Anvisa approves Pfizer vaccine for children 6 months to 4 years old – Portugal (Brazil)

(*4*)Anvisa this Friday (16/9) authorised the growth of the usage of the Kominat vaccine for immunization in opposition to Covid-19 in children aged 6 months to 4 years. The approval permits the beginning of use of the vaccine in Brazil for this age group.

(*4*)The authorization was granted after a technical evaluation of the info and scientific research carried out by the laboratory. The company’s technical crew stated the evaluated information present the vaccine is protected and efficient for children 6 months to 4 years of age.

(*4*)The company’s evaluation started on August 1 and included a radical evaluation of the technical space on the required velocity. The determination to broaden the indication of use or age group for registered vaccines is a technical space.

Only emergency merchandise require session with the council.

(*4*)Wine-colored cap and different details about the vaccine

(*4*)The dose and composition of the vaccine for children 6 months to 4 years old is totally different from that used for beforehand authorised age teams.

(*4*)The at the moment authorised vaccine formulation is 0.2 mL (equal to 3 micrograms) administered in three doses. The first two doses must be administered three weeks aside interval, adopted by a 3rd dose not less than eight weeks after the second dose.

(*4*)The cap of the vaccine bottle is wine-coloured, which makes it simpler to establish the vaccination crew, in addition to fathers, moms and caregivers who take children for vaccination. Using totally different cap colours is a technique to keep away from administration errors as a result of the product requires totally different doses for totally different age teams.

(*4*)The shelf lifetime of the vaccine is 12 months when saved between -90°C and -60°C. After eradicating from the freezer, the unopened bottle will be saved within the fridge. between 2°C and eight°C for a interval of 10 weeks not exceeding the unique shelf life.



(*4*) Anvisa had exterior consultants

(*4*)To consider the age vary growth of this vaccine, the Agency relied on the recommendation and monitoring of consultants from medical societies who had entry to laboratory-offered analysis and outcomes information.

(*4*)External professional opinion was a further concern of Anvisa, so the usage of the vaccine in children was authorised beneath the strictest standards, which took into consideration the information of medical professionals who work with children every day and take care of immunization.

(*4*)Specialists from the Brazilian Collective Health Association (Abrasco), the Brazilian Society of Pulmonology and Tischology (SBPT), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Immunology (SBI), Brazilian Society of (*6*) (SBIM) and the Brazilian Society of Pediatrics (SBP).

(*4*)The Pfizer vaccine has been registered in Brazil since February 23, 2021. On December 16, 2021, Anvisa authorised the vaccine for the age group of 5 to 11 years.

(*4*)When does vaccination begin?

(*4*)Anvisa’s approval permits the vaccine to be used within the nation. The Ministry of Health makes the choice to introduce and set the calendar for sure age teams.

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