The government said on Thursday that it would make an advance payment of Rs 1,500 crore to Hyderabad-based manufacturer Biological E to reserve 30 crore doses of its under-development Covid-19 vaccine.
This is the first time that the Centre has placed an order with a vaccine manufacturer before the product has been granted emergency use authorisation (EUA) by the regulator.
The vaccine doses for which arrangements have been “finalised”, will be “manufactured and stockpiled by Biological E from August-December 2021,” the Union Health Ministry said in a statement.
“For this purpose, the…Ministry…would be making an advance payment of Rs 1,500 crore to Biological E.”
India’s vaccine procurement policy has come under criticism from various quarters for delayed placement of orders. Other countries hit hard by the pandemic, such as the US, had made early investments last year to reserve large quantities of vaccines.
On April 24, against the backdrop of its vaccine augmentation plan, the Centre had made a 100 per cent advance payment of Rs 1,732.5 crore to Serum Institute of India (SII) for 11 crore doses of Covishield during May, June, and July — and Rs 787.5 crore to Bharat Biotech for 5 crore doses of Covaxin during the same period.
Biological E’s vaccine candidate is currently undergoing phase 3 clinical trials. It is a protein sub-unit vaccine, similar to inactivated whole-cell vaccines such as Covaxin, and does not contain live components of the virus. However, unlike inactivated whole-cell vaccines, a sub-unit vaccine contains only the antigenic parts of the virus to trigger a protective immune response.
According to the Centre’s plan, the Hyderabad company is expected to manufacture 30 crore doses of Corbevax between August and December, of which at least 7.5 crore doses will be available by September.
The Health Ministry said the decision was taken on the recommendation of the expert group led by Dr V K Paul, who heads India’s Covid Task Force.
“The proposal of Biological E was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).The arrangement with Biological E is part of the wider endeavour of the Government of India to encourage indigenous vaccine manufacturers by providing them support in Research & Development (R&D) and also financial support,” the Ministry said.
The Biological E candidate had earlier received grant-in-aid of over Rs 100 crore for the transition from preclinical stage to advanced phase-3 human trials. The Department of Biotechnology had partnered with the firm to conduct all-animal challenge and assay studies through the Translational Health Science and Technology Institute (THSTI), Faridabad.