In the year since a public health emergency of international concern was declared for COVID-19, there have been nearly 100 million infections and over 2 million deaths globally. We do, however, now have vaccines that appear to be safe and efficacious — an unprecedented technical achievement.
Can we turn this into a global health triumph, or will successful implementation of a global vaccination strategy be another victim of the quagmire of toxic politics, conspiracies, and exclusionary self-interest that has characterized and hobbled efforts to control the pandemic in countries around the world?
With approved vaccines in hand, and more on the way, the next big questions are manufacturing and delivery. Despite the technical success of vaccine development by major vaccine companies, the scale imposed by a requirement to vaccinate 8 billion people with two doses of vaccine as quickly as possible presents challenges as great as the proof of efficacy.
Putting vaccines into context
If 60% to 70% of 8 billion people need to be vaccinated to achieve herd protection, that would mean 10 billion to 12 billion doses of a two-dose vaccine are needed. If global capacity for COVID-19 vaccine manufacture is 2 billion to 4 billion doses annually, it could be 2023 or 2024 before enough vaccine can be produced.
For perspective, vaccines containing diphtheria toxoid are the most widely used globally and have an annual market of 600 million doses, highlighting the enormity of the COVID-19 vaccine manufacturing problem. Rotavirus vaccine, made by four different manufacturers, amounts to only 100 million doses per year.
Nationalist policies undermine the global strategy and cooperation required to end the COVID-19 pandemic. Nikolaj Gilbert, president and chief executive officer of PATH, makes the case for multilateralism in this op-ed.
Fortunately, the major vaccine manufacturers are using contract manufacturing and licensing arrangements to increase supply. Some of the contracts are for the drug substance — the manufacture of the antigen — while others focus on fill and finish — vialing and packaging of vaccine. Nonetheless, dissemination of vaccine manufacturing to capable low-income country manufacturers may be a useful legacy once COVID-19 has passed.
At the same time, we are going to need to expand the population served by vaccination.
Vaccination is most commonly provided to children, and progress in past decades has meant that a majority of the world’s children receive necessary childhood vaccines. But now, health systems infrastructure designed to receive, store, and deliver vaccines to children will need to cover their brothers and sisters, parents and grandparents. The additional requirements for ultracold chain management of RNA vaccines may mean that LICs and middle-income countries will effectively be excluded from the use of this class of vaccines.
Is this, as well, an opportunity to build the infrastructure and human capacity for lifelong vaccination?
A crisis of access
These efforts are complicated by a crisis of access. Normally, vaccines developed in high-income countries gradually make their way into global policy recommendations, stockpiles, and national vaccination programs in low-income countries. Rotavirus vaccine — highly efficacious and safe — was approved by the United States Food and Drug Administration in 2006 and approved and recommended by the World Health Organization in 2009. In recent years, over 60% of the world’s children have still not been fully vaccinated against rotavirus.
Until Bharat Biotech and Serum Institute of India brought new products to WHO prequalification approval — needed for purchase by United Nations agencies — GlaxoSmithKline and Merck were the only manufacturers of rotavirus vaccine, and Merck canceled its contribution to Gavi, the Vaccine Alliance, and redirected the vaccine supply to China, where it was likely able to be sold at a higher price.
The situation is more complicated for vaccines against diseases found predominantly in low- and middle-income countries; the market incentives driving innovation are absent. Profits cannot be used to offset the costs of vaccine development.
The 73 countries eligible for support from Gavi have better success in securing critical vaccines, such as those for rotavirus and invasive pneumococcal disease. Ironically, MICs have the greatest number of unvaccinated children, not because they cannot implement vaccination programs but because the cost of premium vaccines — like those against human papillomavirus, rotavirus, and Streptococcus pneumoniae — is too high.
Modeling supported by the Bill & Melinda Gates Foundation suggests that if the first 2 billion doses of COVID-19 vaccine are taken by HICs without some equity and access for LMICs, global COVID-19 deaths will double.
COVAX cannot become a heart without a head — a grand effort driven by our mutual recognition of crisis … but incapable of executing its mandate.—
COVAX — commitments or catastrophe
Currently, 189 countries are part of the COVAX Facility, which hopes to supply approximately 20% of participating countries’ COVID-19 vaccine needs, and 92 countries are eligible for participation in an advanced market commitment, securing vaccine at low or no cost.
News reports have suggested that COVAX is at high risk of failure, though WHO has announced that it has secured commitments in principle for all 2 billion doses in 2021. COVAX is important and may be the first time that near-concurrent access to novel vaccine technology is available to countries at all levels of economic development. If it is successful and can be sustained, it will be a remarkable legacy of COVID-19.
Commitment to COVAX and to multilateral approaches to access and equity for COVID-19 vaccines remains the best guarantee that safe and efficacious vaccines can be distributed in a manner that respects the needs of all, provides transparency in allocation, and does not create bottlenecks and maldistribution driven by unprincipled and coercive negotiations that hold populations hostage for political gain.
Despite commitments to COVAX and the announcement by WHO that it has secured sufficient doses for 2021, WHO Director-General Tedros Adhanom Ghebreyesus recently emphasized that we were on the brink of “catastrophic moral failure” in equity. HICs have preordered over 12 billion doses, and many countries have ordered many times more doses of vaccine than justified by their populations. Upper-middle-income countries have also joined the preordering frenzy, and as one might predict, LMICs are not highly represented among preorders.
The facility itself will not solve the complex issues inherent in discussions of equity and access to innovative medicines in LMICs. But it addresses a pressing need and will provide the vaccines developed against COVID-19 to countries rich and poor.
Yet to succeed, there must be focal, unified global health leadership of the COVAX effort, supported by Gavi, the Coalition for Epidemic Preparedness Innovations, and WHO but able to sustain advocacy, conduct both internal and external communication, and hold accountability for the execution of negotiations, logistics, and implementation — not a committee, but an ad hoc entity.
COVAX cannot become a heart without a head — a grand effort driven by our mutual recognition of crisis, given tools by its tripartite leadership, entrusted by participating countries to deliver a vaccine solution, but incapable of executing its mandate. Whether COVAX is at high-risk of failure or has reached its commitments in principle, we must, globally, ensure its success and empower the facility to deliver COVID-19 vaccines and to implement the vaccination programs needed to bring the pandemic to a close.