The Brazilian Immunization Program and the Challenge of Self-Sufficiency in Vaccines and Hyperimmune Sera

Vaccines are biological products that contain antigens capable of inducing specific and active immunity against an infectious agent or the toxin produced by some pathogens. For over a century, passive immunotherapy with polyclonal antibodies has been em-ployed in the treatment and post-exposure prophylaxis against various microorgan-isms and toxins. This study aims to evaluate the quantity and types of antigens and sera distributed by the National Immunization Program (NIP) and to analyze both the duration and challenges associated with technology transfer in vaccine production within Brazil. Furthermore, it assesses the impact of ongoing technology transfers. Methods: The study collected data from official systems for information on vaccine lots and their origin from 2014 to 2024, as well as the production stages in which pharmaceutical laboratories were certified by the national regulatory authority. Re-sults: Out of the 25 antigens provided by the NIP, 4 are produced using biotechnology methods, while the remaining 21 utilize conventional technology. The process of tech-nology transfer to Brazilian manufacturers takes between 3 to 15 years. Moreover, public laboratories still face challenges regarding physical infrastructure and acquir-ing the necessary qualifications certificates for production. Conclusions: Technology transfer in vaccine production is a high-risk endeavor that requires long-term plan-ning and investment. The ongoing technology transfers in Brazil have contributed to the NIP, but challenges remain in terms of infrastructure and qualifications. Ongoing advancements in technology are essential to remain aligned with progress.