This article was originally published in The Lancet here.
By Ann Danaiya Usher
In the next 5 years, Gavi aims to vaccinate 300 million children and will have a greater focus on building primary health-care systems. Ann Danaiya Usher reports.
Gavi, the Vaccine Alliance—a donor-financed alliance of public and private sector contributors that was established in 2000 to make vaccines available to children in the poorest countries—is gearing up for its fifth replenishment. Since its inception, Gavi has financed vaccines for more than 750 million children, with funding coming mainly from donors from high-income countries and the Bill & Melinda Gates Foundation, which provided the initial grant. Gavi estimates that, so far, 13 million lives have been saved through its support for routine immunisation programmes and campaigns. Since 2000, Gavi has received US$17 billion in financing.
Gavi’s funding request for donors for the next 5 years is $7·4 billion, about the same amount as for the last round. The investment case for 2021–25, which was launched in Japan last week, outlines how Gavi plans to increase its range of vaccines from 11 to 18, and to scale up the number of children vaccinated to 300 million, saving 7–8 million lives over the next 5 years. Responding to stagnating vaccine coverage, the agency will also have a “robust focus” on communities with the lowest vaccination coverage. And, for the first time, the organisation will explore expanding its mandate to include middle-income countries (MICs), where vaccination coverage is falling relative to the poorest countries.
With $2 billion in assets in 2019, the agency will have $9·4 billion in resources if it achieves the replenishment target.
Focus on the inadequately immunised
From the inception of Gavi, coverage of the diphtheria–tetanus–pertussis vaccine in 54 African countries increased to 78%. But progress has stagnated since 2016. In low-income countries, more than 15 million children annually do not receive a full course of the most basic vaccines.
Gavi’s strategy for its next 5-year programme aims to address this issue by putting basic immunisation at centre stage focusing its programmes on children who are not receiving adequate vaccine coverage. The investment case states that Gavi will “make equity the organising principle of its 2021–2025 strategy. The Alliance will redouble efforts to extend immunisation services to those communities who are being systematically missed today.”
Gavi will invest $3·3 billion in immunisation systems, enabling infrastructure development in this period. Seth Berkley, Chief Executive Officer of Gavi, explains that Gavi will spend a larger percentage of its resources on health-care systems and technical support, with a focus on children receiving no doses and low-coverage communities.
“If we can do that—and the level of difficulty is extremely high because these are usually areas in countries that are in conflict—what we will be doing is, in essence, building out the primary health-care system. We are focusing on immunisation, of course, vaccines don’t deliver themselves. You need a supply chain, a data system, a cold chain, a health worker, supervision…We see this as the basis of universal health coverage. That is really the way we are thinking of the strategy”, he says.
All Gavi’s health system grants now have a focus on low-coverage areas. Berkley points out that in some countries, like Kenya and Pakistan, the poorly vaccinated communities are not mainly in isolated rural areas, as one might expect, but are often in urban slums.
Gavi will not, however, finance health workers’ salaries. “We do not see that as a sustainable investment”, he says, adding that, in fragile countries, Gavi occasionally provides temporary support for salaries.
Closing the MIC gap
Until now, Gavi has worked exclusively in the poorest countries, setting an upper eligibility limit of $1580 gross national income (GNI) per capita, with modest requirements for governments to co-finance interventions. As the economies of countries grow, the countries transition to being expected to pay a larger share. Eventually, they lose their eligibility for both Gavi grants and low vaccine prices. Sri Lanka, Guyana, and Bhutan are among the 15 countries that have already transitioned out of receiving Gavi support. Three more countries are expected to become ineligible for such support by the end of the 2021–25 funding period, and ten more are expected to become ineligible in the subsequent funding period.
Médecins Sans Frontières (MSF) has raised concerns about the long-term sustainability of immunisation programmes for countries that must self-finance several vaccines. Although some manufacturers have agreed to continue favourable Gavi prices for countries that become ineligible for Gavi support for 5 or 10 years, depending on the vaccine, after this time, the countries must (in principle) pay global-market prices. At its last meeting in July, the Gavi board asked the secretariat to determine how to institutionalise post-transition support to maintain coverage in affected countries, and to assist countries that have never had access to Gavi funding.
