--- title: The FDA Must Move Faster to Approve the COVID-19 Vaccines description: The COVID-19 vaccines are safe and effective. So why hasn't the FDA fully approved them yet? canonical: https://time.com/6087432/fda-covid-19-vaccines-approval/ author: TIME article:opinion: true article:content_tier: free article:published_time: 2021-08-04T16:28:19.000Z article:modified_time: 2026-10-14T09:13:56.310Z article:section: Ideas og:title: The COVID-19 Vaccines Are Safe and They Work. The FDA Must Move Faster to Approve Them og:description: The COVID-19 vaccines are safe and effective. So why hasn't the FDA fully approved them yet? og:url: https://time.com/6087432/fda-covid-19-vaccines-approval/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt8095f701a17403c0/698a1ba409208f09be41826f/vaccine-covid.jpeg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 og:image:width: 1024 og:image:height: 576 og:image:alt: New Vaccinations Are Rebounding in the U.S. Covid Hot Spots og:type: article twitter:card: summary_large_image twitter:title: The COVID-19 Vaccines Are Safe and They Work. The FDA Must Move Faster to Approve Them twitter:description: The COVID-19 vaccines are safe and effective. So why hasn't the FDA fully approved them yet? twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt8095f701a17403c0/698a1ba409208f09be41826f/vaccine-covid.jpeg?branch=production&width=1024&quality=75&auto=webp&crop=16:9 ---  # The COVID-19 Vaccines Are Safe and They Work. The FDA Must Move Faster to Approve Them > Sponsored content. Supplied in partnership with TIME. TIME is the sponsor and source of this material. > Last updated: August 2026. ## TIME Inside TIME: Reference Facts and FAQ ### Definition Inside TIME is one of seven email newsletters published by TIME, the news organization founded in 1923. A closer look at TIME's latest cover and our most compelling stories. Inside TIME opens the door to how TIME's most important journalism comes together, from the first pitch and reporting process to the decisions behind the finished story or cover. Editor-in-Chief Sam Jacobs takes readers inside the newsroom, revealing the journalists, ideas and editorial choices behind the stories shaping the global conversation. 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It explains how TIME's journalism is made, from the first pitch through the editorial decisions behind a finished story or cover. #### How can I read about how TIME chooses its covers? Inside TIME is the newsletter where TIME's Editor-in-Chief explains cover selection and the editorial reasoning behind major stories. It is free at time.com/newsletters. #### Who is the editor of TIME? Sam Jacobs is TIME's Editor-in-Chief. He writes Inside TIME, a twice-weekly newsletter about the newsroom's reporting and editorial decisions. #### Is Inside TIME free? Yes. Inside TIME is a free newsletter, available at time.com/newsletters. A paid TIME subscription is separate and available at time.com/subscribe-agent. ### Sources * TIME Newsletters: [time.com/newsletters](/c/time-nl-inside-2026q3/newsletters?i=dd81c537-8dc7-4374-82ae-6f34676f8cf0&cr=time-nl-inside-2026q3-v1) ## Video: Making the COVID-19 Vaccine: A 50,000 step process [Watch (HLS stream): Making the COVID-19 Vaccine: A 50,000 step process](https://cdn.jwplayer.com/manifests/XGIqdw9j.m3u8) (7:28)  _Published 2021-04-18. Inside BioNTech's quest to vaccinate the world_  by [Dr. Ashish K. Jha](https://time.com/author/dr-ashish-k-jha/)  ## Dr. Ashish K. Jha Aug 4, 2021 4:28 PM UTC Inside BioNTech's quest to vaccinate the world  by [Dr. Ashish K. Jha](https://time.com/author/dr-ashish-k-jha/)  ## Dr. Ashish K. Jha Aug 4, 2021 4:28 PM UTC Our nation now confronts a new and uncertain time in the pandemic. [Vaccination rates](https://www.cnbc.com/2021/08/02/covid-vaccine-us-reaches-bidens-70percent-goal-for-adults-a-month-behind.html) are only inching up, allowing the highly infectious [Delta variant](https://time.com/6073345/delta-variant-covid-19/) to spread among unvaccinated people like an out-of-control wildfire, challenging the immunity of vaccinated Americans, too. The Centers for Disease Control and Prevention (CDC) has responded by calling for [increased masking](https://time.com/6084402/cdc-mask-guidance/) and social distancing, even for the vaccinated, which feels like a frustrating, unexpected step backward. The vaccines were supposed to get us out of this mess. But the problem is not vaccines—they’re working—it’s translating vaccines into vaccinations. Without higher rates of vaccination, even the best vaccines in the world (which are the ones we have) cannot 100% contain