India needs more than patent waivers to deliver more COVID vaccines

German chancellor Angela Merkel was not entirely wrong when she said that waiving patents on COVID-19 vaccines would not immediately increase the supply of vaccines, turning down Prime Minister Narendra Modi’s request for a waiver of intellectual property rights (IPRs) at the WTO, raised in the course of his address to a summit of the European Union.

French President Emmanuel Macron, however, was for transfer of vaccine technology. This comes in the wake of US Presieent Joe Biden’s backing for waiving intellectual property rights (IPR) over vaccines. New Zealand and Russia also show readiness to play along. However, this would not raise vaccine output in the short term any more than mere knowledge of Einstein’s relationship of mass-energy equivalence, e = mc2, enables anyone to create a nuclear reactor.

India must buy out the IPR of indigenously developed Covaxin and make it available as a global public good for anyone capable of producing the vaccine to add to the global supply. The faster the world is vaccinated, the lower the mutations of the virus that could generate strains against which the present lot of vaccines prove ineffective, leading to a resurgence of the pandemic even in the vaccinated rich world, which is limping back to normal right now. India has reportedly asked three other companies in India to produce Covaxin.

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The IP of indigenously developed Covaxin is jointly owned by Bharat Biotech and the Indian Council of Medical Research (ICMR), whose affiliate, the National Institute of Virology, did much of the original job of isolating and sequencing the virus in India. The government can either waive the IP rights, as it has asked the world to do or buy out the IP of Covaxin, compensating the patent holders, Bharat Biotech and ICMR, and donate IP to the world at large. The latter option is the better one, as it would retain the commercial incentive for companies to invest in vaccine research, while freeing up the vaccine knowhow for the world at large. The cost to the government would not be high, and part of the money would go to fund ICMR, which, in turn, could fund much-needed research in a variety of areas.

Not many companies outside the developed world are capable of producing sophisticated vaccines. India has several of them. Even before COVID made vaccines a hot topic, India was already the world’s largest vaccine producer by volume. However, few Indian companies develop vaccines, although they are good at low-cost mass production. And this is the reason why developed world pharmaceutical multinationals are chary of waiving IPR on the vaccines against COVID.

There have been four different kinds of vaccines against COVID-19. Covaxin uses the traditional method of introducing an inactivated whole virus into the human body, for it to generate antibodies and be prepared when an actual infection occurs. The Russian Sputnik V, AstraZeneca and Johnson & Johnson vaccines enclose a gene, whose job is to encode synthesis of the Coronavirus’ spike protein, inside a harmless adenovirus, which is then administered as the vaccine. These are called viral-vector vaccines. The Pfizer and Moderna vaccines entrust the job of asking the human body to produce the spike protein to a messenger RNA, enclosed in a droplet of fat. These are less stable than the viral-vector vaccines that contain a DNA inside the vector, and need to be stored at ultra-low temperatures. The vaccine from another American company, Novavax, offers as its vaccine the spike protein itself, which the company has synthesised, using the original virus genetic sequence. These new vaccines are emerging as the gold standard of immunisation. They could, it is held, be modular in their production process: change the pathogen protein, or the DNA or the mRNA that asks the inoculated human’s body to produce the pathogen protein, which would, in turn, excite the immune system and produce antibodies. The rest of the vaccine would be the same.

An Indian company, Gennova Biopharmaceuticals, is developing an mRNA vaccine of its own, and they claim to rely on indigenously produced ingredients as well.

Biontech, the German biotech company that developed the Pfizer vaccine, as well as Novavax and Gennova, developed their mRNA technology originally in the course of finding treatments for cancers. It is a fair bet to say that the next generation of cancer medicines would come from genetic technologies. This adds to the incentive for pharma multinationals to keep a tight hold over their new vaccine knowhow.

However, waiving of IP rights will not lead to a jump in vaccine production, without transfer of technology and availability of the crucial ingredients that go into vaccine production. While the US government can agree to waive patent rights for the vaccines — it has not committed to waiving these rights for COVID therapies in general, which India and South Africa had asked for at the WTO — but it cannot force its pharma giants to part with their technology voluntarily. Waiver of patent rights, if it materialises, would help insulate Indian companies from charges of patent violation, but they would have to reverse engineer the vaccines and their ingredients themselves.

While Pfizer has agreed to sell some vaccines to India, it would be foolish to rely on imports to meet India’s vaccine requirement for 900 million people, and of much of the developing world, waiting for vaccine exports from India and China. The EU, Australia and Japan struggle to obtain the vaccines they need from Pfizer and Moderna. Even then, India should welcome Pfizer and Moderna to set up their special cold chains or find local partners willing to do that job. A sticking point with Pfizer is that the company wants indemnity against damage claims for any possible adverse reaction to the vaccine. It is logical for the government to give emergency authorisation for mRNA vaccines, based on approvals by the WHO and established regulators, such as those of the US and the European Union, but to leave indemnity to be granted by those receiving the vaccines. Pfizer can find a local partner willing to undertake the paperwork for binding indemnity from vaccine recipients. Only those prepared to grant such immunity need take those vaccines. If a few crore relatively well-off Indians in the big towns shell out the money for these relatively-expensive imported vaccines that would release that many domestically manufactured vaccines for use by others.

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Brazilian drug regulators turned back shipments of the Russian vaccine, because they found the adenovirus to be multiplying within the vaccine. This means that Russian vaccine manufacture is sloppy, even as their scientists do a good job of producing the vaccine. Indian licensees of Sputnik V are likely to do a better job, accustomed as they are to adhering to Good Manufacturing Practice standards.

So, the strategy for India would be twofold. One, the government should expand vaccine production and availability, through imports and transfer of indigenously developed vaccine knowhow to multiple vaccine makers. Two, it should shed its unfathomable and unconscionable stinginess on funding vaccine capacity hitherto and liberally fund a string of startups to develop new vaccines, including for the new variants that show signs of escaping the effect of available vaccines, as well as vaccine ingredients. Fund young scientists, who have reputations and careers to build, and they are likely to deliver. Invite Indian talent working in labs around the world to come back to India to set up their ventures with capital provided by the government of India.

The patent waiver will insulate them from legal tangles, but they will have to do the hard work of engineering the vaccines and their ingredients themselves. And they are likely to, breaking glass ceilings for Indian creativity.

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