Anvisa approves Pfizer vaccine against Covid-19 for children aged 6 months to 4 years

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The National Health Surveillance Agency (Anvisa) approved, this Friday (16), the use of the Covid-19 vaccine, from pharmaceutical Pfizer, in children aged between 6 months and 4 years.

“The authorization came after a technical analysis of data and clinical studies conducted by the laboratory. According to the Agency’s technical team, the information evaluated indicates that the vaccine is safe and effective also for children between 6 months and 4 years of age”, said Anvisa.

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The Agency’s assessment began on August 1st, and included a “meaningful assessment” of the technical area with the required speed.

Wine-colored cap will identify vaccine

Anvisa clarifies that the immunizing agent for children between 6 months and 4 years old has a different dosage and composition from those used for previously approved age groups.

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

According to Anvisa, the cap of the vaccine vial approved for children aged 6 months to 4 years will come in wine color, to facilitate identification by vaccination teams and also by parents and caregivers who will take children to be vaccinated. .

“The use of different cap colors is a strategy to avoid administration errors, since the product requires different dosages for different age groups”, he explains.

Immunizing storage

Anvisa reiterates that the vaccine has 12 months of validity, when stored at a temperature between -90 °C and -60 °C.

“Once removed from frozen storage, the closed bottle can be stored in a refrigerator at 2°C to 8°C for a single period of 10 weeks, not exceeding the original expiration date,” he says.

Source: CNN Brasil

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