Pfizer/BioNTech ask FDA for EUA of Omicron bivalent vaccine in children 5+

A sweet little mixed race boy sits up on an examination table as he receives an immunization.  He is looking up and smiling as the doctor places the bandage on his arm.  Both are wearing medical masks to protect them from COVID.

A submission to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) of a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 through 11 years old has been made by BioNTech and Pfizer, it emerged yesterday.

With a corresponding application for extension of marketing authorisation at the European Medicines Agency (EMA) to be made in days, the EUA request is supported by safety, immunogenicity, and preclinical data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer/BioNTech have also initiated a phase 1/2/3 paediatric study (NCT05543616, C4591048) on the safety, tolerability, and immunogenicity of different doses and dosing regimens of the Omicron BA.4/BA.5 bivalent booster vaccine in children aged between 6 months and 11 years of age.

A previous phase 1/2/3 trial involving both these younger age groups, which took place during a period of high prevalence of the Omicron BA.2 strain, had demonstrated the original Pfizer/BioNTech COVID-19 vaccine (BNT162b2, Comirnaty) to be well-tolerated and offer a high level of protection against the coronavirus.

The forthcoming phase 1/2/3 paediatric clinical trial will include four sub-studies, with sub-study A evaluating doses of 3-µg, 6-µg, and 10-µg in infants between six and 23 months in phase 1, followed by a phase 2 three-dose primary series and booster. Sub-studies B and C will assess up to four doses of the bivalent vaccine in infants and children between six months and four years of age, who have previously been vaccinated; and sub-study D will look at the five to 11 years bracket in similar fashion.

The Pfizer/BioNTech bivalent COVID-19 vaccine (both Original and Omicron BA.4/BA.5) is already FDA-authorized under an EUA for use in individuals 12 years old and above as a single booster dose, actively immunising against the coronavirus. Under current guidance, it is to be administered at least two months after either completion of a primary vaccination with any authorised or approved monovalent COVID-19 vaccine, or after having received the most recent booster dose of such.

The EMA began recommending authorisation of Omicron spike protein booster shots at the start of the month, based on clinical data from trials of BA.1 booster shots.

Just beforehand, Moderna sued Pfizer/BioNTech for what it claims was patent infringement on its Spikevax shot.

Image from iStock by FatCamera.