Brazil’s National Health Surveillance Agency (Anvisa, regulator) this Saturday suspended the distribution of 25 batches with 12.1 million doses of the vaccine against the coronavirus Coronavac, for having been packaged in a plant in the Asian country not approved by the Brazilian control body.
In a statement, Anvisa announced the “precautionary interdiction” of the lots and the “distribution ban”, after the Butantan Institute, attached to the government of the state of São Paulo and responsible for the importation and local manufacture of the vaccine, notified the origin of the immunizers.
“The manufacturing unit responsible for the container was not inspected and was not approved by Anvisa when it granted authorization for the emergency use of the aforementioned vaccine” from the Chinese laboratory Sinovac, the regulatory body detailed.
Another 17 batches packed in the same plant, with nine million doses, are “in the process of shipping and release to Brazil,” Anvisa completed.
The decision, published in the Official Gazette of the Union, was taken “with the intuition of mitigate a possible health risk “ and avoid “exposing the population to a possible imminent risk” with a product packaged in a plant in China that did not pass inspection by the Brazilian regulator.
The Butantan Institute presented a appeal to at least release the emergency use of the 12.1 million doses that reached Brazil.
The Coronavac vaccine, from the Sinovac laboratory, produced in China and in Brazil through the Butantan Institute, was the first to be applied in Brazil in the vaccination campaign that began on January 17 of this year.
The immunizer, however, only has an approval for emergency use, different from the definitive 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 thousand deaths associated with covid-19.
In terms of vaccination, in the country of 213 million inhabitants, 199.1 million doses have been supplied, with 65.6 million in second or single application. Thus, 30.7% of the Brazilian population has a complete immunization cycle.
EFE
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