Pfizer-BioNTech Eye Clearance of Omicron Booster for All Ages

August 23, 2022

2 minute read


Disclosures: Bourla is employed by Pfizer. Sahin is employed by BioNTech.

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After seeking emergency use authorization for their omicron-adapted COVID-19 vaccine in people ages 12 and older, Pfizer and BioNTech said Tuesday they are also working with the FDA to bring a recall. to young children.

On Monday, the companies announced that they had completed an EUA submission for the booster dose of the bivalent COVID-19 vaccine adapted omicron BA.4/BA.5 for people aged 12 and older.

Draw of Pfizer bottles
Pfizer and BioNTech have asked the FDA to authorize a COVID-19 booster shot containing the omicron variant. Source: Adobe Stock.

The application included clinical data of the companies’ omicron BA.1-adapted bivalent vaccine – which they say elicited a “superior immune response” against the BA.1 variant compared to the current vaccine – and preclinical data and manufacturing of the companies’ bivalent vaccine. omicron BA.4/BA.5 adapted vaccine.

The bivalent vaccine targets both the BA.4 and BA.5 subvariants of omicron and the original SARS-CoV-2 spike protein.

In June, the FDA told vaccine makers they should add a spike protein component for both omicron subvariants to their existing vaccines to create bivalent boosters.

“The agility of the mRNA platform, coupled with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has enabled us to develop, test and manufacture updated, high-quality vaccines that align with strains in circulation at an unprecedented rate,” said the Pfizer president. and CEO albert BourlaDVM, PhD, said in a statement.

“Having rapidly ramped up production, we are able to immediately begin distribution of omicron BA.4/BA.5 bivalent boosters, if authorized, to help protect individuals and families as we prepare for power surges. fall and winter potential,” Bourla said.

The companies announced additional data on Tuesday from a Phase 2/3 trial that showed their three doses, 3 µg The vaccine was 75.8% effective in preventing COVID-19 in children aged 6 months to 23 months (95% CI, 9.7% to 94.7%) and 71.8% effective ( 95% CI, 28.6% to 89.4%) for preventing COVID-19 in children 2-4 years old.

The pediatric vaccine has already been authorized for children aged 6 months to 4 years.

“While these results confirm that three 3µg doses of our COVID-19 vaccine provide young children with a high level of protection at a time when the omicron BA.2 strain was widespread with a favorable safety profile, we are also developing an omicron BA.4/BA.5 suitable bivalent vaccine in this age group to treat these sublines. CEO and co-founder of BioNTech Ugur Sahin, medical doctor, said in a statement.

The companies said they were “working with the FDA to prepare an EUA application for a bivalent vaccine suitable for 0 micron BA.4/BA.5 in children 6 months to 11 years of age.”


Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months to 4 Years. Published August 23, 2022. Accessed August 23, 2022.

Pfizer and BioNTech submit an application to the U.S. FDA for emergency use authorization of the adapted bivalent COVID-19 vaccine omicron BA.4/BA.5. Published August 22, 2022. Accessed August 23, 2022.

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