After delays, delivery of Fiocruz’s own vaccine remains unpredictable

The delivery of AstraZeneca’s fully nationally produced vaccine by Fiocruz continues without a concrete forecast, as well as no definition regarding the quantity to be manufactured in the country.

After a series of delays in the process, the foundation started to estimate deliveries for the last quarter of 2021, but without specifying the date.

Initially, the distribution of the vaccine produced from the national IFA (active pharmaceutical ingredient) was scheduled to start in August, totaling 110 million doses by December.

However, the signing of the technology transfer contract with the AstraZeneca laboratory, which should have taken place in December 2020, was postponed to February, then April and May, and ended up happening only in June this year.

With this, the completion of the first two batches with national API by Bio-Manguinhos (Institute of Technology in Immunobiologicals) took place only at the end of September.

According to Fiocruz, these two pre-validation batches were approved in internal quality tests and are now being evaluated in laboratories in the United States. The objective is to compare national and foreign APIs, ensuring that the input produced in Brazil has the same quality and safety standards.

In order for the doses to be distributed, after quality control, it is still necessary for Anvisa (National Health Surveillance Agency) to approve the request to change the registration of the vaccine, contemplating the new manufacturing location of the API, which must occur in November. Therefore, Fiocruz says that it is not yet possible to estimate the amount that will be released for delivery this year.

The production of four other batches from the national IFA is also in progress. According to Fiocruz, by the end of 2021 the forecast is that 30 million doses have been or are being produced.

“Considering all the necessary steps, the great complexity of the production process, the long time of quality control at this stage, regulatory issues and the scarcity of inputs in the international market, it is still not possible to state the national quantity that will be produced and released yet this year, but the monthly delivery of vaccines is guaranteed,” Fiocruz said in a statement.

Throughout the year, vaccination with AstraZeneca was interrupted several times due to the lack of supplies. In August, the Ministry of Health authorized the application of Pfizer for the second dose, when there is no AstraZeneca in stock.

When the vaccine was lacking, Fiocruz reinforced that this was due to the shortage of IFA imported from China, the raw material for the production of doses. The foundation says that it remains with a production capacity greater than that of making the input available.

Initially, the forecast was that 100.4 million doses would be produced by Fiocruz, from the imported API, by July. The foundation ended up delivering, however, 76.4 million doses, which corresponds to 76% of what was expected. In June and July, production was well below expectations.

“From February to April, AstraZeneca made an effort to send a greater number of batches than agreed to allow for the staggering of production. As of May, the pharmacist resumed sending two contracted monthly batches and the institution remained for some periods with production capacity higher than the input received,” Fiocruz said in a statement.

In July, the foundation announced that it had made a commitment to purchase enough imported API to deliver 70 million doses starting in August. From August to October 20th, 33 million doses were distributed. From March to October, Fiocruz delivered 113.8 million doses, which corresponds to 35% of the vaccines distributed in the country.

In a statement, Fiocruz stated that until the third week of November, uninterrupted weekly deliveries will be guaranteed, due to a new shipment of imported API, scheduled to land next Sunday (24), enough to produce another 5.6 million doses.

In addition, according to the foundation, there are over 16.7 million vaccines that are in different stages, 15 million of which in quality control, for release starting next week.