RIO DE JANEIRO, BRAZIL – The Immunobiological Technology Institute of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz) has restarted, on May 25, production of the Oxford/AstraZeneca Covid-19 vaccine, which had been suspended since last Thursday, May 20.
Production was resumed after the arrival of a new shipment of the active pharmaceutical ingredient (API) from China on Saturday, May 22.
Last weekend, Fiocruz received enough raw material to produce 12 million doses, which ensures the production of vaccines until the third week of June and uninterrupted deliveries to the National Immunization Program (PNI) until July 3.
The API is considered the vaccine’s most important component, as it contains genetic information that will trigger the immune response against the novel coronavirus. The raw material is transported at a temperature of -55°C and needs to be slowly thawed once it reaches the plant.
The vaccine production process at Bio-Manguinhos comprises a long quality control protocol, which takes up to four weeks to ensure efficacy and safety of the manufactured batch, until its release to the Ministry of Health’s PNI.
The doses starting to be produced today should only be delivered to the National Health System (SUS) between June 14 and 19.
Next deliveries
The schedule presented last Thursday, May 20, by Marco Krieger, Fiocruz’s vice president of Production and Innovation, to the Chamber of Deputies’ Committee for Combating Covid-19, estimated that the next weekly deliveries would consist of 4.9 million, 5.1 million, and 2.8 million doses.
Last Friday, May 21, 6.1 million doses were delivered – 800,000 more than the initial forecast. According to Krieger, Fiocruz should deliver 26 million more doses to the PNI by early July and reach a total of 62 million with the API shipments that have now reached Brazil.
The technological order agreement between Fiocruz and AstraZeneca pharmaceutical company foresees the production of 100.4 million doses from the arrival of 14 API batches, which are produced by Chinese laboratory WuXi Biologics.
In last Saturday’s shipment, Fiocruz received two batches, totaling 10 shipments already sent. Two more batches are expected to arrive in June, and the last two in July.
To date, Fiocruz has produced and delivered to the PNI 37.1 million vaccine doses against Covid-19. In addition, 4 million doses of the Oxford/AstraZeneca vaccine produced by India’s Serum Institute have also been delivered to vaccination posts.