The US Food and Drug Administration (FDA), the US regulator of health, today granted emergency use of the Pfizer / BioNTech vaccine against Covid-19 for children aged 5 to 11 years.
The FDA decision makes this vaccine the first against Covid-19 approved for use in young children in the United States. Approval makes the Pfizer / BioNTech vaccine available to 28 million children – many of whom will return to school for life-giving in the next few days.
The agency's decision comes three days after an FDA panel of experts voted overwhelmingly in favor of using the Pfizer / BioNTech vaccine against Covid-19 for this solar panel. An advisory committee of the US Centers for Disease Control and Prevention (CDC) is scheduled to meet next week to consider recommendations on how to use the vaccine in this age group.
The CDC director will have the final say. Only a few countries, including China, Cuba and the United Arab Emirates, have so far approved the use of Covid-19 vaccines in children of this age group and younger. The FDA has approved a 10 microgram dose of the Pfizer / BioNTech vaccine in young children, less than 30 micrograms in the original vaccine for people 12 years of age and older.
Pfizer and BioNTech said their vaccine showed 90.7% efficacy against coronavirus in a clinical trial in children aged 5 to 11 years. The companies are waiting until the end of the year for data from a clinical trial in children aged 2 to 4 years. The United States began vaccinating teens between the ages of 12 and 17 with the vaccine in May.
Vaccination coverage in children in this age group is lower than in older groups, according to the CDC. The Pfizer vaccine was the first to be licensed in the United States in December last year for people aged 16 and over. It was licensed for the 12- to 15-year-old age group in May and fully approved by U.S. authorities in August.
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