Anvisa approves Pfizer vaccine for children aged 6 months to 4 years — Portuguese (Brazil)

(*4*)This Friday (16/9) Anvisa has accepted the extension of using Comernati vaccine for vaccination towards Covid-19 in children aged 6 months to 4 years. The approval permits using the vaccine to start in Brazil for this age group.

(*4*)The authorization is obtained after technical evaluation of knowledge and scientific research carried out by the laboratory. According to the company’s technical crew, the evaluated knowledge present that the vaccine is secure and efficient even for children aged 6 months to 4 years.

(*4*)The company’s analysis started on August 1, and included an intensive evaluation by technical space with the required velocity. For registered vaccines, the choice to broaden the indication for use or age group is a technical space.

Only merchandise for emergency use want to be mentioned by the board.

(*4*)Wine coloured cap and different particulars about vaccine

(*4*)The dose and composition of the vaccine for children aged 6 months to 4 years differs from that used for beforehand accepted age teams.

(*4*)Today the official vaccine formulation have to be administered in three doses of 0.2 mL (equal to 3 micrograms). The preliminary two doses needs to be given three weeks aside Interval, the third dose is given at the very least eight weeks after the second dose.

(*4*)The cap of the vaccine bottle will are available wine color, to assist in identification by vaccination groups and in addition by fathers, moms and carers who take children for vaccination. Using totally different cap colours is a technique to keep away from administration errors, because the product requires totally different doses for totally different age teams.

(*4*)The vaccine has a shelf lifetime of 12 months when saved between -90°C and -60°C. Once faraway from freezing storage, the unopened vial might be saved within the fridge. Between 2°C and eight°C for a interval of 10 weeks, not exceeding the unique expiry date.



(*4*) Anvisa had exterior specialists

(*4*)In evaluating the growth of the age vary of this vaccine, the company relied on the session and oversight of a gaggle of specialists from the medical society, who had entry to the examine and outcomes knowledge introduced by the laboratory.

(*4*)The look of exterior specialists was an extra care taken by Anvisa to approve using the vaccine by children in very strict standards, for this, making an allowance for the data of medical professionals who work with children and immunization each day.

(*4*)Experts from the Brazilian Association of Collective Health (ABRASCO), Brazilian Society of Pulmonology and Histology (SBPT), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Immunology (SBI). Brazilian Society of Immunization (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 had already approved the indication of the vaccine for the age group of 5 to 11 years.

(*4*)When does vaccination begin?

(*4*)Anvisa approval permits the vaccine to be used within the nation. It is for the Ministry of Health to determine on the institution in addition to the calendar for particular age teams.

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