Aspects of Testing for and Vaccinations against Coronavirus in Germany and Worldwide
Introduction: Coronavirus has become an important topic of conversation once more. Every day, we follow the news, essentially to be able to assess how high the risk is in everyday life. Targets: This report aims to provide information on the current situation in Germany, simply what people can and should know. Method: The approach includes the investigation and evaluation of literature, analysis and interpretation in the context of the research issue. Results: It appears that a consistently implemented lockdown, together with testing and vaccinations, would be able to curb the effects of the COVID-19 virus. Conclusions: These precautionary measures must be taken and each individual must behave responsibly in order to prevent infection with coronavirus. Vaccinations and tests must be carried out consistently. Outlook: As can be seen, basic immunisation of the population has taken place in Germany.
Introduction
Tests are among the most important tools in the fight against the novel coronavirus. For this reason, Germany has been rapidly establishing and expanding test capacities since the beginning of the pandemic.
- Who is being tested?
- Adaptation of the national testing strategy for the autumn/winter season 2020/2021.
- How to react if you suspect you are infected.
• How a SARS-CoV-2 test is carried out.
Who is Being Tested
When testing, a targeted approach is important. Testing without cause leads to a false sense of security. Even a negative test is also merely a snapshot of a moment and does not absolve the individual from hygienic and preventive measures (keyword AHA+L [keeping distance, hygienic measures, wearing a mask, airing]). Testing without a reasonable suspicion also increases the risk of false positive results and puts strain on the existing test capacity. For this reason, we should test more intensively, but also in a targeted manner [1].
Adaptation of the National Testing Strategy for the Autumn/Winter Season 2020/2021
Those with minor cold symptoms who do not belong to a risk group or have not had contact to someone infected with SARS-CoV-2 will not be tested initially. This decision is to be made by the doctor treating them or contacted by them. These individuals should isolate themselves at home in order to reduce their number of contacts. The RKI recommends that this self-isolation last five days plus two days without symptoms. Those affected should clarify with their employer whether it is possible for them to work from home during this period. If necessary, they should discuss sick leave with their doctor.
The Following Groups of People are Only Entitled to Testing with Near-Patient Antigen Rapid Tests (Poc Antigen Tests) Within the Facility and Business Testing Concept
• Patients, those in assisted living facilities, those requiring care, above all in medical facilities for in-patient and out- patient care (excluding human medical, dental or other medical practices), in in-patient or day patient facilities for the care and accommodation of old, disabled and care-dependent people, of out-patient nursing services and integration assistance services and in day-care hospitals; without COVID-19 cases, according to the facility’s testing concept [1].
• Visitors above all in medical facilities for in-patient and out-patient care (excluding human medical, dental or other medical practices), in in-patient or day patient facilities for the care and accommodation of old, disabled and care-dependent people; immediately before visiting the facility.
Those entering Germany who have spent time in a high- risk area within ten days before entering the country must prove that they are not infected with coronavirus within 48 hours after entering the country. The public health authority responsible or another authority determined by the state can request submission of a negative test result up to ten days after entrance to the country. Those entering from areas with a particularly high risk of infection must provide a negative test result before entering the country.
A negative test result regarding direct pathogen detection of coronavirus SARS-CoV-2 is deemed proof of testing. This proof of testing can be submitted in paper form or in an electronic document in German, English or French. In general, those entering Germany who have spent time in a high-risk area within ten days before entering the country must isolate at home immediately after entering the country. This isolation can also be ended with a negative test result after a minimum of five days. The details depend on the relevant regulations of the federal states.
Antigen tests which verify the presence of the SARS- CoV-2 protein structures work using a similar principle to that of pregnancy tests. A sample of a swab from the nose and throat is placed on a test strip. If the sample contains the SARS-CoV-2 virus, the protein components of the virus react with the test strip and a change in colour is seen on the test strip. The advantages of antigen tests are the comparatively low costs and the prompt test result (in less than 30 minutes). The ease of use of a point-of-care (PoC) antigen test makes testing also possible outside a laboratory, for example in a care facility or in medical facilities and medical practices without a diagnostic laboratory. Here, a PoC antigen test can help to easily identify asymptomatic and potentially infectious people and to prevent transmission of the virus with suitable measures such as temporary isolation at home. Generally, antigen tests are less sensitive than PCR tests, meaning that a larger quantity of the virus is required for the antigen test to show a positive result. This means that a negative antigen test result does not rule out the possibility of infection with SARS-CoV-2. An antigen rapid test is also not as specific as a PCR test, meaning that positive test results occur when the person is not infected more frequently than with PCR tests. For this reason, a positive antigen test must be confirmed with a PCR test [1].
