Fiocruz receives first registration for a Covid-19 vaccine produced in Brazil

The Brazilian Health Regulatory Agency (Anvisa) granted the definitive registration of the COVID-19 Fiocruz vaccine on March 12. Thus, Fiocruz becomes the first holder of a registration of a COVID -19 vaccine produced in the country and adds to its product portfolio the eleventh vaccine to be supplied to the National Immunization Program (PNI). With the registration, the expectation is that Anvisa will authorize the release of the first batches week so that, Fiocruz can deliver to PNI the first one million Covid-19 vaccines produced by the institution.

"Just six months after signing the Technology Order Agreement, we have already started production of a COVID-19 vaccine, based on one of the most advanced technologies at the moment, and obtained its registration for wide distribution in the country. The urgency imposed on us by the seriousness of this pandemic has made everyone involved work tirelessly and be able to accomplish in months a process that normally takes years. This also would not be possible without all of Anvisa's technical support at every step of the ongoing submission process. This is a historical day for Fiocruz and for the Single Health System", highlights Fiocruz's president, Nísia Trindade Lima. 

Also, on March 12, a second production line of the vaccine was started, which increases the production capacity of the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz). The first line in operation was already producing about 300,000 doses per day.  The expectation is to reach the end of March with a production of about one million doses per day.  With this, the Foundation expects to deliver 3.8 million doses to the Ministry of Health by the end of March. In April, the delivery estimate will increase to about 30 million doses, and by July Fiocruz should complete the delivery of the 100 million doses resulting from the technology order agreement with AstraZeneca. 

For Mauricio Zuma, director of Bio-Manguinhos/Fiocruz, “the definitive registration of the COVID-19 vaccine is the result of intense work, in close partnership with Anvisa, since June of last year, through meetings and continuous information submission so that everything could happen as quickly as possible. With this, we will start to deliver the vaccine processed internally to the National Immunization Program, contributing definitively to the fight against the pandemic in the country”.

One of the advantages of a definitive registration for the vaccine is the possibility of mass immunization in the country, expanding the public that can now take the vaccine to adults over 18, as indicated in the package insert. With the authorization for emergency use, the vaccine was restricted to predetermined audiences. Emergency registration continues for ready-made vaccines imported from the Serum Institute in India.

“A vaccine registered by the Agency, with a production stage already carried out in Brazil, represents greater autonomy to the country and access to the vaccine,” clarifies Anvisa's general manager of medications, Gustavo Mendes, during the statement broadcasted by Anvisa.

A safe and effective vaccine for Brazil

As the producer of the vaccine in Brazil, Fiocruz will also have full technical responsibility for it, as is already the case with the other vaccines produced by the institution and distributed to Brazilian Health System. The safety of the vaccine has been extensively studied in phase I, II, and III clinical trials, with data published in internationally recognized scientific journals. Its safety has also been reiterated by several international regulatory agencies.

Importing of ready-made doses

In parallel, Fiocruz remains active in the search for alternatives for the supply of vaccines to the PNI. So far, four million doses produced by the Serum Institute and prepared for distribution by the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) have been supplied, out of the 12 million already agreed upon with AstraZeneca. In addition, Fiocruz will also technically support the receipt of the vaccines from the Covax Facility initiative, which could represent about 2.9 million doses of vaccine ready in March.