Read more

August 23, 2022
2 min read
Save

Pfizer-BioNTech eye authorization of omicron booster for all ages

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

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 Bourla, DVM, 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 cofounder 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 omicron 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 U.S. 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 Aug. 22, 2022. Accessed Aug. 23, 2022.