National Vaccination Strategy
In this document, the essential components of a national vaccination strategy against COVID-19 will be described, as well as the systems with which vaccination of the population in Germany according to consistent standards and prompt evaluation of vaccines in the course of broad usage can be ensured. This document is intended to provide orientation and planning, as well as aid the responsible participants to address any existing omissions. Table 1 provides an overview of the elements and participants involved in the vaccination strategy.
After production of a potential vaccine candidate in the research laboratory, initial animal and cell culture experiments are carried out to examine whether the vaccine candidate, besides its tolerability, is suitable for evoking a protective effect against the target virus or the infectious disease it causes, if there is an animal model for this. Subsequently, toxicological and pharmacological properties are examined in various animal models. Only when there are no concerns regarding use in humans is the tolerability examined in a first clinical trial on healthy adult volunteers (Phase 1). In the subsequent clinical phases, the optimal dosage and vaccination scheme is examined in a larger number of volunteers (several hundred) (Phase 2) and finally the effectiveness and side-effect profile of the vaccine are determined in a large randomised controlled clinical study with several thousand volunteers in various age groups (Phase 3). Various new vaccine candidates (e.g. mRNA and DNA vaccines) are currently being developed and tested in clinical trials on various manufacturing platforms. The federal government sponsors research into vaccines and the production of vaccines, and is advocating for fair global distribution of vaccines in the spirit of global responsibility. Table 2 shows in particular the COVID-19 vaccine candidates for which EU market authorisation is, according to current information, aspired to, and for which early availability could be possible or where a sufficiently large quantity of vaccine doses could be provided for the beginning of a nationwide vaccination campaign in prioritised groups.
| Elements | Participants |
|---|---|
| Vaccine development | Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF)], universities, pharmaceutical companies |
| Vaccine authorisation | Paul Ehrlich Institute [Paul-Ehrlich-Institut (PEI)], European Medicines Agency (EMA) and European Commission, pharmaceutical companies |
| Vaccination recommendations and prioritisation | Standing Committee on Vaccination [Ständige Impfkommission (STIKO)], Robert Koch Institute [Robert- Koch-Institut (RKI)], Leopoldina National Science Academy [Nationale Akademie der Wissenschaften], German Ethics Council [Deutscher Ethikrat] |
| Production and procurement | European Commission, EU member states, BMBF, Federal Ministry for Economic Affairs and Climate Action [Bundesministerium für Wirtschaft und Energie (BMWi)], BMG, pharmaceutical companies |
| Distribution, storage and logistics | BMG, Federal Ministry of Defence [Bundesministerium der Verteidigung (BMVg)]/Federal Armed Forces [Bundeswehr], federal states, logistics specialists, pharmaceutical wholesalers, (hospital) pharmacies |
| Organisation and provision of vaccinations | Federal states, public health service [Öffentlicher Gesundheitsdienst (ÖGD)], National Association of Statutory Health Insurance Physicians [Kassenärztliche Bundesvereinigung (KBV)], Associations of Statutory Health Insurance Physicians in the federal states [Kassenärztliche Vereinigungen der Länder (KVs)], medical personnel |
| Financing | BMG, federal states, GKV, PKV |
| Communication, professional training and public education | Federal Centre for Health Education [Bundeszentrale für gesundheitliche Aufklärung (BZgA)], RKI, PEI, BMG, federal states, Academy of Public Health Services [Akademie für das Öffentliche Gesundheitswesen], professional societies |
| Vaccination coverage monitoring | RKI |
| Surveillance: Monitoring of vaccine effectiveness and vaccine safety in the course of broad usage | RKI, PEI, EMA, pharmaceutical companies |
| International coordination and cooperation | Federal Government, EU, scientific forums |
| Evaluation of overall process | BMG |
