Pfizer seeks FDA approval to vaccinate adolescents

Pfizer asks Food and Drug Administration to expand the emergency use of COVID-19 vaccine in adolescents aged 12 to 15.

Elad Benari, Canada ,

Pfizer injection
Pfizer injection
Flash 90

Pfizer and its German partner BioNTech SE said on Friday they have requested the US Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15, Reuters reported.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

The companies plan to request similar rulings by other regulatory authorities globally in the coming days, according to Reuters.

The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.

Last month, Pfizer also began testing its vaccine on younger children. The global study of 144 participants will also examine whether the vaccine can generate an immune response in children and determine the proper dosage for each age group in the trial: 6 months to 2 years; 2 years to 5 years; and 5 years to 11 years.

Last week, Pfizer and BioNTech said the vaccine provides protection which lasts for at least six months after the second dose.

They also said the vaccine is fully effective against the South African variant, B.1.351.

Previously, a study showed that though the Pfizer-BioNTech vaccine is effective against the South African variant, it is less effective than against the other variants.

(Arutz Sheva’s North American desk is keeping you updated until the start of Shabbat in New York. The time posted automatically on all Arutz Sheva articles, however, is Israeli time.)



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