Pandemic preparedness: defense against the next pandemic
Many experts are certain that the question is not whether, but only when, the next pandemics can be expected. Politicians, organizations, research institutes and the research-based pharmaceutical industry are therefore already working to strengthen preparedness for such pandemics worldwide. One important building block: the German government's planned standby contracts with manufacturers for vaccine development and supply in the event of a pandemic.
In mid-January 2020, development programs for vaccines against SARS-CoV-2 began worldwide. The first vaccine was approved after only about 300 days - an achievement that would have seemed impossible in 2019. However, things would have to move even faster in the future: That's because the probability of a pandemic with similar effects to COVID-19 is quite high, at about two percent per year. This is the conclusion reached by a team from the Nicholas School of the Environment at Duke University in the United States. And because environmental changes are estimated to make it increasingly easy for pathogens to jump from the animal kingdom to humans, this probability is likely to double in the coming decades.
The Coalition for Epidemic Preparedness Innovation (CEPI)
To be better prepared in the future, preparations must be addressed now. That's why the Coalition for Epidemic Preparedness Innovation (CEPI), which is co-financed by Germany, announced as early as March 2021 that it would raise $3.5 billion for a "moonshot" program. It aims to shorten the time between pathogen sequencing and approval of a vaccine for emergency use to 100 days. Contributions to fund the effort have been pledged by the Bill and Melinda Gates Foundation and the Wellcome Trust, among others.
The first projects funded under this program are already underway. For example, Affinivax (USA) and SK Bioscience (South Korea) and a consortium led by BioNet (France-Thailand) are working on vaccines that will protect against all beta-coronaviruses and all sarbecoviruses (a subgenus of beta-coronaviruses).
Several elements of this five-year plan have been adopted by other institutions and organizations, such as the United States, including the 100-day target.
The Pandemic Preparedness Partnership (PPP)
The "moonshot" idea also found its way into the Pandemic Preparedness Partnership (PPP), which the UK government launched in April 2021. It brings together industry, international organizations and leading scientists:inside. As they understand it, the 100 days is the period of time from the declaration of an international health emergency by the WHO: after which a stockpile of vaccines, diagnostics and therapeutics should be available. Like CEPI, PPP expects to achieve this through global collaboration in data sharing, research and development, clinical trials and manufacturing. The ambitious plan won the support of other heads of state and government at the G7 summit in Cornwall, UK, that same year and later at the G20 meeting in Rome.
In early December 2021, the British government published a first interim report by the G7 chief scientific advisors. It cites progress made including the establishment of a Global Pandemic Data Alliance (GPDA) or progress made by research institutes and industry on platform technologies for vaccines and therapeutics such as mRNA or viral vectors.
In 2022, the PPP plan calls for global agreement on which virus families should be the focus of prototype vaccine development, ready for adaptation to a specific pathogen if the need arises. This is one of the approaches CEPI is taking. PPP is about making it possible to assess how likely a particular family of viruses is to give rise to the causative agent of a new "disease X" that is dangerous to humans. Building on such an assessment, a priority list will then be established in collaboration with WHO to best guide research and development funding by governments, philanthropic organizations and industry. In developing the assessment method, the experts are in exchange with the US National Institute of Allergy and Infectious Diseases (NIAID), which is pursuing its own approach to identifying such pathogens.
The WHO Hub for Pandemic and Epidemic Intelligence
The WHO Hub for Pandemic and Epidemic Intelligence has also been opened in Berlin in September 2021 for research and global surveillance of "risky" pathogens. There, artificial intelligence will be used to evaluate data sets on topics such as animal health, the occurrence of unusual diseases in humans, the consequences of climate change and the impact of regional behavioral changes of various kinds. Model calculations will then enable risk assessment for pandemics so that countermeasures can be taken at an early stage.
It is, among other things, the experience with MERS-CoV (the causative agent of MERS, a disease prevalent in Arab countries) that is driving these advance strategies. Finally, knowledge of this coronavirus has helped Covid-19 vaccines to be developed so quickly.
