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The researchers are working fully on a corona vaccine. (Icon Image) Image: Getty Images
Analysis
Fighting Corona: the great description of the vaccine
Research is ongoing around the world on a coronavirus vaccine. With each new day new messages appear. Sometimes it is said that a vaccine will still be available this year, and again only the next or even the next day.
And not only that: sometimes a live vaccine is better, sometimes a dead vaccine, sometimes a gene-based one. Mixed with terms like mRNA or peak proteins, this creates a lot of confusing information.
But with all the confusion, one thing is clear: A vaccine would be the surest way to stop the corona pandemic. That is why it makes sense to get an overview of the current state of research.
Association of Pharmaceutical Research Manufacturers (vfa)
How long does it take to get vaccinated?
First of all, one thing must be clear: it will still take some time before a vaccine can be used on a large scale. Most experts expect a good year and a half. The reason for this is that all vaccines must be thoroughly tested in clinical trials. Basically, the process from vaccine creation to mass production is as follows:
The path of a vaccine. Image: vfa
Clinical testing on volunteers is crucial. It shows how the active ingredient works in the human body. This process is divided into three phases, in which the levels of efficacy, safety and dosage of the medication are verified. Currently, the clinical phases are often carried out in parallel to achieve faster results in the current emergency situation. The duration of a phase may also differ from country to country. Depending on the urgency, the procedure may be expedited.
Once these phases have been completed, the responsible authority follows an approval process. For Europe, this would be the European Medicines Agency, for the USA. USA The Food and Drug Administration.
According to the World Health Organization, there are currently 83 vaccine projects (as of April 23). That sounds a lot at first, but only a few of them are already in the development phase. We provide an overview of those whose vaccines are currently being tested in humans. An overview, sorted by country:
China
A large number of Chinese institutes and pharmaceutical companies are currently working on a corona vaccine. When the first cases of Covid 19 were known in China, it is not surprising. A total of three substances are already being tested in humans there.
Developed one of them Bejing Institute of Biotechnology together with the pharmaceutical company CanSino Biologics. The crown agent is the live Ad5-nCoV vaccine (adenovirus type 5 vector). The first phase started there on March 18. To assess safety and efficacy, the drug was administered to 108 healthy volunteers aged 18 to 60.
Parallel to this is Phase 2, which started on April 12 with 500 test subjects. Phase 1 is expected to complete in December 2020, phase 2 in January 2021.
Shenzhen Genoimmune Medical Institute
A mini-gene was built in Shenzhen based on an analysis of the virus genome. When administered, it ensures that antigen-specific T cells are activated, which should lead to immunity. The LV-SMENP-DC vaccine is currently being tested in 100 adult subjects in the first clinical phase. Completion of the study is scheduled for July 31, 2020. The institute has not yet announced when Phase 2 will begin.
Sinovac Biotech
The Chinese pharmaceutical company has been working on a vaccine made from inactivated viruses since late January. The substance has already been tested on rhesus monkeys and rodents. Animals are said to have produced enough antibodies to contain the virus.
Positive: There was no formation of infection enhancing antibodies. Because in the body, a vaccine can also cause an overreaction that exacerbates the disease. Since April 14, the drug has been tested in a study in healthy adults between the ages of 18 and 59.
USES
Thousands dead, a president whose crisis management is more crisis than management and a health system completely overloaded with work: The crown pandemic is testing the United States. Consequently, researchers are also working hard on a vaccine.
So you have about the American company Moderna Inc. produced the MRNA-1273 gene-based RNA vaccine. This encodes the spike protein of the pathogen Covid19, encapsulated in a shell made of lipid nanoparticles. Simply put, it is supposed to cause the body to make harmless virus proteins. The body can develop immune protection.
For the testing phase, the company divided 45 healthy test subjects into three groups. Among them are men and not pregnant women between 18 and 55 years old. In total, they received two injections 28 days apart. Subjects are followed for one year after the second vaccination.
Inovio Pharmaceuticals
The American company is also working on a gene-based vaccine. According to the manufacturer, the INO-4800 plasmid DNA vaccine has already shown promising results in animal experiments.
On April 6, phase 1 clinical trials began with 40 healthy human subjects. They received two doses of the vaccine in four weeks. The first results should follow in late summer. The company can produce a million cans for studies and emergencies by the end of the year.
Germany
A vaccine is also being investigated in this country. It was particularly interesting when Tübingen biotech company CureVac It made the headlines because President Trump allegedly wanted to secure the privilege of a vaccine the company is working on.
However, which makes Trump’s plans difficult to understand: The company announced that the first phase of clinical testing would not begin until June. Others are one step further.
Biontech / Pfizer / Fosun Pharma
The Mainz-based company received approval from the Paul Ehrlich Institute on April 22 to clinically investigate the BNT162 vaccine developed in cooperation with the American company Pfizer. It is a gene-based candidate vaccine.
A first clinical study will be carried out in collaboration with Pfizer and the Chinese company Fosun Pharma with around 200 healthy volunteers between 18 and 55 years old. If this is successful, another should follow, involving test subjects from the risk groups as well.
Britain
There is hardly a vaccine project that is currently as well known as that of the University of Oxford. Sarah Gilbert, a professor at the renowned institution, told the British newspaper “The Times” that a vaccine was developed there will be available this September could
It is a live vaccine. The English researchers have already started a phase 1 study. In addition, they are preparing a phase 3 efficacy study with 5000 volunteers. The results may already be available in the fall. The Indian Serum Institute wants to produce the vaccine at the same time.
Depending on how the investigation proceeds, the substance may be available in the fall. To keep Gilbert’s ambitious schedule, everything has to go well.
Who is going to run? An investigator explains
It is difficult to say who is the first to provide a vaccine to society. While all companies provide information on when the tests will be completed, This does not mean that they are successful and that there are no delays.
“There is always a risk. Even if animal studies go well, there is no guarantee that a vaccine will also work in humans. Clinical studies are there to find out,” Swiss immunologist Martin Bachmann told Watson. He is also currently working on a vaccine, using a procedure with virus-like particles.
Investigator: “I should be lying if I said …”
Interestingly, regarding the crown pandemic, there is always a lot of optimism from researchers. Bachmann also announces that his vaccine may be available this October. However, the first clinical study on this will only start in June. After that there should be more episodes. It usually takes weeks for the Swiss supervisory authority to approve Swissmedic’s clinical trials with vaccines. However, due to the urgency of the current situation, the approval process should be shortened.
Competitive pressure could also play a role in the researchers’ optimistic reports. “I would have to lie if I said I don’t want to be the first to receive a finished vaccine,” says Bachmann. “On the other hand, I also think: Well, if the Oxford researchers are faster than us, that should be the case,” adds the immunologist.
But regardless of this, it is important that there is a vaccine at all.
In this article we also use material from our Swiss colleague Daniel Huber. You can find the text here.
