Anvisa approves Pfizer vaccine against Covid for children aged 6 months to 4 years

Anvisa (National Health Surveillance Agency) approved this Friday (16) the use of Pfizer’s Comirnaty vaccine for immunization against Covid-19 in children aged 6 months to 4 years.

After technical analysis of data and clinical studies conducted by its laboratory since August 1, the agency disclosed that the information evaluated indicates that the vaccine is safe and effective also for children in this age group.

With the authorization, only the Ministry of Health needs to define the calendar to start vaccination.

To differentiate them from the others already approved, Comirnaty will be identified by the bottle with a wine-colored cap. For children from 5 to 11 years old, the lid is orange and, for the public over 12 years old, purple.

The use of different cap colors is a strategy to avoid administration errors, as the product requires different dosages for different age groups. This facilitates identification by vaccination teams and also by fathers, mothers and caregivers.

“The authorized vaccine formulation should be applied in three doses of 0.2 mL (equivalent to 3 micrograms). The initial two doses should be given three weeks apart, followed by a third dose given at least eight weeks after the second. dose”, declared Anvisa, in a note.

According to the agency, the vaccine has a shelf life of 12 months when stored at a temperature between -90°C and -60°C. Once removed from the freezer, the closed bottle can be stored in a refrigerator at 2°C to 8°C for up to 10 weeks, not exceeding the original expiration date.

Vaccination of children aged 5 to 11 years without comorbidities began on January 14 in the city of São Paulo.

For the 3 to 5-year-old range, the release took place on July 13 in an emergency with the Coronavac immunizer.

Anvisa relied on the consultation and monitoring of a group of specialists from medical societies to authorize the use of the vaccine. Specialists from the Brazilian Association of Public Health (Abrasco), Brazilian Society of Pulmonology and Tisiology (SBPT), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Immunology (SBI) and Brazilian Society of Pediatrics (SBP) participated in the evaluation.