Corona vaccine what's the status in Europe - The Comprehensive Minds

Corona vaccine what's the status in Europe

Corona vaccine what's the status in Europe 

Corona vaccine update

Researchers around the world are working on vaccination against the coronavirus. A vaccine may be available soon. How is the approval process, how is the distribution? How safe will the vaccination be? The most important questions and answers.

How far is the research?

Vaccines against Covid-19 are being researched intensively worldwide. According to the World Health Organization (WHO), 48 possible vaccine candidates are currently being tested, and 164 other candidates are in preclinical development. 

The framework conditions are good: In the case of Corona, researchers don't start from scratch. They are already familiar with other coronaviruses such as MERS and SARS. That is why a diagnostic test was carried out relatively quickly.

When will a vaccine be available?

As we know, UK  has approved the Corona vaccine, but we are also expecting approvals in the whole of Europe that could take place in December or very soon after the turn of the year, said Chancellor Merkel at a press conference on November 19. 

The results of the current vaccination studies and approval procedures are decisive. All testing and evaluation of a coronavirus vaccine will be done with the same care as any other vaccine.

There are currently some promising vaccine projects in the final test phase and the first vaccine candidates for which an application for approval has been submitted to the European Medicines Agency. 

Among them is the vaccine from the cooperation between the German company BioNTech and the Pfizer Group. It is quite possible that several vaccines will gradually be approved. 

However, the approval of a vaccine does not mean that it will immediately be available to the entire population. It still has to be produced and distributed in sufficient quantities. It is therefore important to prioritize which groups can be vaccinated first.

How is the coronavirus vaccination developed?

The first step in developing a vaccine is to carefully examine the virus. In the so-called preclinical phase, it is determined which components of the virus and which additives are taken into account in the vaccine. The vaccine will first be tested on animals. It is then tested on volunteers in a three-step process.

Phase I: The tolerance of a vaccine and its ability to provoke an immune response is tested for the first time in humans. However, only on a maximum of 100 healthy volunteers.

Phase II: The correct dose, tolerability, and immune response are tested on a large number of volunteers (several hundred).

Phase III: In this phase, several thousand to several tens of thousands of volunteers receive the vaccine. In everyday life, it should be tested whether it really protects against infection and whether it is safe. Rare side effects become apparent.

If these tests are successful, an approval procedure can begin. Once this has been successfully completed, the vaccine can be used.

What different types of vaccines are currently being tested?

All vaccine candidates are based on the basic principle of presenting parts (antigens) of the novel coronavirus to our immune system so that the body can build up immunity to the pathogen. 

The different candidates use different approaches. There are three main lines of development: live vaccines with vector viruses, dead vaccines with virus proteins, or RNA / DNA vaccines.

RNA / DNA vaccines: These vaccines contain parts of the genetic information of the virus in the form of RNA or DNA, which provide the blueprint for one or more virus proteins. After vaccination, the RNA or DNA is absorbed by a few cells in the human body.

The body cells use the RNA or the DNA as a template to produce the virus protein or proteins themselves. However, since only one component of the virus is formed, it is impossible to complete viruses that are capable of replication to develop in this way. 

The newly formed, harmless virus proteins are known as antigens because they activate the immune system and thus generate the protective immune response.

Vector vaccines: 

A weakened virus serves as a means of transport (vector) for a harmless part of the genetic information of SARS-CoV-2 in a few body cells. 

Vector vaccines contain the blueprint for one or more antigens. A well-known vector vaccine is, for example, the Ebola vaccine Ervebo, which received European approval from the European Commission in November 2019.

Inactivated vaccines with virus proteins: 

With this method, the genetic information with the blueprint for a virus protein is introduced into bacteria, yeast, or mammalian cells, which then produce the virus protein. After purification, the virus protein is used as an antigen in the vaccine.

How does a vaccine get on the market?

A vaccine is only approved in the EU if it has been proven that it is effective and well-tolerated. The manufacturer must provide this evidence in preclinical examinations and clinical trials. 

