CEPI launches 100-day vaccine “moonshot”

Abstract

CEPI has raised $1·5 billion for its work on tackling the next pandemic as civil society calls for a sharper focus on equitable access to new vaccines. Ann Danaiya Usher reports. The Coalition for Epidemic Preparedness Innovations (CEPI), which was established in 2016 in the wake of the Ebola virus outbreak in west Africa, has become a key player in the global health architecture in a few short years. Its initial focus on research into vaccines against diseases prevalent in low-income and middle-income countries (LMICs) gave way to an active role in supporting the development of COVID-19 vaccine candidates during 2020–21. Now, CEPI proposes to expand its mission further. The first COVID-19 vaccine produced by Pfizer–BioNTech took a record 326 days to complete, but this time period, CEPI argues, was still too long. CEPI aims to accelerate the process of developing a vaccine against the next great pandemic threat in as little as 100 days, in what it is calling its moonshot. If this capability had been in place when COVID-19 first struck, the first vaccines could have been administered in April, 2020, when there were fewer than 4 million cases recorded, rather than in December, 2020, when the number of confirmed cases had reached 67 million. The result, CEPI says, could have potentially averted millions of deaths and trillions of dollars in economic damage. Today, the number of confirmed cases stands at 450 million worldwide. At a replenishment conference hosted by the UK last week, CEPI sought to raise US$3·5 billion for CEPI 2.0, its work programme for 2022–26. Donors pledged $1·5 billion, led by Japan, the UK, the Bill & Melinda Gates Foundation, Wellcome, the USA, and Norway. Several others indicated that they would also contribute. Chief executive officer of CEPI, Richard Hatchett, said that this support would kick-start CEPI's work on preparing for so-called disease X, an unknown pathogen with pandemic potential. “For the first time in history, we have the tools we need to eliminate the risk of future pandemics,” he said. “It is vital that we capitalise on the scientific developments we’ve seen over the last 2 years and seize the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again.” CEPI's investment case for the next 5 years states that the organisation's record on COVID-19 makes it well positioned to assemble the capabilities, actors, and expertise needed to develop vaccines against disease X. CEPI, along with WHO and Gavi, the Vaccine Alliance, established the COVAX mechanism for global distribution of vaccines in early 2020. Over the past 2 years, CEPI has spent almost $2 billion in mostly public funding to support more than a dozen promising COVID-19 vaccine candidates. The idea was that CEPI-funded manufacturers of successful vaccines would supply doses through COVAX, thereby ensuring access for all. COVAX's problems in securing supply are well documented. Of CEPI's four largest investments, two—the Novavax and Oxford–AstraZeneca vaccines—have been given WHO Emergency Use status and only the Oxford–AstraZeneca vaccine so far has been distributed globally in significant volumes. After delays, deliveries of Novavax vaccine to Australia, Austria, France, and Germany began in the first months of 2022. COVAX has been allocated 13 million doses but shipments have not yet begun. “We are of course disappointed that first supply [of Novavax] has not yet come to COVAX”, a CEPI spokesperson said. A burning issue at the centre of CEPI's work through the COVID-19 pandemic has been how to ensure that unprecedented scientific advancements benefit the many rather than the few. CEPI's mission is to accelerate the development of vaccines and other biological countermeasures against pandemic threats, “so they can be accessible to all people in need”. However, grossly unfair distribution of vaccines and other COVID-19 tools have plagued the global COVID-19 response, in which CEPI is a key player. Tedros Adhanom Ghebreyesus, Director-General of WHO, highlighted this dilemma at the CEPI replenishment meeting. He welcomed CEPI's 100-day mission and urged donors to fully fund the $3·5 billion ask. But he added a warning: “the pandemic has…taught us that science can actually serve to widen inequalities rather than narrow them…As we speak, 83 percent of the population of Africa is yet to receive a single dose of vaccine, and there is an even wider discrepancy in access to tests”. Civil society organisations worry that CEPI's work to hasten the development of new vaccines risks deepening this divide even further. In the worst case, a successful vaccine against a new deadly pathogen, produced in just 3 months, would quickly become available in high-income countries but remain out of reach for everyone else. Manuel Martin at the Médecins Sans Frontières Access Campaign says that CEPI has been “spot on” when it comes to the science and “ahead of the curve” in many of its investment decisions. “It's just that we haven’t really seen the impact that they were meant to have on equitable access in a real and tangible way,” he says. Martin has written a policy brief on CEPI, seen by The Lancet, for the People's Vaccine Alliance, a coalition of 100 civil society organisations coordinated by Oxfam. In it, he writes that CEPI's governance structures and policies are in need of fundamental reforms to ensure fair global distribution of future medical innovations. CEPI's equitable access policy, which was whittled down from 13 pages to two back in 2018, is described as “brief, vague, and weak”. Only four of 12 voting board members are from LMICs, and there is no civil society representative. The minutes of CEPI's equitable access committee, which was created in 2019, have not been published on CEPI's website since May, 2020. And of the 17 COVID-19 vaccine candidates and platforms that CEPI has invested in, only five are in LMICs, all of which are in Asia; none is in Latin America or Africa. Martin acknowledges CEPI's recent support to MADIBA, the regional manufacturing hub for COVID-19 and other vaccines in Senegal. But he says that this support has come late. “This is great. But we are into the third year of the pandemic.” A mid-term review of CEPI from last year refers to opposing views between private sector and civil society stakeholders on CEPI's performance in implementing its equitable access provisions. While civil society organisations want to limit the power and influence of pharmaceutical companies over CEPI's funding decisions, others worry that the conditions attached to CEPI's funding agreements have made CEPI an unattractive partner for big pharmaceutical companies. CEPI's commitment to equitable access will be further tested in its work on the 100-day mission in the event of another pandemic. Martin says that this lofty goal risks, again, being relevant for high-income countries only. “The only technology that can even get close to this 100-day objective is mRNA. And the only developers of licensed mRNA vaccines are in high-income countries. So, unless CEPI really invests in mRNA in LMICs, and supports manufacture and development of mRNA in LMICs, the results of all this effort will be skewed toward high-income countries rather than LMICs,” he says. CEPI does not dispute that innovations in mRNA technology will be needed to make vaccines more widely accessible. “It is fair to say there is a strong emphasis on mRNA in the rapid response platform,” says Melanie Saville, CEPI's executive director for vaccine research and development. She explains that the mRNA vaccine was chosen as the initial platform for pilot projects to develop vaccine libraries and prototype vaccines to meet the 100-day mission because it is currently the fastest platform to develop and modify. “The platform developed through these efforts can then be transferred to other technologies in the CEPI portfolio,” she says. CEPI is looking into ways to make mRNA vaccines more easily storable and transportable, to ease the logistical issues related to cold chain, and to improve access for populations in LMICs. Saville says that CEPI is committed to providing equitable access of vaccines to LMICs, which includes vaccines for the 100-day mission to respond to the emergence of a disease X. “The goal is to develop a diversity of very safe and highly effective vaccines for LMICs, but also to develop the platforms as a rapid response platform in the event of a disease X emergence,” she says.