The coronavirus vaccine
Everything you need to know, from vaccine development to clinical use.
When will a coronavirus vaccine be available?
There is still no clear answer to this question but various factors play a role. Quality standards for vaccines may vary considerably from country to country. Even after a vaccine has been approved it may be difficult to ensure mass distribution for logistical reasons. Therefore, some countries may get faster access to the vaccine than others. Certain sections of the population may also be given priority access to the vaccine based on health risk profiles.
For Germany, the most important consideration is that the vaccine has successfully completed all phases of vaccine development.
The exact timing of vaccine approval depends on many factors and is difficult to predict. For now – and the foreseeable future – complying with precautionary measures such as social distancing, wearing face masks, and general hygiene are extremely important.
The level of immunity achieved by vaccination will determine when it is safe to dispense with these measures. If the vaccine works well and enough people are vaccinated, we can prevent the rapid spread of infection.
The following figure shows the current status of coronavirus vaccine development (Source):
Vaccine development
Vaccine development follows a standard set of steps: In the first step, which takes place in the laboratory, researchers identify which structures on the pathogen (disease-causing microorganism) can elicit a sufficient response in the human immune system. Since a vaccine is a highly modified form of the pathogen, there is no risk of infection.
As with all medicines, we need to ensure that vaccines are safe and effective. During the clinical phases, the vaccine is tested on increasingly large groups of people in clinical trials. Only a fraction of vaccines are approved following careful testing in these trials.
Due to the urgency of the COVID-19 pandemic, some researchers are accelerating the vaccine development process by combining Phase 1 and 2 or 2 and 3 clinical trials. Fast-tracking approval is also possible in emergency situations.
Vaccine development process
Vaccines currently in development
A variety of different vaccine types are currently being developed and tested. The table below provides a detailed overview of the different vaccines tested and the development timeline.
Different approaches are used in vaccine development: Some rely on tried and trusted concepts while others involve testing completely new methods. No matter which approach is taken, all vaccines have to go through the same approval steps and their safety and efficacy must be proven in clinical trials. In the end, the main differences between different vaccine types are the different methods that they use to stimulate the human immune system.
Traditional vaccines work by delivering viral components (antigens) to antibodies and immune cells in the body. Newer vaccines, on the other hand, train the immune system by delivering the instructions or “blueprint” for producing the viral antigens instead. It is conceivable that several different vaccines and vaccine types will be available at the same time.
The following figure shows the number and type of vaccines that are currently in each phase of development and testing (State 30.11.2020, Source):
Approval of vaccines in Germany and Europe
Four different procedures are possible for the approval of a vaccine in Germany:
- A national approval procedure according to the German Medicinal Products Act (Arzneimittelgesetz, AMG)
- A mutual recognition procedure (MRP) based on the recognition of a pre-existing national marketing authorization by another member state of the European Union (EU)
- A decentralized procedure (DCP) with the simultaneous submission of applications for marketing authorization by more than one EU member state
- A centralized European procedure via the European Medicines Agency (EMA)
The pharmaceutical companies must fulfill the following five conditions, which are standardized across the European Union, the United States, and Japan:
- Compliance with administrative requirements regarding, for example, user information (package leaflet) and detailed plans for follow-up
- Detailed summaries of the procedure
- Documentation of quality and of the manufacturing methods used
- Results of preclinical laboratory studies of efficacy
- Comprehensive report on human clinical trial phases
Will the coronavirus vaccine be mandatory?
After a vaccine has completed all test phases and been officially approved, the Standing Committee on Vaccination (STIKO) in Germany conducts a scientific evaluation of the vaccine at population level and provides recommendations. These recommendations form the basis for the Vaccination Directive (SI-RL) of the Federal Joint Committee (G-BA), which ensures that vaccinations (with the exception of travel vaccinations) are paid for by health insurance.
Making vaccines mandatory is also subject to legal limitations: Section 20 (6) of the German Protection against Infection Act (Infektionsschutzgesetz, IfSG) stipulates that the Federal Ministry for Health shall be empowered to declare vaccination compulsory only with the consent of the federal states in the German Bundesrat. In addition, mandatory vaccination would only apply to risk groups within the population that could develop a severe form of the disease.
The German population is indifferent to vaccination, whether it’s mandatory or voluntary. A COSMO study monitoring sociologically relevant variables related to coronavirus found that acceptance of vaccination is slightly declining every two weeks.
Due to insufficient data on long-term immunity and the unpredictable social implications of immunity certificates, the German Ethics Council currently rejects such certificates as evidence of a past infection. The Ethics Council’s statement is available (in German) here.
Vaccination intention and belief that vaccination against coronavirus should be compulsory
Rated on a scale from 1 (rejection) to 7 (acceptance).
Mean values and 95% confidence intervals.
The percentages represent the proportion of people who agree (strongly) with the statements.
Between May 19 and June 9 no acceptance of compulsory vaccination was recorded.
Who should get vaccinated?
Due to ongoing clinical trials and incomplete data, there are currently no specific recommendations about who should get vaccinated. However, the Robert Koch Institute (RKI) and the Standing Committee on Immunization (STIKO) have drafted a general, risk-based, prioritization strategy with the goal of preventing as many severe cases and deaths as possible.
Various factors might play a role in future vaccination recommendations. These include age, pre-existing conditions, or exposure at work – especially for people who work in hospitals or schools. A final recommendation will be made based on vaccine properties and epidemiological data.
You can find out more about the topic of vaccination in our article “Lässt sich die Grippe von COVID-19 unterscheiden und lohnt sich eine Grippeimpfung?", which is currently only available in German.
What are the potential side effects?
The top priority in the whole approval process is making sure these vaccines are safe. Investigating side effects is one of the most important research questions in current clinical trials. Up-to-date preliminary data on the side effects of individual vaccines is available in the www.clinicaltrials.gov database. Different vaccination types might have different side effects, but the basic safety of a vaccine is tested during the early clinical phases.
Some rare side effects may only become apparent after the vaccine has been approved. For this reason, vaccines are monitored even after approval. As with all medicines, anyone – not just doctors – can report side effects directly to the Paul-Ehrlich-Institute.
