Oxford vaccine: Serum to apply for emergency-use authorisation in 2 weeks

Serum Institute CEO Adar Poonawalla makes the announcement after a meeting with PM Narendra Modi, who was visiting key vaccine sites in India

Pune-based Serum Institute of India (SII) would apply to the Indian drug regulator within the next two weeks for emergency-use authorisation of the Oxford-AstraZeneca vaccine, Chief Executive Adar Poonawalla said on Saturday after Prime Minister PM Narendra Modi’s visit to the Serum plant.
 
"As of now, we don't have anything in writing with the Government of India on how many doses they would purchase, but the indication is that 300-400 million doses might be procured by July 2021," Poonawalla told reporters. "We are in the process of applying in the next two weeks for emergency-use authorisation."

 
The SII CEO said the safety and efficacy of the vaccine met the expectations and the trials at the moment were more than enough for the efficacy. He added that they might later look at doing more trials on people aged under 18 years.
 
PM Modi was making a three-city tour on Saturday to conduct a review of the vaccine development and manufacturing process at Zydus Biotech Park in Ahmedabad, Bharat Biotech in Hyderabad, and Serum Institute of India in Pune. Modi asked scientists to express their free and frank opinion on how the country could further improve its regulatory process. He also said that India considered vaccines not only as vital to good health but also as a global good, and it was India’s duty to assist other countries, including neighbouring ones, in a collective fight against the virus.
 
A press statement by the Prime Minister’s Office said: “The scientists expressed joy that the prime minister met them face to face in order to boost their morale and help accelerate their efforts at this critical juncture in the vaccine development journey.”

 
In a tweet, the prime minister also congratulated the scientists for their progress in the trials so far. “At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid-19 vaccine. Congratulated the scientists for their progress in the trials so far. Their team is closely working with ICMR to facilitate speedy progress,” he tweeted.
 
Modi also interacted with the team at SII which shared details about its progress so far, on how it planned to further ramp up vaccine manufacturing. He also spoke on "how India is following sound principles of science in the entire journey of vaccine development, while also asking for suggestions to make the vaccine distribution process better".
 
Bharat Biotech International (BBIL) said the prime minister’s visit to the Bharat Biotech manufacturing facility in Genome Valley, Hyderabad, today served as a great inspiration to our team.

 
Covaxin, India’s first indigenous vaccine with Phase-III clinical trial currently underway, was the first, largest, and the only efficacy trial in the developing world involving a large number of volunteers across 25 sites, BBIL said. The Phase-III trial is being conducted across India among 26,000 participants. The vaccine will be produced in the only-of-its-kind Biosafety Level-III production facility in the world.