The fully national vaccine being produced by Fiocruz will have its first batch ready in February. The National Health Surveillance Agency (Anvisa) approved this Friday (7th) the registration of the Active Pharmaceutical Ingredient (IFA) of the Covidshield vaccine (Astrazeneca) produced in Brazil. With this, the country will be able to have a 100% national vaccine.
In a note, Fiocruz stated that “the forecast is that the first doses of the immunizing agent will be bottled in January and delivered to the Ministry of Health in February, as soon as the quality control tests that occur after the final processing of the vaccine are completed.”
“It is a great achievement for Brazilian society to have a 100% national vaccine for Covid-19 produced in Bio-Manguinhos/Fiocruz. The Covid-19 pandemic has made clear the problem of dependence on active pharmaceutical ingredients for the production of vaccines. With this approval today by Anvisa, we conquered a vaccine 100% produced in the country and, in this way, we guarantee the self-sufficiency of our Unified Health System for this vaccine, which has been saving lives and contributing to the overcoming of this difficult historical phase for Brazil and the world”, said the president of Fiocruz, Nísia Trindade Lima.
Anvisa approves national IFA
To approve the input registration, the Anvisa analyzed comparability studies – which showed that the ingredient manufactured in the country had the same performance as the imported one.
In April 2021, Anvisa had already issued a certificate of good manufacturing practices for the new input, that is, Fiocruz’s production line complied with all the necessary requirements to guarantee the quality of the IFA.
It is worth remembering that Fiocruz has been authorized since January 17 of last year when it received the definitive registration in March 2021.
Fiocruz and Oxford work in partnership in the production of the AstraZeneca vaccine.
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