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Fiocruz submits final application for the Covid-19 vaccine registration


05/02/2021

Ricardo Valverde (CCS)

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On January 29th, Fiocruz officially submited the application to register the Covid-19 vaccine to the Healthy Surveillance Agency (Anvisa), which will allow the Oxford-AstraZeneca immunizer Covid-19 vaccine across the country. “This is another key step in facing the pandemic and it will allow the Brazilian population to have broad access to the vaccine, which will be distributed through the Ministry of Health’s National Immunization Program”, celebrates Fiocruz’s president, Nísia Trindade Lima.

The application to the final register is a result of a process that started on June 2020, through continuous submitions, a process created by Anvisa to streamline documentation analysis, by sending information packs shared by AstraZeneca, so that the Agency could gradually analyze and guide both Fiocruz and the pharmaceutical company through the next steps.

“This submission is different from the emergency use authorization we had obtained recently. The emergencial use was specifically granted to the 2 million doses that were bought from the Serum Institute of India to be used emergencially and temporarily. With the last information pack delivered, we aim to get a definitive authorization to produce and supply the vaccine. Through the last couple of months, lots of packs were submited, containing information about pre-clinical and clinical studies, with data about the safety, effectiveness, production and quality of the vaccine. Anvisa’s support was fundamental in this process. We were guided through every step in the submition”, explains the deputy director of Quality of the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz), Rosane Cuber.

Fiocruz delivered 2 million doses of vaccines (imported) in January, and by the start of the production, when the Active Pharmaceutical Ingredient (API) arrives, the Foundation will be able to stagger the delivery to reach 50 million doses by April and 100.4 million doses by July 2021. On the second semester of this year, it won’t be needed to import the API, that will also be produced at Fiocruz after transfer of technology. From August to December, over 110 million doses will be produced entirely at the institution, ensuring the country’s autonomy and the vaccination of the whole Brazilian Population.

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