QUESTIONS ABOUT BIOSAFETY AND HUMAN HEALTH
QUESTIONS ABOUT SOCIO-ECONOMIC AND ETHICAL CONCERS
What is MYCOSYNVAC?
MYCOSYNVAC is a 5-year research and innovation project funded by the European Commission’s Horizon2020 program. A total of 8 partners from 7 EU countries collaborate to develop novel types of vaccines to fight mycoplasma infections in farm animals.
Can MycoSynVac replace or reduce antibiotic use on livestock? How?
In general, vaccines against bacterial infections help to reduce the deployment of antibiotics. In the specific case of MYCOSYNVAC, however, this is unclear, as mycoplasmas are seldom fought with antibiotics, so there is hardly any antibiotic usage in the first place. The reason is that the mycoplasma bacteria lack a cell wall, which means they’re unaffected by many common antibiotics that target cell wall synthesis. However, after a mycoplasma infection sometimes there is another (so-called secondary) bacterial infection (with different pathogens) that might occur, and those are fought with antibiotics. As of now, little data is available on the use of antibiotics on secondary infections.
Could the vaccines increase the risk of passing diseases between different animal species by using serum?
No. The serum that is used in vaccine production is thoroughly inactivated. Moreover, serum and end products are rigorously tested before use.
Could these vaccines contribute to the emergence of resistances and resistant organisms?
No, vaccine-resistant bacteria have never been reported.
Unexpected or unintended results: isn’t it extremely difficult to control mycoplasma?
Fortunately Mycoplasmas have a number of specific characteristics that makes it easier to control them:
Species specific: During the evolution Mycoplasma species have lost large parts of their genome from their common ancestor with Gram-positive bacteria. This genome shrinking was only possible by a change in the way of life: mycoplasmas are now obligate parasite organisms and most of them are able to colonize one species of animal (or in some cases a small number of related species). Therefore, it is unlikely that a given species would be able to disseminate by colonizing different hosts.
No spores formed: Many Gram-positive bacteria that are related to mycoplasmas have the ability to form spores. This property of these bacteria is obviously a factor that helps their dissemination. During their evolution, all mycoplasmas have lost the whole set of genes that is necessary to build spores and they also lack all the machinery to control this form of cell differentiation. Therefore, mycoplasmas cannot survive in a harsh environment as spores can allow for many bacterial species.
No cell wall: Mycoplasmas have a cell structure that is unique. Indeed, they are the only bacteria for which the cell envelope is restricted to the plasma membrane. They lack all the components of a cell wall and are unable to synthetize Lipopolysaccharides or derivatives, necessary for the cell wall. These characteristics explain why the mycoplasma cells are considered extremely sensitive to detergents or to changes of osmotic pressure. Therefore, the mycoplasmas usually do not persist for long outside of their hosts; the only exception that is known is their ability to resist to desiccation for a certain period of time (this has been studied for only a few mycoplasma species).
In order to prevent escape and reverting mutants, we have designed a bacterium that contains a "Trojan horse". This "Trojan horse" is a system based on multiple redundant layers of biosafety to prevent growth of the bacteria outside the defined conditions for its production (i.e. inside a tank). Also, this system has different switches that can be triggered at any time in order to stop growth and kill the bacterium.
A) Dependency of the bacterium on small chemicals, rarely found freely in nature, to survive.
B) Interdependency between elements included in the bacterium. In this way, if one of them fails, it will compromise the survival of the bacterium by making the other elements fail, like in a domino effect.
C) Redundancy, meaning that we have included several elements that individually and independently promote the death of the bacterium when triggered.
Does the vaccination of animals protect humans from communicable diseases?
In some cases, the vaccination of animals can protect humans from disease, especially if the animal disease can be transmitted to humans. Some examples include Salmonella, influenza and rabies.
Can animal vaccines be a protective measure for human health?
Can diseases spread to humans?
Yes, but only in very rare cases like influenza and rabies disease.
Can the vaccines, even if they’re safe for the animals, have any kind of negative effects on human physiology?
No negative effect on humans are known.
Wider scope: Could vaccines developed for animals one day be transformed to be used in humans?
The MYCOSYNVAC project aims to develop a vaccine for animal uses. Once we have the proof of concept that it actually works, we could in a next step envision human vaccines, as well as the use of the chassis for other purposes, such as for human lung infectious diseases etc.
How can you prevent an abuse of the techniques developed in this project?
When research results are published, care is taken not to reveal any significant biosecurity-relevant information that could be easily misused.
How accessible/affordable or expensive would a likely vaccine be for a common farmer?
We believe it could prove very accessible and cheaper than treatment.
What is the role of the pharmaceutical industry in this project? What do they gain from participating in an EU project?
Simply put, the company gains access to fundamental research that normally is not done in company environment.
This is an EU-funded project: is the research openly accessible?
The research will be public, and openly accessible to academic groups through scientific publications. Before making it public, each beneficiary must examine the possibility of protecting their results and must adequately protect them, if they are commercially or industrially exploitable.
What about intellectual property rights?
Results are owned by the beneficiary (partner) that generates them. The IP will belong to the researchers and institutions in the consortium in a manner related to their contributions. The way each project result will be exploited (for example for further research activities; developing, creating or marketing new products or services; etc.) will depend on each beneficiary’s decision.
Who will be able to patent the outcomes out of this research?
In all EU collaborative projects results are owned by the beneficiary that generates them. In case of joint ownership, it the respective contribution of each beneficiary should be established between those partners who are affected. As agreed before the project started (and stated in the Consortium Agreement and the General Agreement), results belong to the partner who generated them and therefore they can decide in which way to protect them (for example with a patent). If a beneficiary intends not to protect their results, to stop protecting them or to not seek an extension of protection, the EU may — with the consent of the beneficiary concerned— assume ownership to ensure (continued) protection, if the exploitable potential persists.
Who will profit economically from this project?
The project will have an economic impact on different stakeholders:
First, all partners in the MYCOSYNVAC consortium that have contributed to the inventions and products would potentially benefit from royalties, sales etc. in case the newly develop products are successful on the market. In addition to that, during the duration of the project, we also benefit due to receiving funding for this research, the generation of new knowledge, opportunities for collaborations, scientific publications etc.
Second, we hope that the project will allow farmers to see a reduction in their costs due to more efficient and cheaper vaccines.
Third, we think that the EU may profit as well, having contributed to improve EU competiveness in cutting edge scientific research, generating new knowledge and new job opportunities as well as utilizing public money usefully for society.
Last, but not least, the meat consumer could see a drop in prices due to lower costs for the farmers and producers.