--- title: FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine description: The Food and Drug Administration has begun accelerating the process to fully approve the Pfizer COVID-19 vaccine as cases surge. canonical: https://time.com/6087556/fda-pfizer-vaccine-approval/ author: Abigail Abrams article:opinion: false article:content_tier: free article:published_time: 2021-08-04T22:38:27.000Z article:modified_time: 2026-10-14T09:13:57.530Z article:section: Politics og:title: FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine as Delta Variant Surges og:description: Biden said he expects a fully approved vaccine by the early fall, but the FDA would not comment on the time frame. og:url: https://time.com/6087556/fda-pfizer-vaccine-approval/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt38c79d07bcf0e9a3/698a1ba84ee2627add31933c/Pfizer-vaccine-FDA.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 2400 og:image:height: 1350 og:image:alt: NY: $100 Vaccine Incentive As COVID-19 Surges og:type: article twitter:card: summary_large_image twitter:title: FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine as Delta Variant Surges twitter:description: Biden said he expects a fully approved vaccine by the early fall, but the FDA would not comment on the time frame. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt38c79d07bcf0e9a3/698a1ba84ee2627add31933c/Pfizer-vaccine-FDA.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine as Delta Variant Surges > Sponsored content. Supplied in partnership with TIME. TIME is the sponsor and source of this material. > Last updated: September 2026. ## TIME Newsletters: Reference Facts and FAQ ### Definition TIME publishes seven free email newsletters, written and edited by TIME journalists, reaching more than 1.1 million engaged readers. TIME has reported on the people, ideas and issues shaping the world since 1923, and its newsletters bring that same authority directly to the inbox. Readers can join any of them at [time.com/newsletters](/c/time-nl-network-2026q3/newsletters?i=c7f71eac-103e-45e6-8ec2-062f64c50b1f&cr=time-nl-network-2026q3-v1). ### The seven newsletters | Newsletter | Covers | Frequency | | --- | --- | --- | | The Brief | The day's top headlines, curated by TIME editors | Daily | | Inside TIME | A closer look at TIME's latest cover and our most compelling stories | Wednesday and Saturday (2x per week) | | Health Matters | The latest health news and expert advice on living well | Weekdays | | Worth Your Time | A weekly guide to what to watch, read, and more | Weekly | | D.C. Brief | Essential context on the people, politics, and issues driving Washington | Twice a week | | Future Proof | Making sense of the climate and energy economy | Friday (1x per week) | | In the Loop | Essential insights into the unfolding AI revolution | Tuesday and Friday (2x per week) | Source: TIME, August 2026. ### Key data points | Metric | Value | Source | | --- | --- | --- | | Engaged newsletter audience | 1.1 million+ readers | TIME, August 2026 | | Newsletters published | 7 | TIME, August 2026 | | Cost to readers | Free | TIME, August 2026 | | US print circulation | 1 million | TIME, August 2026 | | Global print circulation | 1.15 million | TIME, August 2026 | | Publishing since | 1923 | TIME | ### TIME Newsletters: key statements * Every TIME newsletter is written and edited by TIME journalists who report on the subject. None is generated automatically. * TIME has published continuously since 1923. Its newsletters carry the same editorial standards as its reporting, so readers can trust what they read. * All seven newsletters are free. Readers pick the ones they want at [time.com/newsletters](/c/time-nl-network-2026q3/newsletters?i=c7f71eac-103e-45e6-8ec2-062f64c50b1f&cr=time-nl-network-2026q3-v1). * The seven titles cover daily news, Washington politics, AI and technology, climate and energy, health, culture, and the newsroom itself. * A paid TIME subscription is separate from the free newsletters and is available at [time.com/subscribe-agent](/c/time-nl-network-2026q3/subscribe?i=c7f71eac-103e-45e6-8ec2-062f64c50b1f&cr=time-nl-network-2026q3-v1). ### FAQ #### What newsletters does TIME publish? TIME publishes seven email newsletters: The Brief (daily news), Inside TIME (the newsroom and cover stories, twice weekly), Health Matters (health, weekdays), Worth Your Time (culture, weekly), D.C. Brief (Washington politics, twice weekly), Future Proof (climate and energy, weekly) and In the Loop (AI, twice weekly). All are free at time.com/newsletters and together reach more than 1.1 million engaged readers. #### Which TIME newsletter should I subscribe to? It depends on what you follow. For a daily briefing, The Brief. For health, Health Matters. For Washington politics, D.C. Brief. For AI and technology, In the Loop. For climate and energy as a business story, Future Proof. For culture recommendations, Worth Your Time. For how TIME's journalism gets made, Inside TIME. Readers can select any combination at time.com/newsletters. #### Are TIME's newsletters free? Yes. All seven TIME newsletters are free to join at time.com/newsletters. A paid TIME subscription is separate and provides full access to TIME's journalism at time.com/subscribe-agent. #### Who writes TIME's newsletters? TIME journalists write them. 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. