All countries throughout the world must have affordable access to COVID-19 vaccines. The Paul-Ehrlich-Institut supports this goal with its international network.
Viruses do not respect international borders – a pandemic has to be dealt with on a global basis. Countries in different regions and parts of the world are faced with unequal challenges. The virus not only endangers the health of entire populations, but the social and economic effects can also destabilise states, which may have an impact on global political stability. Furthermore, a country in which the infection has not been contained becomes a viral reservoir from which a new wave of the pandemic may emerge. In the long term, the pandemic can only be countered with a common strategy. The prerequisite for this is equitable global access to COVID-19 vaccines, therapeutics and diagnostic devices.
Global regulation of medicinal products
A common regulatory understanding by medicines agencies across the globe forms an important basis of this approach. Prof. Klaus Cichutek, President of the Paul-Ehrlich-Institut, represents Germany in the International Coalition of Medicines Regulatory Authorities (ICMRA), an association of 29 medicines agencies from all parts of the world. Its goal is to facilitate global access to safe, effective, high-quality medicinal products. To this end, the Coalition supports binding scientific standards and efficient regulatory processes throughout the world. The network has published several position and strategy papers for a common approach to the COVID-19 pandemic.
The Paul-Ehrlich-Institut has used its international network to pave the way worldwide for the development, marketing authorisation and availability of COVID-19 vaccines.Prof. Klaus Cichutek , President of the Paul-Ehrlich-Institut
The Paul-Ehrlich-Institut has been working closely with the World Health Organization (WHO) for almost 20 years; two WHO collaborating centres are based at the Institute. Prof. Cichutek is chair of the WHO Expert Committee on Biological Standardization (ECBS) and a member of the higher-level Strategic Advisory Group of Experts on Immunization (SAGE). SAGE issues recommendations on the optimum use of vaccines and advises WHO on the global approach to the distribution of vaccines. The ECBS draws up recommendations and guidelines for the development, manufacture, licensing and control of vaccines, blood products and in vitro diagnostics. The establishment of WHO reference materials is also one of the responsibilities of the ECBS. The Paul-Ehrlich-Institut has already prepared several reference materials for COVID-19 diagnostic devices for WHO and is working with other experts, under the auspices of WHO, to develop guidelines for the testing of mRNA vaccines against COVID-19.
Global coalitions with a common goal
During the pandemic, public-private partnerships of governments, private charitable foundations and businesses are supporting the development and marketing authorisation of COVID-19 vaccines, as well as their acquisition and distribution. As a research platform, the Coalition for Epidemic Preparedness Innovations (CEPI) supports and finances the complete development of a vaccine through to the finished product. The Gavi Vaccine Alliance promotes the expansion of national vaccination programmes. Gavi has the infrastructure to purchase large quantities of vaccines inexpensively and to distribute them worldwide. This makes the Alliance a key player in the acquisition and global distribution of COVID-19 vaccines. The COVAX (Covid-19 Vaccines Global Access) initiative pools the expertise of WHO, Gavi and CEPI to ensure equitable access to COVID-19 vaccines throughout the world. By the end of 2021, all countries, irrespective of their income, are expected to receive sufficient COVID-19 vaccines to protect the most vulnerable 20% of their populations. Germany supports these initiatives financially and was a founding member of CEPI and Gavi.
WHO: World Health Organization
1948 as a specialised agency of the United Nations with 194 member states and its headquarters in Geneva, Switzerland
Promoting the general health of people around the world In order to combat infectious diseases, the World Health Organization (WHO) coordinates international activities, launches global vaccination programmes and supports the development of effective healthcare systems in the Global South. WHO monitors the epidemiological development of infectious diseases and declares a pandemic if an epidemic becomes a global threat, as in the case of the SARS-CoV-2 pandemic. By means of a prequalification, WHO also makes effective and safe medicinal products available to low-income countries. WHO is currently coordinating worldwide measures to deal with the pandemic.
CEPI: Coalition for Epidemic Preparedness Innovations
2017 as a public-private partnership with headquarters in Oslo, Norway
Development of vaccines for the prevention of epidemics
As a consequence of the devastating Ebola epidemic of 2014/15, the Coalition for Epidemic Preparedness Innovations (CEPI) was formed as a public-private partnership with members from governments, private charitable foundations, research institutions and vaccine manufacturers. Germany was one of the founding members.
The research platform finances the complete development of a vaccine from the start to the finished product. In this regard, CEPI focuses on WHO’s priority list of indispensable medicinal products. During the SARS-CoV-2 pandemic, CEPI concentrated on the development of COVID-19 vaccines.
Gavi: The Vaccine Alliance
2000 as a public-private partnership with headquarters in Geneva, Switzerland
Protecting people in the Global South by means of vaccinations against preventable diseases
The Gavi Vaccine Alliance is a public-private partnership of governments, WHO, UNICEF and the World Bank, private charitable foundations, health and research institutions, non-governmental organisations and vaccine manufacturers. Germany was a founding member.
Gavi supports the expansion and sustainable funding of national vaccination programmes. By pooling the global demand for vaccines, the Alliance can buy large quantities at low prices. These assured purchase quantities are an incentive for manufacturers to produce urgently needed vaccines inexpensively. During the pandemic, Gavi is making its expertise, contacts and established distribution channels available for the equitable distribution of COVID-19 vaccines.
COVAX: Covid-19 Vaccines Global Access
2020 as the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator
The equitable worldwide distribution of COVID-19 vaccines
WHO, Gavi and CEPI implemented the COVAX vaccine platform to ensure equitable global access to COVID-19 vaccines. By the end of 2021, participating countries, irrespective of their income, are expected to receive sufficient vaccines to protect the most vulnerable 20% of their populations. 190 out of around 200 countries worldwide are participating in COVAX (April 2021), consisting of 98 more prosperous countries and 92 low-to-middle-income countries.
COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, which was established by WHO, the European Commission and France. The other pillars are therapeutics and diagnostics.
ICMRA: International Coalition of Medicines Regulatory Authorities
2012 as a voluntary association of 29 medicines agencies from all regions of the world.
The worldwide availability of effective and safe medicinal products
The International Coalition of Medicines Regulatory Authorities (ICMRA) aims to facilitate worldwide access to effective, safe, high-quality medicinal products. The prerequisites for this are shared scientific standards and evidence-based regulatory processes. During the pandemic, the ICMRA and WHO have joined forces to establish globally agreed regulatory processes for COVID-19 vaccines, therapeutics and diagnostic devices.