After US-based drug maker Pfizer applied for the approval of its coronavirus vaccine in India, the Serum Institute of India (SII) and Bharat Biotech too have sought from the Central Drugs Standards Control Organisation emergency use authorisation for their Covid-19 vaccines.
Bharat Biotech’s Covaxin is being indigenously developed by the Hyderabad-based company in collaboration with the Indian Council of Medical Research (ICMR). While SII’s Covid-19 vaccine is developed by AstraZeneca-Oxford University.
Sources in the Government said that the top drug regulator, DCGI, has started reviewing their applications on granting of authorisation, which will be made on the basis of three parameters — safety, quality and efficacy.
“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” tweeted SII CEO Adar Poonawala on Monday.
“This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support,” he wrote.
Government officials said that the vaccine, developed from adenovirus which is a common cold virus, will be the first preventive option against Covid-19 available in India and it could be administered to the first priority group comprising healthcare workers beginning the next month. The Government has already geared up for immunising the identified population.
Though the company has not revealed the details of the application sent to the regulator, sources said that it will submit the full analysis released by AstraZeneca-Oxford last month. The analysis showed that their vaccine candidate was 70 per cent effective on average in a late-stage trial in the UK and Brazil.
In India, a phase 2/3 trial being conducted on 1,600 individuals is aimed at looking for only immunogenicity and not for actual protection against Covid-19 as per the vaccine’s trial design.
Also, as the trial in India involves the dosing regimen with two full doses. The regulator can accept just the 62 per cent efficacy and the bridging immunogenicity from SII and grant the approval for restricted use, officials said.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Tuesday, 08 December 2020 | PNS | New Delhi
