Oswaldo Cruz (Fiocruz) reported today (28) that the industrial plant where the active pharmaceutical ingredient (IFA) will be produced from the covid-19 vaccine is being visited by technicians from the National Health Monitoring Agency (Anvisa) this week. Since Monday (26), they are examining the operational technical conditions of the space and analyzing the documents. The inspection ends on Friday (29).
A scientific institution linked to the Ministry of Health, Fiucrose has an agreement with the University of Oxford and the English pharmaceutical company AstraZeneca to manufacture the Covishield vaccine in Brazil. The immune system has been in use in the country since January, when the first doses were imported from India.
Fiocruz began mass production in March. However, the IFA still needs to be imported. It is essential in formulating a vaccine because it brings the information that causes the organism to begin preparing its defenses against the invading virus. It will be produced at the Fiocruz Institute of Technology in Immunology (Bio-Manguinhos), located in Rio de Janeiro.
“Screening is an important step to enable the immune system to be produced in a 100% nationalized manner, starting with the transfer of technology. The main area adaptations and equipment for operations were completed in just six months, with tests for qualifications carried out within the set schedule,” says Fiucruz in note.
Among the duties of Anvisa, a regulatory body linked to the Ministry of Health, is to evaluate and technically approve the use of vaccines in Brazil. IFA production by Fiocruz also needs your approval.
In addition to Covishield, the other vaccine used in Brazil to combat covid-19 is CoronaVac. It is also produced in the country by the Botantan Institute. The Biomedical Research Center associated with the Ministry of Health in São Paulo has signed an agreement with Sinovac, a Chinese laboratory that has developed the immune system. IFA must also be imported for this vaccine.
Both CoronaVac and Covishield were initially approved by Anvisa for emergency use in the midst of the pandemic. In March, the immune system developed by the partnership between the University of Oxford and AstraZeneca obtained the final registration.
In the coming weeks, the vaccination will gain a boost for a vaccine produced by the US pharmaceutical company Pfizer in partnership with the German biotechnology company BioNtech. It is another immunization device that already has final registration with the Brazilian regulatory authority. It was awarded in February. Your down payment must arrive in the country tomorrow (28).
There is a fourth vaccine that has been approved by Anvisa for use in the country. Produced by Janssen, the pharmaceutical arm of the multinational company Johnson & Johnson. The manufacturer approved its request for the emergency use of immunomodulators in March. The first batches will be delivered in August.
On Monday (26), Anvisa decided to reject ten countries requesting emergency import and use of the Sputnik V vaccine, a vaccine developed by the Aesthetic Institute in Russia. According to the agency, there are defects and issues pending in the documentation provided by the manufacturer.