Fiocruz sent, this Friday (26), to the National Health Surveillance Agency (Anvisa) the application for registration for the production of the vaccine with national IFA. Within 30 days, Anvisa completes the analysis of the Foundation’s application. The submission of the request to the agency took place within the deadline stipulated by Fiocruz, which was to deliver the document by November this year.
Anvisa will assess the equivalence of the production process. The objective will be to prove whether vaccines produced with the Bio-Manguinhos API have the same efficacy and safety as immunizing agents made with imported raw material.
The foundation celebrated the delivery and pointed out that the technology transfer process took place in record time. “Completion of technology transfers in immunobiologicals usually takes about 10 years. With the Fiocruz Covid-19 vaccine, Bio-Manguinhos/Fiocruz will complete the incorporation of the technology in just one year, in response to health emergencies”, said Fiocruz in a note published on the institution’s website.
Fiocruz also informed this Friday (26) that, so far, it has concluded the production of five batches of national API. Of these, four were released internally and are in analytical comparability studies abroad. The other three are being processed at the Institute.
The foundation, however, did not say when 100% national vaccines will be able to be applied in the population, nor how many national doses are planned.
“The final processing (formulation, filling, review, labeling and packaging) of batches with the national IFA and the first deliveries of national vaccines will only occur after approval of the post-registration change by Anvisa and agreement with the National Immunization Program (PNI) , in order to guarantee the maximum validity of the doses at the time of their distribution”, informed Fiocruz.
The last forecast made by Fiocruz was to deliver vaccines produced with 100% national API by the end of this year. On that occasion, they also did not say how many doses are expected to be delivered to the national immunization program (PNI).
Initially, the forecast was to start the distribution of doses with the national IFA in August. These deliveries would only be possible with the signing of the technology transfer contract with AstraZeneca. This contract would be signed in December 2020, then it was postponed to February, then to April, May and, finally, it was only signed in June, causing a delay in the production of national vaccines.
Fiocruz has already delivered 135.7 million doses of vaccine against Covid-19, produced with imported API, to the Ministry of Health. The number still represents 64.7 million below what the foundation predicted to deliver by the end of this year to the PNI – according to estimates that appear on Fiocruz’s own website. However, the foundation informs that the delay in the production of the national IFA has not impacted the deliveries agreed with the PNI
Reference: CNN Brasil