After pharma majors Pfizer and Serum Institute of India (SII), Hyderabad-based Bharat Biotech International Ltd on Monday sought emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine, Covaxin.
The vaccine is being developed with the Indian Council of Medical Research (ICMR), and is undergoing phase-3 trials in over 25 centres across India.
Also read: Vaccine shot ‘painless’, say Covishield trial volunteers
“Bharat Biotech today (on Monday) applied for the restricted emergency use of their vaccine. The SEC (Subject Expert Committee) may look at the proposal this week itself along with applications from Serum and Pfizer, and a decision on this will be taken in two weeks,” confirmed a senior official.
Earlier in the day SII CEO Adar Poonawalla tweeted stating: “As promised, before the end of 2020, SII has applied for emergency use authorisation for the first made-in-India vaccine, Covishield.”
The Pune-based vaccine manufacturer has collaborated with Oxford University and pharmaceutical giant AstraZeneca for making the vaccine and its trials at select sites. SII has now sought emergency use authorisation, citing unmet medical needs due to the pandemic and in the interest of the public at large.
A senior Health Ministry official told The Hindu that Covishield, is logistically more feasible for use and distribution in India as it stores well at 2-8 degrees Celsius. The ICMR said the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Replying to a query on whether efficacy figure of SII vaccine trials on Indian volunteers is available, head of the National Expert Group on Vaccine Administration V.K. Paul said “he had not seen the data.”
Meanwhile, Mr. Poonawala in another tweet said, “This will save countless lives and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”
The SII which is the world's largest vaccine producer by volume, has become the second company to apply for the emergency authorisation after Pfizer, India. Pfizer India had applied for emergency-use authorisation for its COVID-19 vaccine , after the company's parent received clearance for the treatment from Britain and Bahrain.
Also read: COVISHIELD completes enrolment of Phase-3 clinical trials under partnership of ICMR and SII
The Pune-based SII has shared interim data with the DCGI of four clinical trials — one in India, two trials in UK and one in Brazil, said a senior official. He added that the phase-3 clinical trial of Covishield is being conducted in various parts of the country.
SII had earlier indicated that the Central government may purchase 300-400 million doses by July 2021 and that it was planning to deliver 100 million doses of the vaccine per month by February.