RIO DE JANEIRO, BRAZIL – The institute’s unofficial claim is that Brazil’s health regulatory agency ANVISA is deferring approval, constantly requesting new data, and that meetings with the agency to reach an agreement on the documentation required for the authorization of the vaccine in the 3 to 17 year old public have been unproductive.
In light of this, the institute intends to abandon its strategy of prior discussions until a new formal request is submitted, which is still pending. The Butantan officially stated, through its press office, that this Friday’s meeting was cancelled “due to scheduling issues of participants.”
ANVISA maintains that it has not received enough data to confirm the safety and efficiency of Coronavac in this age group.
The only official request for authorization to use Coronavac in children and adolescents in Brazil was submitted by Butantan on July 30 and rejected by ANVISA on August 18. At the time, the agency said that the study sample submitted, with 586 participants, was insufficient and that there was no information on outcomes in each of the subgroup age groups (3 to 5 years, 6 to 11 and 12 to 17).
Subsequently, in a meeting held on November 5, Butantan presented the results of studies from Chinese laboratory Sinovac, which developed Coronavac, but ANVISA considered the data not solid enough for the release and requested the presentation of data from phase 3 trials (this is the last stage of research before official registration in the regulatory body).
Although Butantan has since refrained from officially addressing the issue, it has maintained that the data are sufficient, but that ANVISA prefers to defer approval. Last week, the institute’s president Dimas Tadeu Covas said that the study results delivered and the use in children and adolescents in countries like Chile, Ecuador and China demonstrate the vaccine’s safety and efficacy. “There is no longer any reason to defer this decision in Brazil,” he said.
ANVISA denies its intention to defer the matter and says that the Butantan has not formally presented a new request for approval since the one rejected due to lack of data, and that, in the meeting on November 5, there was only a “pre-submission, with a brief description of data”, still deemed insufficient for the release.
In reaction to Covas’ statement, the agency said in a note: “We emphasize the importance of the Butantan Institute to handle 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 rejected the authorization of Coronavac for children and adolescents, ANVISA argued it as important in the fight against Covid-19. The agency’s director Meiruze Freitas said the vaccine “has contributed to reducing the damage of the pandemic, favoring a significant reduction in hospitalization and deaths in the immunized population.”
Last week, Sinovac announced that preliminary data from phase 3 clinical trials in children and adolescents in South Africa, Chile, Malaysia and the Philippines proved the safety for this age group.
In Brazil, Pfizer is the only coronavirus vaccine authorized by ANVISA for children under 18, and only for ages 12 to 17. Last Friday, November 12, the agency received a request from Pfizer for its use in children between 5 and 11 years of age. The request should be analyzed within 30 days.