To support vaccination drive in India and across the globe, Bharat Biotech has ramped up the manufacturing capacity of its COVID-19 vaccine, Covaxin, to 700 million doses per annum, the vaccine maker announced today (Apr 20).
The company said the expansion of the manufacturing capacity has been carried out across multiple facilities at Hyderabad, where it has facilities at Genome Valley, as well as Bangalore where its related entity Biovet Pvt Ltd has facilities at Malur.
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.
Bharat Biotech said it has successfully indigenised the synthesis and manufacture of the agonist IMDG, a key component of Covaxin's proprietary adjuvant Algel-IMDG, at commercial scale in India
The company will collaborate with Indian Immunologicals Ltd to manufacture the drug substance for Covaxin as part of efforts to further increase capacities.
"This is the first instance where a novel adjuvant has been commercialised in India, eliminating dependency on imports. Also, 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,” the company said.
Even as raw materials, packing materials and single use consumables for manufacturing of Covaxin too have been secured to meet its capacity requirements, Bharat Biotech also said it is exploring manufacturing partnerships with its partners in other countries that have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.
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.
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