Butantan submits a new request to approve the use of Coronavac from 3 years old

The Butantan Institute will enter next Monday (8) with a new request from Anvisa (National Health Surveillance Agency) for the approval of the use of Coronavac in children and adolescents between 3 and 17 years old.

According to the information, confirmed by the sheet, the agency is finishing gathering the data requested by the agency, which denied the first request for the use of the immunizing agent against Covid-19 in this age group, made on July 30th.

Anvisa stated, in a decision taken on August 18, that it lacked information to prove the efficiency and safety of Coronavac for this group. The data are being collected by the Chinese laboratory Sinovac, which developed the vaccine, produced in Brazil by Butantan.

The Chinese are responsible for the surveys and, therefore, for the data requested by Anvisa. However, they need to send them to Butantan. The São Paulo institute has, since January 17, authorization for the emergency use of the vaccine in Brazil for people over 18 years of age, and should be responsible for the petition at Anvisa for its application in children and adolescents.

By previously denying authorization for those under 18, the agency stated that the sample used in the research, with 586 participants, was insufficient.

In addition, according to Anvisa said to sheet, there was no information on the results in age 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.

For now, in Brazil, Pfizer is the only vaccine authorized by Anvisa for children under 18, and only for those between 12 and 17 years old. 5 years old, a range that has just been included in the package insert as indicated for the immunizing agent.

This Wednesday (3), the State Department of Health of São Paulo sent an official letter to Anvisa requesting “maximum urgency” in the release of vaccination against Covid-19 for children. The urgent release of vaccination for this public was also defended by Governor João Doria (PSDB) in a press conference.

SUS managers even evaluated prioritizing the use of Coronavac in the third dose for the elderly. The São Paulo institute, however, said it does not agree that one group should be chosen over another. “Butantan’s priority is to save the lives of Brazilians through the vaccine, so all age groups are a priority,” he said in a note sent to the article.

In the political dispute over the pandemic, Coronavac is often the target of attacks by President Jair Bolsonaro (non-party), who has called it “Joao Doria’s Chinese vaccine” — the two came close during the 2018 election, but then they broke up and are now political opponents.

Anvisa, on the other hand, in the report in which it denied the authorization of the immunizing agent for children and adolescents, defended the vaccine as an important weapon in the fight against the pandemic and stated that its “cost-benefit ratio remains favorable”.

Director Meiruze Freitas, rapporteur of the technical statement on the use in children under 18, stressed that Coronavac “has contributed to reducing the damage caused by the pandemic, favoring a significant reduction in hospitalization and deaths in the immunized population”.