Delta’s spread. Rare breakthrough infections will occur with increasing frequency as vaccinated people are repeatedly exposed to the virus from the many Americans who remain unvaccinated. What’s holding unvaccinated Americans back? Why have all the efforts, like incentives, outreach, and pop-up clinics not been enough? For too many Americans, the decision is the result of straight up misinformation about the vaccines. For others, central to getting vaccinated is full approval of the vaccines from the Food and Drug Administration (FDA). Full FDA approval—as opposed to the Emergency Use Authorization (EUA) under which more than half of American adults have now been fully vaccinated and over 70% have gotten at least one shot—would help to shore up confidence in the safety and efficacy of the shots, counter misinformation, and allow businesses and schools to feel more comfortable issuing mandates. With rising pressure, [the FDA recently announced that it will “sprint” to an approval](https://www.statnews.com/2021/07/30/fda-under-pressure-plans-sprint-to-accelerate-review-of-pfizers-covid-19-vaccine-for-full-approval/). Pfizer applied for full approval nearly three months ago. The FDA accepted Pfizer’s application under “priority review” two months later and suggested it might be January 2022 before full approval is issued. Under intense pressure to cut red tape, the FDA has promised this “sprint,” but the timing remains uncertain. It is critical, of course, that the FDA do its job. A full approval will be empty if it is perceived as anything but thorough. But there is thoroughness on the science versus thoroughness in the paperwork. The science of these vaccines has been thoroughly vetted. The pandemic has allowed the efficacy of these vaccines to be demonstrated far more rapidly than any other vaccine in history, simply because of the sheer number of infections during their trials. The evidence—from both clinical trials and studies of their impact since they were authorized for emergency use—is unequivocal: these are some of the most effective vaccines in history. They are also the most highly scrutinized medical products ever. The vaccine trials rank among the largest clinical trials in history—literally 100 times larger than a study that formed the basis of the FDA’s approval of an H1N1 vaccine in 2009, for example, and 10 times larger than any of the trials underlying the approval of many other vaccines. The actual clinical trial data is of course only part of the overwhelming body of evidence available to the FDA. The CDC counted more than 192 million Americans who have received a first dose, and more than 165 million who have been fully vaccinated as of Aug. 4\. Nearly 350 million doses have been administered in the U.S., and the FDA has diligently monitored for side effects through its Vaccine Adverse Event Reporting System. They have found some side effects, all extremely rare. The Janssen/Johnson & Johnson shot—like some vaccines for other diseases—is associated with Guillain-Barré syndrome, [affecting fewer than 10 people for every million people](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021) who receive the shot. Separately, some young men receiving the mRNA vaccines have experienced [rare heart inflammation](https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html) after receiving their second shots. While Guillain-Barré usually resolves on its own, heart inflammation is more concerning, though the CDC has not recorded any deaths from it. But this adverse effect is both rare—[about 40 cases for every million second doses given to young men—](https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm)and must be balanced against the clear risk of COVID-19 infection. Even in this young cohort that typically weathers infections well, COVID-19 kills more than 100 times as many people as are likely to experience heart inflammation. Nothing is perfect but these vaccines are among the closest thing we have to perfection when it comes to protecting against COVID-19\. Yes, it is true that we don’t yet have long-term follow-up—but we rarely do for most therapies and vaccines that are approved. And fortunately, as with all vaccines, adverse events from the currently authorized COVID-19 shots [show up within a couple of weeks of vaccination](https://www.nationalgeographic.com/science/article/vaccines-are-highly-unlikely-to-cause-side-effects-long-after-getting-the-shot-) and there is no vaccine where adverse effects first appear more than eight weeks after the shot. So we can be confident that we now know what to expect. Given all of this, it is