--- title: When Will COVID-19 Vaccines Be Available for Younger Kids? description: There is still not an authorized COVID-19 vaccine for kids younger than 12. One might not be available until October or late 2021. canonical: https://time.com/6093670/covid-19-vaccines-kids-younger-12/ author: Jamie Ducharme article:opinion: false article:content_tier: free article:published_time: 2021-08-30T14:57:05.000Z article:modified_time: 2026-10-14T09:14:38.199Z article:section: Health og:title: When Will COVID-19 Vaccines Be Available for Younger Kids? og:description: And why is it taking so long? og:url: https://time.com/6093670/covid-19-vaccines-kids-younger-12/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt9278b8a10793decb/698a1c5a86f68e0f966f040f/Cincinnati-Childrens-trial.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 1851 og:image:height: 1041 og:image:alt: Cincinnati-Children's-trial og:type: article twitter:card: summary_large_image twitter:title: When Will COVID-19 Vaccines Be Available for Younger Kids? twitter:description: And why is it taking so long? twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt9278b8a10793decb/698a1c5a86f68e0f966f040f/Cincinnati-Childrens-trial.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # When Will COVID-19 Vaccines Be Available for Younger Kids? > Sponsored content. 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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=765928ee-a7ec-40ae-b453-172cf045daff&cr=time-nl-network-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 [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Aug 30, 2021 2:57 PM UTC Inside BioNTech's quest to vaccinate the world  by [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Aug 30, 2021 2:57 PM UTC As the [school year gets underway](https://time.com/6085883/school-delta-covid/) and the Delta variant continues its march through the U.S. population, many parents with kids younger than 12 have the same question: When will vaccines become available for my child? No one knows exactly when the U.S. Food and Drug Administration (FDA) may grant one or multiple COVID-19 vaccines emergency-use authorization for children younger than 12\. But Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center and one of the investigators involved in testing Pfizer-BioNTech’s shot in kids, guesses parents will have to wait at least until October. On Aug. 24, National Institutes of Health Director Dr. Francis [Collins said](https://twitter.com/FPizarro%5FDC/status/1430121983472291847) pediatric shots may not be approved before the end of 2021. That may seem ploddingly slow, given that Pfizer-BioNTech’s shot was [authorized for 12- to 15-year-olds](https://time.com/6047384/teens-pfizer-covid-vaccine/) back in May. (Moderna submitted its shot for authorization among adolescents and teenagers [in June](https://www.nbcnews.com/health/kids-health/moderna-files-authorization-covid-vaccine-younger-teens-adolescents-n1270295), but the FDA hasn’t issued a decision yet.) But the research process is different for young children, who “are not just little adults,” says Dr. William Towner, physician director of clinical trials for the Kaiser Permanente Department of Research & Evaluation in Southern California. One major difference: 12- to 15-year-olds received the same vaccine dose as adults, whereas researchers have had to figure out the right amount to give to younger children. With smaller bodies—and immune systems [that seem better prepared](https://www.scientificamerican.com/article/unraveling-the-mystery-of-why-children-are-better-protected-from-covid-than-adults/) to fight off COVID-19—young kids should be able to get strong protection from a smaller dose, hopefully with fewer side effects, Frenck explains. After landing on the right doses for kids, trial sites moved into safety and efficacy testing, starting with children ages 5 to 11 and then moving down to toddlers and babies. That process is ongoing, and it was disrupted when the FDA in late July [asked researchers](https://www.washingtonpost.com/health/2021/07/26/fda-asks-pfizer-moderna-test-their-vaccines-more-children-under-12-help-rule-out-safety-issues/) testing both the Pfizer-BioNTech and Moderna vaccines to enroll additional children in their trials, in hopes of learning more about whether rare side effects, like[ heart conditions](https://time.com/6075691/covid-19-vaccines-heart-problems/) seen in a small number of teenagers after vaccination, also affect younger kids. Both [Pfizer](https://clinicaltrials.gov/ct2/show/NCT04816643) and [Moderna](https://clinicaltrials.gov/ct2/show/NCT04796896) are still recruiting participants for at least some of their study sites, but reaching that higher enrollment cap shouldn’t be a problem, Towner says. Kaiser Southern California is one of the sites across the country testing Moderna’s vaccine in kids younger than 12—and for each trial spot that opens up, Towner says he receives at least 10 applications from eager parents. “There’s definitely a strong interest in this clinical trial,” Towner says. “We’ve been getting a rather breathtaking response.” Even still, authorization for 5- to 11-year-olds is likely at least a few months off, Frenck guesses. Before granting emergency-use authorizations for adult and teen vaccines, the FDA reviewed two months of follow-up safety data from trial participants. It’s likely