AFTER three months of dithering, the Biden administration has supported South Africa and India’s move in WTO for a temporary waiver of patent rights on Covid-19 vaccines. This had the overwhelming support of countries and public health groups in the world. The opposition is now from EU countries, which had earlier tried to portray themselves as more progressive than the US. Under Trump, that was not difficult. The Biden move has wrong-footed them, leaving them as the only public supporters of the big pharma lobby.

While appearing to support the South Africa-India proposal, the Biden administration has considerably narrowed down the scope of the waiver to just patents and not what the original proposal in WTO was: to waive all intellectual property rights on Covid-19 vaccines, diagnostics, medicine, including industrial designs, copyright, and trade secrets. These are required to scale up vaccines from research and development to production at an industrial scale. Without extending the waiver to other property rights, the Biden stance waiving only patent rights is more optics than a real change. The bigger issue of knowledge transfers to scale up manufacturing in other countries still needs to be fought and won.

Even if it is at the level of optics, why did the US suddenly change its position? The US has been relatively isolated on its America First policy of hoarding vaccines, vaccinating all Americans first before exporting any to the rest of the world. The US is sitting on 60-70 million doses of Oxford-AstraZeneca vaccines which it is not using, while WHO’s Covax programme—on which a large part of the world depends—is not able to get supplies. And lastly, with India facing a huge surge in cases domestically and virtually stopping all exports, China has emerged as the only source of vaccines for large parts of Africa, Asia, and Latin America. This is endangering the Biden plans of a grand alliance against China, isolating it globally.

The US geostrategic view is that the western big pharma companies should dominate the rich country’s markets and that of the global rich. These are the only two markets of interest to big pharma. Moderna is slated to make a profit of $19 billion this year, Pfizer $13 billion. This is the market that the rich countries want to protect.

For the rest, the US was banking on its new Quad partner India to provide vaccines to the rest of the world through WHO’s Covax program. The Covax program though nominally WHO’s,  is dominated by Bill Gates and his various vaccine initiatives: Bill and Melinda Gates Foundation, GAVI and CEPI. Serum Institute of India with AstraZeneca and Novavax vaccines, Biologic E with Johnson &Johnson (Janssen) vaccine would make available 2.6-3 billion doses per year from India for other countries, helping to vaccinate the global population by 2022-23.

This strategy faltered due to the utter incompetence of the Modi government to use the indigenous capability for rapidly ramping up India’s vaccine production. The other constraint was the US export ban under the 1950 Defence Production Act denying Indian manufacturers vital equipment and raw materials. China and Russia have effectively emerged as the only two countries willing to offer vaccines and technology to others.

If the US had banked on the Modi government’s ability to compete with China on the vaccine front, they backed the wrong horse. The Modi administration failed miserably as not only did it not anticipate a second wave, it also did not invest in the indigenous vaccine and bio-pharmaceutical capacity to ramp up India’s vaccine production. Instead, the Modi government believed in the “magic” of the free market that would provide all the vaccines needed without the need for any planning or government support.

The proponents of the patent monopoly, including Bill Gates, argue that a patent waiver is useless as it is a lack of technology, knowledge, and capital, not patents, that is holding up vaccine production outside rich countries. If patents are not stopping vaccine production in other countries, then why did big pharma and the rich countries then oppose such a waiver in WTO for the last six months? Why the outrage on Biden administration’s current stand on patent waivers?

According to big pharma, a patent waiver on vaccines will disincentivise research and is a huge blow to those who innovate. What they hide—and this is not new—is that most of the research money for the new vaccines has come from public funds. A Lancet paper published recently by J  Wouters and others (Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment, March 13, 2021) shows that the governments and philanthropic organisations have given more than 10 billion dollars for the development of the current crop vaccines of vaccines and promising vaccine candidates. This does not include the billions of dollars in advance orders that the US and the UK governments paid to Pfizer and AstraZeneca.

The argument of providing a monopoly to big pharma for incentivising drug discovery is therefore a bogus one. The money and most of the research come from public funds and government laboratories.

