November 2021 marks another grim flashpoint in a stream of them: the global COVID-19 death toll surpassed five million. The rapid development of vaccines has been an extraordinary achievement in the fight against COVID-19. However, successfully vaccinating the global population, especially in low-income countries, has been hampered by several challenges – notably vaccine inequity and weak health systems.
For instance, just 6% of Africa’s population has been fully vaccinated. Over 70% of high-income countries have already vaccinated more than 40% of their people. To further widen the gap, wealthy nations have started booster shots while low-income countries struggle to get enough doses to vaccinate their elderly, front-line workers, and high-risk groups.
Although vaccines are highly effective at preventing COVID-19, it is necessary to continue developing other treatment options. My experience in developing new medicines for malaria has taught me that many experimental medicines don’t end up being used for a variety of reasons. There is also the threat of drug resistance even after a medicine is approved and marketed. So multiple complementary interventions are needed for disease control. In this regard, there’s an urgent need for therapeutics to complement vaccination and keep people out of hospitals.
A year after the first promising news about COVID-19 vaccines, I am hopeful again for new tools against the disease – a pill that could be taken at home by people infected with the virus.
The pharmaceutical company Merck has announced it has a promising COVID-19 treatment. What is more, it will make the treatment available to developing countries royalty free. This deal is the gold standard for expanding access and is a game-changer in the global approach towards the pandemic. Pfizer has already followed with a similar announcement.
Despite this optimism, more needs to be done. The drugs (albeit shown to be safe) are experimental, and few biopharmaceutical companies are signing voluntary licensing agreements. There’s also the need to broaden the range of manufacturing countries.
Increasing global access
Molnupiravir, developed by Merck & Co and Ridgeback Biotherapeutics LP, is an oral antiviral pill found to reduce the risk of hospitalisation and death by 50% when given within days of a positive test. The drug is currently being evaluated by the US Food and Drug Administration for effectiveness and safety.
It is important to note that the antiviral pill is not an alternative to the vaccine. But the fact that it reduces symptoms and speeds up recovery will help ease caseloads in hospitals, especially in low-income countries that already have fragile health systems.
The critical question now is whether the world will avoid the inequity that was witnessed when rich countries hoarded global vaccine supplies, leaving poorer countries without enough.
There’s a reason to hope.
Merck signed a voluntary licensing agreement with the United Nations-backed Medicines Patent Pool. It will allow companies in 105 countries, mainly in Africa and Asia, to manufacture generic versions of its experimental oral antiviral COVID-19 pill.
This will increase affordable global access for the drug in low- and middle-income countries. The agreement implies that the developers will not receive royalties for the sales of Molnupiravir as long as COVID-19 remains a “public health emergency of international concern”.
Broadening the range of countries where the pill is made will ensure the lowest possible price for the drug. That will make it more feasible for public health systems in low-income countries to purchase it. This has been the argument for the establishment of local pharmaceutical manufacturing specifically for diseases that are prevalent in Africa such as malaria, HIV and tuberculosis.
The voluntary transfer of technology is a core part of the biopharmaceutical industry’s business model. Technology transfer has helped the industry scale up COVID-19 vaccines production in various parts of the world. What makes this move by Merck historic is the fact that this has shown a path for many pharmaceutical companies to follow.
For instance, Pfizer has recently struck a similar deal. It will allow generic versions of its COVID-19 pill, Paxlovid, for the world’s poor and will not receive royalties on sales in low-income countries. The Paxlovid pill will be supplied to 95 low- and middle-income nations. This covers about 53% of the world’s population. The pill cuts the risk of hospitalisation and deaths by nearly 90% in people with mild to moderate coronavirus infection.
Deals such as these will make prospective antiviral COVID-19 pills and any other treatment available more cheaply in the world’s least-wealthy countries or countries that lack the capability to manufacture it themselves. This is a positive step in an effort to bring humanity to science. And it will go a long way in bridging the treatment inequality gap.
But the need of the hour is for countries – especially low- and middle-income countries – to improve their own manufacturing capabilities. This will reduce their dependency during similar health crises.
Intellectual property rights
The WHO and 100 other countries have called for a temporary waiving of intellectual property rights to allow for vaccines to be more easily manufactured worldwide. A South African consortium is working to set up a technology transfer hub for mRNA vaccines to boost and scale up vaccine production in Africa. Initiatives like this must be encouraged and promoted.
We need to bridge the COVID-19 vaccine inequity gap and ensure the low-income countries equally benefit from the progress the world has made thus far against the pandemic.
I firmly believe that intellectual property must be respected because it enables research and development efforts. But it is in everyone’s interest to waive intellectual property in some regions to increase manufacturing capacity and ensure global equitable access to COVID-19 vaccines. This vaccination disparity is extending the ongoing pandemic and weakening the global recovery rate.
But waiving intellectual property, establishing technology transfer hubs and granting royalty-free licences will not be sufficient. It will also be critical to remove trade barriers that prevent the export of vaccines and therapeutics from manufacturing hubs. It will be equally crucial to ensure required ingredients, adjuvants and small equipment are rapidly sourced.
Royalty-free agreements mark progress in the global COVID-19 fight. But much more needs to, and can, be done.
Kelly Chibale, Professor of Organic Chemistry, Neville Isdell Chair in African-centric Drug Discovery & Development, and Director of the Holistic Drug Discovery and Development (H3D) Centre, University of Cape Town