| Elements participants | BMBF |
| Vaccine development | |
| Federal Ministry of Education and Research | |
| Universities, pharmaceutical companies | PEI |
| Vaccine authorisation Paul Ehrlich Institute | |
| European Medicines Agency | EMA |
| European Committee, pharmaceutical companies | STIKO |
| Vaccine recommendations and prioritisation | |
| Standing Committee on Vaccination | |
| Robert Koch Institute | RKI |
| Leopoldina | National Science Academy |
| German Ethics Council Production and procurement | BMBF |
| European Commission, EU member states | |
| Federal Ministry for Economic Affairs and Climate Action | BMWi, BMG |
| Pharmaceutical companies | BMG |
| Distribution, storage and logistics | |
| Federal Ministry of Defence/Federal Armed Forces, federal states, logistics specialists, pharmaceutical wholesalers, (hospital) pharmacies | BMVg |
| Organisation and provision of vaccinations Federal states | |
| Public health service | ÖGD |
| National Association of Statutory Health Insurance Physicians, Associations of Statutory Health Insurance Physicians in the federal states, medical personnel Financing, federal states, Federal Ministry of Health, statutory health insurance, private health insurance | KBV |
| KVs | |
| BMG | |
| GKV | |
| PKV | |
| Communication, professional training and public education Federal Centre for Health Education | BZgA, RKI, PEI, BMG, |
| Federal states, Academy of Public Health Services, professional societies Vaccine coverage monitoring | RKI |
| Surveillance: Monitoring of vaccine effectiveness and vaccine safety in the course of broad usage | RKI, PEI, EMA |
| Pharmaceutical companies International coordination and cooperation Federal Government | EU |
| Scientific forums | BMG |
| Evaluation of overall process |
Table 1: Overview of elements and potential participants of the vaccination strategy [1].
Key
COVID-19 Vaccines
Overview of COVID-19 vaccines and vaccine development.
The development of vaccines takes place over various stages, from the explorative and the pre-clinical phase with tests on laboratory animals via clinical phases 1, 2 and 3 with tests on humans to market authorisation.
![Figure 1: Overview of phases of vaccine development [1].](/fulltextimages/10995/fig_1.png)
Pharmaceutical companies and research institutes develop vaccines.
| Company | Vaccine type | Number of doses vaccination interval | Vaccination volume per use | State of per clinical development | Planned submission for EU authorisation |
|---|---|---|---|---|---|
| Oxford/ Astra Zeneca | Vector-based ChAdOx1, non- replicating | (1–)2 doses 0.28 days | 1 vaccine dose of 0.5ml IM | Phase 1/2: UK Phase 3: UK, Brazil, South Africa, India; USA | Start Rolling Review October 2020 |
| BioN- Tech/Pfizer | mRNA enclosed in lipid nanoparticles | 2 doses 0.21 days | 1 vaccine dose of 0.3ml IM | Phase 1/2: Germany, USA Phase 3: USA, Brazil, Argentina, Turkey, Germany | Start Rolling Review 10/1/2020 |
| J&J/Jans-sen | Vector-based Ad 26, non- replicating | (1–)2 doses 0.56 days | 1 vaccine dose of 0.5ml IM | Phase 1/2: Belgium, USA, Phase 2: Germany, Phase 3: global | 2021 |
| SP/GSK | Recombinant, adjuvanted | 2 doses 0.28 days | 1 vaccine dose of 0.5ml IM | Phase 1/2: USA, Phase 3: USA | 2021 |
| Moderna/Lonza | mRNA enclosed in lipid nanoparticles | 2 doses 0.28 days | 1 vaccine dose of 0.5ml IM | Phase 3: USA | Possibly end of 2020 |
| Novavax | Recombinant, adjuvanted | 2 doses 0.21 days | 1 vaccine dose of 0.5ml IM | Phase 1: Australia, Phase 2: USA, Australia, South Africa Phase 3: UK | Possibly end of 2020 |
| Curevac | mRNA enclosed in lipid nanoparticles | 2 doses 0.28 days | 1 vaccine dose of 0.6ml IM | Phase 1: Belgium, Germany, Phase 2: Peru, Panama | Unknown |
| *Note: Preliminary information based on current state of knowledge |
Table 2: Overview of vaccine candidates and the current state of their development (manufacturer information, last updated Novemb
What are the New Covid-19 Variants
The fact that more people are talking about COVID-19 again is also due to new Sars-CoV-2 variants. This focus is currently particularly on two new Omicron variants: initially, the World Health Organisation (WHO) advanced EG.5, also known as Eris, to one of now three “virus variants of interest”.
