“It was expected”, says Dalcolmo about choosing the WHO for Fiocruz to manufacture vaccine

Researcher at the Oswaldo Cruz Foundation (Fiocruz) Margareth Dalcolmo was not surprised with the choice of the World Health Organization (WHO) for the foundation to develop and produce a new vaccine against Covid-19.

“It was expected”, he told the CNN, to later justify that the WHO selection took into account the fact that Fiocruz already has a new plant to manufacture the immunizing agent against the coronavirus with Brazilian API. The delivery of this work is scheduled for November this year.

The current producer of AstraZeneca’s Covid-19 vaccine in Brazil, Fiocruz’s Institute of Technology in Immunobiologicals (Bio-Manguinhos), in Rio de Janeiro, has already started the testing phase of the new immunizing agent with the antigen in rodents. The next step is to start testing primates. After these two stages of the pre-clinical stage, the immunizing agent will go through three more stages of clinical analysis (in humans).

WHO technicians will pay a visit to Bio-Manguinhos, which should be supported by international experts. According to Dalcolmo, Fiocruz presents good quality work and has expertise when it comes to vaccine production. The researcher reinforced the importance of the National Health Surveillance Agency (Anvisa) in supervising the work. “Everything goes through Anvisa,” he said.

Head of the Respiratory Virus and Measles Laboratory at the Oswaldo Cruz Institute (IOC/Fiocruz), which acts as a reference for the WHO in Covid-19 in the Americas, virologist Marilda Siqueira said that Fiocruz’s choice to produce the new vaccine is extremely positive news because researchers intend to have the immunizer also activate mechanisms to increase protection against the new strains of the coronavirus. The formula will teach the body to make the S protein of SARS-CoV-2 and trigger the defense process.

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The virologist is also a researcher at the Fiocruz Genomic Network and the Ministry of Health and worked on the identification of the Delta variant in at least six states. She reinforced that, despite the decrease in cases and hospitalizations, the coronavirus is evolving and acquiring mutations.

There is still no deadline for the vaccine to enter the stage of clinical trials in humans. This decision will depend on the preliminary results of animal studies and needs to be discussed with the WHO and the Pan American Health Organization (PAHO). The intention is that the production of the vaccine at Fiocruz meets all of Latin America.

So far, the preparation of the immunizing agent was funded by Fiocruz’s resources received from the Ministry of Health. The expectation is that this will reduce the final value of the vaccine for Latin American countries. WHO, through PAHO, will make available to Fiocruz a team of international experts with experience in the development and production of immunization agents to contribute to the studies.

On September 21, the Pan American Health Organization (PAHO) announced the selection of Fiocruz in Brazil and the private biopharmaceutical company Sinergium Biotech, in Argentina, as the two regional centers for the development and production of messenger RNA vaccines (mRNA) in Latin America, in order to face Covid-19 and the future challenges of infectious diseases. “We congratulate the two selected centers”, said, at the time, Jarbas Barbosa, deputy director of PAHO.