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Safe and Effective Pfizer COVID Vaccine for Children Under 5: FDA Staff

The COVID-19 vaccine by Pfizer and its German partner BioNTech was reported to be effective and safe to use in children aged 6 months to 4 years, citing a reviewer from US Food and Drug Administration staff. I am.

FDA staff said the data available support the effectiveness of the Pfizer-BioNTech COVID-19 vaccine triple-dose primary series in the prevention of COVID-19 in the 6-month to 4-year-old age group. I did.

Officials said their assessment did not reveal new safety concerns associated with the use of the Pfizer-BioNTech vaccine in infants.

Pfizer and BioNTech recently completed an application with the FDA, seeking an emergency permission for the Covid-19 vaccine for children aged 6 months to 5 years.

According to the two companies, data from the vaccine’s Phase 2/3 trial included 1,678 children who received a third dose during the Omicron wave. Test results released on May 23 revealed that the vaccine is safe and has a strong immune response among children.

The latest FDA analysis of data from Pfizer’s vaccine trials was published prior to the next major meeting of external advisors. The recommendation determines the authorities’ vaccine decision.

FDA advisors are meeting for two days starting Tuesday to discuss children’s mRNA vaccines. Reportedly, Pfizer’s application for vaccine clearance in infants will be discussed on June 15.

An application for vaccine approval from another vaccine manufacturer, Moderna, for children aged 6 months to 5 years will be considered at the same time. Last week, the FDA said Moderna’s vaccine was effective in preventing symptomatic treatment in children under the age of 6 without causing annoying side effects. Moderna submitted vaccine data to the FDA in late April for children aged 6 months to 5 years.

Only children under the age of 5 are not eligible for vaccination against Covid-19 in the United States.

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Safe and Effective Pfizer COVID Vaccine for Children Under 5: FDA Staff

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