“One of the things that we are going to explore”, says Berkley, “is whether there are ways to create a longer period of being able to help countries in this post-transition period, including some issues around pricing and procurement.”
MICs that have never been poor enough to receive Gavi grants face a different problem. They are starting to lag behind Gavi countries on vaccine introductions because of the prohibitive prices of some vaccines. Gavi estimates, for example, that such MICs pay on average 3·5 times the Gavi price for rotavirus vaccine and eight times the Gavi price for pneumococcal vaccines. By 2030, 70% of the world’s least-vaccinated children will be in MICs.
In the next few years, Gavi will investigate how it might support the MICs that have never been eligible for Gavi funding but are only slightly wealthier than those that have previously received support. The board has agreed that up to 3% of Gavi’s resources—potentially $280 million—can be used to assist countries after they transition away from Gavi support, and to find ways to provide technical assistance and catalytic funding to MICs with a GNI per capita of up to $6000.
“From an equity point of view, the under-$4000 countries are very similar to the transitioning countries”, says Berkley.
Ironically, Gavi is partly to blame for the imbalance. “Gavi’s success has created a new inequity with children in middle-income countries now least likely to have access to the full range of vaccines universally recommended by WHO … Gavi needs to adapt to ensure no child is left behind”, Berkely told the Gavi board in July.
Saving $1·1 billion
Of the requested resources of $9·4 billion, the amount to be spent on the purchase of vaccines will decrease slightly from $5·5 billion in 2016–20 to $5·3 billion in 2021–25. The planned expansion in activities is possible, partly, because Gavi will spend so much less on pneumonia vaccines.
Pneumococcal vaccines have dominated Gavi’s budget during the past decade, claiming 44% of resources available for vaccines. In the next 5 years, the share of the vaccine budget taken by pneumococcal vaccines will decrease to 25%, freeing up $1·1 billion. Simultaneously, Gavi plans to increase the number of children receiving pneumonia vaccine from 190 million to 280 million during 2021–25.
Berkley says the huge saving can be attributed to several factors. The two manufacturers of pneumococcal vaccine, Pfizer and GlaxoSmithKline, have reduced their prices for Gavi-eligible countries by 15–17% during the past decade. Moreover, the $1·5 billion Advance Market Commitment, a donor-financed incentive scheme for pneumonia vaccines, will expire by the end of 2020. Another key reason for these savings is the expected entrance of a third supplier of the pneumococcal vaccine that will create competition in this market.
Although several vaccine candidates are in the late stages of development, the pneumococcal vaccine candidate being developed by the Serum Institute of India is the closest to being available on the market. The firm hopes for WHO prequalification to be completed before the end of this year, and it has indicated a price of $6 per child, 35% lower than the two existing suppliers. The Executive Director of the Serum Institute, Suresh Jadhav, says he expects the production capacity for pneumococcal vaccine to be 80–100 million doses in the first year, increasing to 150 million doses in the next couple of years. Each child requires three doses.
Vaccine experts have welcomed the advent of a new supplier that can push the price of pneumococcal vaccine down, allowing countries to switch over to the cheaper product. MSF has called this introduction of a third supplier a “game changer”. And Keith Klugman, Director of the Bill & Melinda Gates Foundation’s Pneumonia programme, has said that countries switching to the cheaper pneumococcal vaccine could potentially free up a huge amount of Gavi’s resources for vaccines that, so far, have not rolled out in developing countries, such as those against typhoid, cholera, and respiratory syncytial virus, which is in the late stages of development.
When asked what proportion of the $1·1 billion saving is due to the entrance of a third supplier, Berkley insisted that nothing is certain yet. “We don’t know what the price will be for the new entrants yet. There is an estimated cost. But it will depend on what the timeline is, ultimately, of getting prequalification, as well as the availability of that vaccine”, he says. “Normally, we do not provide that type of breakdown for estimates because we don’t want to give manufacturers a sense of what we think the price points are going to be.”
In the investment case, while the allocation for vaccines against pneumonia drops, Gavi plans to increase spending to $800 million on polio, to $150 million on stockpiles of vaccines against Ebola virus disease, to $302 million on typhoid, to $516 million on human papillomavirus, and to $360 million for new vaccines, potentially including a vaccine against respiratory syncytial virus.
The Gavi replenishment will be hosted by the UK next year.