Although the number of infected people is currently falling, the acute phase of the corona pandemic appears to be subsiding. However, the question arises how to keep the corona infections under permanent control. Vaccines are one of the most effective methods of protecting against diseases and have already proven themselves among TBE or influenza. However, a vaccine to protect against coronavirus infection is not yet available.
The author
Christina Nicolodi is a virologist and has a doctorate in medical science. She has been developing and approving biotechnological drugs for more than 15 years and advising pharmaceutical manufacturers on the development of innovative drugs.
To Open Science
The non-profit association Open Science is active in the field of science communication and sees itself as a hub between science and the public. He organizes projects and events on topics from the life sciences and supports scientists in public relations.
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The development of medication usually takes many years – from its discovery to its market launch. Of the 10,000 molecules that are discovered, a few make it to the market. The costs for this are usually immense: research and development of a drug costs an average of around 90 million euros. The following applies: the more complex the drug, the more expensive and the longer the development.
The pharmaceutical industry is working intensively worldwide to develop an effective vaccine to protect against infection with SARS-CoV-2. According to the European health authority, two clinical studies have already been started in Europe. On May 5, the World Health Organization reported 8 vaccine candidates worldwide that are already being tested on humans and another 100 in development.
The phases of vaccine development
The development of vaccines is usually divided into six steps: (1) the phase of (basic) research (exploratory), (2) the pre-clinical development (pre-clinical), (3) the clinical development (clinical), (4) the approval process and approval, and (5) manufacturing and (6) quality control.
In the first phase, research, potential candidates are examined for their properties and their effectiveness against the pathogen. However, the screening of potential candidates is complex and involves enormous costs. Ultimately, a maximum of 25 out of 1,000 molecules are suitable to start with the second step, preclinical development. Before doing so, however, a manufacturing process must be established that follows “Good Manufacturing Practice” (GMP). In essence, this means that the process must be reproducible and that strict rules must be followed regarding quality, purity, premises and controls. Additional guidelines apply to vaccines, since they are usually administered subcutaneously or intramuscularly and must therefore be sterile.
If there is a candidate that can be produced under strict national and international guidelines, the preclinical tests begin. Analyzes of the characterization, infectivity and behavior of the molecule on selected cell cultures are carried out in the laboratory (in vitro tests). Subsequently, studies are carried out in animals in order to obtain initial information on safety, efficacy, but also on possible harmful (toxic) properties. The question often arises whether animal studies are really necessary and cannot be replaced by tests in cell cultures. Unfortunately, however, the current state of science and the legal framework do not allow an analysis of the active ingredient in animals to be dispensed with entirely.
If an active ingredient is promising even after these studies, clinical testing in humans can begin. The clinical development is divided into three phases. In phase 1, the vaccine is only tested on a small, limited number of voluntary and healthy people (test subjects). The primary goal of this phase is to research the safety of the vaccine. The criteria for participation in these early studies are therefore mostly limited to young, often male subjects without previous illnesses. In phase 2, production is increased and the vaccine tested on a larger group of people. Use on children and the elderly is now also being tested, again using the strictest guidelines. In phase 3 of the development, the manufacturing capacity is increased to market size and the vaccine is tested on several 1,000 people with regard to its safety and efficiency.
Rapid pandemic procedures
For the development of vaccines in pandemics, as is the case for those protecting against SARS-CoV-2, somewhat simplified conditions apply to ensure faster availability. According to the latest guidelines of the International Coalition of Medicines Regulatory Authorities (ICMRA), a global association of numerous European and non-European health authorities (such as Australia, Russia or the USA), the European Commission and the WHO, the guidelines for trials are shortened, and the Vaccine only needs to be tested on a few 100 subjects before the manufacturer can apply for approval. An approval process for vaccines usually takes between 18 and 24 months. For pandemic vaccines, there is an option to speed up the approval process, which shortens the time by about a third of the regular time.
How quickly a vaccine will be available does not only depend on research and development. Production capacity must also be taken into account here in order to give as many people as possible access to vaccination. Since it is difficult for a manufacturer to handle this alone, it is important that as many vaccines as possible reach approval. The Austrian federal government, for example, is funding the development of medicines and new types of therapy with 23 million euros. The Bill & Melinda Gates Foundation has also announced that it will support the production of seven potential vaccine candidates in the fight against Corona in the millions.
In addition, companies set up so-called Product Development Partnerships in order to carry out research on a vaccine jointly and with the support of universities, foundations, government and aid organizations. For example, CEPI is an alliance founded by Norway, India, the Gates Foundation, the Wellcome Trust and the World Economic Forum to develop vaccines with financial support from other countries that a company would not be able to finance on its own.
Good things come to those who wait
SARS-CoV-2 has been keeping a firm grip on the world for four months now. Research institutes and the pharmaceutical industry are feverishly looking for an effective drug for the prevention and treatment of Covid-19. Remdesivir, an antiviral agent for the treatment of infectious diseases with RNA viruses, has recently been approved by the United States agency for the acute treatment of serious illnesses. However, only immunization with an effective vaccine will slow down the spread of the virus in the long run. A vaccine is unlikely to be available later this year. The European health authority assumes that a vaccine will not be approved until spring 2021 at the earliest. Until then, we will continue to have to do without our welcoming buses and hugs.
This guest contribution was created in cooperation with Open Science – Life Sciences in Dialogue.
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