Before a vaccine can be launched on the market, it must go through a comprehensive approval process. For Europe, the centralized approval process for Covid-19 vaccines is coordinated by the European Medicines Agency (EMA). 

The EMA's vaccine assessment is carried out by experts from the national drug authorities in Europe, including the experts from the German Paul Ehrlich Institute. The quality, effectiveness, and safety of the vaccines are thoroughly examined and assessed.

Safety comes before speed: Until a vaccine is approved, there are many tests, assessments, and controls - from which no deviations are made.

How safe will the vaccination be?

In Europe, a vaccine is only approved if it has successfully passed all three phases of the clinical study program. As with all other vaccine developments, these national and international quality standards also apply to the approval of a coronavirus vaccination. 

Aftermarket approval, vaccine use will continue to be closely monitored and evaluated in order to record very rare side effects.

Corona vaccine what's the status in Europe

Even if the vaccine development can succeed much faster this time than before, this is not accompanied by a lowering of the standards for approval. 

The acceleration of vaccine development can be explained, on the one hand, by the fact that a lot of money is invested in it so that studies can be carried out on a large scale without delay. 

On the other hand, the regulatory authorities monitor and check vaccine development as quickly as possible. This prioritization enables the researching companies and laboratories to save time and move from one test phase to the next more quickly.

Can side effects be excluded?

No, established vaccines also have side effects. It is important to know them exactly. Only then is it possible to make a safe decision about who the vaccine is safe for and who has more benefits than risks from a vaccination? A central task of the testing and approval process is to be able to clearly describe the side effects. This also includes being able to name for which groups of people and to what extent they can occur.

But even after approval, a newly used vaccine will continue to be monitored and researched. Sometimes very rare side effects can only be recorded after approval. 

Very rarely, for example, means a case for more than 10,000 vaccinated people. For Germany, the Paul Ehrlich Institute (PEI) centrally records all side effects and vaccination reactions - regardless of the manufacturer. 

By combining national and international observations, it can be ensured that risks of vaccines are also recorded that are so rare that they only become visible after a very large number of vaccinations have been carried out.

Is there an expedited process in developing a coronavirus vaccine?

Until a few years ago, ten to 20 years would have been assumed for going through all stages. However, new technologies, previous experience with vaccine projects against related viruses, and intensive cooperation with the responsible authorities could make it possible to develop a vaccine that meets the high national and international quality requirements as quickly as never before.

When using vaccines on humans, it is important to avoid risks as much as possible. More important than rapid vaccine development are other principles that will not be deviated from: The vaccine must be safe, effective, and well tested.

The procedure is similar at the international level: Both the World Health Organization (WHO) and the European Medicines Agency (EMA) have announced that they will simplify the approval process in individual points due to the urgency. The safety of the vaccines remains a top priority.

For their part, individual manufacturers have accelerated the process - at their own risk. It takes time to manufacture a large number of vaccine doses, so some companies have already started production. 

In doing so, they bear the risk that the vaccine in question will fail in the trials and, after an independent review by the authorities, will not be approved.

How should the vaccine be distributed?

Even after one or more vaccines have been approved, it will take time until sufficient vaccine doses are available for everyone. Nobody can say how much time, because we don't know when which vaccine will be approved. 

A staggered distribution is therefore likely. What this will look like, nationally and internationally, has not yet been conclusively clarified.

Uk become first nation to approve corona vaccine

The Standing Vaccination Commission at the Robert Koch Institute (STIKO), together with representatives of the Ethics Council and the Leopoldina, developed a concept of the order in which vaccinations should be given in Germany. Basically, groups at particular risk - risk groups and medical staff - should be among those who are vaccinated first.

The vaccine will be distributed centrally in the first phase. To this end, the federal states set up regional vaccination centers. Further information on the status of the preparations can be found on the website of your federal state. When sufficient vaccine is available, the resident doctors should vaccinate again - as with all other vaccines.

Where can I get vaccinated?