Diagnostics and therapeutics organizations
Other organizations have other aspects of pandemic preparedness in mind. In the area of diagnostics, these include the non-profit organization Foundation for Innovative New Diagnost ics FIND, which has been working for many years on diagnostics that can be used in poorer countries.
In contrast, the International Readiness for Preventing Infectious Viral Disease Alliance, or Intrepid Alliance for short, is working on antiviral therapeutic drugs. This alliance aims to bring together research-based pharmaceutical companies to work with non-profit organizations to develop 25 oral therapeutics over a five-year period until clinical phase 1 (i.e., testing in healthy individuals) is completed.
The Center for Pandemic Vaccines and Therapeutics (ZEPAI)
For such strategies to achieve their goal, efforts must also be made on the regulatory side. In Germany, the Federal Ministry of Health established the Center for Pandemic Vaccines and Therapeutics ZEPAI at the Paul Ehrlich Institute in October 2021. One of its core tasks is to establish an infrastructure that will enable the population to be supplied with effective and safe vaccines and therapeutics as quickly as possible in the event of an emergency. To this end, a pool of interdisciplinary experts is to be set up, covering the entire spectrum of pandemic-relevant disciplines: from production to logistics, infectiology or communications, and public health care. Among other things, the aim is to establish digital data collection and monitoring structures to control and optimize planning and logistics.
Companies and consortia with which the German government plans to conclude pandemic preparedness contracts
ZEPAI will also draw on the companies with which the Federal Government concluded pandemic preparedness contracts in May 2022: With the conclusion of the contract, the companies have committed themselves to using production capacities for mRNA-, vector- and protein-based vaccines in the event of an emergency in such a way that they can produce vaccine against the pathogen in question within months. A total capacity is envisaged that goes far beyond Germany's own needs, as the capacities are also to contribute to the supply of other countries.
As long as no new pandemic or epidemic has broken out, ZEPAI will also support the conception of projects in the field of pandemic preparedness and accompany them until they are approved. If the situation becomes serious, ZEPAI will coordinate and support all necessary steps for the care of the population.
Germany does not intend to go it alone in pandemic preparedness. Therefore, ZEPAI will also ensure communication with other national and international actors.
The European Health Emergency Response Authority (HERA)
A new regulatory actor at the EU level is HERA, the Health Emergency Preparedness and Response Authority. HERA reports to the EU Commission. Its tasks largely correspond to those of ZEPAI (but with the entire EU in mind), which is why the two institutions are to cooperate closely. Like ZEPAI, HERA is to operate initially in a preparatory mode and, in the event of an emergency, switch from "cross-border health threats" to a crisis mode. Then HERA is to convene a crisis team to quickly order vaccines and therapeutics for the entire EU and to promote targeted research and development. Representatives of the EU Commission and member states will then sit on this team to enable rapid decisions to be made.
The pharmaceutical industry
In response to the Covid 19 pandemic, a plethora of projects have been initiated in the pharmaceutical industry, a double-digit number of which have now resulted in approved vaccines and therapeutics against SARS-CoV-2. However, quite a number of the projects still underway are aimed not only at this one pathogen, but at agents that could be used against other pathogens in the beta-coronavirus family, should they spill over into the human population. The aforementioned Intrepid Alliance is also looking at other families of pathogens with the participation of companies.
CEPI, ZEPAI, HERA, and other government or government-supported institutes are doing essential work and channeling grant funds to address important preparatory activities and ensure better and faster international information sharing in the future. Essential, however, remains the role of pharmaceutical companies because they are the ones who develop and produce vaccines and therapeutics against new pathogens and also do most of the preparatory work needed to do so. Despite subsidies, they finance most of their work privately. Private investment and the necessary patent protection are therefore a crucial basis for ensuring that vaccines and therapeutics are available as quickly as possible in the event of another pandemic.