The number corresponds to about 19% of the total of 21 million doses of CoronaVac applied in the state throughout the entire vaccination campaign against Covid-19, said, in a statement, the State Health Department of São Paulo. In the statement, the folder also stated that “intercurrences in general terms” were not observed in people who received these immunizers.
The government of São Paulo also stated that “the entire network is oriented on importance of monitoring all vaccinated people, regardless of the immunizing agent administered” and that will await “the opinion of the health authorities to proceed with the distribution of 1.5 million doses of Coronavac delivered to SP this Friday (3)”.
Anvisa announced, this Saturday afternoon, that more than 12 million doses of the vaccine have gone through production processes in a factory in China that has not been inspected by Anvisa and, therefore, will have their use suspended in Brazil. Another 9 million doses of these batches are in the process of being sent and may arrive in Brazil soon.
The Health Departments of at least 13 states and the Federal District confirmed that they received vaccines from these batches and that they are contacting the municipalities to suspend the application from now on.
Four of these states (Rio Grande do Norte, Paraíba, Rio de Janeiro and São Paulo) confirmed that have already applied part of the doses received from these batches to the population.
According to the director of Anvisa, Antônio Barra Torres, from now on, states and municipalities should not use vaccines from these batches. Furthermore, those who received doses that were subject to the suspension must be accompanied by the health authorities, said the director of Anvisa.
“The first measure is not to use those. [doses] that eventually have already been used, people who have already been vaccinated, these people will be monitored,” said Barra Torres in an interview with GloboNews.
The director of Anvisa also said that, in addition to monitoring done by the Ministry of Health, there will be monitoring by the agency itself.
“There is monitoring carried out by the Ministry of Health itself, there is monitoring carried out by Anvisa, and by local surveillance. So these are people who will be observed and, obviously, any need for vaccination adjustment for the future will be done,” said Barra Torres .
Butantan attests quality
According to the head of regulatory affairs and quality at the Butantan Institute, vaccines bottled in an uncertified factory pose no risk to the population. She also highlighted that these doses went through the Butantan quality control process.
“All these batches that come from China, that come from Sinovac to Butantan, they are analyzed by our quality team, not only documentally, but also, we analyze the product, and we had no indication of a quality problem “, explained Patricia Meneguello, from Butantan.
The suspension of doses produced in the non-certified factory has a period of 90 days. During this period, Anvisa will work on evaluating the conditions of good manufacturing practices in the uninspected unit to find out if the quality, safety and efficacy of the vaccine are compromised, and what the impact will be on the population vaccinated with these doses.
“There was no other decision than to promote the precautionary interdiction. The precautionary interdiction is preventive of any possible problem. In the meantime, once the interdiction is installed, the negotiations continue, the dialogues with the institute so that the necessary documents are presented”, said Barra Torres.
Anvisa suspends 25 batches of CoronaVac produced in China
In a statement, the Butantan Institute said that “Anvisa’s measure should not cause alarmism“, he declared that it was the institute itself that warned Anvisa for “extreme precaution” and that “invites the top of Anvisa to get to know again the facilities of Sinovac factories” in China.
“All batches released by the institute are in the possession of the Ministry of Health, as signed in the contract. We reaffirm, however, that all doses that left the factory are certified by the rigorous quality control of Butantan”, said the institute in a statement .
The Institute also said that it forwarded to Anvisa, 15 days ago, the necessary documentation for the certification of the production process in which the doses now banned were made.
Health professional applies CoronaVac vaccine against Covid-19 in Rio de Janeiro, in a photo of May 4th. — Photo: ADRIANO ISHIBASHI/FRAMEPHOTO/ESTADÃO CONTENT
On Friday (3), Anvisa was informed by Butantan that pharmaceutical company Sinovac, manufacturer of vaccine inputs, sent 12,113,934 doses to Brazil, in the vial presentation (single dose and two doses).
However, according to the agency, the factory responsible for filling these doses was not inspected and approved in the Emergency Use Authorization granted to CoronaVac.
Anvisa provisionally suspends batches of CoronaVac vaccine
O G1 had access to the letter sent this Friday (3) to Anvisa. In the document, the director of Butantan, Dimas Covas, says that technicians from the Institute analyzed the information available in the lots and pointed out the safety and quality of the vaccines produced at the factory, which has not yet been inspected.
In the text, Dimas Covas requests authorization for vaccines to be applied on an emergency basis, so as not to compromise the national immunization program.