The Immunobiological Technology Institute (Bio-Manguinhos / Fiocruz) is conducting a Brazilian project for the development of a synthetic vaccine for the new coronavirus (Sars-CoV-2). The studies now advance to the pre-clinical phase, in which safety aspects are evaluated in an animal model. The synthetic form of the vaccine was chosen because it is faster, compared to traditional methodologies, due to the reduced cost of production, the stability of the vaccine for storage and the fact that it does not need level 3 biosafety facilities for the first stages of development (required only from pre-clinical studies). 

Even in an accelerated process of technological development and with positive results in all future steps, the national vaccine from Bio-Manguinhos / Fiocruz will not reach registration before 2022. The Fiocruz project is added to other national institutional initiatives, which include the evaluation and discussion of different development models and aim to contribute to Brazilian production. The Ministry of Health appointed Fiocruz, through Bio-Manguinhos, as the institution with the capacity to evaluate technologies and establish partnerships with the main global developers, aiming at clinical development and production at its facilities, with future distribution by the Brazilian Public Health System (SUS). 

The synthetic vaccine is based on B and T cell antigenic peptides or biomolecules, i.e., it contains small parts of Sars-CoV-2 virus proteins capable of inducing the production of specific antibodies in the body's defense process. Bio-Manguinhos / Fiocruz identified these biomolecules in a computerized model (in silico) and they were produced by chemical synthesis and validated “in vitro”. The peptides were coupled in nanoparticles, which work as a form of "delivery" to the immune system, activating its defense. 

In this next step, vaccine formulations will be made with these biomolecules coupled in nanoparticles, for “in vivo” evaluation, where the first results related to the immunity conferred to the new coronavirus will be obtained. Based on the results of pre-clinical studies, we move on to the phase of clinical studies of phases I, II, and III (human trials). 

Bio-Manguinhos / Fiocruz also works with a technological development project for a vaccine, still in the preliminary phase, based on a subunit platform, i.e., that uses only antigen fragments capable of stimulating the best immune response. This approach tests different constructs of protein S, which is the main protein for binding the Sars-CoV-2 virus to the patient's cells, and is responsible for the generation of protective / neutralizing antibodies.