Infectious Disease

Pfizer-BioNTech eye authorization of omicron booster for all ages

August 23, 2022

2 min read

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

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After requesting emergency use authorization for their omicron-adapted COVID-19 vaccine in people aged 12 years and older, Pfizer and BioNTech said Tuesday they are also working with the FDA on bringing a booster to younger children.

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

Pfizer vial draw

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 from the companies’ bivalent omicron BA.1-adapted vaccine — which they said elicited a “superior immune response” against the BA.1 variant compared with the current vaccine — and preclinical and manufacturing data from the companies’ bivalent 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.

The FDA in June told vaccine manufacturers that they should add a spike protein component for the two omicron subvariants to their existing vaccines to create bivalent boosters.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Pfizer chairman and CEO Albert bourlaDVM, PhD, said in a press release.

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

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

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

“While these results confirm that three 3 µg 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 highly prevalent with a favorable safety profile, we are also developing an omicron BA.4/BA.5-adapted bivalent vaccine in this age group to address these sublineages.” CEO and co-founder of BioNTech Ugur Sahin, MD, said in a press release.

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

References:

Pfizer and BioNTech announce updated COVID-19 vaccine data supporting efficacy in children 6 months through 4 years of age. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-updated-covid-19-vaccine-data. Posted Aug 23, 2022. Accessed Aug 23, 2022.

Pfizer and BioNTech submit application to US FDA for emergency use authorization of omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-use. Published August 22, 2022. Accessed August 23, 2022.

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