A vaccine will be distributed via vaccination centers set up by the federal states. Furthermore, there will probably be mobile vaccination teams that visit, for example, inpatient care facilities. 

When vaccinating in facilities such as hospitals or inpatient care facilities, the use of company doctors for the vaccination is also an option. Current information on the vaccination centers and their organization can also be found in the respective federal states.

Why will there be vaccination centers?

There are several reasons for setting up vaccination centers:

The logistics and organization in external vaccination centers are seen as easier than the integration into standard care. The vaccination centers are set up by the federal states so that more people can be vaccinated in a shorter time. 

If all people considering vaccination were to be vaccinated in their family doctor's practice, it would take considerably longer than in vaccination centers, especially since two vaccinations will be necessary every few weeks. 

The earlier many people are vaccinated, the sooner the vaccination can help bring the pandemic under control.

Vaccination centers can also ensure that certain vaccines are stored correctly. For example, some vaccines have to be stored at particularly low temperatures, which cannot easily be guaranteed in general practices or pharmacies. 

In addition, in centers where hundreds of people can be vaccinated every day, large quantities/batches of vaccine shipments are used up before they expire. This is especially significant given the initial shortage of vaccines.

Vaccination centers also facilitate the distribution of the vaccine to people who are prioritized for ethical and medical-epidemiological reasons, i.e. who should receive the vaccination first. 

This can be, for example, people at a very high risk of a severe course of Covid 19 disease. If more and more vaccine doses should become available and all other conditions such as storage can be met, a transition from vaccination to standard care is planned.

Who is committed to vaccine development on an international level?

The World Health Organization (WHO), together with other global actors, has launched a historic initiative to fight the coronavirus: the "Access to Covid-19 Tools Accelerator" (ACT-A). 

The aim of the global association is to advance the development, production, and equal access to vaccines, diagnosis, and treatment options for Covid-19 worldwide.

Under the umbrella of ACT-A, the vaccine alliance Gavi and the CEPI initiative lead the field for vaccines. While CEPI is responsible for vaccine development, Gavi is working as part of the Covax initiative to ensure that approved coronavirus vaccines are produced, purchased, and distributed fairly to the participating countries as quickly as possible. 

A total of two billion vaccine doses are to be made available by the end of 2021. One billion of these will go to 92 low and middle-income countries.

Will there be compulsory vaccination against the coronavirus?

No. "Nobody will be forced to be vaccinated, it is a voluntary decision," stressed Chancellor Angela Merkel. There is basically no compulsory vaccination in Germany. The only exception to this is the measles vaccination recommended by the Standing Vaccination Commission (STIKO), which since March 1, 2020, must be presented for all children from the first birthday when entering kindergarten or school.

Who pays for the vaccination?

Vaccination should be free of charge for citizens regardless of their insurance status. The federal government bears the cost of the vaccine. The federal states, together with statutory health insurance and private health insurance, bear the costs of running the vaccination centers.

Will there be a special vaccine for children?

Initially, the vaccines will only be available for adults, as their efficacy and safety in children and adolescents have not yet been sufficiently tested.

There are several reasons why vaccines are currently being developed primarily for adults:

Children are not intended for early testing for ethical reasons alone. Before starting the clinical trial in children, it must be ensured that no serious side effects have occurred in the studies in adults. 

Vaccine development for children is similar to vaccine development for adults, i.e. it goes through various stages in which the safety and effectiveness of the vaccinations are checked before they can be approved.

The focus will initially be on protecting those who are most seriously ill with Covid-19. These are especially older people and/or people with previous illnesses.

It can be assumed that effective vaccines against Covid-19 for adults, which over time will be available in sufficient quantities for the population, can also reduce the overall infection rate. Children can also be protected in this way.

According to all that is known so far, kindergarten and elementary school children do not seem to drive the infection process in a special way and become ill less frequently and severely than adults.

How often does the vaccination have to be repeated?

In the case of the most advanced vaccine candidates, it can be assumed that two vaccine doses every few weeks are necessary to build up immune protection.

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