Vaccines to protect against Covid-19, the new coronavirus infection
Covid-19, the new respiratory infection caused by the coronavirus SARS-CoV-2, is spreading internationally. However, companies and research institutes are developing protective vaccines against it.
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At least 68 vaccine projects against SARS-CoV-2, which has only been known since about New Year's Day, have started within a short period of time: The World Health Organisation WHO currently counts 62 (list of 04 April 2020). In addition, there are six other projects that the WHO does not yet list: one project of the Israeli Institute for Biological Research, one of the Swiss company Alpha-O Peptides, one project of the South Korean company SK Bioscience, a project of Translate Bio and Sanofi (USA and France), a project of the Swiss consortium Universitätsspital Zurich/Inselspital and University of Bern/Company Saiba, and a project of the US company Kentucky Bio Processing (subsidiary of British American Tobacco).
Status of vaccine development
Each vaccine project must pass through six stages. They are shown in the following diagram:
Until a few years ago, it would have taken 15 to 20 years to complete all the stages. New technology and previous experience with vaccine projects against related viruses (see below) make an enormous acceleration possible. This is shown by the interim results that some companies and research groups have reported for their projects. The projects that have made the most progress have already entered stage 4, the volunteer testing; or they plan to do so in the coming months:
- Moderna: Testing since 16.03.
- CanSinoBIO (China): Release for testing granted according to report of 17.03.
- Inovio: Trial starting in April. Tests with animals are currently underway.
- Oxford University: Trial according to media reports from April. (Study plan)Tests with animals are currently underway.
- BioNTech/Pfizer/Fosun Pharma: Trials starting at the end of April in Europe, the USA and China
- Novavax: Trial from May or June.
- University of Queensland: According to media reports, testing possible from June.
- CureVac: Trial from early summer.
- Janssen (Johnson & Johnson): Trials from September 2020 or earlier.
- OpenCorona Consortium (Karolinska Institute, University of Giessen and partners): Trial 2021.
Several projects have been reported by companies or research institutions to have reached the stage of testing with animals:
Efpia: European pharmaceutical industry response to COVID-19
As the impact of COVID-19 continues to be felt across the world, the biopharmaceutical industry in Europe remains committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.
How quickly vaccination campaigns can be started depends not only on the speed of vaccine development, testing and approval, but also on production capacities. Therefore, it is not decisive who first gets approval for a vaccine, but that as many vaccines as possible get approval and can be produced using many production facilities.
First companies have already announced to expand their production capacities for a Covid 19 vaccine. In addition, Janssen (Johnson & Johnson) and Kentucky BioProcessing will already start large-scale production of their vaccines during the ongoing volunteer trials - even at the risk of having to dispose of the produced goods if the study results turn out negative.
The Bill & Melinda Gates Foundation has announced that it will provide billions of dollars to co-finance the construction of production facilities for seven selected vaccines while the associated clinical trials are still ongoing. Ultimately, two of these vaccines will be selected and focused on.
GSK is examining whether it can contribute to the production of vaccines with some production capacities that were actually built up for other vaccines.
Types of vaccines
The companies and research institutes are working towards different vaccines. Most of their projects are aimed at one of the following three types of vaccines:
Live vaccines with vector viruses: Several projects are based on well known harmless viruses, such as the "Modified Vaccinia Virus Ankara" (MVA), the adenovirus serotype 26 or the virus from measles vaccine. Such so-called vector viruses can multiply in humans without causing disease. It is also known how they can be replicated in large quantities. Now they "disguise" researchers as SARS-CoV-2 (concretely: they exchange one or more of their surface proteins with SARS-CoV-2 proteins) using genetic engineering methods, so that they can make the immune system believe that a Covid-19 infection has occurred. Those who are vaccinated with this protein build up an immune protection that can also fend off a real infection - this is the plan. Based on a vector virus, the first approved Ebola vaccine, another Ebola vaccine (for which approval is pending) and other experimental vaccines have also been developed. This strategy is now being applied in the SARS-CoV-2 projects of Janssen, DZIF and the University of Oxford, for example.
Inactivated vaccines with viral proteins: Several projects targeting vaccines with viral proteins (such as those of Novavax, Greffex and the University of Queensland) are based on long-established technology: many approved vaccines are composed in this way; for example, those against tetanus, hepatitis B or influenza. However, it may be easier to produce large quantities of vaccine units quickly with other vaccines. However, this will only become apparent when the time comes.
