The Yellow Fever Vaccine Improvement Project of the Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz), which began in 2008, reached a major milestone in February this year. The National Health Surveillance Agency (Anvisa) authorized the withdrawal of antibiotics and the optimization of the production process of the Active Pharmaceutical Ingredient (API) of the yellow fever vaccine (attenuated).
The withdrawal of antibiotics is a significant improvement, made at the request of the World Health Organization (WHO). "Decades ago, we used antibiotics to prevent vial contamination and this ended up being in the process. Nowadays, the areas are sterile and the use of antibiotics is no longer necessary. This does not affect the safety or efficacy of the product," said Elena Caride, manager of the Viral Vaccine Program (PVIR) at Bio-Manguinhos/Fiocruz. Project manager Ana Claudia Machado Duarte pointed out that there is a great effort by the WHO to reduce the large-scale use of antibiotics worldwide, due to the high levels of resistance of the bacteria. "Bio-Manguinhos is aligned with this," she said.
"This project and this approval encompass practically all areas of Bio-Manguinhos, from Innovation, through Production, Quality and Management, as this fact, in addition to practically doubling our production capacity of the immunizer, also meets a request from the World Health Organization [WHO]", commented the deputy director of Quality of Bio-Manguinhos/Fiocruz, Rosane Cuber.
Unlike development projects, in which there is a predetermined life cycle, this one is always in motion since the intention is to make continuous improvements to the immunizer. "Early on, we wanted to test protamine sulfate to clarify the viral suspension. That was the first scope of the project. Other demands were later added to the project, as we observed more opportunities for improvement, especially in the areas of production and quality", recalled Ana Claudia.
"In 2016, it had already been observed, during the production process, that it would be possible to reduce the number of embryos in the formulation of the vaccine", commented Elena Caride. She added that Wania Renata dos Santos, who currently manages the Project to improve the API Production Process of the MMR vaccine, and Caroline Ramirez, then head of the Yellow Fever Laboratory (Lafam), collaborated a lot for the initial experiments. "They gradually reduced the number of embryos and saw that we were able to maintain the vaccine's specifications and efficacy, even reducing the number of embryos. A whole series of experiments was made to establish the ideal ratio between the amount of chicken embryos and the amount of water for injection (WFI)", detailed Elena.
"With the optimization we made in the API, we obtained a great increase in production capacity, going from 60 million vials/year to 107 million vials/year, that is, almost doubling the amount of vaccines with half the embryos", detailed Ana Claudia.
The project manager also said that the current feat was achieved shortly after Bio-Manguinhos was appointed a laboratory on standby for the production of vaccines in a health emergency situation, and the Institute will be even more prepared in case there is a new outbreak of the disease, such as the one that occurred in 2016/2017. "At the time, the demand was enormous and the strategy was to fractionate the dose, which was proven to achieve the same efficacy with one fifth of the dose. We are one of the largest manufacturers of this vaccine in the world; we can cover the needs of the whole country and still export to control outbreaks in other countries. Our next step is to put this new version of the vaccine in pre-qualification by the WHO for export," said Ana Claudia.
Source: Fiocruz News Agency (AFN).
