Updated: April 20, 2021 10:56:32 pm
Bharat Biotech on Tuesday announced expansion of its manufacturing capacity to produce as many as 700 million doses of Covaxin annually. Covaxin has received Emergency Use Authorisations (EUA)s in several countries with another 60 in process.
EUAs have now been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana and Zimbabwe, among other countries. EUAs are in process in the USA and several European countries. Pricing for international markets and supplies to govt’s under EUAs have been established between $15 and $20 per dose.
“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,” said an official statement issued Tuesday.
To further increase capacity, 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 capability and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.
Manufacturing scale up has been carried out in a stepwise manner across multiple facilities in 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.
Capacity expansion in vaccine manufacture is a long and tedious process, requiring investments of a lot of money and 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, a first-of-its-kind for manufacturing in India, which has been repurposed, and preexisting expertise and knowhow 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, which 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. This is the first instance where a novel adjuvant has been commercialised in India, the statement said.
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