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 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 our partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.
To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for COVAXIN®. The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.
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 commercialized 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.
COVAXIN® has received Emergency Use Authorizations in several countries across the globe with another 60 in process. EUA’s have now been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUA’s are in process in the USA and several European countries. Pricing for international markets and supplies to govt’s under EUA’s have been established between $15 – 20 / dose.