June 17, 2021


Let'S Talk Law

As India Burns Amid a Lethal 2nd Wave, It’s Now Evident that the World Has Failed in Ensuring Equitable Access to Vaccines. While Vaccine Doses Reach 9.7 Billion by 2025, Will They be Equitably Distributed?

Edition: 1; Released: May 2021
Executive Engagements: 11708
Companies: 335– Players covered include Moderna, Inc.; Pfizer Inc./BioNTech; AstraZeneca/University of Oxford; Johnson & Johnson; CanSino Biologics, Inc.; China National Pharmaceutical Group Co., Ltd. (Sinopharm); Sinovac Biotech Ltd.; Novavax, Inc.; Inovio Pharmaceuticals; Sanofi/GlaxoSmithKline; Gamaleya Institute and Others.
Coverage: All major geographies and key segments
Segments: Age Group (18 Years & Above, Under 18 Years)
Geographies: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

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The new study projects the global COVID-19 vaccines market at 9.7 billion doses in 2025 trailing a 4.8% CAGR over the analysis period 2020 through 2025. But how these vaccines are distributed and made available to countries worldwide will determine the course the pandemic will take in the coming months and years. In this heated battle between virus evolution Vs science, the ability to move fast is of utmost importance. To bring this pandemic to an end or atleast under control, a large share of the world’s population needs to develop immunity to the virus which can be offered only by vaccines. After the victorious launch of the first vaccines in late 2020, the world is now staring at international vaccine politics that threatens to undermine the battle against the virus. Global inequality in access to COVID-19 vaccines is currently the biggest challenge faced in this battle.

Six months into the massive vaccination drive against COVID-19 countries are beginning to falter; second, third and fourth waves of infections are sweeping through the globe once again; protective policies on critical vaccine ingredient exports continue to be legislated; and vaccine patents continue to be aggressively guarded by countries. India’s losing battle against the uncontrolled and unchecked spread of mutant, virulent COVID virus strains raises questions on whether the world has done enough in inoculating people against the virus and helping everyone, everywhere recover from the pandemic. With vaccinations being the only way out of this crisis, failing vaccination campaigns amid deepening shortages paints a grim future for India. Even as India burns amid the devastating crisis, the global fight for COVID-19 vaccine patents rages on. Are patents and intellectual property rights even appropriate in the current context of this global pandemic?

With more than 7 billion people to be vaccinated, there are only a handful of companies that are authorized to produce vaccines. As production efforts are ramped up in North America, Europe, India and elsewhere, raw materials shortages are beginning to emerge. Global shortages of raw materials are linked to the policy of prioritizing domestic production, which limits exports of inputs to other countries dependent on imports. This global pandemic can be brought to an end within a year if more companies are allowed to produce the approved vaccines. Even amid this desperate human crisis and testing times, the battle against the virus is intersecting with international politics. Vaccine patents are slowing down the world’s vaccination drive. Supply of vaccine shots has and still continues to be slow and there are no enough vials to go around the world, especially the poor and the densely populated countries that need them the most. India and South Africa have been on the forefront lobbying for a ban on vaccine patents, a move that continues to be resisted by rich countries. Despite the enormous impact of the pandemic which has infected 150.2 million people and claimed over 3.1 million lives to date, the much needed weapons for fighting this disease are being politicized; leveraged for gain, superiority, and influence over other countries. The war against the virus has brought with it challenges of international and political selfishness.

Lesser developed countries in addition to challenges such as poor healthcare, logistics and storage infrastructure also have to deal with vaccine hoarding by rich countries. Wealthy countries in the world have already reserved the bulk of the life-saving vaccines being produced. Political nationalism which is as old as human history has primed the world for vaccine nationalism. In the U.S. the number of surplus vaccines available, after every American has been vaccinated, is estimated at around 70 million, highlighting the massive prioritization measures undertaken by the country. Although the Biden administration, buckling under pressure, has voiced plans to ship surplus AstraZeneca vaccine to India and other countries in need, the move is too little too late. While the U.S. has vaccinated over 50% of its population with the first dose, other countries and regions are still lagging behind.

