MycoSynVac applies synthetic biology techniques to develop bacteria to vaccinate farm animals. While possible vaccines developed in MycoSynVac will not come on the market within the lifetime of the MycoSynVac project, which ends in March 2020, in this deliverable we prepare for the future product development process. To do so, the roadmap for vaccine market authorizations in the European Union (EU) and selected non-EU countries have been reviewed, providing necessary information on what requirements have to be dealt with for successful introduction of MycoSynVac based vaccines.
One of the regulatory requirements in Europe, but also internationally, to bring a vaccine to the market, is the assessment of risks. The risk assessment is to identify potential hazards and their probability, but also takes into account areas of uncertainty that could be relevant for risk assessment. We conducted the risk assessment on the putative vaccine chassis strains developed by the MycoSynVac Project by collecting and analyzing information provided by the partners of the consortium, as well as systematic review of case studies relevant to live vaccine development available from PubMed (the website for life science and medical publications), EUR-Lex (the website for EU legislation documents), EMA (European Medicines Agency), websites of other regulatory agencies, and company websites. The main focus of the biosafety risk assessment is to find out if the genetically modified organisms (GMOs) used for the vaccines and/or the proposed administration in animals, might lead to harm to people, animals and the environment. Risks are characterized based on potential harms, while taking into account the current published scientific knowledge, technological data from the consortium, and relevant risk assessment done for the similar approved vaccines. In this deliverable we assessed whether changes made in the genome of Mycoplasma pneumoniae could result in organisms that are toxic or pathogenic to people, animals and environment, risk of unintended changes in the recipient's genome and its characteristics; chance for unintended exposure to the vaccine, and probability of horizontal gene flow.
Two main potential risks have been identified for the vaccine chassis: (1) the unintended exposure of people to the vaccine chassis strains and (2) unintended mutations in the vaccine strains. Risk management measures have been identified and presented to further mitigate the risks. The main focus of the biosecurity risk assessment was to find out if the modification techniques developed by the MycoSynVac could raise the likelihood of misuse for nefarious purposes. One potential biosecurity risk that has been identified is to apply techniques to engineer fast-growing pathogenic mycoplasma strains, however, this is considered a rather low risk. The further development of the techniques and their applications require further case-by-case assessment.