RIO – The Institute of Biotechnology in Immunobiologicals (Bio-Manguinhos), linked to Fiocruz, closed the month of March delivering 2.8 million doses of the AstraZeneca / Oxford vaccine to the National Immunization Program (PNI). Three months ago, when it released the first schedule of the agreement with the Anglo-Swedish pharmaceutical company, Fiocruz mentioned the delivery of 15 million doses in March.
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This Thursday (1), Fiocruz said in a note that, in addition to the 2.8 million units already shipped, on Friday (2) it will deliver another 1.3 million doses of the PNI immunizer. The text states, however, that the schedule “is subject to the distribution logistics defined by the folder, in addition to the quality control protocols”. The director of Bio-Manguinhos, Maurício Zuma, said that the delay in sending this last batch is partly explained by the malfunction of a seaming machine. The device was stopped a week after failing.
Bio-Manguinhos Achilles heel in the vaccine filling, the seaming machine fulfills the function of sealing the vaccine bottles already closed with a stopper with aluminum. After this stage, the bottles go on to labeling and packaging. The director explained that the machine “performed poorly” by sealing the last of the three vaccine validation batches (intended for quality control tests with the National Health Agency, Anvisa), discarding vials that were in good condition.
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To remedy the problem, according to Zuma, Bio-Manguinhos was forced to buy parts in Italy – country of origin of the machine manufacturer, IMA, Industria Macchine Automatiche. After the repair, a technician from the Italian company and a quality control specialist from Fiocruz started to monitor the performance of the engraving machine 24 hours a day, said Zuma, guaranteeing that the processing returned to the expected pace and that the sealed batch with problems – around 450 thousand doses – it is separated for analysis but has not been discarded.
R $ 1.3 billion contract
Bio-Manguinhos is committed to making the final processing of the AstraZeneca / Oxford vaccine, which comprises the operations of formulation, filling, seaming, labeling and packaging. The operation, according to Transparência Brasil, involves a contract of R $ 1.35 billion, of which R $ 991 million has already been paid to the manufacturer to supply the Active Pharmaceutical Ingredient (IFA), raw material for the vaccine.
The first batch of IFA, sent by the Chinese government on February 6, contained 90 liters, enough to produce 2.8 million doses. The filling of this first shipment started on February 12th. On February 27, another shipment of two batches of IFA arrived, enough for 12.2 million doses. These two lots completed a total of three received in February.
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In admitting the problems of converting a yellow fever vaccine production line to Covid-19, Zuma says that “technical issues need to be faced daily”. In the case of the seaming machine, the machine operated with a certain torque (the pressure at the time of sealing) that had to be changed to follow the technical specifications of the manufacturer of the Covid-19 vaccine. Although he admits that Bio-Manguinhos is working with some exceptionalities allowed by Anvisa, he says that the institution cannot rule out care – which ends up slowing down the processing of the vaccine.
The production line for the final processing of the immunizer is composed of a formulation area (dilution of the IFA with the addition of a buffer solution), a filling line composed of a bottle washer, a depyrogenization tunnel, a filling and sealing machine for placing metallic seals, an inspection line made up of automatic proofer and a packaging line made up of labelers, cartoners and wrappers.
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At the moment, according to the director, Bio-Manguinhos has two filling lines for the vaccine. The first, where the technical problem arose, works in two shifts. The second, which came into operation recently, still works in one shift. According to him, the two together are managing to produce 900 thousand doses per day. But the production, says Zuma, cannot be delivered immediately to the PNI, as it undergoes quality analysis in a period of three weeks before being released.
Check out the full Fiocruz note this Thursday:
“Through the Institute of Technology in Immunobiologicals (Bio-Manguinhos), Fiocruz delivered, until March 31, more than 2.8 million Oxford-AstraZeneca vaccines to the National Immunization Program. A new delivery is scheduled for this Friday. fair (2/4), with approximately 1.3 million doses of the immunizer, with this, the Foundation totals more than 4.1 million vaccines produced and made available to the Ministry of Health. The delivery schedule agreed with the Ministry of Health it will follow the weekly delivery schedule and is subject to the distribution logistics defined by the folder, in addition to the quality control protocols.
The Foundation continues to work on scaling production to reach a capacity of 1 million per day. Still this week, Fiocruz will receive another batch of Active Pharmaceutical Ingredient (IFA), enough to produce an additional 5.5 million doses. ”
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