The National Health Surveillance Agency (ANVISA) on Wednesday (14/9) approved the use of the Cominternity Vaccine from manufacturer Pfizer for immunization against COVID-19 in children aged 6 months to 4 years. The authorization, issued this Friday (16/9) night, comes after the conclusion of an evaluation that guarantees the efficacy and safety of the vaccine for the age group.
According to Anvisa, the data and clinical studies conducted by the BioNTech laboratory, Pfizer, were analyzed by the agency’s technical team, which, according to the information it evaluated, guaranteed that the vaccine was safe for children aged 6 months to 4 years. Suitable for group. , Such evaluation began on August 1. “For the age-group expansion evaluation of this vaccine, the agency relied on the consultation and monitoring of a group of experts from medical committees who had access to data from laboratory-submitted studies and results”, highlighted. Via Anvisa, Note.
The dosage and composition of the vaccine that applies to this group of people is different from those used for other accepted age groups. Anvisa recommends that the vaccine formulation be applied in three doses of 0.2 mL, which is equivalent to 3 micrograms.
“Two initial doses should be given three weeks apart, followed by a third dose at least eight weeks after the second dose,” the agency said.
There is still no date set for the start of vaccine applications in children in the approved age group this week. Now, after approval, it is up to the health ministry to set up a vaccination schedule and put into practice the distribution of the vaccine to these children.
Anvisa had outside experts
Apart from Anvisa’s technical team, the agency was also helped by a group of experts from medical societies. “An additional care was taken by Anvisa to see outside experts so that the use of the vaccine by children was approved within the most stringent criteria, for this, the knowledge of the medical professionals who work with children on a daily basis and immunization”, the agency said.
Experts from the Brazilian Association of Collective Health (Abrasco), the Brazilian Society of Pulmonology and Ticology (SBPT), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Immunology (SBI) and the Brazilian Society of Pediatrics (SBP).
Different colored bottle for age group
The cap of the vial of the vaccine will be in the color of wine, which will be different from the one used for other age groups. The difference in color is to facilitate identification by vaccination teams and by fathers, mothers and caregivers taking children for vaccinations. “Using different cap colors is a strategy to avoid administration errors, as the product requires different dosages for different age groups”, Anvisa explained.
The cap color is orange for children aged 5 to 11. For the age group over 12 years, the color used is purple. Vaccines have a shelf life of 12 months when stored at temperatures between -90°C and -60°C. Once removed from frozen storage, the unopened bottle should be stored between 2°C and 8°C. May be stored in the refrigerator for a period of 10 weeks, not exceeding the original expiration date.