Inequitable distribution amid acute shortage has derailed the global vaccination drive against COVID-19. We need to act fast to win the race against emerging virus variants
With 177 million people already affected and almost four million dead, the vaccination drive to combat the novel coronavirus disease (COVID-19) is perhaps the most anticipated event of our times. It is, after all, the best chance the world has to curtail the risk of new outbreaks and break the cycle of lockdowns and misery.
But for it to work, all countries need to vaccinate their people as fast as possible. Otherwise the constantly mutating SARS-CoV-2 virus, that causes the disease, might develop ways to escape the immunity provided by the vaccines, making the entire exercise futile.
This is something that the world leaders knew much before the first COVID-19 vaccine was administered in the UK in December 2020. The COVID-19 Vaccines Global Access or COVAX was set up in April 2020 to accelerate the development, production and equitable access to vaccines. The alliance, by the World Health Organization (WHO), GAVI and the Coalition for Epidemic Preparedness Innovations, hopes to deliver 2 billion doses that would ensure at least 20 per cent of the population in each of its 190 member countries is fully vaccinated by 2021.
Yet six months later, shortages and inequitable distribution of doses threatens to derail the largest vaccination campaign the world has ever seen.
For one, COVAX has been facing acute shortfall since April 2021 after the major source of its vaccine, Serum Institute of India (SII), slipped on the delivery timeline because of a surge in COVID-19 cases in India. So far, the alliance has received only around 30 per cent of the 252 million doses it had hoped to by June 2021.
COVAX can procure only WHO-approved vaccines. The UN agency has given a nod to just six of the 17 vaccines that are being administered in different countries across the world. Of these, Covishield, manufactured by SII, is the cheapest at around US $3 a dose. The other vaccines cost anywhere between $1 and $40, as manufacturers are selling them at different prices to different countries to maximise profits. Sputnik V, developed by Russia, is the only other cheap vaccine selling at almost the same price as Covishield in at least some countries. WHO, however, is delaying its approval even though the manufacturer says it has submitted the necessary paperwork.
As a result, COVAX is now being forced to reach out to the expensive WHO-approved manufactures. This is a drain on funds that are already in short supply. Even if the alliance had the money, these manufacturers are not too keen on sharing their doses.
WHO gave approval to the vaccine produced by Moderna on March 12, 2021. On June 2, the company, after persuasion by UNICEF, agreed to deliver 34 million doses in the last quarter of 2021. A similar delay can also be seen in the case of Johnson & Johnson, which agreed to provide 200 million vaccines more than two months after receiving WHO approval. Pfizer, which was the first company to get WHO’s nod, has supplied only 15.3 million doses to COVAX so far. While the delays by WHO in authorising new vaccines is leading to shortages, COVAX alone is to be blamed for the way it has so far distributed the vaccines.
Of the 2.42 billion vaccine doses that had been administered globally till June 14, 2021, the low-income nations had received a negligible 0.3 per cent. In contrast, high and upper-middle income nations had administered a little over 85 per cent of the vaccines and low-middle income nations accounted for the remaining 14 per cent or so, as per Our World in Data.
Monica de Bolle, professor at the Johns Hopkins University, US, has criticised COVAX for allocating vaccines in proportion to population sizes, which is not the best public health metric. As a result, it has short-changed nations in desperate need of vaccines, while providing it to others that have comparatively fewer cases. The alliance also does not consider countries’ capacities to roll out massive immunisation campaigns.
COVAX hopes that vaccine donations from developed countries would help it deal with the shortfall. The G7 group, a consortium of seven high-income countries including the US, Japan and the UK, on June 11 announced plans to donate 870 million vaccines to low-income countries; only half of them will be delivered by the end of the year. However, developed countries are reluctant to route their surplus vaccines through COVAX because bilateral transfers allow them to increase their sphere of influence.
This approach of circumventing COVAX has further skewed distribution. Countries in East and South Asia have received 55.59 per cent of all pledged donations, despite having just 20.73 per cent of the confirmed cases since November 2020. In contrast, Latin America and Eastern Europe, which continue to suffer high case burdens and have struggled to secure vaccine access outside of COVAX, are receiving far fewer donated doses than necessary, reads the June 4 analysis by Think Global Health, an initiative by think-tank Council on Foreign Relations and the Institute for Health Metrics and Evaluation.
UNICEF’s COVID-19 Vaccine Market Dashboard estimates that the world would have 9 billion vaccine doses by the end of 2021. This should be enough to completely inoculate more than 90 per cent of the adult population. The concern is that only 38 per cent of these promised doses will come from the 17 vaccines that are currently in the market (see ‘Outnumbered’).
The industry seems to have promised overambitious production numbers without actually setting its house in order. The unavailability of enough raw materials is likely to make matters worse. “We have been issuing warnings since March this year that some crucial raw materials are in short supply,” says Thomas Cueni, director general, International Federation of Pharmaceutical Manufacturers & Associations, which represents big pharmaceutical companies (see column, p34). The shortage of raw materials has already forced the Oswaldo Cruz Foundation and Butantan Institute in Brazil to suspend production of the AstraZeneca and CoronaVac vaccines in May.