According to the WHO, Eris could lead to cases increasing once more, and could become dominant in some countries or even worldwide.
The variant BA.2.86 is significantly more mutated than Eris, but has not yet been identified in Germany. Some scientists feel that BA.2.86 is reminiscent of the early days of Omicron. At the time, Omicron spread extremely quickly worldwide. But this will not necessarily happen again [3].
Conclusion
In principle, it seems that the only rational hope during the first wave of the dangerous coronavirus or COVID-19 was that a vaccine would be developed. Now that the vaccine has arrived, those affected are focussing on new problems, and in all probability, everyone is affected. How much vaccine is available and how it is distributed depends to a high degree on politics. Furthermore, it needs to be established who is to be vaccinated first (vaccine prioritisation). The effectiveness and vaccine safety are other concepts which people need to address. Mutations of the dangerous coronavirus must also be observed and analysed with regard to their effects on the vaccine. However, it is not only vaccination that has gained importance, but also testing, which has been possible for some time. Here, as with vaccinations, there are country- specific differences. National testing strategies are developed and implemented. A multitude of organisations participate, or rather are involved, in these processes, as shown by the example of Germany.
Outlook and Actual Tendencies
Vaccination Dashboard
Vaccination Status: up to 8 April 2023. 64.9 million people (77.9% of the population) have received one dose of vaccine. Of these, 63.6 million people (76.4%) have primary immunisation. 52.1 million people (62.6%) have also received a booster vaccination. 12.7 million people (15.2%) received at least two booster vaccinations. 18.4 million people have not been vaccinated (22.1% of the population).
![Figure 2: Vaccination dashboard (extract) [4].](/fulltextimages/10995/fig_2.png)
As can be seen in Figure 2 above, basic immunisation of the population has taken place in Germany.
Vaccine Manufacturers
Deliveries by manufacturer and vaccine type
- By 8 April 2023, 224.1 million doses of vaccine had been delivered.
- The deliveries were from the manufacturers BioNTech/ Pfizer
- (164.7 million doses), Moderna (37.7 million doses), AstraZeneca
- (14.4 million doses), Johnson & Johnson (5.4 million doses), Novavax
- (1.9 million doses), Valneva (100 thousand doses) and Sanofi (6 thousand doses).
- The deliveries also included 13.6 million doses of adapted Omicron vaccine.
![Figure 3: ** Administered doses by manufacturing company [4-7].](/fulltextimages/10995/fig_3.png)
■ BioNTech/Pfizer ■ Moderna ■ AstraZeneca ■ Johnson & Johnson ■ Novavax ■ Valneva ■ Sanofi Vaccines adapted to the Omicron virus variants Figure 3: Administered doses by manufacturing company [4, 5, 6, 7].
References
-
(2021) Nationale Impfstrategie COVID-19.
-
RKI - Coronavirus SARS-CoV-2 (2021) Test criteria for SARS-CoV-2 diagnostics: Adjustments for the autumn and winter season 2020/2021.
-
The Robert Koch Institute (2023) MDR.DE-Seite Nicht Gefunden. Deutschland, Germany.
-
Impfdashboard.de RKI, BMG (2023) Overview of vaccination status.
-
ECDC (2020) Clinical characteristics of COVID-19.
-
Nishiura H, Kobayashi T, Yang Y, Hayashi K, Miyama T, et al. (2020) The Rate of Underascertainment of Novel Coronavirus (2019-nCoV) Infection: Estimation Using Japanese Passengers Data on Evacuation Flights. Journal of clinical medicine 9(2).
-
Read JM, Bridgen JRE, Cummings DAT, Ho A, Jewell CP (2021) Novel coronavirus 2019-nCoV: early estimation of epidemiological parameters and epidemic predictions. Philos Trans R Soc Lond B Biol Sci 1376(1829): 20200265.
- hMPV: Is It Another Covid-19 Like Situation?
- Streptomyces: Sources of Novel Discoveries in Antibiotic Research to Combat Antimicrobial Resistance
- A Review of Mosquitoes (Diptera: Culicidae) and Their Biodiversity, Medical and Veterinary Importance
- Past and Current Immunotherapy in Cancer
- Hematological Cancer and Viral Infection
- The Growing Threat of Antimicrobial Resistance in India: Challenges and Solutions