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Sunday, August 14, 2022

The world must come together on Covid vaccines

Patent waiver is not the only issue in easing gaps to vaccine access. Manufacturers in developing countries would also require handholding on technology-related matters

Written by Virander S Chauhan |
Updated: June 14, 2021 10:19:36 am
The Covid-19 vaccine narrative, however, seems to have taken a healthier turn after the US agreed to waive intellectual property rights (IPR) on vaccine formulae. (Illustration by C R Sasikumar)

Does the coronavirus, SARS-CoV-2, have anything to teach us about globalisation? It is hard to ignore the rather obvious disregard any virus, especially this one, has for borders of countries and continents. Yet, decades after waves of globalisation buoyed many countries economically and other respects, we are witnessing an element of protectionism by nations when it comes to vaccines and vaccine policies — all this in the face of something that affects not just one country but the world at large. The Covid-19 vaccine narrative, however, seems to have taken a healthier turn after the US agreed to waive intellectual property rights (IPR) on vaccine formulae. And on June 1, the BRICS countries — including China and Russia — endorsed a proposal helmed by India-South Africa at the WTO to waive certain provisions of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement that relates to patent waivers for Covid-19 vaccines.

In this backdrop, it is important to contextualise the arguments about what really matters in a global push to ensure vaccines for all and the many other complexities of vaccine-making. It might help to take a macro view before moving on to the micro one. Regarding the US decision to waive patents for Covid-19 vaccines, we must understand the implications of such a decision for vaccine manufacturers across countries. The waiver could be crucial for countries where efforts are on to develop an mRNA-based vaccine that is not dependent on the technologies of Pfizer, Moderna or any other company. Manufacturers in these countries can work on indigenous technologies without the fear of any legal retribution. For example, there have been reports about such an initiative by the Pune-based Gennova Biopharmaceuticals, which received regulatory approval for clinical trials of its indigenous mRNA vaccine, and was slated to start human trials in April. In May, there were reports that vaccine developers in Thailand were on the verge of launching human trials of an mRNA Covid-19 vaccine. Similar efforts to develop mRNA-based vaccines are underway in Russia and China. The US supporting the IPR waiver is certainly a welcome and positive step.

Moving on to the micro perspective on the issue of patent waivers to ease huge gaps in vaccine access, particularly in poor countries, there may still be hurdles. These hurdles will seem even more pronounced if the idea is to ramp up vaccine production domestically on an immediate basis. Developing and manufacturing Covid-19 vaccines entail specialised production capacity, several dozens of special ingredients, adjuvants and small equipment produced largely by the US and EU-based companies. Export restriction on any of the vaccine raw materials would hold up the manufacturing/production process, impacting the overall output of the vaccine supply chain. Unfortunately, the US, on February 5, invoked the Defence Production Act to restrict exports of raw materials — perhaps to safeguard and boost domestic vaccine production. Even though commitments have been made by the US administration to ease curbs on raw materials, we are yet to see them come into effect.

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To address the current huge supply and demand gap worldwide, the vaccines that have already been approved for human use need to be produced in many locations. The most appropriate course of action will be through suitable and mutually-agreed contracts between the companies that have developed the vaccines and the ones that will produce them. In this context, complete technology transfer comes into the picture. Vaccines are not generics that can be reverse-engineered quickly and scaled up by domestic companies. Continuous hand-holding by the manufacturer would be central to the eventual success of high-quality vaccine production in multiple locations.

These concerns related to micro-level obstacles have perhaps informed India and South Africa’s revised text proposal at the WTO. Together with about 62 WTO member countries, they pushed a revised draft decision text in May. The revised text focuses on “health products and technologies as the prevention, treatment or containment of Covid-19 involves a range of products and technologies. Intellectual property issues may arise with respect to the products and technologies, their materials or components, as well as their methods and means of manufacture”. Also, the revised proposal limits the waiver period to three years, with a provision to review the duration, thus trying to make it a feasible option for manufacturers.

One hopes that the revised proposal can build on the positives with regards to the US waiver of patents, and that there is a consensus among all WTO states on vaccine equity. An editorial in the journal, Nature, recently stated that according to the pharma industry data, approximately 10 billion vaccine doses are to be made by the end of 2021. However, the editorial also cites research by the International Monetary Fund, which says that the industry is probably going to end up producing only about six billion doses by the end of 2021. This shortfall “increases the risk that people in low-income countries will need to wait even longer for their first doses”. That a lot of high-income countries have accumulated much more than what they require to vaccinate their entire population hasn’t helped the cause either. The global community needs to understand that in an interdependent world order, the actions of one country can create a ripple effect, negative or positive, on others. The virus will eventually be defeated but done collectively, the victory can come about faster, be long-lasting and help save millions of lives.

This article first appeared in the print edition on June 14, 2021 under the title ‘Share, collaborate and innoculate’.
The writer is former chairman UGC and former director of the International Centre for Genetic Engineering and Biotechnology, where he currently holds the Arturo Falaschi Chair

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First published on: 14-06-2021 at 03:40:55 am
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