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Covid-19: Fiocruz will begin pre-clinical trials for a vaccine


12/06/2020

Fiocruz

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The Institute of Technology in Immunobiological Products (Bio-Manguinhos/Fiocruz) is running a Brazilian project to develop a synthetic vaccine against the novel coronavirus (SARS-CoV-2). The studies are now advancing to a pre-clinical phase, in which safety aspects will be assessed in animal models. The synthetic form of the vaccine was chosen for being quicker than traditional methodologies, for its lower production costs, the stability of the vaccine under storage, and for requiring no biohazard level 3 labs for the initial development phases (these are necessary only once the pre-clinical trials begin). 

Even undergoing a fast-track process of technological development and assuming positive results will be achieved in all future phases, a national vaccine by Bio-Manguinhos/Fiocruz will not be registered prior to 2022. The Fiocruz project is joining other national institutional initiatives that include the evaluation and discussion of different development models, with the goal of contributing for Brazilian vaccine production. The Ministery of Health has indicated Fiocruz, through Bio-Manguinhos, as the institution able to assess technologies and establish partnerships with the world’s main developers, aiming for clinical development and production in its premiss, with future distribution through the Brazilian Public Health System (SUS). 

The synthetic vaccine is based on biomolecules or antigenic peptides of B and T cells, that is, they contain small parts of proteins of the SARS-CoV-2 virus that can induce the production of specific antibodies in the body’s defense process. Bio-Manguinhos/Fiocruz has identified these biomolecules in a computer model (in silico), and they were then produced by chemical synthesis and validated in vitro. The peptides were coupled in nanoparticles that work as a kind of “delivery” to the immune system, activating its defense. 

In this next phase, vaccine formulations will be made using these biomolecules coupled to nanoparticles, for the in vitro evaluation in which the first results related to immunity against the novel coronavirus will be obtained. Based on the results of the pre-clinical trials, the clinical trial phases I, II and III (tests in humans) can be initiated. 

Bio-Manguinhos/Fiocruz is also working in a project for the technological development of a vaccine, still in preliminary stage, based on a sub-unit platform, that is, using only fragments of antigens that can stimulate the best immune response. This approach uses different constructions of protein S, the main protein for the binding of the SARS-CoV-2 virus to the patient’s cells, and is responsible for the generation of protective/neutralizing antibodies.

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