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Bundesministerium für Gesundheit
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16:54 Uhr · 15. Dezember 2020

Vaccines, Immunity and Medicines: Combating COVID-19

Around the world, researchers are working on a COVID-19 vaccine. Read on to learn about the phases of vaccine development and what Germany and the EU are doing to make a vaccine available quickly.

Research institutes and pharmaceutical companies are conducting intensive research in the race for a COVID-19 vaccine. But despite their ongoing efforts, face coverings, hygiene and distancing remain important for everyone to avoid infection.

The vaccine development process

Developing a new vaccine usually takes years. Although the new coronavirus (SARS-CoV-2) was only identified as the cause of COVID-19 in early 2020, a number of vaccine development projects are already well advanced. To end the COVID-19 pandemic, effective, tolerable and safe vaccines must be made available in sufficient quantities worldwide. 

Before a vaccine can be approved, it goes through several development phases.

In the first phase, suitable antigens are identified. Here, the focus is on finding what antigen can trigger the desired reaction in the immune system and thus provide protection against the coronavirus. A decision is also made on what vaccine platform is best used to produce the new vaccine. Laboratory tests and pre-clinical trials are conducted to see if a specific immune response against the antigen is induced and if there may already be indications of potential intolerances and side-effects.

A clinical trial phase follows in which the vaccine is administered to humans for the first time. This is the phase where tolerance, dose and the vaccination schedule are decided in tests on a small group of volunteers. In trials involving several thousand volunteers, the efficacy and safety of the vaccine is closely examined. Only when it passes through all of these phases can evidence be provided that a vaccine is sufficiently tolerable, effective and safe. If the results of the tests and trials are positive and a favourable risk-benefit ratio is confirmed, the vaccine is approved for broad application. 

For the EU, approval processes for COVID-19 vaccines are usually coordinated by the European Medicines Agency and approval is given by the European Commission. In Germany, the Paul Ehrlich Institute (PEI), as the competent higher federal authority for vaccines and biomedical medicinal products, is responsible for advising vaccine manufacturers, licensing issues and the testing of COVID-19 vaccines.

Approaches taken in the search for a COVID-19 vaccine

Research institutes and companies are following a variety of different paths in the search for a vaccine against the new coronavirus. The following options in developing a vaccine are currently being pursued. One is the development of a live vaccine, similar to the one we are familiar with in vaccinating against measles and in which weakened (or attenuated) viruses are used. So-called viral vector vaccines using certain attenuated viruses (e.g. smallpox vaccine viruses) as well as non-replicating – meaning non-reproducible – viral vector vaccines containing target structures of the new coronavirus are also being developed, for example on the basis of certain adenoviruses. Another option involves the development of an inactivated or dead vaccine consisting of viral proteins of the killed pathogen itself or of individual components of them. This type of vaccine is used, for example, in some influenza vaccines or pneumococcal vaccines. Innovative RNA – and DNA – vaccines are also being developed on nucleic-acid platforms. These vaccines contain selected fragments of the genetic material of a virus. RNA is used, for example, as so-called messenger RNA (mRNA) in the vaccine and causes the formation of (harmless) viral protein in the body after the injection, which then causes the immune protection to be built up, as with a conventional vaccine. 

Can the process be accelerated?

Until a few years ago, it would have taken between 10 and 20 years to go through all the stages of vaccine development. However, new technologies, previous experience from vaccine projects against related viruses and existing production platforms, as well as intensive support from the responsible authorities, make tremendous acceleration possible – especially in early development of these vaccines.

But nonetheless, developing a vaccine takes time. To better understand the effects and possible side-effects, extensive data must first be collected in non-clinical and clinical tests and trials. As part of that process, successive studies with increasing numbers of test persons are carried out. At the Paul Ehrlich Institute, which advises on the development of vaccines, approves the implementation of clinical trials in Germany and is involved in or carries out the approval processes in the licensing of vaccines, all procedures connected with the development of vaccines against COVID-19 are currently underway with the deployment of increased numbers of staff. Thanks to these and many other accelerations on the administrative side, the approval processes take less time but with the same level of attention and care. 

Around the world, several different vaccine development approaches are now in pivotal Phase 3 clinical trials and some are already targeted for approval, possibly in 2020 or early 2021.

And in the EU? How will the vaccines be distributed?

Germany began securing production capacity at an early stage. In June, we joined forces with the Netherlands, Italy and France to form a vaccine alliance. The activities involved were conducted in conjunction with the European Commission to further increase the impact with which we could work. The European Commission, with key input from the Federal Ministry of Health, is now negotiating agreements with manufacturers of promising vaccine candidates on behalf of the EU member states. The aim is to build up production capacity for vaccines in the EU in good time by means of advance purchase agreements (APAs) and to secure purchase options for EU member states for vaccine doses from different manufacturers and based on different platform technologies. The EU Commission has already signed APAs with a number of pharmaceutical companies. Under the provisions of those APAs, Germany is entitled to receive the number of doses corresponding to the German share of the total EU population.

Also, in September Germany joined the international vaccine platform COVAX as part of a “Team Europe” approach. COVAX is committed to ensuring fair and transparent global distribution of future COVID-19 vaccines and aims to provide access to vaccines to the 92 low and middle-income countries participating in the COVAX initiative. COVAX is financed as part of development cooperation. Both the EU and Germany provide funding to COVAX for use in vaccine procurement in low-income countries.

Who can be vaccinated first?

As vaccines cannot be produced in sufficient quantities to begin with, it is not expected that sufficient vaccine doses will be available to vaccinate the entire population immediately they are approved. 

In Germany’s National Vaccination Strategy, ethical principles are applied to ensure fair distribution of a potential COVID-19 vaccine. In an initial phase, risk groups and especially vulnerable sections of the population, such as hospital staff, will be vaccinated first. In the second phase, the vaccine will be distributed to the entire population.