100-day vaccine development and an ‘all-in-one’ coronaviruses vaccine: CEPI’s $3.5bn ambition
Such a plan could potentially avert millions of deaths and trillion of dollars in economic damage, notes the organization, as it sets out a five-year period for achieving its goals.
Supporters of the plan include the governments of Germany, Norway and Ethiopia; major philanthropies Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; global health institutions such as WHO, Gavi and UNICEF; and industry partners.
The plan would tackle SARS-CoV-2 – both now and against emerging variants – as well as looking at future threats such as Nipah.
Learning from COVID-19
'We can never let this happen again'
“COVID-19 has killed millions and destroyed the livelihoods of hundreds of millions of people. By the end of 2025, it will have cost the global economy $28 trillion.
“We have the tools. We know what we need to do. For the first time in history, we can credibly aim to eliminate the risk of epidemics and pandemics.”
CEPI highlights the human and economic cost of COVID-19 – but also underlines the unique set of circumstances and collaborations that have emerged as a result.
“It is vital that we capitalise on the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again. But if we do nothing, it will—and perhaps soon," it says as it launches its plan.
“We were fortunate, in a way, that COVID-19 was caused by a coronavirus and that we could build on years of work on vaccines against related coronaviruses to rapidly develop highly effective vaccines against it.
"However, developing vaccines against a new pathogen—one that mutates quickly, is highly transmissible, and deadly—could take much longer.”
It is now setting out to raise the funds to make its ambitions a reality.
Priority #1: SARS-CoV-2 variants
CEPI – one of the partners behind the global COVAX vaccine scheme – notes the implication of COVID-19 virus variants as they evolve, and whether vaccines will continue to be effective against them.
“CEPI is therefore urgently seeking to mobilize $1bn in 2021 of the $3.5bn plan, so the organization can carry out critical R&D that will enable us to meet the challenges of this rapidly evolving pandemic and facilitate equitable access to safe and effective vaccines.
“If we are to secure the gains we have made in the past year, and end the acute phase of this pandemic as soon as possible, we must move aggressively to control the spread of these variants. CEPI will not delay in starting this vital work immediately.
"We have already launched R&D programmes to initiate development of next-generation vaccines against COVID-19 variants and we are planning studies to answer critical scientific questions related to the durability of immunity, effectiveness of mixed-vaccine regimens, and vaccine effectiveness in vulnerable populations such as pregnant women.
"We are also bringing forward our plans to develop vaccines that could protect against multiple COVID-19 variants and other coronavirus species."
Cut vaccine development to 100 days
An unprecedented effort saw COVID-19 vaccines become available in less than a year. But CEPI wants to accelerate this program further, targeting 100 days.
“During COVID-19, the time from the release of the SARS-CoV-2 genetic sequence to the submission of Phase 3 clinical trial data of the first vaccine candidate for regulatory review was 314 days. But against a threat such as COVID-19, this was far too long. Our “moonshot” will be to compress this timeline to just 100 days.
“Had this timeline been achieved during the COVID-19 pandemic, regulatory review would have begun in April 2020, 7 months faster than the 10½ months achieved by Pfizer/BioNtech with their mRNA vaccine. A vaccine could have been ready for emergency use much sooner, potentially averting millions of deaths and trillions of dollars in economic damage. Instead of the first injections occurring on December 8, 2020, when more than 67 million cases had been confirmed, they might have begun on May 8, when fewer than 3.8 million cases had been recorded.
“100-day vaccine development is an ambitious objective, but it is what we must achieve if we are to break the cycle of epidemics and pandemics stalking humanity.”
This could become possible by optimizing the capabilities of rapid response platforms including mRNA, which has been successfully used by Pfizer and Moderna among others to speed vaccines into use.
Further stages of the development process could also be accelerated, says CEPI. That could mean developing clinical trial networks to respond rapidly to new threats, as well as working with authorities worldwide to streamline regulatory requirements. Manufacturing facilities could also be linked to enable rapid production of pandemic vaccines.
Later this month, CEPI will launch a Call for Proposals to provide $200m funding for an ‘all-in-one’ vaccine that could provide protection against a broad range of coronaviruses, including SARS, MERS-CoV and SARS-CoV-2.
“SARS-CoV-2 is the seventh human coronavirus to be identified, but it is highly unlikely to be the last. The coronaviruses that cause SARS and MERS have far higher mortality rates than COVID-19, but fortunately are significantly less transmissible. The emergence of a coronavirus combining the transmissibility of COVID-19 with the lethality of SARS or MERS would be utterly devastating, so a successful all-in-one coronavirus vaccine would be a powerful tool in preventing the devastating human and economic costs of future coronavirus pandemics and epidemics."
CEPI's six-point plan
- Strengthen defenses against COVID-19 and reducing the risk of future coronavirus pandemics, by optimizing current vaccines, addressing variants of concern, developing next-generation COVID-19 vaccines, and initiating the development of broadly protective or universal coronavirus vaccines.
- Develop vaccines for known threats, to include completing the development of vaccines for Chikungunya, Lassa Fever, Nipah, and MERS, advancing the development of vaccines against Rift Valley Fever, and completing additional clinical trials to broaden the populations eligible for the Ebola vaccines.
- Work to compress vaccine development timelines to 100 days by optimizing the capabilities of rapid response platforms including mRNA, preparing clinical trial networks to respond rapidly to new threats, working closely with global regulators to streamline regulatory requirements, and linking manufacturing facilities to enable rapid production of pandemic vaccines.
- Produce a library of prototype vaccines and other biological interventions against representative pathogens from critical viral families. The “library of prototype vaccines” will be developed through phase 1 clinical trials and use rapid response platforms that will allow rapid adaptation if related viruses emerge.
- Establish global networks for lab capacity, assays, and preclinical models that are critical for rapid vaccine development and developing arrangements with existing national or regional clinical trial and manufacturing networks.
- Support the efforts of low- and middle-income countries to take full ownership of their national health security by developing the infrastructure and expertise to conduct epidemiological and clinical studies, support technology transfer, and establish national and regional vaccine manufacturing.
CEPI's investment case can be found in full here.