The role of philanthropic money in developing private monopolies merits a more detailed discussion. But for this article, it should be treated on par with public money as it comes out of tax-free dollars. Bill Gates and his initiatives—the Bill and Melinda Gates Foundation—deserve a special mention here as their role has been to directly strengthen the big pharma monopoly. It was Bill Gates and the power he wields through Melinda Gates Foundation, GAVI, and CEPI that led the Jenner Institute, Oxford University to abandon its initial idea of making their vaccine technology available to any company on a non-exclusive basis. Instead, it signed an exclusive contract with AstraZeneca.

There are three major technology platforms that have emerged in the current lot of successful vaccines. They are i) the old-fashioned inactivated virus as a vaccine e.g., Sinovac, Sinopharm, and ICMR-Bharat Biotech ii) using a relatively innocuous virus as a vector to carry a SARS-CoV-2 protein, e.g., AstraZeneca, Cansino, Gamaleya Institute’s Sputnik V, Johnson & Johnson iii) mRNA that tells the body cells to produce the SARS-CoV-2 protein, e.g., Pfizer-BioNTech, Moderna. All of the three technology platforms have produced successful vaccines.

Almost all the big pharma arguments on why patent waivers are of not much use are for mRNA vaccine platforms. Though the argument that countries such as India, China, and South Korea, the three largest generic vaccine manufacturing countries, do not have biologic capability is not correct, the mRNA vaccines are not of immediate public health interest to most countries. They require an ultra-cold chain as otherwise, they degrade rapidly. The cost and effort involved in building such an ultra-cold chain preclude the use of mRNA vaccines in mass vaccination programs in most countries. What are of interest for most countries is the inactivated virus vaccines or the adenovirus vector vaccines.

The WHO supported platforms—CEPI and GAVI—where Bill Gates has an outsized influence, have focussed much more on the new vaccine platforms, the mRNA, and the adenovirus vector vaccine platforms, and not on the traditional inactivated virus vaccines. Dr Palacios of Butanta Institute, speaking in a South Centre event on April 1st, 2021, pointed out that CEPI and COVAX funded largely newer vaccine technologies and disregarded the inactivated virus vaccines (e.g., Sinovac, Bharat Biotech vaccines). These vaccines are effective, cost less and can be produced easily in many developing countries. Before we dismiss these vaccines as yesterday’s technology, it is relevant to note that this is still the vaccine platform for flu vaccinations across the world with about 1.5 billion doses per year.

What about the adenovirus vector vaccines and how complex are they? The only novel part of the adenovirus vector vaccines of AstraZeneca, Cansino and Gamaleya’s Sputnik V, is inserting a small spike protein snippet in the adenovirus vector and then growing the adenovirus as we do for the inactivated virus. Five companies in India, a consortium of South Korean companies, and another consortium of Chinese companies are planning to scale up the production of Sputnik V to 1.5 to 2 billion doses per year.

For any company involved in biologics, this is pretty much routine technology. India has about 20 such companies. So has South Korea and China. Bangladesh, South East Asia and Latin American countries also can produce biologic drug manufacturing capability, therefore can become major manufacturers. Cuba has developed five vaccines, out of which two are in advanced clinical trials. The Bill Gates argument recently in a Sky TV interview, that “without us teaching the Indians” (or Koreans, Chinese, Latins, Africans, Arabs, etc.) or our money, “they cannot produce vaccines” is just a racist view of the world- a repetition of the white man’s burden that cloaked the earlier genocidal colonial enterprise.

Do we want to spend the next few years re-inventing the wheel on vaccines to protect the monopoly profits of a few big pharma companies? And thereby condemn the world to a much longer Covid-19 pandemic? Or do we believe that public health demands rapid sharing of knowledge so that we vaccinate all the people within the next 6-12 months? If we don't, new virus mutants will emerge requiring that we rejigging our vaccines in a never-ending game of snakes and ladders. This is of interest to big pharma, as it will create a perpetual money-making machine. But not for us, who believe that a caring world needs sharing of knowledge.