Fiocruz and its Immunobiological Technology Institute (Biomanguinhos/Fiocruz) signed, on Tuesday (6/1), the contract for Technology Transfer of the COVID-19 vaccine (recombinant) with AstraZeneca for the 100% national production of the immunizing agent. The contract formalizes the transfer of knowledge that has already been passed on by the technological partner to speed up the production of the Active Pharmaceutical Ingredient (API) at the Biomanguinhos/Fiocruz facilities.
With the information received by then, the Institute carried out, in a few months, with funds from private donations, the adaptations of the manufacturing plant and the acquisition of the necessary equipment for the incorporation of the API production technology in the Henrique Penna Center (CHP), part of the Vaccine Technological Complex (CTV) in the Fiocruz campus in Manguinhos, Rio de Janeiro. The facilities have already received the Technical-Operational Conditions (CTO), granted by the National Health Surveillance Agency (Anvisa), as well as the Good Manufacturing Practices (GMP) certificate for API production. Thus, Biomanguinhos/Fiocruz is able to start production. Now, the institution continues with the preliminary stages of training the technical team and elaborating the technical documentation related to the national API production processes.
API production at Biomanguinhos/Fiocruz will begin in June. This is a complex production run that will include a series of steps, from the initial production of two pre-validation and three validation batches, which will undergo comparability testing by AstraZeneca, to full-scale production.
In parallel, in the continuous submission modality to Anvisa, the necessary documentation will be prepared to request the change in the vaccine registration, including the new API manufacturing site, a necessary condition to deliver the product to the National Immunization Program (NIP). The first 100% national doses are expected to be delivered in October. The facility will have the capacity to produce API for about 15 million doses of the vaccine per month.
This is the milestone of a strategic Fiocruz project for the COVID-19 vaccine technological incorporation that began back in March 2020, when we started the prospective studies of the more than 100 vaccines in development at the time. This project was composed of two phases: the first being the Technological Order contract signature, which allowed us access to the imported API for final processing of the vaccine at Fiocruz, while the technical information was transferred to the institution, and we adapted the facilities for the national API production. The contract signing materializes the second phase of this great project, in which we can produce a 100% national vaccine from one of the most advanced technological platforms on the world stage, celebrates the president of Fiocruz, Nísia Trindade Lima.
For the director of Biomanguinhos/Fiocruz, Mauricio Zuma, "the signing of the technology transfer contract brings materiality to national independence in the COVID-19 vaccine production. Biomanguinhos is 45 years old and, throughout these years, has developed technological competencies that make the institution capable of internalizing all the production stages, with all the complexity involved in biotechnological processes. It is an important response that we bring to the country in fighting the pandemic, allied to the incorporation of a new technology that can also be used to bring future solutions to the population's health."
The document, which formalizes an important milestone for the country, is being prepared to be made available on Fiocruz’s Portal in the same way as the Technological Order contract, reaffirming the commitment to transparency in the institution's actions, a mark present in its 120 years of history.
The institution is still formalizing a contract for the acquisition of additional imported API for the final processing of another 50 million doses, which would compose the second semester's deliveries together with the national production.
History and perspectives
In June 2020, an Understanding Memorandum was signed and, in September, Fiocruz formalized the Technological Ordering (Etec) contract with AstraZeneca, by which the technology of the vaccine final processing transfer and subsequent technology from the API transfer for the 100% national production of the vaccine was already assured.
Etec ensures the development and consequent importation of API for final processing (formulation, filling, review, labeling and packaging) and quality control of 100.4 million doses at Biomanguinhos/Fiocruz. The resources for the production and acquisition of the vaccine were made possible by the Provisional Measure that provided for a R$ 1.9 billion extraordinary budget credits.
In total, 50.9 million doses have already been delivered to the NIP until 4 June, including 4 million ready doses of the Serum Institute vaccine from India. With IFA already in stock at the Institute, another 18.5 million doses are guaranteed to sustain weekly deliveries until the week of 6/27 to 7/3. Fiocruz is waiting for possible confirmation of accelerating the new API shipments to inform about the next deliveries availability.
Technological competence for SUS
The Covid-19 (recombinant) vaccine, the result of the partnership with AstraZeneca, was developed by the University of Oxford through the non-replicating virus technology platform (from chimpanzee adenovirus, a genetically modified adenovirus, harmless to humans, is obtained through the insertion of the gene encoding the Sars-CoV-2 virus S protein).
The industrial structure existence for the immunobiological production, allied to the technological competence established throughout the Institute's 45 years of existence and the 121 years of the Foundation, facilitated the vaccine's final processing stages implementation and the structuring for technological incorporation in record time.
Besides the Covid-19 (recombinant) vaccine, Biomanguinhos/Fiocruz supplies other vaccines to the Brazilian Unified Health System (SUS) through the NIP: yellow fever, pneumococcal 10-valent, oral polio, inactivated polio, rotavirus, triple viral (measles, mumps, and rubella), and tetravalent viral (measles, mumps, rubella, and varicella).
In 2020, even with the efforts to establish Covid-19 vaccine production, the immunizers production levels for the other diseases were maintained, with more than 111 million doses delivered to the Ministry of Health. In the last 5 years, the Institute has delivered more than 500 million vaccine doses to the NIP.