Butantan cancels meeting with Anvisa about Coronavac for children and adolescents

The Butantan Institute canceled the meeting with Anvisa (National Health Surveillance Agency) to discuss the release of Coronavac for children and adolescents. The meeting between technicians from the two bodies was scheduled for this Friday (19), at 11 am.

The version that the institute supports, unofficially, is that Anvisa is postponing approval, always requesting new information, and that, therefore, meetings with the agency in order to reach an agreement on the documentation have been unproductive. required for the authorization of the vaccine in the public aged 3 to 17 years.

Therefore, the institute intends to abandon the strategy of prior discussions until a new formal request is presented, which does not yet have a date to occur. Officially, Butantan stated, through its press office, that this Friday’s meeting was canceled “due to problems with the participants’ agenda”.

Anvisa continues to claim that it has not received enough information to attest to the safety and efficiency of Coronavac in this age group.

The only official request for authorization of the use of Coronavac in children and adolescents in Brazil was made by Butantan on July 30th and denied by Anvisa on August 18th. The agency, at the time, said that the sample of the study presented, with 586 participants, was insufficient and that there was no information on results in each of the age group subgroups (3 to 5 years, 6 to 11, and 12 to 17).

Later, at a meeting held on the 5th, Butantan presented some results of studies by the Chinese laboratory Sinovac, which developed Coronavac, but Anvisa considered the information to be weak for release and requested that data from the phase be shown. 3 of the studies (this stage is the last of the surveys before official registration with the surveillance agency is obtained).

Since then, Butantan, even though it avoids talking officially about the subject, has defended the thesis that the information is already enough, but that Anvisa prefers to postpone approval. Last week at sheet, Dimas Tadeu Covas, president of the institute, stated that the results of studies already delivered and the application in children and adolescents in countries such as Chile, Ecuador and China demonstrate the safety and effectiveness of the vaccine. “There is no longer any reason to extend this decision in Brazil,” he said.

Anvisa denies the intention to postpone it and says that Butantan has not formally submitted a new request for approval since it was rejected due to lack of data, and that, at the meeting on the 5th, there was only a “pre-submission, with a brief description data”, considered still insufficient for the release.

TO sheet, in response to Covas’ statement, the agency stated, through a note: “We emphasize the importance of the Butantan Institute dealing with the process within the regulatory guidelines in Brazil, which are similar to the precepts of the World Health Organization”.

In the August 18 report in which it denied Coronavac authorization for children and adolescents, Anvisa defended it as important in the fight against Covid-19. The agency’s director, Meiruze Freitas, stated that the vaccine “has contributed to reducing the damage caused by the pandemic, favoring a significant reduction in hospitalization and deaths in the immunized population”.

Last week, the Sinovac laboratory announced that preliminary data from phase 3 clinical trials in children and adolescents, carried out in South Africa, Chile, Malaysia and the Philippines, proved the safety for this age group.

In Brazil, Pfizer is the only vaccine against coronavirus authorized by Anvisa for children under 18, and only for those aged between 12 and 17. Last Friday (12), the agency received a request to use this immunizing agent in children aged 5 to 11 years. The request must be analyzed within a period of up to 30 days.​