NEW DELHI: The Centre on Thursday announced that it is making an advance payment of Rs 1,500 crore to Hyderabad-based vaccine maker Biological E for procuring its Covid vaccine, still under phase 3 clinical trials, marking the first such deal for securing coronavirus vaccine.
The government had entered into purchase agreements with Serum Institute of India and Bharat Biotech, the two other companies whose vaccines are being used for India’s Covid vaccination drive now, only after their vaccines had received regulatory approvals.
The advance payment, said the Centre, is to secure 30 crore doses of the vaccine candidate, which is a foreign construct, being produced in India.
Its candidate includes an antigen developed by Texas Children’s Hospital Centre for Vaccine Development and licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies -- all in the US.
The Union government said that the vaccine candidate is currently undergoing phase-3 clinical trials after showing promising results in Phase 1 and 2 clinical trials, whose details however are yet to be published in a peer reviewed scientific journal.
The vaccine, based on RBD protein subunit- had been tested in about 360 people between November and April in early-stage trials and has got approvals for late-stage trials in 1268 healthy volunteers—aged 18-80 years—across 15 sites in India as part of a larger global efficacy trials.
It is however not yet fully clear whether phase 3 trials have actually started in India.
The Centre maintained that the proposal by the Hyderabad based company was examined and recommended for approval after due diligence by National Expert Group on Vaccine Administration for Covid, adding that the vaccine is likely to be available in a few months.
It also said that this vaccine candidate has been supported by government from preclinical stage to phase-3 studies and the department of biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with the firm to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute, Faridabad.
As part of India’s “Covid Suraksha - the Indian Covid-19 vaccine development mission”, development of 5-6 Covid vaccine candidates are being supported and some of them are now closer to licensure and introduction in public health systems.