Gene based vaccines: These vaccines contain selected genes of the virus in the form of mRNA or DNA. After the injection, these genes are supposed to induce the formation of (harmless) viral proteins in the body, which in turn, as with a conventional vaccine, cause the build-up of immune protection. Such mRNA- and DNA-based vaccines have the advantage that many injection doses can be produced very quickly. However, no vaccine against any disease is yet available on the market. Companies developing such vaccines against Covid-19 include CureVac, BioNTech, Moderna, Inovio, Arcturus, LineaRx/Takis, Anges and Translate Bio/Sanofi; the OpenCorona consortium led by the Swedish Karolinska Institute and involving the University of Gießen is also developing a DNA-based vaccine.
SWR2 FORUM of 23.03.2020: Fight against Corona - When will drugs and vaccines be available?
Radio discussion with Dr. Siegfried Throm (vfa Managing Director Research), Prof. Dr. Rolf Hilgenfeld (German Centre for Infection Research) and Volkart Wildermuth (science journalist)
For the recording of the show in german language please click HERE.
Several vaccine projects are financially supported by CEPI, the Coalition for Epidemic Preparedness Innovations. These are the projects of:
- CureVac(Tübingen, Germany)
- Inovio (USA) with the Wistar Institute (USA) and Beijing Advaccine Biotechnology (China)
- Moderna(USA) with the U.S. National Institute of Allergy and Infectious Diseases
- Novavax (USA)
- University of Queensland (Australia) with the companies Dynavax and GSK, providing the adjuvants(1)
- University of Oxford (UK)
- Institut Pasteur, the company Themis and the University of Pittsburg (France / Austria / USA)
- University of Hong Kong (China)
In conjunction with CEPI, GSK also offers to contribute its proprietary adjuvant technology for vaccines to projects for a SARS-CoV-2 vaccine. In addition to the aforementioned collaboration with the University of Queensland, GSK also entered into a collaboration with the Chinese vaccine developer Clover Biopharmaceuticals.
CEPI is a Product Development Partnership funded by Norway, Canada, Germany (Federal Ministry of Education and Research), Japan, Australia, and the Bill & Melinda Gates Foundation and the Wellcome Trust, among others. It was founded in 2017 specifically to financially strengthen vaccine projects against major epidemics or pandemics.
Product Development Partnerships
Product Development Partnerships (PDP) are alliances that organize joint projects between foundations, governmental and aid organizations, research groups and companies. The funds provided by donors in the context of a PDP are usually awarded to companies or research institutions in the form of fixed-term grants. In PDPs, drugs can be developed that would not be economically viable for a single company or for which rapidly available funding is required. This is because they ensure that the associated costs and economic risks are spread over the shoulders of several partners. This has already proven successful for new drugs against malaria, tuberculosis and sleeping sickness.
Other examples of ongoing vaccine projects against Covid-19
The Mainz-based company BioNTech is working with Pfizer to develop a vaccine which it plans to test with volunteers in Europe, the USA and China from the end of April onwards. The companies are also cooperating with the Chinese company Fosun Pharma.
Janssen (in the Johnson & Johnson group) has also announced a vaccine. The vaccine is being developed using a technology that has already been used for an Ebola vaccine that is currently undergoing approval procedures in the EU. It is working with the Biomedical Advanced Research and Development Authority (BARDA) in the USA.
Sanofi Pasteur, the vaccine division of Sanofi, also cooperates with BARDA. The goal is to develop a Covid-19 vaccine using the company's proprietary technology platform for recombinant DNA. The project follows on from an earlier one, which was aimed at a SARS vaccine.
Tonix Pharmaceuticals, Altimmune, Greffex, Vaxart, GeoVax (with BravoVax in China) and LineaRx with Takis Biotech, all based in the USA, also reported on the development of their own vaccines. Altimmun's vaccine will be administered nasally, like a previously developed influenza vaccine by the company. For its TNX-1800 vaccine, Tonix is modifying a Horsepox virus. Vaxart is planning a vaccine that is swallowed as a tablet and not injected.
Also active in the USA is Kentucky BioProcessing, a subsidiary of British American Tobacco. The company uses genetically modified tobacco leaves to produce the viral proteins for its dead vaccine. This technology is suitable for the rapid production of such proteins, but has not yet been used for an approved vaccine. The new vaccine is currently being tested with animals.
In Denmark, the company ExpreS2ion is developing a vaccine with partners.
