--- title: Moderna Is Seeking FDA Authorization for Its Omicron Booster description: Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. canonical: https://time.com/6208279/moderna-omicron-booster-fda/ author: TIME article:opinion: false article:content_tier: free article:published_time: 2022-08-24T14:42:58.000Z article:modified_time: 2026-02-24T14:39:26.453Z article:section: Health og:title: Moderna Is Seeking FDA Authorization for Its Omicron Booster og:description: Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. og:url: https://time.com/6208279/moderna-omicron-booster-fda/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt8021673b761caf5d/698a34dae6e84ab8ae2af3b2/moderna-to-seek-omicron-booster-fda-approval.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 og:image:width: 1024 og:image:height: 576 og:image:alt: Moderna Set to Seek FDA Approval of Booster Against Omicron Variants og:type: article twitter:card: summary_large_image twitter:title: Moderna Is Seeking FDA Authorization for Its Omicron Booster twitter:description: Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt8021673b761caf5d/698a34dae6e84ab8ae2af3b2/moderna-to-seek-omicron-booster-fda-approval.jpg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 ---  # Moderna Is Seeking FDA Authorization for Its Omicron Booster > Sponsored content. 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Health Matters is TIME's daily health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free daily newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. by [Robert Langreth/Bloomberg](https://time.com/author/bloomberg/) ## Robert Langreth/Bloomberg Contributor Aug 24, 2022 2:42 PM UTC  Injection of the third dose of the covid 19 vaccine at a Covid-19 vaccination center in Dinan, Brittany. France. Injection of the third dose of the covid 19 vaccine at a Covid-19 vaccination center in Dinan, Brittany. France. Martin Bertrand—Majority World/Universal Images Group/Getty Images by [Robert Langreth/Bloomberg](https://time.com/author/bloomberg/) ## Robert Langreth/Bloomberg Contributor Aug 24, 2022 2:42 PM UTC Moderna Inc. completed its filing to request U.S. clearance for a booster shot that targets the latest [Omicron COVID variants](https://time.com/6206640/covid-19-omicron-asymptomatic-infection/), a move to provide more protection against the [persistent coronavirus](https://time.com/6197127/doctors-covid-19/). In a statement, the company said it had wrapped up the submission for emergency authorization for the company’s bivalent COVID booster vaccine that targets the BA.4 and BA.5 strains along with the original version of COVID. The filing includes preclinical data for the booster against the latest strains, along with clinical data from the company’s other bivalent booster that targets the original Omicron strain. Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. Moderna’s booster application is for adults 18 years and older. **Read More:** [_Need Another Reason to Exercise? It Could Protect You from COVID-19_](https://time.com/6207838/exercise-covid-19-linked/) Advisers to the Centers for Disease Control and Prevention will hold a two-day meeting next week to discuss booster shots for COVID-19 vaccines, an agency spokesperson confirmed in an email. The Advisory Committee on Immunization Practices posted notice of the meeting, which will be held Sept. 1 and 2, on its [website](https://www.cdc.gov/vaccines/acip/index.html) on Tuesday. The panel of outside experts advises the CDC on how best to administer new vaccines. No agenda for the meeting was posted. Vaccine makers are working to design shots that match the circulating strains of the coronavirus more closely in an attempt to give better protection against the pathogen that’s still spreading around the world more than 2 1/2 years after it was first detected in China. New cases in the US averaged about 95,000 in the seven days ending Aug. 17, according to the U.S. Centers for Disease Control and Prevention, but hospitalizations and deaths have fallen as more people gain immunity through vaccination and earlier exposures to the virus. Rival vaccine partners Pfizer Inc. and BioNTech SE said Monday they had sent data to the Food and Drug Administration seeking authorization for [their own bivalent booster](https://time.com/6207691/pfizer-biontech-omicron-booster-fda/) against BA.4 and BA.5 for people 12 and older. Pfizer said Tuesday that a three-dose regimen of its existing COVID vaccine was 73.2% effective against the disease in a trial in children ages 6 months through 4 years of age, adding to data that led to the shot’s authorization in young children in June. The companies are working with the FDA to prepare an application in kids ages 6 months through 11 years old for a bivalent booster targeting BA.4 and BA.5. **Read More:** [_COVID-19 May Have Long-Term Effects on the Brain_](https://time.com/6207214/covid-19-brain-impact/) Moderna shares rose less than 1% in late trading. Moderna [said](https://twitter.com/moderna%5Ftx/status/1557743654013259776) on Aug. 11 that it had started a clinical trial of the booster against [BA.4 and BA.5.](https://time.com/6187762/ba-4-ba-5-omicron-subvariants-symptoms-risk/) UK regulators have cleared another Moderna booster that focuses on the original Omicron strain. _–With assistance from Fiona Rutherford._ ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6208279/moderna-omicron-booster-fda/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6208279/moderna-omicron-booster-fda/"},"headline":"Moderna Is Seeking FDA Authorization for Its Omicron Booster","datePublished":"2022-08-24T14:42:58.000Z","dateModified":"2026-02-24T14:39:26.453Z","description":"Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame.","url":"https://time.com/6208279/moderna-omicron-booster-fda/","keywords":["COVID-19","Vaccines","wire","healthscienceclimate"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt8021673b761caf5d/698a34dae6e84ab8ae2af3b2/moderna-to-seek-omicron-booster-fda-approval.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Robert Langreth/Bloomberg"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt8021673b761caf5d/698a34dae6e84ab8ae2af3b2/moderna-to-seek-omicron-booster-fda-approval.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Moderna Set to Seek FDA Approval of Booster Against Omicron Variants","caption":"moderna-to-seek-omicron-booster-fda-approval","creditText":"Martin Bertrand—Majority World/Universal Images Group/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/6208279/moderna-omicron-booster-fda/","name":"Moderna Is Seeking FDA Authorization for Its Omicron Booster"}}]}] ```