With the end of the contract of Coronavac scheduled for this month, the Ministry of Health it no longer intends to acquire new batches of the immunizing agent, according to sources heard by the metropolises. “Coronavac still has the emergency registration by Anvisa. Thus, future purchases (within planning for next year) are no longer legally justified by a public agency in this situation,” claimed a member of the federal agency.
In the internal discussion, the lack of authorization from the National Health Surveillance Agency (Anvisa) for the application of Coronavac in adolescents is also presented as a justification. Another argument is the fact that the technical standards do not recommend, as a booster dose, the application of the formula developed in partnership between the Chinese laboratory Sinovac and the Butantan Institute. This is because studies show that there is greater effectiveness with the heterologous scheme – application of vaccine with another technology as an additional dose – and Coronavac protection falls over time in the older age groups.
The Ministry of Health also maintains that 100% of the population over 18 years old received the first dose, and there are enough immunizing agents to guarantee the second application for all Brazilians – including those who took Coronavac. “As the system does not identify this information, we are carrying out a survey, together with the municipalities, to see if there are still people in this age group who need to start the vaccination scheme. [E para isso] We could send the doses that we have in our Coronavac stock”, he points out.
Last week, the Butantan Institute has already anticipated the possibility of staying out of new purchases by the Ministry of Health and announced the sale of doses of Coronavac to five states. The federal government, however, reacted and pointed out that the agreement with the pharmaceutical provides for full exclusivity until the end of the contract.
The folder declared that the institute linked to the São Paulo government may pay R$31 million in fines if it fails to comply with the agreements. Between January and February of this year, the federal folder signed two contracts with the entity: one for the acquisition of 46 million doses, and the other for the purchase of 54 million vaccines, totaling 100 million units.
In a statement, Butantan claimed that the Ministry of Health “has no right to prevent states and municipalities from acting quickly to protect their populations” and stated that the delivery of vaccines to the federal government was completed on 15 September. The replacement of lots banned by Anvisa would have already started. In a statement released on Wednesday, the institute said it had collected 1.8 million doses.
Anvisa
On Thursday (9/30), Anvisa stated that “the registration request is a decision of the laboratory and, so far, has not been presented to the agency”.
Coronavac received authorization for emergency use on January 17 of this year, after analysis by Anvisa regarding the results of tests in phases 1, 2 and 3.
Butantan
O metropolises contacted the Butantan Institute, through various channels, to obtain a position on the issue, but has not yet received an answer. The space remains open.
Coronavac x politics
Since the beginning of negotiations for the acquisition of vaccines, the President of the Republic, Jair Bolsonaro (no party), has been attacking Coronavac – the first immunizing agent to be approved on an emergency basis and applied in Brazil. In July, the head of the Palácio do Planalto lied when he said that the immunobiological has no proven scientific efficacy against the new coronavirus.
Bolsonaro again criticized Coronavac on September 23. He used the infection of the Minister of Health, Marcelo Queiroga, by Covid-19, even though he had taken the two doses of the vaccine from Butantan.
“Do you see Minister Queiroga now, who took two doses of Coronavac and is infected? He lived in a mask and is infected. You can delay, but you will hardly avoid it”, said the president, about the chance of contracting the disease.
Coronavac is produced by the Butantan Institute, linked to the São Paulo government, with technology from the Chinese pharmaceutical company Sinovac. The questions surrounding Coronavac are part of the dispute that Bolsonaro wages against the São Paulo governor, João Doria (PSDB), who may be one of his opponents in the 2022 elections.
“Complicated decision”
For the infectologist Leon Capovilla, who works at Hospital Moriah and at Hospital das Clínicas in São Paulo, the justification for presenting a record is “a bureaucratic issue, which can be easily settled”. For him, Coronavac has already proven to be effective and important for the epidemiological moment facing the country.
Capovilla considers the possibility of the government abandoning Coronavac “complicated”. “Taking off an option for a vaccine that can be produced in Brazil is something complicated. There is still the issue of the booster dose, and it is needed at this time.”
The infectious disease specialist believes in the effectiveness of Coronavac and also makes a reference to the others: “There is no way for us to assess the quality of Coronavac with Pfizer, for example. Pfizer is much more studied, for the reason that the laboratory has a better financial condition, more resources to finance research”.
Finally, Capovilla raises the issue of side effects, usually smaller in the case of the Chinese immunizing agent: “They are much calmer. It is a vaccine with an old and already known methodology”.
“There are still people taking the first dose”
Amanda Lara, an assistant infectologist at the Hospital das Clínicas, also complains about the possibility of withdrawing Coronavac from the immunization program. She points out that there are still people over 18 who are getting immunized in São Paulo, including with Coronavac. Another claim is that there is a lack of doses for D2. “At the end, I see the lack of all vaccines. For example, there are weeks that AstraZeneca ends, in another Pfizer. The lack of one hampers the whole progress”, he says.
The infectious disease specialist says she is hopeful that Coronavac has “a good safety profile for children and adolescents,” and adds: “Studies from China have also shown that a third dose of Coronavac is effective and raises antibodies.”
Finally, Lara argues that the government is placing “a lot of hope” on Pfizer. “I don’t know if it will be able to cover all the expectations, such as the booster dose and the vaccination of young people”, he says.
–
