After the National Health Surveillance Agency (Anvisa) authorized the use of Pfizer’s Covid-19 vaccine in children aged 5 to 11 years in Brazil, the president of the Brazilian Society of Immunizations (SBIm), Juarez Cunha, told CNN this Thursday (16) that parents must be aware at the time of immunization.
The dose of the vaccine for this age group will be adjusted and lower (one third) than that used by people over 12 years old. According to Anvisa, the proposal is to have different bottles, with specific dosage for each group. The bottles will be differentiated by color: purple for adults and orange for children.
“The vaccine has a different composition, the dose and the interval differ [em comparação aos adultos]. The training of our network will be essential, and of course we have to draw attention to parents at the time of immunization”, said Cunha.
“The vaccine that we have in the country is currently not approved for use in children, it has a purple cap, which is only administered from the age of 12 onwards.”
As Brazil still does not have the doses of the orange cap, that is, those adjusted for children, there is no forecast when the immunization will start. Deadline must be defined by the Ministry of Health.
According to the doctor, a large part of adverse events — reactions after vaccination — are related to programmatic errors, which are those that occur as a result of non-compliance with the technical standard, such as error in dosage or error in vaccines.
“When people look at the adverse event numbers, about 60% are programmatic errors. Scientific societies participated in the meetings with Anvisa, and all the data show that the vaccine is safe and effective. We have a way to protect our children”, he emphasized.
For the president of SBIm, a possible logistics to vaccinate children in the country would be to create “a separate room for Covid vaccination for children so that there is no risk of applying the vaccine or the wrong dose”.
Use of Pfizer in Brazil
Pfizer’s vaccine is one of four immunizing agents against Covid-19 applied in Brazil, in addition to AstraZeneca, Coronavac and Janssen – being the only one authorized for use in children and adolescents.
The vaccine has been registered in the country since February 23rd. The initial registration included individuals over 16 years of age. On June 11, Anvisa authorized the inclusion of the age group from 12 to 15 years old.
How age group inclusion requests work
For a new age group to be included in the indication of the package insert for a vaccine in Brazil, the laboratory that produces the immunizing agent must make the request with Anvisa.
The laboratory needs to conduct and present studies that demonstrate the safety and efficacy of the vaccine for this new age group.
According to Anvisa, the main points of attention in relation to children are the safety data and identified adverse events, vaccine dosage adjustments and specific factors of the organisms of children in the development stage.
The period for evaluating the request by Anvisa is up to 30 days.
(*With information from Lucas Rocha, from CNN, in São Paulo)
Reference: CNN Brasil
