Coronavac approval for children and adolescents jams at Anvisa

Coronavac approval for children and adolescents is stuck at Anvisa (National Health Surveillance Agency). While the Butantan Institute, responsible in Brazil for the production of the vaccine against Covid, claims to have presented the necessary documents for the release, the regulatory agency denies having received sufficient information for the authorization.

Butantan had announced that it would deliver last week the data requested by Anvisa. According to the agency, however, the institute had not filed a new request for the use of Coronavac for children and adolescents until this Monday (15).

Butantan argued that the request has not yet occurred because, in a meeting on the 5th between its technicians and representatives of Anvisa, additional data were requested.

The first request for authorization of use for the public from 3 to 17 years old was made on July 30 by Butantan and denied on August 18 by Anvisa. At the time, the agency stated that the sample of the study presented, with 586 participants, was insufficient and that there was no information on the results of each of the age group subgroups (3 to 5 years, 6 to 11 and 12 to 17).

The agency’s technical team also pointed out the lack of data on effectiveness in children with comorbidities or immunosuppressed, that is, with a weakened immune system.

According to Butantan, the information requested in August was presented at the meeting to technicians from Anvisa, who then asked for more information, including those from phase 3. This stage is the last of the researches before official registration with the surveillance agency is obtained. and that, in phase 4, it is applied to the population.

In the case of the Covid-19 pandemic, vaccines for people over 18 were authorized by Anvisa, earlier this year, on an emergency basis, with the results of phase 2. Since then, Pfizer and AstraZeneca have received definitive authorization in Brazil, while Janssen and Coronavac continue with the emergency guarantee.

Last week, the Chinese laboratory Sinovac, which developed Coronavac, produced in Brazil by Butantan, 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.

Countries like Chile, Ecuador and Indonesia have already approved Coronavac for children and adolescents, in addition to China.

According to the Chinese laboratory, there were no serious side effects, and the reactions recorded were pain at the injection site, headache and fever.

President of Butantan, Dimas Tadeu Covas told the sheet that, with the research and the application, in other countries, of Coronavac in children and adolescents, its safety and efficacy are already evident. “It is very important for Brazil to approve Coronavac from 3 to 17 years old and there is no longer any reason to postpone this decision.”

Anvisa stated, through the press office, that it is necessary for the Butantan Institute to enter “with a more solid request and with information for this target audience, so that the analysis and results have a positive outcome”.

The agency informed that it is necessary “to carry out the formal protocol with the request to expand the use of Coronavac in children and adolescents”. “In this petition”, stated Anvisa, “Butantan must present the efficacy and safety studies for these audiences, including phase 3 clinical data”.

Anvisa confirmed the meeting held with Butantan, in which there was, according to the agency, “a pre-submission”, with “a Power Point presentation with a brief description of data”. The agency denied that new documents were required. “At this meeting, Anvisa identified that information was lacking so that it would be possible to proceed with an order and subsequent analysis.”

There is a new meeting scheduled for next Friday (19), at 11 am. “We emphasize the importance of the Butantan Institute dealing with the process within the regulatory guidelines of Brazil, which are similar to the precepts of the World Health Organization”, stated Anvisa to sheet, by way of note.

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.