--- 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: 2026-10-14T09:38:44.333Z 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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Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-health-2026q3/newsletters?i=24696a00-9c36-4d21-82fd-1a732d816964&cr=time-nl-health-2026q3-v1) ## Video: These Virus Hunters Want to Stop Future Pandemic Threats [Watch (HLS stream): These Virus Hunters Want to Stop Future Pandemic Threats](https://cdn.jwplayer.com/manifests/cuwedOEw.m3u8) (5:30)  _Published 2022-07-29. Abbot’s Pandemic Defense Coalition is the first public-private effort led by industry to bring scientists around the world together to track current and emerging pathogens. The team is collecting virus samples from all over the world, searching for mutations, and so far they managed to alert the world to several that have swept the globe—including Gamma from a lab in Brazil and Omicron from a lab in South Africa._  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Aug 22, 2022 5:21 PM UTC Abbot’s Pandemic Defense Coalition is the first public-private effort led by industry to bring scientists around the world together to track current and emerging pathogens. The team is collecting virus samples from all over the world, searching for mutations, and so far they managed to alert the world to several that have swept the globe—including Gamma from a lab in Brazil and Omicron from a lab in South Africa.  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. ## Transcript [00:00] Finding a new virus or different strains of an existing [00:03] one is like searching for a needle in a haystack. [00:06] And when the haystack is, as big as the planet, [00:10] it takes a really good microscope and a large coordinate [00:13] a team. [00:20] here is a scientist to [00:23] dreams of the pandemics were living with like stars Cove to or [00:27] covid-19. And that's where we're trying to understand [00:39] what could potentially become the next pandemic in the future [00:42] for the painful. [00:43] Few years that we've all lived through this another pandemic. [00:48] So we need to do to learn the lessons and not reinvent the wheel. [00:54] After March of 2020 and wave after wave of new variants of [00:58] covid-19, researchers realize they needed a better way to stay [01:03] ahead of a virus that doesn't appear to be going away anytime [01:06] soon, Abbott's. Pandemic defense Coalition, is the first public-private [01:12] effort led by industry to bring scientist together to track [01:17] current and emerging pathogens. [01:18] The team is collecting virus samples from all over the world [01:22] and searching for mutations so far they managed to alert the [01:28] world to several that have Globe including gamma from a lab in [01:32] Brazil and Omicron from a lab in South Africa. [01:37] The whole process start to finish begins with a collaborator in [01:41] a site that collecting samples from people who've been tested [01:44] for covid and once they get a result, [01:47] I want to know what strain was present in the sample after [01:50] an inactivation step. [01:52] We take the sample itself and remove everything else about [01:55] the sample of stuff. [01:56] For the nucleic acid, which is where the Genome of the material that [02:01] we can use to either determine how much is there a virus, [02:06] or we can use that material to the sequence and determine [02:09] the coronavirus is constantly mutating, but not all of its changes [02:17] are important. One of the most difficult aspects of staying [02:20] ahead of the virus is figuring out which of these could become [02:25] a threat to Public Health. [02:37] The virus is in charge here. [02:46] It's still surprising us. [02:50] Abbott's. Pandemic defense Coalition is a network of experts [02:53] in infectious disease, genetic sequencing, phylogenetics [02:58] and epidemiology they have more than a dozen Partners. [03:03] On five continents, who work to collect samples, [03:06] test them, and share the data among themselves and with other [03:10] public health, and political leaders around the world. [03:13] Researchers say the data collected from sequencing can help [03:18] them to ensure that tests for detecting the virus continue [03:22] to work. So people will know when they are infected. [03:26] Even with newer variance and take proper safety measures [03:30] like isolating and wearing masks to buy having a network [03:34] eyes in the field boots on the ground that will spot the trans. [03:42] Identify the cases enable us in real time to share information, [03:46] sequence, samples. And also. [03:50] Rebuild diagnostic test that can then be distributed [03:52] background or seen something in South Paulo are we also seeing [03:55] it in Thailand? [03:56] That type of information is critical to have quickly so that [04:00] different countries can prepare and respond. [04:03] We're building this coke capability and capacity at our partner [04:06] sites around the world as it is limited and need worshipping [04:10] of samples. That information is shared through the cloud, [04:14] excetera, as of November 2021 Abbott's. [04:18] Pandemic defense Coalition has analyzed over 1.4 million [04:23] sequences from 63 different variants and it's clear they won't [04:28] be done anytime soon. [04:30] And silently, once we have all that amount of data, [04:41] we don't have a pipeline of five, [04:43] a Matic tools that can quickly identify if maybe there's just [04:47] a [04:50] Test for it or maybe there's something that's completely [04:52] novel. And that's where diagnostic tests are really important [04:55] early on. As we have Dal, you ate that and help Public Health [04:58] responses accordingly. This is one of the main focuses of the [05:04] Abbot pandemic defense Coalition, is to democratize the knowledge [05:08] and the expertise that we've developed over the decades here, [05:10] to our partners, around the world to build the next generation [05:14] of virologist. A virus Hunter is an epidemiologist. [05:17] I think that's critical preventing the next. [05:20] Pandemic is a team sport and collaboration is the only way we [05:23] win. ```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":"2026-10-14T09:38:44.333Z","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":"https://time.com/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"https://time.com/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"}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"These Virus Hunters Want to Stop Future Pandemic Threats","description":"Abbot’s Pandemic Defense Coalition is the first public-private effort led by industry to bring scientists around the world together to track current and emerging pathogens. 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