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Updated on April 28, 2020, 12:34 p.m.
It usually takes several years, sometimes even decades, to develop a vaccine. Now, in the coronavirus pandemic, the first tests with volunteers are already running after a few months. This is because there are new, more flexible types of vaccines, and a diverse scope for development.
When an epidemic begins, a race against time begins. Because many outbreaks only stop when you find a drug or a vaccine against the disease.
It used to take decades to develop a vaccine. Thanks to new methods, things are going faster these days. In the event of an epidemic, there are additional ways to save time.
WHO: 83 vaccines are being investigated
According to the World Health Organization (WHO), until April 23, 2020, 83 vaccines against SARS-CoV-2 are being investigated. Six of them are in the “clinical studies” phase, so they are being tested in humans.
This phase is the fourth of six stages before a vaccine goes into mass production. The first is the virus analysis, the second is the vaccine design, the third is the animal test, the fourth is the voluntary test.
The fifth stage is the approval process, the sixth is mass production. “There are many different ways to speed up the procedure,” says infectologist Christine Dahlke of the Hamburg-Eppendorf University Medical Center (UKE) in an interview with our editorial team.
Quickly test on many people
Dahlke is a project manager at the German Infection Research Center (DZIF) and is responsible for a project that supports the Coalition for Outbreak Preparedness Innovations (CEPI). CEPI is an alliance to finance and coordinate the development of new vaccines.
The goal is for such funds to ideally be operational before an epidemic or pandemic breaks out, or at least as soon as possible when it occurs. CEPI intervenes, for example, when pharmaceutical companies have to fear the financial losses of accelerated vaccine tests because they quickly produce a lot without knowing if they can sell the product later.
“Accelerated vaccine testing” means that in an emergency like a pandemic, vaccines are sometimes tested on more people faster than they would under normal circumstances. Like the vaccine production process as a whole, the clinical trial (i.e. human trial; all volunteers) is divided into different phases.
In phases I and II, the vaccine is tested in relatively few healthy subjects, in phase III there are several thousand. In phase IV, people who are at risk are added.
“It is possible to let some of the phases run in parallel, for example, to add at-risk patients in an earlier phase than phase IV,” infectious disease specialist Ulrich Heininger of the University Children’s Hospital told our editorial team. from Basel.
Side effects may become noticeable later
Accelerated testing may be at the expense of vaccine safety: “Of course, the longer and more intensively a vaccine has been tested, the easier it will be to recognize undesirable events, and therefore possible rare side effects. therefore, there may be fewer, but more serious, side effects that occur with accelerated testing not being discovered. ”
However, this approach may be justifiable. After all, faster delivery of the vaccine can ideally save more lives.
It is also possible to carry out several vaccine studies in parallel, as is already the case with SARS-CoV-2. “It would be better to test all vaccines in a large, standardized study,” says virologist Ulrike Protzer of the Technical University and the Helmholtz Center in Munich in an interview with our editorial team. However, pharmaceutical companies are often quite skeptical because they are “combining” the data, putting their company’s secrets at risk.
As a complement kit for viruses
If a vaccine is tested quickly in many people, it could save a few months until it is ready for the market, says Dahlke, CEPI project manager. Because to give approval, responsible authorities need reliable numbers, and reliable also means: as big as possible.
In Germany, the Paul Ehrlich Institute (PEI) is responsible for admission. Its president Klaus Cichutek told “Ärzte-Zeitung” that SARS-CoV-2 could be tested in 2021 on more issues, “perhaps thousands, perhaps tens of thousands.”
The fact that clinical trials are conducted is also due to scientific advances. For example, researchers increasingly use vaccine platforms to develop vaccines.
Vaccination platforms worked on Ebola and MERS
Simply put, they take a harmless virus like scaffolding and populate it with parts of harmful viruses. If this combination is vaccinated, the vaccinated person at best forms antibodies against the harmful virus. Ebola and MERS already have successful tests with such vaccines.
Depending on which parts of a virus are used or which vaccination approach, the vaccines are called RNA, DNA, or vector vaccines. Renowned research institutions such as the German Infection Research Center (DZIF) develop these platforms. Combined correctly, they could quickly become an emergency vaccine, according to the DZIF website.
An RNA-based vaccine was recently approved as the first vaccine in Germany for clinical trials. “RNA-based vaccines can be produced very quickly, but their safety has not yet been tested and proven as other, more established methods,” says Ulrike Protzer.
Scope of approval
How quickly approval is granted also depends on the responsible authorities. “It usually takes several months for a company to collect all the necessary data from the animal models and compile the documents, and then again for several months before the competent authority has decided to approve a clinical trial,” says Christine Dahlke .
However, in the case of a pandemic, the procedure can be shortened by not having to have all the documents in the package for examination, but it can be presented individually. Experts call it “continuous review.” Such individual feedback could save up to six months, Dahlke said.
Challenge Models Against Corona in the US USA
The tests themselves also have other considerations on how to get results faster. For example, American scientists recently proposed a SARS CoV-2 vaccine test that is used only in animal experiments with very few exceptions.
This involves so-called challenge models, in which one group is vaccinated with the vaccine candidate and the other with a placebo. Both are infected with the pathogen. However, such attempts are ethically difficult.
“I can hardly imagine that with SARS-CoV-2 as long as there is no established ‘rescue’ treatment,” says Ulrich Heininger of the University of Basel Children’s Hospital.
Also read: All developments related to corona virus on our live blog
Sources used:
- Telephone interview with Dr. Christine Dahlke, research assistant at the University of Hamburg-Eppendorf Medical Center (UKE) and project manager at DZIF for a project funded by the Coalition for Outbreak Preparedness Innovations (CEPI) ,
- Telephone interview with Professor Ulrich Heininger, Head of Infectious Diseases / Vaccination at the Children’s Hospital of the University of Basel and member of the Permanent Vaccination Committee of the Robert Koch Institute (Stiko)
- Telephone interview with Professor Ulrike Protzer, director of the virology institutes of the Technical University of Munich and the Helmholtz Zentrum München
- German Infection Research Center: Emerging infectious diseases: vaccine development
- World Health Organization (WHO): Draft overview of candidate vaccines COVID-19 – April 23, 2020
- Ärzte-Zeitung: Interview with Klaus Cichutek, President of the Paul Ehrlich Institute: “Start testing with the SARS-CoV-2 vaccine”
- Association of Researching Pharmaceutical Manufacturers (vfa): Vaccines to protect against COVID-19, the new coronavirus infection
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