In a major development, the Drugs Controller General of India (DCGI) has given nod to Pune-based Serum Institute of India (SII) for conducting phase II and III clinical trials of Oxford University-Astra Zeneca vaccine against Covid-19 in the country.
The drug regulator has allowed the trial on 1,600 participants in India in over 20 selected trial sites. Now, SII can start the process to begin the trials, said the Union Health Ministry in a statement here.
The DCGI approved SII’s revised protocol to start the human trials on Sunday, a day after subject expert committee (SEC) of the DCGI gave its nod to the SII proposal.
“The DCGI has granted permission for phase 2 and 3 clinical trials of vaccine candidate named Covishield after it was found that the subject expert committee that went through the data and protocol submitted for the trial was satisfied with the results,” it said.
On July 20, the initial trial results for the vaccine candidate, Covishield, which were made public by Oxford University had shown promising results. The preliminary trial results published in The Lancet said the vaccine candidate was safe and induced immune reaction against SARS-CoV-2, which causes Covid-19, and protect healthy people from infection.
“As soon as they (DCGI) grant permission, we will begin trials for the vaccine in India. We will soon start manufacturing it,” Adar Poonawalla, CEO, SII, had said.
SII, the world’s largest vaccine manufacturer by the number of doses produced and sold globally, has entered a manufacturing partnership with biopharma major AstraZeneca to produce the Oxford vaccine.
The company plans to start human clinical trials in India with about 5,000 participants.
“One billion doses of the AstraZeneca Oxford vaccine will be produced over the next one year. The vaccines will be for India and middle-and low-income countries across the world,” Poonawalla had said.
The vaccine is made from a weakened version of a common cold adenovirus taken from Chimpanzee and genetically modified to make it impossible for it to infect humans.
Researchers added genetic material to ChAdOx1 from the Sars-CoV-2 virus’s surface protein, spike glycoprotein (S), which helps the virus to bind to Ace2 receptors to enter human cells and cause an infection.
The new trial included 1,077 healthy adults aged between 18 and 55 years with no history of Covid-19, and took place in five hospitals in the United Kingdom (UK) between April 23 and May 21.
The data that was published in The Lancet covered the first 56 days of the trial and is ongoing.
The widely-followed trial is currently at an advanced stage, with trials in the UK, Brazil and South Africa.
A collaboration has already been reached between Oxford, the UK Government and AstraZeneca to produce the vaccine on a mass scale if the final results are also positive.
“India is one of the vaccine hubs globally, and wherever the Covid-19 vaccine is developed we will take lead in its manufacturing. The vaccine is the ultimate solution to prevent Covid-19 transmission even though India has managed to control the outbreak very well so far,” said Dr Vinod Paul, a Niti Aayog member and the chairman of the Empowered Group on the Government’s medical emergency management plan.