Serum Institute to have 100 million doses of vaccine by early January

Though it still hasn’t gotten a green signal from the drug regulator, the Serum Institute of India (SII) will have a stockpile as much as 100 million doses of its Covid-19 vaccine ready in the first week of January because of proactive steps taken by the government, said Umesh Shaligram, Director of Research and Development at SII, on Thursday.

Taking part in a webinar on the science of vaccines, organised by the Biotechnology Industry Research Assistance Council, Shaligram hoped that its vaccine would receive emergency use authorisation from the Drugs Controller General of India (DCGI) in a few days.

The Pune-based SII has manufacturing rights for making the AstraZeneca-Oxford University vaccine, which received emergency use approval in the UK on Wednesday. Though the subject expert committee attached to DCGI met here on Wednesday, it hasn’t cleared the vaccine for use in India as yet.

Shaligram said the stockpiling of so many doses was made possible by the efforts of Principal Scientific Adviser K Vijay Raghavan and Department of Biotechnology (DBT) Secretary Renu Swarup, who impressed upon the government the need to allow vaccine firms to manufacture and stock Covid-19 vaccine candidates so that a quick rollout could become possible once they are cleared. If a vaccine doesn’t get approval, the manufacturer will be left with no option but destroy the stockpile.

He pointed out how Pfizer and Moderna, whose vaccines received emergency use approvals in the UK and the US, are struggling to keep up with their supply commitments.

Trials underway

V Krishna Mohan, Executive Director of Bharat Biotech India Limited, said his was the only vaccine company in the country that has done large-scale efficacy (Phase 3 clinical trials) studies of a vaccine in India in the past and enrolment of volunteers for the Phase-III trials of covaxin are almost over. He requested the Indian Council of Medical Research and the DBT to develop capacities in the country to do largescale trials so that India is prepared similar health emergencies in future. He said BBIL is also making a Covid-19 nasal vaccine which would be easy to administer.

Pankaj Patel, CEO of the Zydus Cadila, said the company is getting ready for doing the Phase-III trials of its ZyCov-D in 30,000 subjects, besides working on another vaccine that uses measles virus vector as well as a monoclonal antibody cocktail, which would be a therapeutic product for Covid-19. Both the vaccine and the drug are pre-clinical trials stage.

As regards the Sputnik V vaccine, being produced and marketed by Dr Reddy’s Labs, CEO Deepak Sapre said Phase-II of the Phase-II/III bridge trials is over in 1,000 volunteers and no adverse effect was seen. Similarly, the firm is putting in place a -18o Celsius cold-chain infrastructure to take the vaccine to all parts of the country, and is simultaneously working on a vaccine variant which is stable at 2-8o Celsius.

DCGI VG Somani said the drug regulator has been able to accelerate the approval processes without compromising safety and efficacy by allowing to do pre-clinical trials and animal studies parallelly and allowing the firms to submit data as and when they are ready without waiting for the conventional way of submitting it after the data was completely ready. This has helped compress time required for vaccine development and validation without sacrificing quality, Somani said.

DBT Secretary Renu Swarup said it was for the first vaccines are developed less than 12 months in history and the learnings would be beneficial beyond Covid-19, indicating that new vaccines for other diseases too could be developed faster using similar ecosystem in future.