FDA request prompts rolling submission for EUA of COVID-19 jab in children under five years

US pharma giant Pfizer (NYSE: PFE) and its German partner BioNTech (Nasdaq: BNTX) have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of their Comirnaty COVID-19 vaccine to include children six months through four years of age.

The companies, which expect to complete the EUA submission in the coming days, say that this has followed a request from the US Food and Drug Administration (FDA) due to perceived urgent need in this population.

"We believe that three doses of the vaccine will be needed for children six months through four years of age to achieve high levels of protection against current and potential future variants"This application is for authorization of the first two 3µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of the requested EUA.