The National Sanitary Surveillance Agency (Anvisa) of Brazil has suspended this Saturday the distribution of 25 batches with 12.1 million doses of the Coronavac Coronavirus vaccine, from the Sinovac laboratory, for having been packaged in a Chinese plant that had not been been approved by the Brazilian regulator.
In a statement, the agency announced the “precautionary interdiction” and the “distribution prohibition” of the batches after the Butantan Institute, responsible for the import and local manufacture of the vaccine, warned of the origin of these doses. “The factory responsible for the container was not inspected and authorized by Anvisa when it granted the emergency authorization for the use of the vaccine” to the Chinese laboratory Sinovac, the regulator explained in a statement. Another 17 batches packed in the same plant, with 9 million doses, are “in the process of shipping and release for Brazil.”
The decision, published in the Official Gazette of the Union, was taken “with the intention of mitigating a possible health risk” and avoiding “exposing the population to a possible imminent risk” with a product packaged in a plant in China that was not inspected by the Brazilian regulator.
The Butantan Institute has filed an appeal to release the use, on an emergency basis, of the 12.1 million doses that are already in Brazil. This center is responsible for the production in Brazil of the Coronavac vaccine, which is also produced in the Chinese laboratory Sinovac, the first that began to be applied in Brazil in the vaccination campaign that began on January 17.
The immunizer, however, only has an approval for emergency use, different from the final one granted for those of the American-German consortium Pfizer-BioNTech and the Anglo-Swedish laboratory AstraZeneca and the British University of Oxford, produced in India and in the state-owned Fiocruz. AstraZeneca accounts for 44.8% of immunization in Brazil, followed by Coronavac (33.8%), Pfizer-BioNTech (19%) and the Belgian single-dose Janssen (2.3%).
Brazil, one of the three countries most affected by the pandemic in absolute numbers along with the United States and India, accumulates almost 21 million confirmed cases and about 583,000 deaths associated with covid-19. In terms of vaccination, in the country of 213 million inhabitants, 199.1 million doses have been provided, with 65.6 million in second or single application. Thus, 30.7% of the Brazilian population has the complete immunization cycle.