Bharat Biotech has announced a scaling up of its manufacturing capacity to produce 700 million doses of Covaxin annually. The vaccine has received Emergency Use Authorisations (EUA) in several countries across the globe with another 60 in process including the US. Pricing for international markets and supplies to governments under EUAs have been established between $15 and $20 per dose.
To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment. The manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bangalore.
Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years.
Bharat Biotech claimed it is able to expand Covaxin manufacturing capacity in a short timeline, mainly due to the availability of new specially designed BSL- 3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines.
Manufacturing partnerships are being explored with partners in other countries, who have prior expertise with commercial-scale manufacture of inactivated viral vaccines under biosafety containment, the statement added.
Bharat Biotech uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the IMDG component has been successfully indigenized and will be manufactured at commercial scale within the country. This is the first instance where a novel adjuvant has been commercialised in India.
The protocols for manufacturing, testing and release of inactivated vaccines have been tried, tested and validated across several of our vaccines, these also meet the requirements of WHO, Indian and other regulatory authorities. These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record, an official statement issued today has said.