The Israeli company Vaxil has also reported on the development of its own vaccine.
Vaccines against other corona viruses
Experience with other corona viruses helps in the development of Covid-19 vaccines. These include the SARS virus, which appeared between the end of 2002 and summer 2003. At that time, 22 projects were initiated against it, but they could not be completed because the virus disappeared again. What remains are good interim results.
Corona viruses also include the MERS virus, which jumped from camels to humans in 2012 and has since caused severe respiratory infections (called "Middle East Respiratory Syndrome"). At least four companies and several research groups have been working on vaccines against it for several years (partly with CEPI support). The German Centre for Infection Research (DZIF) with the company IDT Biologica is among those involved.
In Japan, the biotech company Anges and Osaka University have developed a DNA-based vaccine, for which they have now announced the start of animal testing.
The Indian companies Zydus Cadila and Serum Institute (in cooperation with the US company Codagenix) are also working on vaccines. The vaccine from Serum Institute and Codagenix is already being tested on animals, according to media reports.
In China, the company Cansino Biologics is working on a vaccine. It is already being tested with humans.
Active research institutions include VIDO-InterVac (Vaccine and Infectious Disease Organization - International Vaccine Centre) at the University of Saskatchewan, Canada.
A vaccine is also being developed at the Cambridge Infectious Diseases Research Centre at the University of Cambridge in the UK.
The University of Hong Kong has announced that it has already completed a vaccine candidate for further testing. However, it will be months before the vaccine has completed all animal and human studies. This vaccine candidate is derived from an influenza vaccine that is administered as a nasal spray.
In the USA, the US Army Medical Research and Development Command (USAMRDC) is working with the Walter Reed Army Institute on a vaccine.
In Germany, the German Centre for Infection Research (DZIF) is working on two vaccines with partners in Munich, Marburg and Hamburg. In one of these, researchers are modifying a vaccine against the MERS virus (see below), which is currently being tested in clinical trials. Er beruht auf dem Vektorvirus MVA. Die Herstellung des Impfstoffs für die Erprobung wird das Dessauer Unternehmen IDT Biologika übernehmen.
In the second vaccine, which is being developed at DZIF, the virus from the measles vaccine serves as the vector virus basis.
Israel's Institute for Biological Research and the Israeli Ministry of Health were also contracted to develop a vaccine. The Galilee Research Institute (MIGAL) is also based in Israel. The Institute is developing a Covid-19 vaccine based on a previously developed vaccine against a coronavirus that infects poultry.
Several companies are willing to cooperate in the development of Covid-19 vaccines. This is shown not only by the example of GSK and its adjuvants, but also by the cooperation agreement signed on 2 March at a meeting with the US government between Moderna, Janssen and Sanofi.
Which is what?
Coronavirus: This is the generic term for a family of viruses that infect humans or animals. It also includes the pathogens that cause SARS in 2002/2003, MERS and several forms of the common cold.
SARS-CoV-2: The causative agent of the current pandemic was given this name in February 2020 and is often simply called "novel coronavirus". The abbreviation stands for Severe Acute Respiratory Syndrome-Coronavirus-2.
Covid-19: Fortunately, not every person who is infected with SARS-CoV-2 falls ill. Those who show symptoms after infection with the new pathogen suffer from the respiratory disease Covid-19, which is named after "coronavirus disease" and the year of its first appearance, 2019.
Does a tuberculosis vaccination help against Covid-19?
It is possible that other vaccines might be able to contribute to the protection against an infection, although they were not developed against corona viruses: Tuberculosis vaccines. The idea behind this: Tuberculosis vaccines increase the general immune defence against germs and could therefore also help people to fend off SARS-CoV-2 or at least not be affected so severely.
The suitability of the old tuberculosis vaccine BCG is to be tested at clinics in Nijmegen and Utrecht (Netherlands). This vaccine has not been used in Germany for a long time.
For Germany, however, the companies Vakzine Projekt Management (Germany) and Serum Institute of India are planning to test the newer Tuberculosis vaccine VPM1002, which has not yet been approved because the last studies against tuberculosis are still ongoing. The Covid-19 study is to be carried out at several German hospitals with elderly people and healthcare workers. The vaccine was originally developed at the Max Planck Institute for Infection Biology in Berlin.
(1) Adjuvants are "potentiators" for vaccines which, among other things, can make it possible that considerably less viral protein per vaccine injection is sufficient for immunisation or that more injection doses can be produced with a given amount of viral protein produced.