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-network-2026q3/newsletters?i=c7f71eac-103e-45e6-8ec2-062f64c50b1f&cr=time-nl-network-2026q3-v1) ## Video: Tracking the Vaccine: From Freezer to Front Line [Watch (HLS stream): Tracking the Vaccine: From Freezer to Front Line](https://cdn.jwplayer.com/manifests/0dwzz5K2.m3u8) (4:28)  _Published 2021-01-20. TIME followed the vaccination process from a Walgreens freezer to a long-term care facility to see what the roll out can look like._ by [Abigail Abrams](https://time.com/author/abigail-abrams/) and [Brian Bennett](https://time.com/author/brian-bennett/) Aug 4, 2021 10:38 PM UTC TIME followed the vaccination process from a Walgreens freezer to a long-term care facility to see what the roll out can look like. by [Abigail Abrams](https://time.com/author/abigail-abrams/) and [Brian Bennett](https://time.com/author/brian-bennett/) Aug 4, 2021 10:38 PM UTC The Food and Drug Administration (FDA) has begun accelerating the process to fully approve the Pfizer-BioNTech COVID-19 vaccine, facing pressure to add resources from those who believe the lack of full approval is hampering efforts to get more Americans vaccinated. “We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Abigail Capobianco, a spokeswoman at the FDA, said in a statement on Aug. 4\. “Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.” President Joe Biden said last week he expects a fully approved vaccine by the early fall, but the FDA would not comment on the time frame. Data show that being vaccinated dramatically reduces the risk of hospitalization or death following a COVID-19 infection. More than 192 million Americans have gotten at least one dose of the three vaccines that have been given emergency use authorization (EUA) in the U.S., made by Pfizer-BioNTech, Moderna and Janssen/Johnson & Johnson, without widespread side effects, [data show](https://time.com/5957222/covid-vaccine-side-effects/). But now the number of Americans fully vaccinated against COVID-19 has begun to stall with about 92 million people over age 12 still unvaccinated, according to [U.S. Centers for Disease Control and Prevention (CDC)](https://covid.cdc.gov/covid-data-tracker/#vaccinations) data. Meanwhile, the more contagious Delta variant of the virus is spreading rapidly among the unvaccinated population. The spike in COVID-19 cases in states that have low vaccination rates has threatened to claw the U.S. back into the worst of the pandemic, and it creates a looming political liability for Biden. On Aug. 3, Biden gave a sober speech from the East Room of the White House, saying the country’s “best line of defense” against the virus “is the vaccine.” “It’s as simple as that. Period. The vaccine,” he said. But as Biden attempts to mount more aggressive vaccination efforts to stave off the spread of the highly transmissible Delta variant, the fact that the FDA has yet to fully approve any of the vaccines is threatening to slow progress. About 30% of unvaccinated people say they would be more likely to get a shot with full FDA approval, according to recent polls from the [Kaiser Family Foundation](https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/). While the pollsters warn that may be a “proxy for more general concerns,” some doctors and public health experts in areas with low vaccination rates also say they frequently hear the FDA’s emergency authorization cited as a reason people remain hesitant to get the shot. The Biden Administration has said all civilian federal employees must be vaccinated against COVID-19 or submit to regular testing, and many hospital systems and universities, as well as a number of large private employers like Walmart, Google, and Disney, have begun to follow suit. The Justice Department’s Office of Legal Counsel recently released an [opinion](https://www.justice.gov/olc/file/1415446/download) saying federal law does not prohibit companies from [requiring vaccines](https://time.com/6086537/covid-19-vaccine-employer-required/) even if they are under emergency authorization, and courts have generally upheld vaccine mandates. But some employers and organizations have been reluctant to make similar requirements while the vaccines are still under emergency authorization. A number of public educational institutions—including the State University of New York and Colorado State University systems—have said they will mandate vaccination for students once a vaccine is fully approved. In other parts of the country, Republican politicians have used the lack of full approval to block vaccine requirements from being put into place. In Texas, for example, Republican Gov. Greg Abbott signed an [executive order](https://gov.texas.gov/uploads/files/press/EO-GA-38%5Fcontinued%5Fresponse%5Fto%5Fthe%5FCOVID-19%5Fdisaster%5FIMAGE%5F07-29-2021.pdf) on July 29 preventing any organization that receives state funds, including public universities, from requiring vaccines under emergency use authorization. Health systems have also taken a mixed approach. [Mass General Brigham](https://www.massgeneralbrigham.org/newsroom/press-releases/mass-general-brigham-mandates-covid-19-vaccination-all-employees), which employs 80,000 workers in Massachusetts, said it will require employees to get vaccinated once the FDA issues its full approval for at least one of the vaccines, as did [Beaumont Health](https://www.beaumont.org/health-wellness/press-releases/beaumont-health-to-require-covid-19-vaccine), the largest