Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines, it noted.
“The company 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,” the company said.
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, it added.
The Hyderabad-based firm said it 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, it added.
The company said it 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 indigenised and will be manufactured at commercial scale within the country, it added.
“This is the first instance where a novel adjuvant has been commercialised in India,” Bharat Biotech said.
COVAXIN has received Emergency Use Authorizations (EUAs) for Covid-19 treatment in India and in several countries across the globe with another 60 in the process.
EUA’s have now been obtained from Mexico, the Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries.
Besides, EUA’s are in process in the US and several European countries, the company said. Pricing for international markets and supplies to governments under EUA’s have been established between USD 15-20 per dose, it added.