Brazil predicts 140 million doses of vaccine against Covid-19 for the first half of 2021

Federal Government Immunization Plan must require CPF and will monitor and track each applied dose

Oct 9, Brazil has planned, for the first half of 2021, access to 140 million doses of vaccines against Covid-19 that will be destined for the National Immunization Program.

Of this total, around 40 million doses are part of the Covax Facility initiative, which Brazil signed in September. It is a global access instrument that has 9 vaccines under testing. This quantity of doses is sufficient to cover 10% of the Brazilian priority population, that is, 20,242,106 million people; there considering the need for a double dose, as provided for in the agreement. The priority population includes people aged 80 or over, with morbidities and health professionals.

The other doses refer to the contract that Brazil signed, in the amount of R $ 1.9 billion, with the Astrazeneca laboratory for the delivery of 100.4 million doses of the Oxford Vaccine. This partnership also provides for the transfer of vaccine technology to Biomanguinhos, in Rio de Janeiro.

Vaccine Registration

And to speed up the registration process of these vaccines by the National Health Surveillance Agency (Anvisa), a new procedure was created (Continuous Submission Procedure), which allows the optimization of the Agency's workforce. That is, as the vaccine data is being generated, Anvisa is working on adding them. With that, the work is streamlined.

It is worth mentioning that, to be commercialized and made available in Brazil, a vaccine needs to follow several mandatory steps, ranging from initial tests to registration.

“The challenge is: we need a quick response, but without giving up technical criteria for safety, quality and effectiveness. And so, then, we prepare. We made an administrative innovation regarding the way Anvisa will review these data ”, said Gustavo Mendes Santos, general manager of Medicines and Biological Products at Anvisa.

“Traditionally, a complete vaccine dossier is expected, that is, all data must be generated so that afterwards, registration with Anvisa can be requested. We needed to rethink this flow ”, he explained. “So, as data is being generated, of security, efficiency, quality, this data is shared with Anvisa; and Anvisa then begins to carry out its review, already identifying for researchers, for companies, if there is any need for further clarification if there are any requirements or any information that needs to be rectified ”, added Gustavo Santos.

Immunization Plan for Covid-19

The Ministry of Health also announced that between November and December, the Federal Government's Immunization Plan for Covid-19 in Brazil should be presented. And to avoid queues, agglomerations and to have agility in the registration of information, the Ministry of Health will monitor and track each applied dose, in each individual, who must provide the CPF at the time of vaccination. To this end, the Government is investing in the modernization of the National Immunization Program System.

“Unlike others, this campaign will require univocal identification of the citizen, through the use of the CPF. It is very important that everyone contributes to this due record. This record will allow for constant monitoring of adverse events. All notification systems will be connected, ”said Jacson Venâncio de Barros, director of the SUS Department of Informatics.

A validator was also created to allow the safety and validity of the vaccination certificate issued to be guaranteed. The Ministry of Health expects the priority population's vaccination campaign to start in the first quarter of 2021.

“For the prognoses, for the monitoring of the phases of tests, of the development and of the productive capacity in scale that is being designed. But, it is good to always remember, that, as it is a product that is still unfinished, we have a prototype that is still being tested in the population and that goes through a validation process with the regulatory and health agencies, in Brazil and in the world, there is a possibility of a delay. Although it is not what is being designed at this moment ”, said the executive secretary of the Ministry of Health, Elcio Franco.

Vaccines under test in Brazil

According to the National Health Surveillance Agency, four vaccines against Covid-19 are being tested in Brazil: One from the United Kingdom; one from China; one from the United States in partnership with Europe; and another from Europe.

All of these tests were approved by ANVISA and are conditioned to four main aspects: safety data; design of the proposed study; production and quality control data; and good clinical practice.

Vaccine United Kingdom

UK vaccine tests are being coordinated by the Astrazeneca laboratory in partnership with the University of Oxford. This vaccine is made from a weakened version of the adenovirus, which causes colds in chimpanzees. It is genetically altered to carry traces of the Coronavirus S protein, responsible for coupling the invader to human cells. The Oxford vaccine is being tested on 10,000 volunteers over the age of 18; and the test sites, here in Brazil, are in São Paulo, Rio de Janeiro, Bahia, Rio Grande do Sul and Rio Grande do Norte. The Oswaldo Cruz Foundation (Fiocruz) has resources to receive, process, distribute and start manufacturing the vaccine, if its effectiveness is proven.

China vaccine

The vaccine from China, known as Coronavac, is being produced by the Sinovac laboratory, together with the Butantã Institute, in São Paulo. The technology used is virus inactivated. Clinical studies are being carried out on 13,000 volunteers over 18 years of age. In Brazil, people living in the states of São Paulo, Rio Grande do Sul, Minas Gerais, Paraná, Rio de Janeiro and the Federal District participate in the tests.

US-Europe vaccine

This vaccine is developed by the Pfizer-Wyeth laboratory. The technology is based on ribonucleic acid (RNA), which encodes a specific antigen of the Sars-CoV-2 virus. RNA is translated by the human body into proteins that will induce an immune response. It is being tested on 2,000 people over the age of 16. In Brazil, the states of São Paulo and Bahia participate in clinical studies.

Vaccine Europe

The other vaccine tested in Brazil is developed by the Janssen-Cilag laboratory. Clinical studies are being carried out on 7,560 volunteers over 18 years of age. The technology employed is also Adenovirus Vector. In Brazil, the states of São Paulo, Rio de Janeiro, Rio Grande do Sul, Paraná, Minas Gerais, Bahia, Rio Grande do Norte, Federal District, Mato Grosso, Mato Grosso do Sul and Santa Catarina participate in the tests.