One month after delivering the first 100% national vaccine against Covid-19, Fundação Oswaldo Cruz (Fiocruz) is also interested in exporting immunization agents to other countries.
It was a complex path to self-reliance. Producing the vaccine against Covid-19 with the national Active Pharmaceutical Ingredient (IFA) was Fiocruz’s goal.
And the director of the Bio-Manguinhos Institute guarantees that the vaccine is exactly the same as the one produced with the API that came from China, as explained by the director of the Institution Mauricio Zuma. “The API we produced was subjected to international quality control tests, including comparability, to demonstrate that the vaccine is the same. It makes no difference,” he said.
The process is also practically the same as the production with the API that came from China. There are several steps to check the quality.
After being thawed, the API goes through the formulation, when it is mixed with other ingredients, and packaging, to be packed in the bottles. The entire process is subjected to a quality control, which lasts about two weeks.
In the final phase of the entire process, only authorized employees enter, wearing personal protective equipment. When they arrive in the room, the bottles have already been filled and reviewed, they are labeled and then go to the boxes.
From the laboratory, vaccines against Covid-19 leave for a warehouse and are then delivered to the Ministry of Health. The ministry contracted 105 million doses of Fiocruz vaccine for 2022. Of these, 45 million will be 100% national.
Until March, according to the foundation, IFA was produced for 25 million doses. A total of 550,000 doses have already been made available in February and 2 million are in different stages until release. There is still no forecast of when the contract will be concluded with the Ministry of Health.
In July last year, the foundation managed to transfer technology. Until November, there were months of preparation of the paperwork that would be delivered to Anvisa, and in January came the approval.
With the production of its own doses underway, Fiocruz begins to think about exporting the Brazilian vaccine to other countries.
“We have already requested prequalification by the World Health Organization (WHO), it needs to be prequalified by them, we are already for other vaccines and we are asking for this vaccine as well. It’s the first step”, explained the director of the Bio-Manguinhos Institute, Mauricio Zuma.
Source: CNN Brasil