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Ministry of Health recommends vaccination of children aged 5 to 11 against Covid-19

The Ministry of Health recommended the vaccination of children aged 5 to 11 years against Covid-19. According to the document published on Friday (24), the immunization of the public from 5 to 11 years old must be carried out with the permission of parents or guardians and with a medical prescription.

According to the ministry, the vaccination of children should prioritize groups with permanent disabilities or comorbidities, in addition to children who live in the same house as people at high risk of serious development from Covid-19.

For children without comorbidities, immunization will be performed by age group:

  • From 10 to 11 years old
  • From 8 to 9 years old
  • from 6 to 7 years old
  • 5 years old

The recommendations remain in open public consultation until January 2nd. The Ministry of Health states that the measure aims to provide transparency and open dialogue in the process of expanding the vaccination campaign against Covid-19.

The full document from the Ministry of Health is available online.

Anvisa Authorization

The National Health Surveillance Agency (Anvisa) authorized the use of Pfizer’s vaccine against Covid-19 in children aged 5 to 11 years in Brazil on December 16th. The decision was the result of a technical evaluation of the request submitted by the pharmaceutical company on November 12th.

The dosage of the vaccine for this age group will be adjusted and lower than that used by people over 12 years old. The doses will have bottles differentiated by color, purple for adults and teenagers and orange for children, according to Pfizer.

Vaccine composition

The Pfizer vaccine for use in children has a different dosage and composition than the immunizing agent used for over 12 years. The vaccine formulation for pediatric use is two doses of 0.2 mL (equivalent to 10 micrograms), with a schedule of at least 21 days between doses.

With the aim of differentiating vaccines for children from immunizing ones for over 12 years old, the lid of the vial of the vaccine for pediatric use will be orange. For those over 12 years old, the vaccine, which will be applied in doses of 0.3 ml, will have a purple cap, as is already standardized.

Anvisa advised that children who turn 12 years old between the first and second dose, should maintain the pediatric dose. In addition, he informed that there are no studies on co-administration with other vaccines for this age group.

The vaccine also has a different conservation scheme, being able to remain for 10 weeks at a temperature of 2ºC to 8ºC.

Risks of adverse effects are low

According to Anvisa, the main points of attention in relation to children for the approval of the vaccine are the safety data and adverse events identified.

In the presentation about the approval of the vaccination of children, the technicians from Anvisa showed results of a panorama of the United States with 4.9 million children from 5 to 11 years old vaccinated with at least one dose of Pfizer. Suspected adverse events represented 0.05% of the total doses administered in the North American country.

According to the European Medicines Agency (EMA), which approved the use in the same age group on November 25, “the most frequent adverse effects in children aged 5 to 11 years are similar to those in people with 12 years or older. They include pain at the injection site, tiredness, headache, redness and swelling at the injection site, muscle aches and chills. These effects are generally mild or moderate and improve a few days after vaccination.”

vaccine is safe

According to the evaluation of the technical team at Anvisa, the vaccine is safe for use in children aged 5 to 11 years.

To reach the decision, the agency relied on the advice of a group of specialists in pediatrics and immunology. The researchers had access to data from the studies and results presented by Pfizer.

The consultancy had the participation of the Brazilian Association of Public Health (Abrasco), the Brazilian Society of Pulmonology and Phthisiology (SBPT), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Immunology (SBI) and the Brazilian Society of Pediatrics (SBP).

“I see the coming of a vaccine as excellent in terms of protection for these children. The studies regarding the efficacy and mainly in relation to the safety and immunogenicity were presented to the regulatory bodies. [capacidade de indução da resposta imunológica pelo organismo]”, said the physician Rosana Richtmann, from the Brazilian Society of Infectology, in a video broadcast by Anvisa.

At the public meeting broadcast live by Anvisa, the director-general of Medicines at Anvisa, Gustavo Mendes, stated that the available scientific evidence indicates that the vaccine administered in a two-dose regimen for children aged 5 to 11 years can be effective in preventing serious illness and death.

Reference: CNN Brasil

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