Hyderabad-based Bharat Biotech said on Tuesday it has expanded its manufacturing capacity across multiple facilities in the city and Bangalore to produce 700 million doses of Covaxin annually. The announcement comes at a time when India reported 2,59,170 fresh coronavirus infections and 1,761 fatalities.
The government on Monday approved a payment of about Rs 4,500 crore as advance to vaccine makers including Bharat Biotech and Serum Institute of India (SII) that is producing AstraZeneca’s Covishield in India, against future supplies. The move came ahead of opening the vaccination drive to all citizens over 18 years of age. SII will supply 200 million doses and Bharat Biotech is set to supply another 90 million doses to the government by July at a pre-agreed rate of Rs 150 per dose.
Bharat Biotech said manufacturing has been scaled up in a step-wise manner, and raw and packing materials, and single-use consumables have been secured adequately, the firm said. 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 was able to expand Covaxin’s manufacturing capacity in a short time due to the availability of new specially designed BSL-3 facilities, a 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, it said.
It further said manufacturing partnerships are being explored in other countries with facilities that 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 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 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 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.
SII on Tuesday hailed the government’s initiative to provide financial aid to manufacturers to ramp up production of COVID-19 vaccines in the country. “On behalf of the vaccine industry in India, I would like to thank and applaud Shri @narendramodi Ji, @nsitharaman Ji, for your decisive policy changes and swift financial aid which will help vaccine production and distribution in India,” SII CEO Adar Poonawalla said in a tweet.