U.S. – Pfizer and BioNTech seek emergency approval for vaccine in adolescents
Pfizer Inc 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 Covid19 vaccine in adolescents aged 12 to 15.
Whether Covid-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching ‘herd immunity’ and taming the pandemic, according to experts.
It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky said as she expects the vaccine to be authorised for 12- to 15-year-olds by mid-May.
The Pfizer-BioNTech two-shot vaccine is already authorised for use in people as young as 16. Moderna and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, and data from Moderna’s trial could come soon.