The capacity expansion has been implemented across multiple facilities in Hyderabad and Bangalore, to reach ~ 700 million doses / year
Bharat Biotech has announced the scale-up of manufacturing capacity to produce ~ 700 million doses of COVAXIN annually. Manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad and Bengaluru. Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines.
Bharat Biotech can 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.
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 a 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 have been successfully indigenised and will be manufactured at a 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 15 years 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, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. EUA’s are in process in the US and several European countries. Pricing for international markets and supplies to govt’s under EUA’s have been established between $15 – 20 / dose.