Pfizer plans to send a vaccination request for children aged 5 to 11 by the end of the month

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Pfizer informed, this Thursday (11), that it intends to formally send the request for permission to vaccinate children from 5 to 11 years old by the end of November. The request will be sent to the National Health Surveillance Agency (Anvisa). The information was passed on by Pfizer’s Vaccine Doctor, Júlia Spinardi.

The period for the agency to issue a final opinion on the application or not of vaccines in children under 12 years of age only starts to apply after this formal application is submitted. Normally, Anvisa takes between 2 to 3 weeks to decide on the possibility of a new vaccine.

“We have already started the submission deal with Anvisa here in Brazil. We hope that by the end of November we will be able to complete the data analysis procedures so that Anvisa can take a position on the authorization or not in relation to the use of the vaccine in the population aged 5 to 11 years”, informed Spinelli.

Last Tuesday (9), the laboratory and the agency met for a pre-submission meeting for this application. This procedure for setting is common. As Anvisa analyzes the first data received, other information is usually requested to clarify possible doubts. It is precisely this process that Pfizer estimates will be completed this month.

According to Anvisa, this analysis protocol “is carried out through a specific system of the Agency used by pharmaceutical laboratories to petition for new products or changes to existing products”.

As informed by Pfizer, the dose of vaccine for children between 5 and 11 years will be modified and will be lower than the dose for people over 12 years. The laboratory explained that this adjustment is due to a new formulation developed by the company.

In the same announcement of the estimated deadline for formal delivery of the request for immunization in children under 12, the director of the Brazilian Society of Immunizations (SBIm), Renato Kfouri, called attention to the lethality of Covid-19 in children.

“Covid alone kills more children than the sum of all other vaccine-preventable diseases,” he warned.

Along the same lines, the president of SBIm, Juarez Cunha, said that the lethality of coronavirus in children in Brazil is much higher than in other countries and defended that the inclusion of children aged 5 to 11 years is a “necessity” in the country.

Reference: CNN Brasil

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