Anvisa (National Health Surveillance Agency) authorized this Friday (11) the use of the Pfizer vaccine in children and adolescents aged 12 to 15 years in the country.
The immunizing agent was already registered for use in the entire population over 16 years of age. Now, the package insert also includes all teenagers over 12 years old.
In Brazil, the Cominarty vaccine, trade name of the American immunizing agent, is the only one that has authorization for use in children under 18 years of age.
The statement with the change in the package insert was published in the Official Gazette of the Union. According to the agency, the expansion was approved after the presentation of studies developed by the laboratory that indicated the safety and efficacy of the vaccine for this group.
Pfizer was the first manufacturer to announce results of its study in teenagers 12 to 15 years old, in early May, with 100% effectiveness.
According to the results of the combined phase 2/3 study in adolescents, which started on October 12, 16 cases of Covid-19 were detected among the 2,260 adolescents involved, all in the placebo group.
In addition to the efficacy data, the vaccine also proved to be safe. And the immunogenicity of the vaccine, that is, its ability to induce an immune response in the body, was almost twice as high in the age group from 12 to 15 years old compared to those aged between 16 and 25 years old.
Upon completion of the study in this age group, the US regulatory agency FDA authorized, in early May, the use of the vaccine in people over 12 years of age. In the United States, Pfizer was already being applied to the entire population over 16 years of age. The United Kingdom and the European Union also endorsed it for use in children under 16 at the end of May.
And, last Wednesday (9), Uruguay began vaccinating teenagers from 12 to 17 years old, becoming the first Latin American country to vaccinate this age group.
Chile has also authorized the vaccination of teenagers between 12 and 16 years old with Pfizer, but the campaign will start on June 20, according to the minister of health.
In late May, the company began another combined phase 1, 2 and 3 trial to test its immunizing agent in children aged 5 to 11 and in babies aged six months. The goal is to assess approximately 4,600 children in the United States and Europe.