Anvisa approves emergency use of Coronavac for children aged 3 to 5 — Portuguese (Brazil)

Anvisa accepted, this Wednesday (13/7), the extension of the authorization for the emergency use of the coronavac vaccine, which now contains in its bundle the age group of 3 to 5 years. The administrators vote unanimously in accordance to the reporting director’s vote. In its approval, the company didn’t impose software restrictions for immunosuppressed children 3 to 5 years of age.

To consider this new indication for the immunizer in opposition to Covid-19, Anvisa analyzed and searched all out there knowledge on the vaccine and its use in children.

The evaluation depends on knowledge submitted by the Butantan Institute, together with analysis knowledge carried out in Chile, the place the vaccine is already used on this age group, the outcomes of analysis on vaccination in opposition to Covid-19 in Brazil, opinions of invited medical societies, proof life and revealed scientific literature knowledge.

Anvisa’s emergency use authorization permits the 3- to 5-year-old age group to be vaccinated in Brazil, the place they’ll obtain the identical dose that’s now utilized to the 6-17 age group and adults.

The request to develop the use of Butantan Institute was filed with the company on March 11 this 12 months. Since then, Unvisor’s servers have performed a sequence of conferences and evaluations of all out there knowledge to confirm vaccine efficacy and security for this new viewers.

(*5*)Director-Reporter, (*3*)in Meirouz(*5*) Freitas mentioned in his vote: “I consider that, as a result of of the historical past of widespread use of the coronavirus vaccine amongst children ages 3 to 17 in China and Chile, in Brazil and different nations amongst children and adolescents ages 6 to 17, with out these security precautions, the viral Based on an evaluation of circulating and public well being wants, well being administrators might advocate vaccination of children 3 years of age, significantly among the many highest-risk and susceptible populations, with CORONAVAC. Based on the proof, I conclude that the recognized and potential advantages of CORONAVAC vaccine in children 3 years of age and older The dangers outweigh the dangers of scaling up vaccines.”

How Anvisa analyzes requests

For this evaluation, Anvisa carried out an lively search for knowledge that may make it doable to clearly confirm the profit of the vaccine for the 3- to 5-year-old group, together with data often called “real-life knowledge”, that’s, outcomes from already vaccinated populations. The company analyzed the next knowledge:

  • Butantan Institute: Data submitted by Butantan Institute and which initiated the evaluation course of.
  • Study report – Curumim mission, which evaluated the efficacy, security and immunogenicity of an inactivated vaccine (Coronavac) for Covid-19 in children and adolescents.
  • Report of the Immunita Study from the René Rachou Institute in Fiocruz Minas, which performed a cross-sectional research of the immunogenicity, efficacy and responsiveness of the coronavac vaccine.
  • Data from the Vigivac program from Fiocruz Bahia, an anti-Covid-19 vaccine efficacy program in Brazil.
  • Vaccination knowledge in Chile: despatched by researchers within the nation who observe the vaccination of children with coronavac of their area.
  • External knowledgeable opinion: For the analysis, Anvisa relied on the opinion of exterior consultants invited to help the group in evaluating the vaccine. Experts had technical and analysis data on vaccines. The Brazilian Society of Pediatrics (SBP), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Pulmonology and Tcology (SBPT), the Brazilian Society of Immunization (SBIM) and the Brazilian Association of Collective Health (ABRASCO) participated. This exercise..
  • Data from revealed scientific literature.

The historical past of the coronavirus vaccine in Brazil

  • The coronavirus vaccine has been accepted for emergency use in Brazil since January 17, 2021.
  • On January 20, 2022, Anvisa accepted increasing the use of the vaccine to children and adolescents ages 6 to 17.
  • On March 14, 2022, Butantan Institute requested the extension of use to children aged 3 to 5 years.
  • On April 8, Instituto Butantan requested the inclusion of a booster dose forecast for CoronaVac. This request is beneath evaluation and is topic to the submission of extra knowledge and data.
  • On July 9, the Butantan Institute requested particular registration of CoronaVac. The request is being analyzed by the company’s technical group.

Covid-19 vaccination for children in Brazil

Currently, two vaccines in opposition to Covid-19 are accepted in Brazil: the Pfizer vaccine, from age 5 and the Coronavac vaccine, from age 6. Today’s resolution authorizes the growth of use of CoronaVac to vaccinate children as younger as 3 years previous.

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