> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pfizer/BioNTech Seek EUA for New Booster Vaccine
- URL: https://www.fdaweb.com/pfizer-biontech-seek-eua-for-new-booster-vaccine/
- Published: 2022-08-22T12:00:00.000Z
- Updated: 2026-09-14T17:56:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152554

Pfizer and BioNTech have filed a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for individuals 12 years of age and older. “The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2,” the companies say.

“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,” said Pfizer CEO **Albert Bourla**. “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.”

Last week, an NPR report ([see story](http://fdaweb.com/login.php?sa=s&searchCompanyNameOnly=no&search=1&matchingRules=exact&searchWords=booster&category=&searchCriteria=&publishDate=&orderBy=PublishDate+desc&doSearch=Search&ref=fdaweb.com)) said Covid-19 vaccine makers needed to get data on their reformulated booster shots into FDA by the end of the month so they can begin administering them starting in September. To expedite their authorization, FDA is permitting mouse data instead of human data to be submitted, which is a controversial strategy causing some grumbling among health experts, the report said.

Acknowledging the expedited data submission plan, FDA spokesman **Michael Felberbaum** told ***FDA Webview*** the agency “will be using the totality of the available evidence to authorize the fall bivalent boosters. There are data on many millions of individuals who have received the prototype component as a booster. As for the BA.4/5 component, a combination of nonclinical data obtained in mice, data from prior variant vaccines (including those to beta, delta, and omicron BA.1), along with our extensive knowledge of the safety and efficacy of the mRNA platforms will be used for this decision-making. This is similar to what is done for influenza vaccine strain changes.”