Need to change
To ramp up the production of vaccines and raw materials, the developed countries and pharmaceutical companies have to break their monopolies and allow the vaccine technology to be freely shared with manufacturers around the world.
But they are not willing to do so. In October 2020, India and South Africa floated a proposal at the World Trade Organization (WTO) to suspend patents on products needed to control the pandemic, including vaccines. The proposal was on the back burner for almost eight months; finally, in June this year, member nations agreed to move ahead with text-based negotiations (‘What India wants’, p37). If everything goes smoothly, a final call will be taken at the WTO Ministerial Conference in November 2021.
COVAX can play an important role here. On May 6, Human Rights Watch, Amnesty International, and Public Citizen demanded that COVAX publish its contracts with vaccine manufacturers.
“Publishing contracts and prices while sharing intellectual property is a good way to start ensuring that vaccines are affordable and available for billions of people who desperately need them,” says Arvind Ganesan, business and human rights director at Human Rights Watch.
So far, the alliance has refused to disclose the deal details citing confidentiality obligations. For long-term sustainability, COVAX will also need to align its work with other UN programmes like the COVID-19 Technology Access Pool by WHO that encourages voluntary contribution of intellectual property, technology and data to increase availability of medical products.
The alliance can also ensure compensation for people in poor countries who suffer from severe side effects after taking the vaccines. WHO has set up a programme that makes compensation available to individuals in 92 low- and middle-income countries without going to court. This is the first and only global no-fault compensation mechanism and it is funded by a small levy on each COVID-19 vaccine dose supported by the COVAX. Similar systems already exist in developed countries to protect consumers. For example, the UK has a Vaccine Damage Payments Scheme, which authorises one-time tax-free payments of up to £120,000 for individuals who have been disabled due to vaccine side-effects. The US has enacted the Countermeasures Injury Compensation Program to deal with COVID-19 vaccine injuries. Japan too has a long-established compensation scheme set up in 1979 and financed by contributions from pharmaceutical companies.
Deliveries via COVAX will also protect poor countries that are currently being bullied by vaccine manufacturers for immunity against lawsuits due to adverse effects. Pfizer is negotiating with the Indian government for such immunity in return of its vaccines. The government has not taken a decision on this as yet. “The discussions lack transparency, the absence of which would be akin to trading away the rights of people who could be affected by serious adverse events and other acts of negligence of the pharmaceutical corporation in the future,” says Amulya Nidhi of civil society group Jan Swasthya Abhiyan, who has written to the Prime Minister advising against such agreements. He says that India also needs to develop its own no-fault compensation mechanism.
Nidhi’s concerns are valid because Pfizer is known for its arm-twisting methods. Even before its vaccine was approved, Pfizer had asked Argentina to pass a law which would provide the company protection from lawsuits related to adverse reactions. The country passed a law which absolved Pfizer of adverse reactions but still held the company liable for acts of negligence or malice. Unhappy, the company demanded sovereign assets to be handed over as collateral in return of vaccines. When Argentina rejected this, the company pressured the government to take international insurance to pay for potential future cases against the company. The country has refused to agree to the demands and as a result, it has failed to forge a deal with Pfizer till date. The company has supply agreements with nine countries in Latin America and the Caribbean: Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Panama, Peru, and Uruguay. The terms of those deals are unknown.
The central reason why private players are getting away with blatant malprac-tices and shady deals, while developed countries remain mute spectators, is because the world lacks a comprehensive vaccination plan, a point highlighted by UN director general Antonio Guterres recently while he criticised the recent G7 announcement.
In such a situation, COVAX has a crucial role to play, which goes much beyond vaccine distribution. It is still to be seen if the alliance can work against the industry which indirectly supports it through GAVI.
Call for waivers
India and South Africa demand relaxations of patents on technologies needed to fight COVID-19
In October 2020, India and South Africa had floated a proposal to suspend the intellectual property rights on products such as medicines, diagnostics and materials needed to control the pandemic, including vaccines. Developed countries initially blocked the proposal and the discussions finally began on May 3, 2021, after it received partial support from the US.
The proposal, which now has 63 co-sponsors, limits the period of waiver to three years, after which it can be suspended if the pandemic situation improves. “Legal obstacles, pressure from pharmaceutical corporations and red tape make it too cumbersome, slow and complicated to address pandemic-level challenges,” says Leena Menghaney, regional head (South Asia) at the Access Campaign of Médecins Sans Frontières. The proposed waiver would provide developing countries with an effective and expeditious way to remove key intellectual property rights barriers in advance and ensure domestic production of supply of everything that they need to curb the pandemic. “If granted, the patent waiver with technology transfer may help to harness unutilised capacities for the production of vaccines in India,” says Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance, which represents research based pharmaceutical companies.
The narrative that the big pharmaceutical companies are now building is that the waiver is not going to help as the developing countries do not have the know-how to use the free technologies. This is not completely true, especially for India, which has been a global vaccine hub for decades. In 1986, Merck and GSK held patents for a type of hepatitis B vaccines which were sold at US $23 per dose. The company refused to share the technology with the poor nations. The technology was then developed by India-based Shantha Biotech and they managed to sell the vaccine at US $1, allowing it to be a part of the global vaccination drive led by UNICEF.
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