The intellectual property rights for the use of Bharat Biotech’s indigenous vaccine, Covaxin, was shared between the drug manufacturer and the Indian Council of Medical Research, with both entities gaining the royalty payments, reported The Hindu.

“The Public-Private Partnership was executed under a formal Memorandum of Understanding (MoU) between the ICMR and the BBIL [Bharat Biotech International Limited] which includes a royalty clause for the ICMR on net sales and other clauses like prioritisation of in-country supplies,” ICMR Director-General Balram Bhargava told The Hindu in an email conversation.

“The product IP [intellectual property] is shared,” he added. “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.”

Bhargava, however, did not comment on how much money was spent on this.

The ICMR and Bharat Biotech’s partnership involves 12 activities. The Bharat Biotech funds five of these, including candidate vaccine development, phase one and two clinical trials, recruiting Clinical Research Organisation for trial monitoring, preclinical safety and toxicity studies in small animals, among other activities.

The medical research agency funds isolation of the SARS-CoV-2 virus from a large number of samples, passage testing and confirmation, electron microscopy, next generation sequencing and others.

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Whose intellectual property is Bharat Biotech’s publicly funded Covaxin? India deserves an answer

The clarification came amid doubts being raised about the ownership of the rights to this Covid-19 vaccine, which was partly funded by taxpayers’ money.

On April 21, Bharat Biotech announced that Covaxin showed an overall efficacy 78%, according to an interim analysis of its third phase of clinical trials. This was slightly lower than the 81% efficacy that the company reported in March.

Under India’s inoculation programme, which began on January 16, the country has been using two vaccines – Serum Institute’s Covishield and Bharat Biotech’s Covaxin.

The Serum Institute is the local maker of the Covid-19 vaccine developed by Oxford University and pharmaceutical company AstraZeneca. The vaccine manufacturer is among multiple companies in the world with a licence to produce it. The Serum Institute pays 50% royalty to the British-Swedish company.

AstraZeneca had in March announced that its coronavirus vaccine showed 76% efficacy in the primary analysis of its phase three trials. The company had then said it was 100% effective against cases of severe or critical disease and hospitalisation. In case of symptomatic patients above the age of 65, who took part in the trials, the company revised the vaccine’s efficacy to 85%, from the earlier stated 80%.

Over 90% of India’s vaccine supply is comprised of Covishield. The Indian government on Monday refuted reports that claimed that it has not placed any new order for coronavirus vaccines despite the devastating second wave of the pandemic. It called such reports “incorrect and not based on facts”.

On April 19, the Union health ministry announced that vaccine manufacturers would have to allot 50% of the doses produced to the Centre and sell the remaining 50% to state governments and private organisations in the open market. The decision was part of the new vaccination policy under which all adults will be eligible for the shots from May 1.

The two companies declared prices of their respective vaccines after this. Initially, the Serum Institute of India chief announced that the Covishield vaccine will be sold to states at Rs 400 per shot and at Rs 600 per dose to private hospitals. Bharat Biotech set the price of its Covaxin shot at Rs 600 per jab for state governments and Rs 1,200 for private hospitals. Both vaccines would be priced at Rs 150 per dose for the central government.

But, after objections from various quarters, Bharat Biotech reduced the price of Covaxin for state governments to Rs 400 per dose and Serum Institute of India reduced Covishield’s rate to Rs 300 per dose for states.

State governments have raised objections against differential pricing of vaccines and on having to procure the shots at open market prices to inoculate those in the age group of 18-45. But the Centre has dismissed these arguments as patently false.