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AstraZeneca will run a clinical study in India on its “promising” Covid-19 vaccine candidate being developed along with Oxford University.
“We will be doing a study in India. It’s a big country and there is a lot of infection,” AstraZeneca Chief Executive Pascal Soriot told BusinessLine , in a media interaction after interim data on the prospective vaccine showed positive results in terms of strong antibody and T-cell responses.
Giving details from the ongoing Phase I/II COV001 trial, led by Oxford University, the company said that interim results showed “AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.”
“We are on track,” Soriot indicated on the projected September time lines to be ready with the vaccine, but it could take a couple of months more, he said, since the trials depended on the infection rate of people with the virus in the region.
The only way to be ready is to manufacture in parallel with the clinical trial, he said, on the “at risk” production that AstraZeneca had undertaken to supply governments in the UK and others, from the get-go.
AstraZeneca has multiple distribution tie-ups, including one with Pune-based Serum Institute for a billion doses in low and middle-income countries.
Serum Chief Executive Adar Poonawalla, said in a statement, “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.”
The AstraZeneca Chief said the company was racing ahead with late-stage Phase II/III clinical trials in the UK, Brazil, South Africa and the US, possibly by the end of the month, he said. So by the time all the trials ended, there would be a large database on safety of the vaccine, he said.
The trial
COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart, AZ said.
Results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 per cent of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection, the note added.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial, said: “The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type. The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this. We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
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