The Oswaldo Cruz Foundation (Fiocruz) will sign an agreement with pharmaceutical company AstraZeneca for the acquisition of batches and transference of technology regarding the Covid-19 vaccine developed by the University of Oxford. The agreement will be the result of the cooperation between the Brazilian government and the pharmaceutic company, announced last Saturday, June 27, by the Ministry of Health.
This is a Advance Purchase Agreement in which the institution acquires the product before the end of the clinical trials, due to the global movement for mobilization and acquisition of vaccines. The agreement with AstraZeneca includes two production phases. The first consists in the production of 30.4 million doses before the end of the clinical trials, which would represent 15% of the quantity necessary for the Brazilian population, at a cost of 127 million dollars. The investment includes not only the vaccine batches, but also the transference of technology, so that the production can be fully internalized and national.
“The production of this vaccine is an initiative of the Brazilian government. Combined with other actions, it may contribute to fight the Covid-19 pandemic. As a strategic institution of Brazil, Fiocruz is backed by 120 years’ experience and work in public health. In such a moment of public health emergency, we already boast a sturdy infrastructure, with enough production capacity to incorporate new technologies and quickly introduce new vaccines in our Public Health System (SUS, in the Portuguese acronym). This is the direct result of this accumulation and of all the investments made on Fiocruz in the past years, especially in the updating of its technological infrastructure”, highlights Fiocruz president, Nísia Trindade Lima.
AstraZeneca expects a first batch of 15.2 million doses to be produced by December 2020, and another, with the remaining 15.2 million doses, to be delivered in January 2021. After this production, it would still be necessary to go through the phases of registration and validation, prior to a possible distribution.
As of right now, Fiocruz would already be capable of carrying out the entire final processing of the vaccine, starting with receiving the active pharmaceutical ingredient (API) from AstraZeneca and including the phases of formulation, bottling, labelling, packaging, and quality control. Simultaneously, Fiocruz must carry out the necessary adaptions to its plants, to incorporate the production of APIs so as to become self-sufficient in all process phases. It is expected that the API can be fully incorporated in the early months of 2021.
At the end of the clinical trials and after the efficacy of the vaccine is proven, the agreement will include a second phase, with the production of more than 70 million doses, at the cost of US$ 2.30 per dose.
“If the vaccine proves to be truly effective, the agreement with AstraZeneca also gives us the possibility, as reference in the region and with a large production capacity, to become responsible for supplying the vaccine to all of Latin America”, adds the Fiocruz president.
Designated by the Ministry of Health as the institution with capacity to evaluate technologies, Fiocruz has been carrying out prospective analysis of different projects of vaccines currently being developed all over the world, also taking into account the risks associated to each of them.
“We have been focusing on vaccines at a more advanced stage, with technological potential to meet the demands of the Ministry of Health and that use platforms that can be reused for future emergencies. The vaccine developed by the University of Oxford meets all these criteria. This means that, as we are not only acquiring the batches of vaccine, but also internalizing the production, even if the vaccine proves not to be effective after the clinical trials, we can still use these new technological platforms acquired now and adapted to other production lines”, comments Fiocruz Vice-President of Production and Innovation in Health, Marco Krieger.
40 million doses per month
Fiocruz has the capacity to act immediately in the stages of formulation and final processing of the vaccine, through its Institute of Technology in Immunobiology (Bio-Manguinhos/Fiocruz), and can reach a production maximum of 40 million doses per month, without having to neglect any other of its current production lines, taking into account the structure that is already installed and an increase in productivity, calculated by means of the establishment of new workshifts and rearrangement of production activities.
According to Mauricio Zuma, director of Bio-Manguinhos, “this agreement established by the Brazilian government is fundamental to ensure the availability of doses for the country as soon as the vaccine is registered. And Bio-Manguinhos has the technological skill and the industrial capacity necessary to supply the Brazilian Public Health System quickly to incorporate the technology, so as to guarantee national sovereignty regarding this immunobiological drug that is essential for the fight against the pandemic”.
The vaccine developed by the University of Oxford was developed through the non-replicant virus technological platform. A chimpanzee adenovirus was genetically modified through the insertion of a gene that codifies protein S of the SARS-CoV-2 virus. Although based on a new technology, this platform has already been tested for other diseases, such as in the outbreaks of ebola and MERS (Middle-East Respiratory Syndrome), caused by another coronavirus. It is similar to other platforms of Bio-Manguinhos/Fiocruz, which facilitates its implementation in a short period of time.
The institution currently meets the demands of the National Immunization Program of the Ministry of Health, supplying 7 vaccines against 8 diseases (yellow fever, pneumonia, polio, rotavirus, measles, mumps, rubella, and varicella).
Vaccine under study in Brazil
Considered by the World Health Organization (WHO) one of the most promising projects to this moment, the vaccine in currently in phase 3 of clinical trials - the last test phase in human beings - to determine its safety and efficacy.
Preliminary studies of phases 1 and 2 showed that the vaccine has promising immunological responses. In phase 3, the vaccine has been tested in different countries. In Brazil, the protocol includes 2,000 participants recruited in São Paulo by the Federal University of the State of São Paulo (Unifesp) and in Rio de Janeiro by the Instituto D’Or. The study assesses the so-called vaccine scheme: one group receives one dose of the vaccine, while the other is given two doses, the second being administered 4 weeks after the first. The study will be expanded to 5,000 participants in Brazil. Preliminary results of this phase are expected to be available in October or November this year.
Specialists say that carrying out clinical trials in the country will be very important to determine the efficacy of the vaccine in the Brazilian population.
“The population of Brazil has its own characteristics, and we have been made important advancements in clinical research. It is important to test vaccines taking into account the genetic variations in our population, as well as the variations of virus that have been circulating in the country. This will ensure a much higher level of safety than what would have been obtained incorporating a vaccine tested in other conditions, on another profile of population”, comments Krieger.
Development of a national vaccine
Fiocruz is also working in other initiatives in the search for an immunizing agent, as in two of its development projects:
- Synthetic vaccine, based on antigenic peptides of B and T cells - that is, with small parts of viral proteins that can induce the production of specific antibodies to defend the organism against unknown agents - in this case, SARS-CoV-2; and
- Vaccine with the sub-unit platform, using only fragments of antigens capable of stimulating the best immune response. It tests different constructions of protein S, the main protein for the binding between the virus and patient cells, responsible for the generation of protective/neutralizing antibodies.
In addition, Fiocruz has been developing a vaccine that uses the influenza virus as a vaccine vector to generate immune response. With this process, one of the possibilities is the development of a double vaccine that can be used against the influenza virus as well as the new coronavirus.
These actions add materiality to the strategic role played by this public institution in establishing national self-sufficiency in the production of health products.