After successive delays and frustrated forecasts in deliveries to the Ministry of Health, the Oswaldo Cruz Foundation (Fiocruz) had to resort to a donation to ensure that it would be able to manufacture the vaccine against the coronavirus with a national Active Pharmaceutical Ingredient (IFA), as predicted. The help of the English laboratory was the only way to guarantee the Brazilian version of the vaccine this year.
One of the reagents, a salt necessary for the composition of the API, would only arrive next year due to the availability of suppliers. The information was verified by CNN with people linked to the production process.
Fiocruz has suffered from the global crisis of the IFA. The foundation was impacted by an overload in the global supply chain. Throughout the vaccine manufacturing process, it was faced with a lack of items such as bottling bottles, plastics and tampons, items needed on a large scale to be able to safely store and distribute doses throughout the country.
They chose to wait for the arrival of these items and then actually start production, so that the work would not be halted along the way – jeopardizing the stability of the vaccines.
“The start of production is scheduled for April, but it is also a complex process, so it takes a while for us to have the batches produced, the batches validated, the batches certified in terms of quality, in regulatory terms, so the expectation is that we will only be able to distribute these batches in the second half, possibly something around August is our expectation today”, said in February the director of the BioManguinhos plant, Maurício Zuma.
The prediction, however, did not materialize. The foundation recognized that the first batch that began production in July – not April – should only be ready for November – not August. They also say that deliveries will extend to 2022, totaling 50 million doses, less than half of the 112.4 million initially estimated.
Fiocruz said that the schedule will be updated according to the progress of the project and the fulfillment of established objectives and goals and that “since it is a complex process, any change in the schedule will be communicated with transparency and as soon as possible”.
In a statement, the Oswaldo Cruz Foundation stated that ‘there is an increase in global demand for inputs used in the production of vaccines, which is reflected in some supply difficulties, which affect producing companies to a greater or lesser degree’ and that ‘Bio- Manguinhos has been working daily with suppliers and partner companies to maintain their production schedules’.
Due to contractual issues, Fiocruz does not comment on specific items, but said, in a note, ‘that at the moment the supply of these inputs is considered’.
They did not answer the questions asked by CNN on the possible counterparts of the donation, the role of the reagent in the formula, the value of the shipment sent by AstraZeneca and the delay of other essential items for the vaccine. THE CNN questioned Astrazeneca but until the closing of this report there was no return.