The U.S. Food and Drug Administration (FDA) have issued advice following full approval of the Pfizer COVID-19 vaccine for people aged 16 an older that it should not be given to young children as off-label use.
Pfizer’s COVID-19 vaccine was authorised for use in children ages 12 to 15 in May by the FDA, meeting all the criteria to amend the EUA and with 100% effectiveness in children ages 12-15. Additionally, the Moderna and Johnson & Johnson vaccines are both available in the U.S. for anyone 18 years and older, with Moderna still awaiting a decision for approval on emergency use authorisation with the FDA.
Pfizer vaccine safety data on 5–11-year-olds is due to be submitted by the end of September, with Moderna due to report in the middle of fall. Clinical trials are still ongoing, however, it is expected that the first vaccine shots for children ages 5-11 could happen by the end of 2021, or early 2022. In order to detect the rarest of side-effects before the roll out begins across the U.S., the FDA have advised that the trials will need to expand the pool of volunteers.
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ABC News US: FDA-approved Pfizer vaccine not OK for off-label use in kids, official says