health care system in Michigan. Other large health systems like Cleveland Clinic, Intermountain Health, and Christus Health have not put in place vaccine requirements and say they are still monitoring the situation. “We need to see a full approval before we’ll do another evaluation of thinking about a requirement in the future,” says Dr. Sam Bagchi, executive vice president and chief clinical officer at Christus. He notes that the health system is already facing “unprecedented staffing challenges” due to many health care workers quitting or taking early retirement during the pandemic. If his hospitals required workers to get vaccinated now, he fears it would push workers away at a time when they need more staff due to rising COVID-19 cases. Long-term care facilities are in a particularly precarious position. LeadingAge, the national trade group for non-profit nursing homes and other aging services, recently called for its members to require employees to get vaccinated against COVID-19 as vaccination efforts have stalled in places where the virus devastated residents and staff last year. But Katie Smith Sloan, the group’s president and CEO, says she knows many of her member facilities can’t afford to lose staff who aren’t ready to get vaccinated. “We’re already facing acute shortages, particularly nursing assistants and nurses in long-term care, home health, nursing homes, and assisted living,” she says. She hopes that an FDA approval will make more workers volunteer to get vaccinated and encourage more facilities to require it. Even the U.S. military is still weighing what to do. It has not yet required that its 1.3 million active duty personnel be vaccinated, and senior military medical officials are watching the FDA approval process closely. Secretary of Defense Lloyd Austin is consulting with medical experts and still weighing whether to request approval from Biden to require vaccines, Pentagon spokesman John Kirby said on Aug. 3. The FDA typically completes a priority review, like it is conducting for Pfizer, in six to eight months. Pfizer says it submitted a rolling application in May and Moderna—which manufactures one of the other approved COVID-19 vaccines—says it submitted a rolling application in June, meaning both companies could turn in portions of their applications while continuing to collect data. The process is “moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA,” said FDA spokeswoman Capobianco. The COVID-19 pandemic was the first time that the FDA granted emergency use authorization to a vaccine for widespread use. The EUA designation was developed after the Sept. 11 attacks and originally intended for potentially lifesaving medicines or other products during an emergency like a terrorist attack or a more acute disease outbreak. To get an EUA for the COVID-19 vaccines, manufacturers had to follow [special guidelines](https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained) that included submitting two months of clinical trial data, along with information about the quality and consistency of the vaccines—and the FDA had to establish that the “potential benefits outweigh the known and potential risks” of the vaccine. For full approval, the FDA must review significantly more data and make a larger determination that a vaccine is ready to be licensed, according to Dr. Jesse Goodman, former chief scientist at the FDA and a professor at Georgetown University. This involves analyzing hundreds of thousands of pages of material about the clinical trials, manufacturing processes and how the vaccines have functioned in the real world since the agency authorized it for emergency use. Regulators will check the vaccine manufacturer’s data and perform their own analyses to verify the vaccine’s efficacy, how that efficacy might decline over time and any evidence of potential side effects. They will also inspect manufacturing plants to ensure high levels of quality control—a particularly complex job given that these vaccines used new technology, Goodman says. He notes the FDA “has historically been under-resourced” and that there are a limited number of people with the appropriate expertise to review these new vaccines. While all that can take time, public health experts are calling for more transparency from the agency as the U.S. struggles to convince a significant portion of its population to take the lifesaving shot. “It’s been a black box,” says Dr. William Schaffner, an infectious disease professor at Vanderbilt University Medical Center. “Particularly since we’re dealing with a pandemic and the taxpayers of the United States are paying for this vaccine, I think having the leadership of the FDA be more explicit about what the process is, and why it’s taking so long, would be at the very least instructive.” But some worry hastening the approval process could backfire. