--- title: First Omicron Booster Submitted to FDA By Pfizer-BioNTech description: The shot will be the first in the U.S. to target the Omicron subvariants BA.4 and BA.5, which are currently dominant. canonical: https://time.com/6207691/pfizer-biontech-omicron-booster-fda/ author: Alice Park article:opinion: false article:content_tier: free article:published_time: 2022-08-22T17:21:44.000Z article:modified_time: 2026-02-24T14:38:56.460Z article:section: Health og:title: Pfizer-BioNTech Submits the First Omicron COVID-19 Booster for FDA Authorization og:description: The shot will target the dominant Omicron subvariants, BA.4 and BA.5 og:url: https://time.com/6207691/pfizer-biontech-omicron-booster-fda/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltfd9034bffbfea5c1/698a34cbd0753368b3e6d215/GettyImages-1241995654.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 og:image:width: 1024 og:image:height: 576 og:image:alt: Vaccination Campaign for Covid-19 Booster Dose og:type: article twitter:card: summary_large_image twitter:title: Pfizer-BioNTech Submits the First Omicron COVID-19 Booster for FDA Authorization twitter:description: The shot will target the dominant Omicron subvariants, BA.4 and BA.5 twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltfd9034bffbfea5c1/698a34cbd0753368b3e6d215/GettyImages-1241995654.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 ---  # Pfizer-BioNTech Submits the First Omicron COVID-19 Booster for FDA Authorization > Sponsored content. 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Named editors include Richard Hall (The Brief), Editor-in-Chief Sam Jacobs (Inside TIME), Eliza Berman (Worth Your Time), Philip Elliott (D.C. Brief), Justin Worland (Future Proof) and Harry Booth (In the Loop). Health Matters is written by TIME's health desk. #### How do I sign up for a TIME newsletter? Go to time.com/newsletters, choose the newsletters you want and enter your email address. There is no cost and no subscription requirement.  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Aug 22, 2022 5:21 PM UTC  Doses of Pfizer-BioNTech's COVID-19 vaccine used during a vaccine booster campaign at UCEP Ghasitula School in Sylhet, Bangladesh on July 19, 2022. Doses of Pfizer-BioNTech's COVID-19 vaccine used during a vaccine booster campaign at UCEP Ghasitula School in Sylhet, Bangladesh on July 19, 2022. Md Rafayat Haque Khan/Eyepix Group/Future Publishing—Getty Images  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Aug 22, 2022 5:21 PM UTC All COVID-19 vaccines that are used in the U.S. target the same original strain of SARS-CoV-2\. But boosters designed to protect against the latest Omicron subvariants could be coming soon. On Aug. 22, Pfizer-BioNTech submitted a request to the U.S. Food and Drug Administration (FDA) to authorize its Omicron-specific vaccine. The shot targets BA.4 and BA.5, which now account for [nearly all new infections](https://covid.cdc.gov/covid-data-tracker/#variant-proportions) in the U.S. In an [announcement](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-use), Pfizer-BioNTech requested emergency use authorization for a booster dose of the vaccine, which contains a combination of the genetic material mRNA from the original virus circulating when the vaccine was initially approved in August 2021, and mRNA from the newer BA.4 and BA.5 subvariants. The vaccine is intended for anyone 12 years or older. The companies have been studying the BA.4 and BA.5 vaccine in animal models and submitted that data to the FDA for review. Those studies showed the vaccine was safe and produced a “strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5,” the companies said in the statement. Pfizer-BioNTech says it has scaled up production of the BA.4/BA.5 vaccine and is ready to begin shipping immediately if the FDA authorizes the shot. The FDA has not indicated a timetable for if and when that might happen, but given that the agency requested that vaccine makers develop a BA.4/BA.5 booster in time to protect people in the fall and winter months, when respiratory viruses like SARS-CoV-2 circulate more quickly, the agency will likely act as quickly as possible. If the agency authorizes the booster, the White House’sCOVID-19 response coordinator Dr. Ashish Jha [predicted on Aug. 16](https://www.cnbc.com/2022/08/18/dr-ashish-jha-covid-ba-5-booster-shots-could-be-just-weeks-away.html) that the shot could be available “by early to mid September.” Data regarding the safety and efficacy of the Omicron-specific vaccine in people are not available yet; those studies in humans are expected to start later in August, the companies said. In addition to the animal data**,** the request is based on limited human data Pfizer-BioNTech generated with a related vaccine, which targeted another version of the Omicron variant, BA.1\. An FDA panel of independent experts reviewed that data in [June](https://time.com/6192092/new-covid-19-booster-omicron/) and decided not to consider it for authorization, and asked the companies to develop a vaccine targeting the BA.4 and BA.5 subvariants instead. Other vaccine makers are also developing Omicron-specific vaccines and likely won’t be far behind in requesting FDA authorization. Moderna, which makes the other mRNA COVID-19 vaccine approved by the FDA, released [promising data](https://time.com/6185406/omicron-booster-moderna/) in June showing its vaccine, which also targeted the BA.1 subvariant, produced higher levels of virus-fighting antibodies against Omicron in people compared to the original vaccine. At the FDA’s request, Moderna is also developing a BA.4/BA.5-specific version of its Omicron vaccine. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6207691/pfizer-biontech-omicron-booster-fda/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6207691/pfizer-biontech-omicron-booster-fda/"},"headline":"Pfizer-BioNTech Submits the First Omicron COVID-19 Booster for FDA Authorization","datePublished":"2022-08-22T17:21:44.000Z","dateModified":"2026-02-24T14:38:56.460Z","description":"The shot will target the dominant Omicron subvariants, BA.4 and BA.5.","url":"https://time.com/6207691/pfizer-biontech-omicron-booster-fda/","keywords":["COVID-19","healthscienceclimate"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/bltfd9034bffbfea5c1/698a34cbd0753368b3e6d215/GettyImages-1241995654.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Alice Park","jobTitle":"Senior Correspondent","url":"https://time.com/author/alice-park/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/bltfd9034bffbfea5c1/698a34cbd0753368b3e6d215/GettyImages-1241995654.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Vaccination Campaign for Covid-19 Booster Dose","caption":"Vaccination Campaign for Covid-19 Booster Dose","creditText":"Md Rafayat Haque Khan/Eyepix Group/Future Publishing—Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/covid-19/","name":"COVID-19"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6207691/pfizer-biontech-omicron-booster-fda/","name":"Pfizer-BioNTech Submits the First Omicron COVID-19 Booster for FDA Authorization"}}]}] ```