The Fiocruz Institute of Immunobiological Technology, Bio-Manguinhoswill become a ready laboratory for producing vaccines in health emergency situations.
Through association with a network formed by the UN (United Nations), the Brazilian laboratory will be activated to supply vaccines to other countries, especially in Latin America, in the event of an epidemic or pandemic. The terms of cooperation should be signed soon, according to the director of Bio-Manguinhos Maurício Zuma.
“The year 2023 was the most remarkable in recent years, because we have been in great demand, not only nationally, but internationally, with the visibility we have today. To provide international support, to fill this gap of lack of vaccines in the world”he explained.
Bio-Manguinhos is the main producer of vaccines for the PNI (National Immunization Program), and already supplies vaccines to more than 70 countries in cooperation with Opas (Pan American Health Organization) and Unicef (United Nations Children's Fund , in its acronym in English).
“Obviously our priority is always internal. But we must also commit to releasing doses abroad, which we already do. But they want to count on our commitment, and that we are prepared to be able to provide this response”, Zuma said.
MRNA TECHNOLOGY
This is not the agency's only major expectation for 2024. The clinical testing phase of the Covid vaccine on a messenger RNA platform should begin in the first half of the year. “As it is our technology, we cannot order these clinical tests abroad. We are waiting for the last equipment from the downstream part, which we call, to arrive so that we can produce the clinical batch and then submit the order for clinical studies”, Zuma said.
This is the same platform used in the Pfizer vaccine and consists of producing a synthetic copy of part of the infectious agent's genetic code. When this synthetic molecule is injected into the body, it activates the immune system, even without having any real fragment of the disease-causing substance. Its main advantage is the ease of adapting the basic platform to combat different agents.
Animal tests have already been carried out and have yielded excellent results, according to Zuma. He believes that mastery of this technology is a lever for the future:
“It is our base vaccine [a vacina para a covid-19]. With this vaccine, we are already working on other initiatives, on the same platform. Respiratory syncytial virus is one of them. I think that with the first vaccine progressing well, we will be able to accelerate several other projects on this platform. This project addresses the issue of us being a regional readiness laboratory. […] By choosing the genetic sequence of the virus, you can quickly make a prototype and carry out a clinical study on it. So it’s very fast.”
There are also two other prominent vaccines under development at the Institute, but they are still in the proof-of-concept stage, when researchers verify, using animal tests, whether the vaccine produces an immunological response in the body.
One of them is to combat the Zika virus, and the other is an option against yellow fever made with inactivated, that is, dead, virus. Currently, the available vaccine against yellow fever – made with the weakened virus – is not generally applied to the elderly, because they are at greater risk of developing adverse effects. This new vaccine can solve this limitation.
Structure
And to allow the Institute to produce these new vaccines and meet possible international demand, some adaptations and a major expansion are underway.
In 2028, Fiocruz should inaugurate the Health Biotechnology Industrial Complex, which is being built in Santa Cruz, in the West Zone of Rio de Janeiro. Now that the initiative has received a new contribution of R$2 billion from the Growth Acceleration Program (PAC), the works should advance more quickly.
When the new unit is operational, Bio-Manguinhos will be able to double the amount of processing and produce up to 1 billion doses of vaccines per day, if necessary. Zuma emphasizes that the project is being designed so that Bio-Manguinhos is at the forefront of the pharmaceutical industry.
But before that, the Institute's plants are being adapted to optimize current production. “We are going to use an area of ours that was demobilized to create modular construction for viral vaccines. For example, the Rotavirus vaccine, today we do not produce the IFA [Ingrediente Farmacêutico Ativo – substância que produz a reação imunológica] because we have no place to produce. It will be able to be produced there and we will be able to complete this technology transfer. In the case of vaccines like rubella, it will also greatly increase our capacity. And by making room there for rubella, we make room in our other plant to increase the capacity for measles and mumps”, says Zuma.
And all of this is also related to the increase in the Institute’s international relevance. Still in the first quarter, Bio-Manguinhos must be certified by the World Health Organization (WHO) to export the double viral vaccine, which protects against measles and mumps, and is already in negotiations with PAHO and Unicef, to deliver these vaccines in African countries.
“In addition, this plant should also have a new production of the current yellow fever vaccine in a more automated way. In other words, we will have more capacity for this vaccine, which also has great international appeal. So we are committing to more yellow fever vaccines and double viral vaccines abroad.”said the director of the institute.
And if there is an epidemic or pandemic before the new Santa Cruz factory is ready, a new bottling line recently opened can produce up to 1 million doses per day, in emergency situations.
Advanced therapies
Zuma declined to give further details, but also revealed that the institute is finalizing agreements for the production of advanced therapies, with viral vector technology, similar to that used to develop vaccines. These therapies are biological products created from processed human cells and tissues, and even genetically modified, to treat serious diseases or those resistant to traditional medicines.
“And this will be extremely important for the government. Because, firstly, some large pharmaceutical companies already provide treatment on this platform at very high costs, of US$500 thousand for a treatment like this. And this being judicialized forces the government to pay these amounts. With our entry, we intend to reduce this to around 10% of the value currently on the market and introduce this treatment into the SUS. Even if it is not as a first line, due to the cost, but if other treatments fail, it can be used at a more affordable cost”said Zuma.
With information from Brazil Agency
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