Fiocruz plant for Covishield vaccine production undergoes inspection

Brazil’s Oswaldo Cruz Foundation (Fiocruz) today (Apr. 28) announced that the industrial plant where the active pharmaceutical ingredient (API) for the vaccine against COVID-19 will be produced is being inspected this week by experts from the country’s national sanitary regulator Anvisa. Since Monday (26), they have been verifying technical and operational conditions in the premises and assessing documents. The inspection should be concluded Friday (29).

A scientific institution linked to the Health Ministry, Fiocruz has a deal with Oxford University and UK pharmaceutical company AstraZeneca to manufacture vaccine Covishield in Brazil. The inoculation has been used in the country since January, when the first doses were imported from India.

Friocruz kicked off the large-scale production of the vaccine in March. The API, however, still needs to be imported. It is crucial in the formulation of the vaccine as it brings the information that makes the human body start preparing its defenses against the invading virus. Its production will take place at the Institute for Technology in Immunobiologicals of Friocruz, or Bio-Manguinhos, in Rio de Janeiro.

“The inspection is a key step in making the entire production of the inoculation viable domestically after the technological transfer. The adaptations in the main area and the acquisition of the necessary equipment took place in just six months, with the qualification testing conducted within the estimated schedule,” Fiocruz states in a note.

Among Anvisa’s duties are the assessment and approval of the use of vaccines in Brazil. The production of the API by Fiocruz also needs its approval.

Other vaccines

In addition to Covishield, the vaccine being used in Brazil in the fight against COVID-19 is CoronaVac. It is also manufactured in the country, by Butantan Institute—a biomedicine research center linked to São Paulo’s State Secretariat, which signed a deal with Sinovac, the Chinese laboratory developing the inoculation. This vaccine’s API also requires importing.

Both CoronaVac and Covishield received the approval of Anvisa for the emergency use during the pandemic. In March, the inoculation developed by the partnership between Oxford University and AstraZeneca obtained its definitive registration.

The vaccination will be reinforced in the coming weeks by the vaccine produced by US Pfizer in collaboration with Germany’s BioNtech. This is another vaccine with a definitive registration with Anvisa, granted in February. The first batch of this vaccine is likely to arrive in the country on Thursday (29).

There is also a fourth vaccine, with Anvisa’s approval for use in the country, produced by Janssen, the pharmaceutical branch of multinational Johnson & Johnson. Its request for emergency use was granted in March. The first batches are likely to be delivered in August.

On Monday (26), Anvisa decided to deny to ten states the request for the import and emergency use of Sputnik V, the vaccine developed by Russia’s Gamaleya Institute. There are flaws and pending requirements in the documentation submitted by the manufacturer, the watchdog reported.