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). The last commitment was to deliver 3.8 million doses by Wednesday 31 March.
Sad record:March has 66,898 deaths from Covid-19
This Thursday (1), a note from Fiocruz reported that Bio-Manguinhos “delivered, until March 31, more than 2.8 million Oxford-AstraZeneca vaccines to the National Immunization Program” and that on Friday (2 ), will deliver an additional 1.3 million doses of the immunizer. Three months ago, when it released the first schedule of the agreement with the British company AstraZeneca, Fiocruz mentioned the delivery of 15 million doses in March and another 28 million in April.
The director of Bio-Manguinhos, Maurício Zuma, said that one of the reasons for the delay is the seaming machine for one of the two vaccine processing lines, which had to be 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.
In the plans:Ministry of Health maintains Covaxin forecast for April despite Anvisa’s refusal to import
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.
Private doses:Chamber postpones vote on project supported by Lira for vaccine purchase by entrepreneurs
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.
But doses:Anvisa authorizes emergency use of Johnson vaccine
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.
Get the latest news delivered to your inbox
Follow us on social media networks