Due to the news that has been published in the press associating the non-signing of the technology transfer contract with AstraZeneca to a possible delay in the delivery of vaccines, the Oswaldo Cruz Foundation (Fiocruz) comes to the public to clarify some points:
1) The Technological Order Contract, signed in September 2020, related to the supply of Active Pharmaceutical Ingredient (API) for the production of 100.4 million doses of vaccine, already establishes general parameters for technology transfer, which should be detailed in a specific contract due to the need for extensive technical content;
2) The fact that the technology transfer contract until that moment had no impact on the current vaccine delivery schedule during this first phase, in which immunizing agents will be produced from the imported API. The first phase continues until July. Only in the second half of 2021, vaccines fully produced at Fiocruz are expected to be delivered, including the API;
3) All the technical information necessary for the first phase has already been passed on to Fiocruz, which incorporated the technology for formulating the vaccine from the API and has already started the production of the first vaccine batches;
4) The contract detailing the technology transfer was expected to be entered into in 2020. However, the degree of detail required for this type of documentation required more preparation time. The document must be entered into by March;
5) The preparation schedule for the national production of the API continues normally until that moment. The Bio-Manguinhos/Fiocruz industrial plant is already being adapted for this production, and it is expected to be ready in April for the national production of the API. The beginning and conclusion of this transfer process for the national production of the API, as well as the delivery of vaccines entirely produced by Bio-Manguinhos/Fiocruz, scheduled for the second half, will be detailed in a schedule to be agreed in the transfer contract.
Fiocruz also confirms the arrival, next Tuesday (February 23), of two million ready vaccines from the Serum Institute, one of AstraZeneca's production centers in India. The initiative is part of a strategy parallel to the production of vaccines from the arrival of the Active Pharmaceutical Ingredient (API), aiming at contributing to the supply of vaccines for the National Immunization Program of the Ministry of Health (PNI/MS) in view of the country’s health situation. On February 27, two more batches of API are also expected to arrive, with an equivalent input for the production of about 12 million doses of the vaccine.
