events were deemed unrelated to Covid-19 or control vaccines, one case of the neurological disorder transverse myelitis may be linked to the shot, the paper said.
AstraZeneca said it would be up to regulators to decide based on the data whether people would receive two full doses or a half dose followed by a full dose. It has started to submit the data to regulators around the world for early approval and it is ready to begin delivering hundreds of millions of doses, the company said in a statement. The drugmaker said it is also seeking an emergency-use listing from the World Health Organization to accelerate the delivery of the vaccine to low-income nations.
The Oxford-Astra data will be scrutinized around the world, with many countries counting on the vaccine to protect their populations. The vaccine will cost a fraction of the price set by Pfizer and partner BioNTech SE, and another shot from Moderna, both of which showed 95% efficacy. The Astra shot should also be easier to deploy, with storage temperatures of between two and eight degrees Celsius, compared with minus 70 for Pfizer’s shot.
The results come as the U.K. released the first vaccine in the western world. The Pfizer-BioNTech shot was approved in Britain last week and starting Tuesday is being given to people over 80 and those in care homes, including workers, before being rolled out more broadly over the coming months. The jab could also be approved in the U.S. as soon as this week and the EU by the end of the year.
The news of the vaccine's efficacy is a positive development for India as according to experts, the Oxford vaccine is logistically feasible for distribution in the country's both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.
The Oxford vaccine is being manufactured by Serum Institute of India in Pune and is in the phase-three clinical trial of the Oxford Covid-19 vaccine, Covishield.
On 7 December, Serum became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large.
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