Pic: Diego DestroBrazil lives the expectation for the beginning of vaccination against Covid-19 at the same time that it experiences a new increase in the number of cases and deaths, potentiated by the holidays.

The vaccine developed by the Oxford University in partnership with the biopharmaceutical company AstraZeneca, is the main immunizing agent in the vaccination program of the Brazilian federal government and will be produced here in Brazil by Bio-Manguinhos/Fiocruz. The president of the Foundation, Nísia Trindade Lima, announced that the first million doses of the vaccine are expected to be delivered in February.

Fiocruz is getting ready to start production as early as January, with imported Active Pharmaceutical Ingredient (API), planning a total of 100.4 million doses in the first half of the year. And also continue the technology absorption process that will ensure the autonomy of the input production. The process is part of a project whose financial and administrative management is carried out by Fiotec, which will allow the production of over 110 million doses of the vaccine in the second half of 2021. The production of the immunizing agent will become 100% national.

The director of Bio-Manguinhos/Fiocruz, Mauricio Zuma, spoke to Fiotec about the processes of importing the Active Pharmaceutical Ingredient (API) and the absorption of technology by the Henrique Penna Center (CHP), which belongs to the unit.

What does the agreement between Bio-Manguinhos/Fiocruz and AstraZeneca consist of in practice?

In fact, there are two phases: the first is the production of the vaccine in our complex, using the Active Pharmaceutical Ingredient (API) imported from AstraZeneca. Here, we will do the final processing, we will do the API formulation, by adding a series of other inputs so that we can fill, revise the vaccine, and then label, package and carry out its quality control. Finally, we will distribute it to the Ministry of Health, through the National Immunization Program (PNI). In this first phase, the agreement with AstraZeneca provides for a total of 100.4 million doses of the vaccine during the first half of 2021.

The technology transfer process itself consists of the production of the API here, at the Bio-Manguinhos complex. We are holding weekly meetings and already preparing our infrastructure for the beginning of this work, which will allow the production of a 100% Brazilian vaccine, we will no longer depend on the import of the Active Pharmaceutical Ingredient. The whole process will take place here, and the production of the first batches – the validation batches –, are expected to start in April this year. Those batches, we will enable us to demonstrate our capacity to produce the API and the vaccine with the same quality as those produced in other countries. We plan to ask Anvisa [National Health Surveillance Agency], in August, to register for IFA production here in Bio-Manguinhos, so that in the following month, September, we can start distributing a 100% Brazilian vaccine.

The technology transfer project with AstraZeneca is managed by Fiotec. What has this joint work been like?

We obtained a good number of resources from donations, just as Fiocruz has been raising funds for other actions to fight against Covid-19. A group of companies, formed by Ambev, Americanas, Itaú Unibanco (Todos pela Saúde), Stone, Instituto Votorantim, Fundação Lemann, Fundação Brava and Behring Family Foundation, made donations that have been directed directly to internal adaptations for the production of the vaccine. Those resources are being managed by Fiotec and used for the construction of an API storage area, which should be completed and duly validated as early as January. In addition, the construction of the structure in which we will produce our Active Pharmaceutical Ingredient, for which a company responsible for adapting the entire area has already been hired, a process expected to be completed by the end of February. Also, in February, the tanks to be used in the production of solutions, currently installed on the fourth floor of the building, will be repositioned. They will be taken to the ground floor in order to supply the production lines of the Henrique Penna Center (CHP), where the API production will be concentrated.

Donation funds, managed by Fiotec, are still being used for the purchase of equipment for the quality control area, which is undergoing an expansion process. All those revisions and adaptations will assist us in requesting Anvisa, in March, for the technical-operational certification of the areas, except for the one intended for final processing, which is already duly certified. Fiotec's operation is paramount in the management of all these resources.

Vaccination still faces resistance from the population. What is our role in ensuring really broad protection?

Vaccines have their efficacy and safety more than proven by science and history itself. There is no more room to raise doubts about their importance and the benefits they produce. Here in Brazil, we have an agency, Anvisa, that would never allow the approval of a vaccine that did not have its efficacy and safety proven. Vaccines that are approved by Anvisa will be reliable immunizing agents that will bring a good result. People can rest assured about this; vaccination is very important and should be done within the established criteria.

However, patience is needed. The race for the vaccine is long distance, it is a marathon. At this first stage, vaccination will not have a considerable impact on public health, as we still have a small number of doses available. It is important, of course, to start vaccination, but we need to understand that only over time, with a larger quantity of doses, will we have a considerable impact on the health of the population. We all need to maintain a commitment to prevention until immunizing agents have protected most of the population. For a while, some measures, such as the use of masks, hand hygiene, will still be necessary.