NEW DELHI :
In a glimmer of hope for the world reeling under the covid-19 pandemic, interim data from a clinical study published in The Lancet, a peer-reviewed medical journal, on Monday showed that the University of Oxford’s vaccine candidate was safe and started providing immunity against the fatal respiratory disease after 14 days of the first dose.
The vaccine candidate is being co-developed by the University of Oxford and British pharmaceutical giant AstraZeneca plc, with the Serum Institute of India mass producing it for low- and-middle income countries, including India.
Serum Institute chief executive officer Adar Poonawalla said that the company would soon be applying for permission from the Drug Controller General of India V.G. Somani for a trial of the vaccine candidate in India.
“We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes,” Poonawalla said.
Last month, AstraZeneca licenced the vaccine candidate to Serum Institute of India for supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses.
Preliminary results from a phase-1 and- 2 Oxford trial, involving 1,077 healthy adults in the age group of 18-55 years, found that vaccine induced strong antibody and T cell immune responses up to day 56 of the ongoing trial.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV2 virus, although we must continue with our rigorous clinical trial programme to confirm this,” Andrew Pollard, chief investigator of the Oxford Vaccine Trial, was quoted as saying in a statement by AstraZeneca.
He added that the strongest immune response was seen in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.
The vaccine candidate, called ChAdOx1 nCoV-19, showed a marked increase in T-cell responses targeting SARS-CoV-2 spike protein in 43 of the participants that were studied, with the response peaking after 14 days, as per the journal. T cells is a type of white blood cell that plays an important role in the body’s immune system and is at the core of adaptive immunity.
Late-stage phase-II and -III trials are also currently underway in the UK, Brazil and South Africa, and are due to start in the US, AstraZeneca said in its statement.
To be sure, the vaccine by the University of Oxford was one of two candidates showing promising results, with China-based CanSino Biologics’ candidate being the other vaccine showing promising phase-2 results.
However, the focus continues to be on the candidate being developed by University of Oxford due to the potential volumes that have been put in place by the university and the co-developer AstraZeneca.