In all, 12.1 million doses were interdicted that were produced by Sinovac in China, in a factory not inspected and approved by Anvisa. Of this total, the state of São Paulo has already applied 4 million doses.
According to Anvisa, the “documents presented by Butantan do not respond to the uncertainties about the new manufacturing location” of CoronaVac.
“The Butantan Institute did not present the inspection report issued by the health authority, which is essential for evaluating the conditions for approval of the plant, which may include commitments and conditions to allow the operation at the site,” the agency said in a statement.
“The risk analysis presented by the Butantan Institute was not considered sufficient to guarantee the safety of the manufacturing process in the new location. Such analysis does not replace a sanitary authority inspection or the sanitary inspection report. Only the sanitary authorities are competent to certify the GMPs (Good Manufacturing Practices) of a manufacturing site,” informed Anvisa.
“It is up to Butantan to present the missing documentation, including the inspection report issued by a health authority to support Anvisa’s analysis or to make it possible to carry out a face-to-face inspection by Anvisa itself”, informed the agency, which stressed that it had already activated the Ministry of Foreign Affairs to seek contact with Chinese authorities about the case.
In a statement, Butantan reiterated that it does not have the documents requested by Anvisa.
“The Chinese health agency (NMPA) does not grant the inspection report directly to the institute for internal reasons, which is why the Butantan requested the National Health Surveillance Agency (Anvisa) to request the document from the agency. The report is already approved by the agency. plant by the local health authority, which show that the filling line is fully operational,” said Butantan.
The institute pointed out that the batch of immunizing agents that is under Anvisa’s embargo “comes from the industrial site of Chinese biopharmaceutical Sinovac, a partner of Butantan and which has all the necessary international sanitary credentials for the manufacture of CoronaVac”.
Task force to unlock doses
Butantan said it created “a task force to meet all demands and clarify doubts” at Anvisa.
“All questions requested by the Agency will be attended to by the Institute, with the speed that the situation demands. It is noteworthy that before distribution to the population, the 4 million doses made available in the state health network underwent strict quality control and were certified by the National Institute of Quality Control (INCQS), Fiocruz body of the Federal Government, responsible for evaluating the quality of all immunizing agents distributed in Brazil. The vaccines were validated and, therefore, had guaranteed quality for use in the population.” defends Butanta.
On Monday (6), the Ministry of Health announced the blocking of the doses under investigation in the system and declared that the banned vaccines that have already been distributed or applied “are being tracked by the technical teams responsible and will be monitored and controlled until the final decision of Anvisa”.
In addition, the folder instructed health authorities to record the doses administered in the SUS information systems.
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 the orientation.
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.
Nurse applies a dose of vaccine against Covid-19 in the state of SP — Photo: Leandro Ferreira/Fotoarena/Estadão Content
According to the director of Anvisa, Antônio Barra Torres, 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 on Saturday.
“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.
‘Nobody bans such a large vaccine batch for no reason,’ says Anvisa’s CEO
Anvisa spokesman 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 at 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.
In a meeting held this Monday (6) with Anvisa, the Butantan Institute presented an analysis of the blocked batches. “The objective was to subsidize the release of batches as quickly as possible, considering the urgency within the pandemic context. Although the institute concluded that there is no evidence of deviations that could pose quality and safety risks, the documentation was not accepted by the regulatory agency “, says note from Butantan.
“One of the documents requested by Anvisa, for exceptional use of vaccine batches, is the inspection report of the Chinese Health Authority (NMPA) which, for internal reasons of the international body, cannot be made available directly to the institute. Butantan requested that Anvisa directly request the document from the NMPA.
Butantan will send, even today, the non-compliance reports detected during the inspection by the Chinese health regulatory agency in the new filling line. In addition, the document with the action plan to adjust these non-conformities is being translated and will be delivered by the end of this week to Anvisa. It is worth reiterating that the Chinese factory has certification that follows good international practices, the GMP.
Voluntarily, the IB will send a risk analysis of the lots already distributed to the PNI. It is noteworthy that CoronaVac is a safe immunizing agent available to the Brazilian population and all batches of the immunizing agent were certified by the institute’s strict quality control.
Butantan reinforces that, at this time, it is important to join forces so that the risk x benefit assessment of blocked batches is carried out as soon as possible, always bearing in mind the commitment to public health,” he says in a note.