Anvisa publishes the Pfizer vaccine for children aged 6 months to 4 years

Posted on 09/16/2022 22:44

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(Credit: Carlos Vieira/CB/DePress)

The National Health Surveillance Agency (Anvisa) on Wednesday (14/9) accepted the use of the Comirnaty vaccine from producer Pfizer to vaccinate towards Covid-19 in children aged 6 months to 4 years. The approval, revealed this Friday (16/9) evening, comes after the conclusion of evaluations that assure the effectiveness and security of the vaccine for the age group.

According to Anvisa, the knowledge and scientific research carried out by the BioEntech laboratory, Pfizer, have been analyzed by the company’s technical staff, which ensures, in accordance to the evaluated knowledge, that the vaccine is appropriate for children aged 6 months to 4 years. . Such evaluation began from final August 1. “For the analysis of the age improve of this vaccine, the company relied on the recommendation and remark of a bunch of specialists from medical societies, who had entry to the analysis and outcomes knowledge introduced by the laboratory”, highlighted. Unvisa, via observe.

The doses and mixtures of vaccines that ought to be administered to folks on this group differ from these used for different accepted age teams. Anvisa recommends that the vaccine formulation be administered in three doses of 0.2 mL, equal to 3 micrograms.

“The two preliminary doses ought to be given three weeks aside, adopted by the third dose at the very least eight weeks after the second dose,” the company mentioned.

No date has but been set for the begin of vaccine administration in children of the accepted age this week. Now, after the approval, it’s up to the Ministry of Health to arrange a vaccination schedule and follow distributing vaccinations to these children.

Anvisa was an out of doors knowledgeable

In addition to Anvisa’s technical staff, the company was assisted by a bunch of specialists from medical societies. “The view of the exterior specialists was an extra care taken by Anvisa to enable the use of vaccines by children inside the strictest standards, making an allowance for the data of medical professionals who work each day with children and vaccinations,” the company mentioned.

Experts from the Brazilian Association of Collective Health (ABRASCO), the Brazilian Society of Pulmonology and Tcology (SBPT), the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Immunology (SBI) and the Brazilian Society of Pediatrics (SBP).

Different shade bottles for age

The vial cap of the vaccine might be wine coloured, completely different from the one used for different ages. The shade distinction facilitates identification by immunization groups and fathers, moms and caregivers who will take children to vaccinate. “The use of various cap colours is a method to keep away from administration errors, since the product requires completely different doses for completely different age teams”, defined Anvisa.

For children aged 5 to 11 years, the shade of the cap is orange. For the over 12 age group, the shade used is purple. “The vaccine has a shelf lifetime of 12 months when saved at temperatures between -90°C and -60°C. Once faraway from frozen storage, the closed bottle may be saved in a fridge between 2 °C and eight °C for 10 weeks. could, with out exceeding the authentic expiry date.


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