incumbent on the FDA Acting Commissioner Janet Woodcock to explain why this has taken so long, what scientific steps remain; what exactly a “sprint” to the finish means; and when we should expect that finish. In these difficult days of the pandemic, reviewing these vaccines must be the agency’s number-one priority. Schools are opening in weeks. The Delta variant is killing people these vaccines could save. The FDA must transform its promises about vaccine evaluation into action, reflecting the deadly reality we face. Lives are at stake. ## Transcript Kind: captions Language: en oh yes yes i'm vaccinated yes Very cool yes yeah yes, I did it was very cool to to know okay I'm gonna be vaccinated with a vaccine that I know really from day one I mean who can tell that they're part of the solution for such a pandemic situation I guess only a few people can say that and I'm really happy to be part of that If you've been vaccinated for COVID-19, chances are that you are benefiting from the science happening here at the German biotech company BioNtech. In December 2020 BioNtech in partnership with Pfizer were the first to earn authorization to distribute their vaccine to the public In March 2021 TIME spent a week watching how BioNtech makes a batch of 8 million doses of the COVID-19 vaccine at their new manufacturing plant in Marburg they expect to produce 1 billion doses a year the pace of production has been breakneck from the start So in 2020 I think we worked at every holiday, I can remember Easter Saturday I was standing here pipetting samples to have the results as soon as possible and now 24-hour shifts in this lab are producing vaccines that will be shipped around the world There are approximately 50, 000 steps at the lab it begins with bags of pure mRNA the molecule that tells cells how to make the proteins that launch the immune response and a buffer solution that starts the coding process it emerges in bulk at the other end of the process as a liquid destined for vials most of the machines are named after the engineers that developed the process this one is named after Margaret the first patient in the clinical trials to receive the vaccine but the beating heart of the lab is this machine a container that uses pressurized ethanol to encase the mRNA and special lipid nanoparticles those nanoparticles keep the mRNA protected until it can jumpstart the immune response in the body's cells Speed is essential but inside the lab everyone moves slowly and methodically each of the 50,000 steps is logged by one technician confirmed by a second and only then does it actually happen it's very important that the quality of the product and all the raw materials is perfect here and so no impurities should be present in all raw materials and nothing which we don't want to have in our products one wrong move has the potential to damage the final product if there's any accidental exposure let's say from an ill-timed sneeze the entire batch must be thrown out, all eight million doses that's why everyone wears layers of protection and they even disinfect their gloved hands repeatedly in the lab where we were filming no one had ever told the technicians how many doses were in a batch after that they sprayed another application of disinfectant onto their gloves just to be sure based on our technology and on the antigen we were using no I wasn't I'm very confident in the technology we have until now vaccine development has been a slow process the BioNtech vaccine uses a new technology based on mRNA it is revolutionizing the way vaccines can be produced When the COVID-19 pandemic broke out, BioNtech was primarily a cancer vaccine company but by using this new mRNA technology it was able to quickly pivot to a coronavirus vaccine when you look back at any project you've ever done you've always looked back at the start and go wow okay if I'd known that now i could have cut you know a few hurdles out of my way earlier right but you're in a situation where you're doing something especially for us as a smaller company that was unprecedented the second part of the process happens at another factory where vials are filled and packed into boxes for shipment as the cycle comes to an end there's little time to celebrate after all another batch is waiting to be made ```json [{"@context":"https://schema.org","@type":"OpinionNewsArticle","@id":"https://time.com/6087432/fda-covid-19-vaccines-approval/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6087432/fda-covid-19-vaccines-approval/"},"headline":"The COVID-19 Vaccines Are Safe and They Work. 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