Pamela Lang (Fiocruz News Agency)
This Friday (January 7), Fiocruz received assent from the National Agency of Sanitary Surveillance (Anvisa) for the alteration in the register of the COVID-19 vaccine (recombinant), which requested the addition of the Foundation as a producer of the Active Pharmaceutical Ingredient (API). After the transference of the AstraZeneca technology and with the approval of Anvisa, the Foundation is now the first institution in the country that is allowed to produce and distribute a 100% Brazilian COVID-19 vaccine to the Ministry of Health.
Up to this moment, Fiocruz has the equivalent of 21 million doses of national API, in different steps of production (Image: Bio-Manguinhos)
Fiocruz started the national production on July 2021, after the signing of a contract for Technology Transfer with the partner AstraZeneca. Up to this moment, the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) has the equivalent of 21 million doses of national API, in different steps of production and quality control. The first doses of the immunizations are expected to be bottled in January and delivered to the Ministry of Health in February, as soon as the quality control tests that occur after the vaccine's final processing stages implementation are completed.
“It is a great achievement for the Brazilian society to have a 100% national vaccine for COVID-19 produced by Bio-Manguinhos/Fiocruz. The Covid-19 pandemic made clear the problem of depending on an active pharmaceutical ingredient to produce vaccines. With the Anvisa approval, we conquered a vaccine that is 100% produced in the country and, this way, we guarantee the self-sufficiency of our Unified Health System (SUS, the Brazilian public health system) for this vaccine, which has been saving lives and contributing to overcome these difficult times in the Brazilian and world history”, highlights the president of Fiocruz, Nísia Trindade Lima.
In order to achieve the register, Anvisa evaluated the equivalence of the production process, proving that the vaccines produced with the Bio-Manguinhos/Fiocruz API have the same efficacy, safety and quality as those processed with imported API, in addition to the analytical methodologies demanded and the steps of the production process.
According to Mauricio Zuma, director of the Institute, “the approval of the register of the 100% national COVID-19 vaccine, with the API produced in Bio-Manguinhos, demonstrates our capacity in establishing a high complexity production process. More than that, it represents the fulfillment of our role as an official laboratory of the Ministry of Health, incorporating essential technology for Brazil and bringing solutions for public health”.
The technology absorption occurs in record time, taking around one year, meeting the needs of the pandemic. Procedures following the same patterns for immunobiological used to take around 10 years. The national COVID-19 vaccine is an important achievement for the country. Fiocruz, reaching productive self-sufficiency, is still contributing to national sovereignty in the production and supply of the immunobiological.