Since the beginning of the fight against the pandemic in Brazil, as one of the pillars in the strategy to combat the Sars-CoV-2 virus, Fiocruz has been part of the various national and international fronts for the search and production of a vaccine against Covid-19. With a long history and a tradition of more than 100 years in the production of vaccines, the Foundation has been engaged in this field, together with the Ministry of Health (MS), reinforcing the importance of the Brazilian Unified Health System (SUS) as the basis to support the development, production and national distribution of vaccines for the disease. In the field of vaccine production for Covid-19, Fiocruz's main bet is the agreement with the biopharmaceutical company AstraZeneca, which enabled the production, in Brazil, of the Covid-19 vaccine (recombinant), an immunizing agent developed by the University of Oxford. The Brazilian government's agreement with the United Kingdom was announced in 2020, by the Ministry of Health, and was consolidated in September of the same year, with the signing of the Technological Order agreement, also aiming at the transfer of technology for the production of the vaccine against 100% national form, which had the contract signed in June 2021.

The Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz) announced, on March 8, 2021, the start of large-scale production of the Covid-19 vaccine and, since then, has been making regular deliveries of the immunizer to the PNI. In December 2021, Bio-Manguinhos surpassed the mark of 153 million doses delivered from imported Active Pharmaceutical Ingredient (API).

Fiocruz also delivered, between January and February 2021, 4 million ready-made doses of the Covid-19 vaccine imported from the Serum Institute in India.

National Vaccine

The Oswaldo Cruz Foundation, through Bio-Manguinhos, made available, in February 2022, to the Ministry of Health (MS), the first 550 doses of the Covid-19 vaccine (recombinant) produced with the national Active Pharmaceutical Ingredient (API). Currently, the Institute has 35.2 doses of national API in different stages of production. The immunizers are being delivered according to the agreed schedule and demand established by the folder.

The agreement between Fiocruz and the United Kingdom made it possible to produce entirely nationally with the total transfer of Covid-19 vaccine technology (recombinant), obtaining national autonomy. The Covid-19 vaccine Technology Transfer contract was signed, in Brasília, in June 2021, formalizing the transfer of knowledge that was already being done by the technological partner, in order to speed up the production of the API at the Bio-Manguinhos facilities. /Fiocruz.

On January 7, 2022, Fiocruz received a favorable opinion from the National Health Surveillance Agency (Anvisa) to change the registration of the Covid-19 vaccine (recombinant), which requested the inclusion of the Foundation as a producer of the Active Pharmaceutical Ingredient (IFA). ). After the transfer of technology from AstraZeneca and with the approval of Anvisa, the Foundation becomes the first institution in the country capable of producing and distributing a 100% national Covid-19 vaccine to the Ministry of Health.

The production of a 100% national vaccine is a technology transfer process in record time, since the conclusion of technology transfers in immunobiologicals usually takes about 10 years. With the Fiocruz Covid-19 vaccine, Bio-Manguinhos completed the incorporation of the technology in just one year, in response to the health emergency.

Updated in march 31st, 2022