Understand Anvisa’s endorsement of the use of Coronavac in children aged 3 to 5 years

Anvisa (National Health Surveillance Agency) unanimously approved this Wednesday (13) the emergency use of the Coronavac vaccine in children aged 3 to 5 years, without restrictions.

See questions and answers about the use of the immunizer in children and about vaccination against Covid in this age group.

What does release mean?

Anvisa made the release for emergency use of Coronavac in children aged 3 to 5 years. Emergency use refers to the use of new drugs (or immunizers, as the case may be) during public health crises. Manufacturers must continue providing data to Anvisa and later request the definitive registration.

In January, Coronavac began to be applied to children and adolescents aged 6 to 17 years. Before that, only people over 18 could take the immunizer.

In the previous release, in January, for the age group from 6 to 17 years old, Butantan had already requested approval for children from 3 to 5 years old. At that time, however, Anvisa had stated that there was not enough data for the lowest age group.

The situation has changed since then, despite still limited efficacy data and “uncertainty still existing”, as the rapporteur Meiruze Freitas, director of Anvisa, highlighted in her vote, the benefits of the immunizer outweigh known and potential risks.

What do the Coronavac vaccination data point to?

Part of the information used by Anvisa was “real world data”, that is, the effectiveness seen of immunizers outside clinical studies.

Freitas highlighted, for example, the widespread use of Coronavac in children aged 3 to 17 years in China and Chile and in the age group of 6 to 17 years in Brazil and among other countries. There are no safety alerts about the immunizer. In addition, there is no therapeutic alternative in Brazil aimed at the pediatric public to prevent Covid.

There are even published data on vaccination with Coronavac in children aged 3 to 5 years in Chile. A study published in the scientific journal Nature Medicine looked at more than 490,000 children in this age group. The researchers found a 38% effectiveness rate to prevent symptomatic cases, but for more serious cases (such as barring ICU hospitalizations), the effectiveness rate jumps to 69%.

For the release, Anvisa also relied on expert opinions based on research data. Members of the SBP (Brazilian Society of Pediatrics), SBI (Brazilian Society of Infectious Diseases), SBPT (Brazilian Society of Pulmonology and Tisiology), SBIm (Brazilian Society of Immunizations) and Abrasco (Brazilian Association of Collective Health) provided opinions.

Anvisa also relied on data from the Curumim Project, a study that evaluates the efficacy, safety and immunogenicity of Coronavac in younger age groups, and from the Immunita study, from the René Rachou Institute, Fiocruz Minas.

Is the vaccine the same as in adults?

Yup. Dosage and dosing interval (28 days) are the same as in adults.

What is the vaccine made of?

The vaccine is “made” with inactivated viruses, something also used in flu vaccines. Basically, Sars-CoV-2 is modified so that it becomes non-infectious. Even without causing infection, it becomes “known” by our immune system, which gains weapons to fight it in case of a real contagion.

When should vaccination in this age group begin?

There is no forecast yet. The Ministry of Health still has to make the request for vaccines to the Butantan Institute, responsible for Coronavac in Brazil.

The Secretary of State for Health of São Paulo, Jean Gorinchteyn, says that Butantan will import doses of Coronavac from China to carry out the immunization of children aged 3 to 5 years. This is because the vaccine stock in São Paulo is small.

According to Gorinchteyn, after Butantan learned the size of the demand from the Ministry of Health, it is estimated that the delivery time to Brazil will be 45 days.

Butantan was even questioned whether it will manufacture Coronavac in the country again, but the institute said that it is first necessary to know what the demand will be.

Are there any other vaccines for this age group?

In Brazil, not yet. In the country, the Pfizer vaccine is approved for children from 5 years old. In the US, vaccines from pharmaceutical companies Pfizer and Moderna have already been approved for use in children as young as 6 months of age.

However, here, no pharmaceutical company has asked Anvisa to release it after six months.

Pfizer says, however, that it “seeks to make the submission to Anvisa as promptly as possible”.

Zodiac, Moderna’s representative in Brazil, expects to deliver the application to use its immunizer in all age groups, including children aged 6 months to 5 years, in early August.