--- title: FDA Finds Pfizer's COVID-19 Vaccine Safe and Effective description: The FDA today published a review of data from Pfizer/BioNTech’s late-stage COVID-19 vaccine studies in advance of a meeting on Dec. 10. canonical: https://time.com/5919077/fda-pfizer-vaccine-data/ author: Alice Park article:opinion: false article:content_tier: free article:published_time: 2020-12-08T22:24:05.000Z article:modified_time: 2026-02-24T09:30:34.989Z article:section: Health og:title: FDA finds Pfizer-BioNTech COVID-19 Vaccine Safe and Effective og:description: The FDA today published a review of data from Pfizer/BioNTech’s late-stage COVID-19 vaccine studies in advance of a meeting on Dec. 10. og:url: https://time.com/5919077/fda-pfizer-vaccine-data/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blte42145bd44d1db2f/698a150097cdff35fa6bb710/GettyImages-1227710766.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 5741 og:image:height: 3229 og:image:alt: Food And Drug Administration Headquarters In Maryland og:type: article twitter:card: summary_large_image twitter:title: FDA finds Pfizer-BioNTech COVID-19 Vaccine Safe and Effective twitter:description: The FDA today published a review of data from Pfizer/BioNTech’s late-stage COVID-19 vaccine studies in advance of a meeting on Dec. 10. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blte42145bd44d1db2f/698a150097cdff35fa6bb710/GettyImages-1227710766.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # FDA Finds Pfizer/BioNTech's COVID-19 Vaccine Safe and Effective > 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 [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Dec 8, 2020 10:24 PM UTC  WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images) WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)Getty Images—2020 Getty Images  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Dec 8, 2020 10:24 PM UTC In a review of data from late-stage trials of Pfizer/BioNTech’s experimental COVID-19 vaccine, scientists at the Food and Drug Administration (FDA) [found](https://www.fda.gov/media/144245/download) the vaccine had a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization.” The review is part of Pfizer and BioNTech’s [request for emergency use authorization (EUA)](https://time.com/5914139/pfizer-covid-19-vaccine-fda-authorization/) for its vaccine, which it filed on Nov. 20\. On Dec. 10, the FDA’s vaccine review committee will vote on whether the vaccine will be the first authorized in the U.S. to start shipping. FDA commissioner Dr. Stephen Hahn will take the committee’s vote into consideration in ultimately making that decision. The vaccine is already [approved for use](https://time.com/5917109/u-k-covid-vaccine-approved/) in the UK, where it was administered for the first time earlier today. An EUA would allow the companies to start distributing their vaccine in the U.S. even while studies on its safety and effectiveness continue. The EUA requires that Pfizer/Biotech conduct a two-month follow-up of a subset (38,000) of the more than 44,000 people who participated in Phase 3 trials; Pfizer/BioNTech plan to continue following the volunteers for two years and then file for standard approval of their vaccine once they have longer-term data. The two companies filed a 92-page request to the FDA, which included data from a Phase 3 study that showed the vaccine was [95% effective](https://time.com/5912966/pfizer-vaccine-fda-authorization/) in protecting people from COVID-19 disease, with most of the vaccinated people showing only mild side effects. FDA scientists reviewed the data and concluded that the study results satisfied the EUA requirements for a safe and effective vaccine. That analysis will be one of the presentations the vaccine review committee will hear on Dec. 10; scientists from Pfizer/BioNTech will also [break down](https://www.fda.gov/media/144246/download) the data from the Phase 3 study and answer questions from committee members. The public is also invited to listen to the discussions and provide comment. Following the meeting, which will be virtual and is scheduled to run from 9 a.m. to 5:15 p.m. E.T., the FDA could decide at any time whether to authorize the vaccine. If it does receive the green light, Pfizer CEO Albert Bourla has said the company will be ready to start shipping doses within hours. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/5919077/fda-pfizer-vaccine-data/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/5919077/fda-pfizer-vaccine-data/"},"headline":"FDA Finds Pfizer/BioNTech's COVID-19 Vaccine Safe and Effective","datePublished":"2020-12-08T22:24:05.000Z","dateModified":"2026-02-24T09:30:34.989Z","description":"The review is an important part of Pfizer-BioNTech’s efforts to get authorization to distribute its vaccine","url":"https://time.com/5919077/fda-pfizer-vaccine-data/","keywords":["COVID-19"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blte42145bd44d1db2f/698a150097cdff35fa6bb710/GettyImages-1227710766.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/blte42145bd44d1db2f/698a150097cdff35fa6bb710/GettyImages-1227710766.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Food And Drug Administration Headquarters In Maryland","caption":"Food And Drug Administration Headquarters In Maryland","creditText":"Getty Images—2020 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/5919077/fda-pfizer-vaccine-data/","name":"FDA Finds Pfizer/BioNTech's COVID-19 Vaccine Safe and Effective"}}]}] ```