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The Covid-19 pandemic is a unique event in the modern history of humanity, which has generated great challenges and, at the same time, valuable opportunities for public health. A number of examples of them are found in the more than three hundred pages of this book. In each chapter it is possible to understand how a vaccine for Covid-19 was developed in record time - due to the urgency of an antidote that would allow us to deal with this terrible disease - through the acceleration, compliance and improvement of all labor criteria, production, evaluation, timely release, and security. This entire process of developing the first vaccine produced by Brazil was described in a very creative way, allowing the reader to dive into a technical-scientific content of the highest level. The book presents an overview that goes through the origin of the virus, the transmission mechanisms of SARS-CoV-2, the vaccine development process and the regulatory and legal instruments to guarantee access to vaccination - starting with the most vulnerable populations. It also describes the trials and phases of clinical study development that ensured the vaccine's safety and efficacy. It also covers the logistics of distribution and pharmacovigilance for monitoring the product in the user population until the detailing of the technological prospection, as well as showing the necessary steps to carry out a process of technology transfer of the vaccine from the viral vector. Among the various innovations, it is worth highlighting: preparation of a technological order through ETEC; use of continuous submission to the National Health Surveillance Agency (ANVISA); and emergency use authorization. This effort made it possible to meet the expressive demand for Covid-19 vaccines in Brazil in a timely manner and on an unprecedented scale. For the Pan American Health Organization (PAHO), which turns 120 on December 2, 2022, it is an honor to have Bio-Manguinhos/Fiocruz as part of our history. Due to its outstanding performance on the international scene, this institute is a true heritage of humanity. And now, with the first Brazilian vaccine for Covid-19, Bio-Manguinhos/Fiocruz consolidates Brazil's leadership in the production of immunobiologicals in Latin America and the Caribbean, ensuring greater self-sufficiency and sustainability of basic health supplies not only for the country, but for the entire region of the Americas.

Original publication

DOI

10.35259/vacinacovid.2022_52830

Type

Book

Publisher

Fundação Oswaldo Cruz / Bio-Manguinhos

Publication Date

2022