Covishield: Oxford's Covid vaccine has 70% efficacy, shows peer-reviewed result in Lancet
Peer-reviewed analysis of Oxford vaccine confirms that the second group which received a low first dose of vaccine demonstrated 90% efficacy, while the first group with standard dose showed 62.1% efficacy. Overall efficacy, at least 14 days after the second dose of the vaccine was therefore calculated to be 70.4%.
Researchers at the University of Oxford who have been involved in the development of the varsity's Covid-19 vaccine candidate - Covishield - on Tuesday published the first peer-reviewed results of a Phase 3 trial of the vaccine candidate.
In India, the Serum Institute of India is manufacturing Covishield and it has already made a request for its emergency use.
During peer review, a research work is analysed by neutral experts who are not associated with the vaccine development of its trials. Peer-reviewed analysis of Phase 3 trials of the Oxford vaccine tested across two different dose regimens has been published by leading medical journal Lancet.
"The efficacy data are based on 11,636 volunteers across the United Kingdom and Brazil and combined across three groups of vaccinated people vaccinated," Oxford researchers said in a statement.
Among the two groups, one received a standard dose followed by a booster dose, while the second group received a low first dose vaccination followed by a standard second dose.
The peer-reviewed analysis of the trial confirms that the second group which received a low first dose of vaccine demonstrated 90.0 per cent efficacy, while the first group with standard dose showed 62.1 per cent efficacy.
The overall efficacy, at least 14 days after the second dose of the vaccine was therefore calculated to be 70.4 per cent.
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said, "Today, we have published the interim analysis of the Phase 3 trials and show that this new vaccine has a good safety record and efficacy against the coronavirus. We are hugely grateful to our trial volunteers for working with us over the past eight months to bring us to this milestone."
Trial's safety database notes that only three cases of trials-related fever were found. Out of these, two people had received the vaccine.
According to the authors, "One of them was directly considered possibly related to the vaccine."
No person who received the Oxford vaccine had severe disease or needed hospitalisation.
Of the 11,636 volunteers, only five cases occurred in those who were more than 55 years old during the primary analysis.
"The vaccine efficacy in older age groups will be determined in future analyses after more cases have accrued in this age range," the researchers said.
Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford who led the team of scientists on the vaccine, said, "We have known for many years that adenoviral vectored vaccines fulfil the requirements for use against outbreak or pandemic diseases. They are safe, highly immunogenic, can be manufactured in large quantities at low cost and do not require frozen storage. Following the demonstration of vaccine efficacy in many preclinical studies, we now have clear evidence of efficacy in the trial results presented in a peer-reviewed publication today. Now under regulatory review, we hope that this vaccine will shortly be in use to start saving lives."
The researchers are hopeful that this data might also suggest that the low dose/standard dose vaccine may provide a protection against asymptomatic infection, but stressed that these data are at an early phase.
Pascal Soriot, Chief Executive Officer of AstraZeneca, the drug manufacturer with whom Oxford University has collaborated for developing the vaccine, said, "Today's peer-reviewed publication enables a full disclosure of the Oxford program interim analysis. The results show that the vaccine is effective against Covid-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated. We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit."
Further analysis of the trial data is ongoing which will be provided to the regulators.
Based on this data the regulators may decide on the best dose protocols, if the vaccine gets an emergency use authorisation.
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