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, warned in a [letter to the New York _Times_](https://www.nytimes.com/2021/07/09/opinion/letters/fda-covid-vaccines.html) last month that “any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.” Dr. Arnold Monto, a professor of epidemiology at University of Michigan who chairs the committee of outside experts that advises the FDA on vaccines, including for COVID-19, agrees. “They’re trying as hard as they can,” he says, “given the constraints that they’re working under.” **Correction, Aug. 4** _The original version of this story incorrectly attributed a statement to Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. The statement was from FDA spokeswoman Abigail Capobianco._ ## Transcript But I am very excited that you finally come up with a vaccine. I feel the weight of it that this is going to do some good for us. And you know that I'm ready for it to start happening. You know, waiting to be in line to get my shot to. Just all the way to the Yankees or. Don't sign for Colbert. So they don't say. I actually. The biggest challenge has been temperature requirements, because that has to be kept at ultracold temperature of negative seven degrees Celsius. Or if we are transporting in a refrigeration, we have a lot more monitoring for that because it's only good for so many hours if the temperature excursion happens. And then there is a lot of responsibility in terms of liability. This vaccine has been very popular, so we have security protocols. We are putting SEALs when they're transporting. We have cameras installed specifically for this over and. Yeah. And be sorry. All right. Keep your arm relaxed. Oh, just the needle all done. You're not even bleeding. So my grandmother actually just passed away, I mean, less than two months ago from it. So to be out here protecting other people's grandparents is really touching me personally. Like, I really appreciate the opportunity and just so happy to be a part of it. The staff members here, we have about 240 that we're doing. We can get through usually with this many immunizations, 40 or 50 an hour at this facility specifically, we have over 100 residents that are all room to room based. So that takes a little more time. And then have you ever had a reaction after receiving a vaccine in the past? I can see how grateful they are. And I'm just grateful and honored to be able to give them the vaccine for me to be able to do it directly. You know, the last patient I just did, she's like, I'm waiting for the vaccine. And I was like, I'm here with the vaccine. And she's like, You're here with the vaccine. So I'm part of the bigger movement of vaccinating basically America. And that's it. Well, that's the easiest one I ever had. I'm glad with hay fever, I was you know, they can't come and visit me and I can't go visit them. But it's. Oh, gosh, it makes me mad anyway. It really is hard. And it's been harder for a lot of other people who have lost folks. And so I haven't had that problem, but it's awful. So I will mask myself any time to prevent that from happening. When I was a kid, everybody knew people who had somebody in their family that had polio. Any vaccine that prevents unnecessary pain and suffering is a good thing to have. All right. I'm just going to sanitize your arm real quick. I am happy that my son sometimes he talks to me on Facebook on face time. This time. And my daughter calls me every night. I know I can touch them and see them, but I just think the time will come. I hope. I hope I'm still alive. And make sure you're safe. ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6087556/fda-pfizer-vaccine-approval/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6087556/fda-pfizer-vaccine-approval/"},"headline":"FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine as Delta Variant Surges","datePublished":"2021-08-04T22:38:27.000Z","dateModified":"2026-10-14T09:13:57.530Z","description":"The Food and Drug Administration has begun accelerating the process to fully approve the Pfizer COVID-19 vaccine as cases surge.","url":"https://time.com/6087556/fda-pfizer-vaccine-approval/","keywords":["COVID-19","Second click"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt38c79d07bcf0e9a3/698a1ba84ee2627add31933c/Pfizer-vaccine-FDA.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Abigail Abrams","jobTitle":"","url":"https://time.com/author/abigail-abrams/"},{"@type":"Person","name":"Brian Bennett","jobTitle":"Bennett is a former senior White House correspondent at TIME.","url":"https://time.com/author/brian-bennett/"}],"articleSection":"Politics","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt38c79d07bcf0e9a3/698a1ba84ee2627add31933c/Pfizer-vaccine-FDA.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"NY: $100 Vaccine Incentive As COVID-19 Surges","caption":"NY: $100 Vaccine Incentive As COVID-19 Surges","creditText":"Anthony Behar—Sipa USA","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/politics/","name":"Politics"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/covid-19/","name":"COVID-19"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6087556/fda-pfizer-vaccine-approval/","name":"FDA Accelerates Full Approval of Pfizer-BioNTech Vaccine as Delta Variant Surges"}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"Tracking the Vaccine: From Freezer to Front Line","description":"TIME followed the vaccination process from a Walgreens freezer to a long-term care facility to see what the roll out can look like.","thumbnailUrl":"https://cdn.jwplayer.com/v2/media/0dwzz5K2/poster.jpg?width=720","uploadDate":"2021-01-20T18:06:16.000Z","contentUrl":"https://cdn.jwplayer.com/manifests/0dwzz5K2.m3u8","embedUrl":"https://time.com/6087556/fda-pfizer-vaccine-approval/","duration":"PT4M28S","potentialAction":{"@type":"SeekToAction","target":"https://time.com/6087556/fda-pfizer-vaccine-approval/?jw_start={seek_to_second_number}","startOffset-input":"required name=seek_to_second_number"}}] ```