ICMR to get royalty from Covaxin sale

Intellectual property governing use of vaccine jointly developed by Bharat Biotech and ICMR is ‘shared’

The intellectual property governing the use of Covaxin, jointly developed by Bharat Biotech and the Indian Council of Medical Research, was “shared” and the ICMR would receive royalty payments, the organisation confirmed to The Hindu.

“The Public-Private Partnership was executed under a formal Memorandum of Understanding (MoU) between the ICMR and the BBIL which includes a royalty clause for the ICMR on net sales and other clauses like prioritisation of in-country supplies. The product IP is shared. It is also agreed that the name of ICMR-National Institute of Virology (NIV) will be printed on the vaccine boxes. The same is being done now,” ICMR Director-General Balram Bhargava said in an email.

However he didn’t say how much money was spent.

12 activities

The partnership between the two organisations involves 12 activities that include clinical and preclinical studies. Five of these were funded entirely by Bharat Biotech: Candidate vaccine development, preclinical safety and toxicity studies in small animals (rats, mice and rabbits), phase-1 clinical trials including funding of sites, hiring Clinical Research Organisation (CRO) for trial monitoring, insurance, laboratory testing; phase 2 clinical trials including funding of sites, hiring CRO for trial monitoring, insurance, laboratory testing and all other logistics and hiring a CRO for phase-3 trial monitoring, insurance and laboratory testing.

The activities funded by the ICMR were: Isolating the SARS-CoV-2 virus from a “huge number” of clinical samples, passage testing and confirmation; BSL-3 facility validation of BBIL for Covaxin production; vaccine strain characterisation by ELISA tests, electron microscopy, next generation sequencing; testing serum samples from preclinical studies in small animals; preclinical safety and efficacy in golden Syrian hamsters and preclinical safety and efficacy studies in rhesus macaques (monkeys); testing sera of Covaxin vaccinated individuals for U.K. strain, Brazil strain, South African strain and double mutant strain of SARS-CoV-2; U.K. variant virus isolation and characterisation, titration, sequencing from clinical specimens and funding the site for the phase 3 clinical trial.

Covishield constitutes over 90% of the country’s vaccine supply so far and has been developed as partnership between the Oxford University and AstraZeneca. Serum Institute of India is one among the many manufacturers in the world with a production licence and has to pay royalty to a foreign company. Covaxin on the other hand is almost entirely indigenous and yet is priced higher than Covishield. Both are so far being bought by the Central government for ₹150 a dose. However, Covishield was first offered to States at ₹400 a dose and ₹600 to private hospitals and Covaxin was offered at ₹600 for State governments and at ₹1,200 for private hospitals.

Later Covishield’s price was reduced to ₹300 a dose for States and Covaxin reduced theirs to ₹400.

So far however, the Centre had procured 40 million doses of Covaxin till March. An order for 20 million doses, presumably for April, had been half fulfilled (8.8 million doses) and orders for 50 million were placed for supply in May, June and July.

In the case of Covishield, the Centre had ordered 260 million doses. About 150 million had already been supplied and 110 million was in the process. Another 110 million was being supplied to States and private hospitals.


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