The gap between the number of vaccines administered in rich countries and those administered through COVAX, an international platform for global equitable access to COVID-19 vaccines, is widening with each passing day pushing up the risk of COVID transmissions. Faster COVID transmission increases the risk of mutations and virus variations which in turn reduces the efficacy of vaccines. This is turning into a reality as India emergences into the new epicenter of the pandemic with several grim implications for the global community. India’s crisis which now shaping into a humanitarian crisis in the country is also beginning to present a global challenge. Worry is shifting to India as the country becomes the breeding ground for newer more dangerous strains. The double mutation strain continues to be detected in India in large numbers and is seen as responsible for the rapid spread and higher morbidity risks. Fears over the double mutant variant undergoing further mutations and becoming a triple-mutant is already becoming real. Triple-mutant variants have already been isolated in samples collected from the Indian states of Maharashtra, Delhi, West Bengal and Chhattisgarh.

There is a real risk of India’s double and triple mutations of the virus spurred by unchecked and rapid spread, jumping borders and spreading to countries. India’s new variants will not be limited to India but will very likely emerge in other parts of the world. A variant with two mutations known as E484Q and L452R identified in India, have already been isolated in South Asia. Barely weeks after the second wave overwhelmed India, the Indian coronavirus variant has already been found in northern Italy in the city of Bassano. India’s battle with deadlier new virus strains brings grim news for scientists across the world as it underscores the insidious nature of viruses. The repercussions of India’s losing battle with the virus can be very serious for the world and for the global efforts to contain this pandemic. The exploding outbreak of mutant viruses in India now has a strong potential to derail the hard-won victory and progress in vaccination and containment in other countries. Efficacy of vaccines also stands a real threat of being compromised if the country fails in its attempts to contain the spread. The more the pandemic is prolonged the higher will be the risk of viruses outwitting our current vaccine technology. The Indian double and triple mutant is already turning this fear into reality. New strains stunting the efficacy of vaccines have the potential to push the world back into square one and such a setback in a battle such as the one we are waging now is almost unthinkable.    

The need of the hour is to accelerate equitable rollout of vaccines worldwide. Bilateral deals are encouraging and even fueling vaccine hoarding. Close to 45 bilateral deals were signed for securing vaccine supply in the year 2020 and over 15 have already been signed in the year 2021. The result is rich countries accounting for just 14% of global population have purchased over 50% of global vaccines produced till date. The me-first approach of the rich nations that leave the world’s most vulnerable and poorest population at risk will end with the world losing this battle. A self-defeating exhibition of selfishness will only prolong the pandemic and the human and economic suffering that accompanies it. The end of the pandemic will continue to elude us for as long as vaccines are not made available for countries that need them most.

It’s a race against time and to successfully end the pandemic, mass vaccination drives must outpace the speed with which the coronavirus is currently mutating. And for this patents and IP rights on drugs, vaccines, treatments, diagnostics, medical supplies and test data needed to control COVID-19 must be removed. Real hope will come when the world including WTO member states engage in research, manufacturing, scaling up and supplying COVID-19 tools and vaccines without fear of risking a trade dispute. Patent holders are currently opposing the waiver contending that the Trade Related Intellectual Property Rights (TRIPS) already has adequate flexibilities such as the option to issue compulsory licenses for less expensive generic equivalents when facing a public health emergency and the option of allowing countries unable to manufacture drugs to import them from other countries. But these flexibilities are more flexible on paper than in reality and as a result ability of countries to scale up production of needed COVID-19 products is dangerously slowing down.  While the U.S. announced its support of temporary waiver, other European countries still continue to oppose the move, stretching even further a solution to the immediate problem.

Other challenges related to logistics, storage and vaccine hesitancy among people pales significantly in comparison with the challenges related to technology transfer and sharing needed to ramp up vaccine production and distribution. While it’s true that supply chains for COVID-19 vaccines and drugs are strained and stretched thin, from raw material availability to manufacturing capacity, these challenges can actually be eased to a large extent with international cooperation and concerted efforts to remove barriers to vaccine production and trade. Now is the time for patent-holding rich countries to collaborate with developing world by agreeing to the proposed TRIPS waiver. While science has moved fast to discover new therapies and vaccines, will human selfishness fail us in this epic humanity’s battle against the virus?  More 

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Zak Ali
Director, Corporate Communications
Global Industry Analysts, Inc.
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