The Serum Institute of India has sought the Drugs Controller General of India’s approval to conduct a small domestic trial of the Novavax coronavirus vaccine, Chief Executive Officer Adar Poonawalla told Reuters on Friday. The vaccine has been found to be 89.3% effective in a trial conducted in the United Kingdom.
“We have already applied to the drug controller’s office for the bridging trial a few days ago,” Poonawalla said. “So they should also give that approval soon now.”
The bridging trial will determine if a vaccine is safe and generates an immune response among Indian citizens, whose genetic structure can be different from people in western nations. However, there are provisions under rules to waive such trials in certain conditions.
In its UK trial, Novavax enrolled 15,000 people aged between 18 and 84. The United States company is likely to apply for the vaccine’s use in Britain, the European Union and other countries. According to reports, Novavax plans to rope in a total of eight plants in seven countries to produce the vaccine at the rate of 2 billion doses per year, reported Mint. Currently, it is stockpiling its vaccine at six manufacturing sites.
The Serum Institute is the world’s largest vaccine manufacturer. In July, Novavax had signed a deal with the institute to produce 2 billion doses of coronavirus vaccines. Earlier this month, Poonawalla told Reuters that his company would manufacture the Novavax vaccine “upwards of 40-50 million doses per month” from around April.
The Serum Institute is already bulk producing a coronavirus vaccine jointly developed by Oxford University and AstraZeneca. The vaccine, Covishield, is one of the two approved by Indian authorities for emergency use. Over 29 lakh people have so far been inoculated in India so far, in the vaccination process that began on January 16.