He pointed out that this is also the first time the Government of India has given permission to build a stockpile when conducting clinical trials.
SII is the largest vaccine manufacturer in the world in terms of the number of doses it produces. It has the wherewithal to manufacture 1.8-1.9 billion doses of the bulk drug, from the existing 1.6 billion doses of life-saving biologicals it manufactures.
The Pune-based manufacturer of immunobiological drugs has entered into multiple international collaborations for the Covid-19 vaccine. It is expanding capacity to 1.9 billion doses of the vaccine to treat SARS-CoV-2 disease by the end of this year.
Bharat Biotech, whose vaccine candidate Covaxin is undergoing clinical trials, said vaccine makers are either repurposing capacities that they have for other products or redirecting upcoming capacities for new products to make way for the Covid-19 vaccine.
Sai Prasad, president of quality operations of Bharat Biotech, further added that the biotechnology company headquartered in Hyderabad is in talks with middle- and high-income countries for procurement of their vaccines. This will ensure the requisite funding for vaccine development, he said. “Funding research in the absence of push funding (during the research phase) or pull contracts (assurance to buy a certain quantity at a stipulated price) is a challenge,” said Prasad.
Indian Immunologicals (IIL), a Hyderabad-based biopharmaceutical company, is working on its Covid-19 candidate based on a live attenuated virus model. It has set up a 200-milion-doses-per-annum facility for drug products, and is building a manufacturing facility for drug substances, said Anand Kumar, managing director of IIL. Drug substances are used to make vaccines. These can be whole bacterial cells, viruses, parasites, antigens, etc.
“All these are multi-product facilities. No one will set up a dedicated facility for one product,” clarified Kumar.
The Indian vaccine industry largely feels there are two ways in which vaccine innovation can be spurred — one, get a high price for the product (which again may deprive many from getting a jab), and two, have the government buy a few hundred million doses of the product at a certain price. “For a vaccine player to take a risk of Rs 200-300 crore for a new product development can seem a daunting task in the absence of any assurance,” said one Indian vaccine maker.