to want at least that much data from pediatric trials, and perhaps more. An FDA spokesperson referred TIME to agency [documents](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19) and officials’ previous comments suggesting it will review at least two months of data for kids. A Pfizer spokesperson said in a statement to TIME that the company expects to have enough data to potentially support an emergency-use authorization for 5- to 11-year-olds by the end of September. Moderna representatives did not provide a statement before press time. Dr. Kari Simonsen, who is leading Omaha Children’s Hospital and Medical Center’s pediatric trial of the Pfizer-BioNTech vaccine, says she feels two months of follow-up is enough. “As a pediatrician, I do feel like using that same rationale that we did for adolescents and adults makes good sense,” Simonsen says. Her Nebraska hospital has already enrolled and vaccinated its 50 pediatric study participants and is now waiting for the FDA’s signal to move ahead. “It’s outside my hands,” Simonsen says. “I’m just anxiously awaiting when the FDA will take that up.” Many parents can’t wait for that day, as evidenced by the overwhelming response research centers around the country have gotten to their recruitment requests. That anticipation was seemingly only heightened when Pfizer-BioNTech’s shot [received full FDA approval](https://time.com/6092081/pfizer-vaccine-full-approval-fda/) in August. In fact, after that approval, the American Academy of Pediatrics (AAP) issued [a statement](https://www.aap.org/en/news-room/news-releases/aap/2021/american-academy-of-pediatrics-cautions-against-off-label-use-of-covid-19-vaccines-in-children-under-12/) urging pediatricians not to prescribe the Pfizer shot off-label for children, apparently anticipating the wishes of concerned parents. “We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Dr. Yvonne Maldonado, chair of the AAP committee on infectious diseases, said in the statement. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.” Even as some parents count down the days until pediatric shots are available, however, an even larger group remains skeptical. An international [study](https://www.tandfonline.com/doi/full/10.1080/21645515.2020.1834325) published in November 2020 found that just 18% of parents said they would enroll their child in a vaccine trial. And in an August 2021 Kaiser Family Foundation [survey](https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-parents-and-the-pandemic/), only 26% of U.S. parents with kids ages 5 to 11 said they would vaccinate them right away. Forty percent said they would “wait and see,” while 9% said they would vaccinate their kids only if required and 25% said they wouldn’t under any circumstances. Dr. Kelly Moore, president and CEO of the pro-vaccine Immunization Action Coalition, says pediatricians should start counseling parents about the benefits of vaccination as soon as possible, even though shots aren’t authorized for young kids yet. “Families are used to looking to their pediatrician for guidance on what happens to their child,” Moore says. “More than ever, the pediatrician’s ability to educate families is going to be critical.” Schools can play a similar role, particularly for kids who may not have regular interactions with a health care provider, she says. Frenck also urges parents to pay attention to current [pediatric COVID-19 surges](https://time.com/6092446/pediatric-covid-19-surge/) in parts of the South and Midwest, and to use that when making decisions about vaccination and other precautions. “We can show you that kids are getting sick, we can show you that kids are getting hospitalized, we can show you that kids are dying,” he says. “Please use that data.” ## Transcript [00:01] oh yes yes i'm vaccinated yes [00:06] Very cool [00:10] yes [00:11] yeah [00:12] yes, I did [00:13] it was very cool to to know [00:15] okay I'm gonna be vaccinated with a vaccine that I know really from day one [00:26] I mean who can tell that they're part of the solution for such a pandemic situation [00:30] I guess only a few people can say that and I'm really happy to be part of that [00:51] If you've been vaccinated for COVID-19, chances are that you are benefiting from the science [00:56] happening here at the German biotech company BioNtech. [01:00] In December 2020 BioNtech in partnership with Pfizer [01:04] were the first to earn authorization to distribute their vaccine to the public [01:17] In March 2021 TIME spent a week watching how BioNtech makes a batch [01:22] of 8 million doses of the COVID-19 vaccine at their new manufacturing plant in Marburg [01:29] they expect to produce 1 billion doses a year [01:44] the pace of production has been breakneck from the start [01:48] So in 2020 I think we worked [01:51] at every holiday, I can remember Easter Saturday I was standing here pipetting [01:55] samples to have the results as soon as possible [01:59] and now 24-hour shifts in this lab are producing [02:03] vaccines that will be shipped around the world [02:25] There are approximately 50, 000 steps at the lab [02:28] it begins with bags of pure mRNA the molecule that tells cells how to make the proteins that [02:33] launch the immune response and a buffer solution that starts the coding process [02:39] it emerges in bulk at the other end of the process as a liquid destined for vials [02:46] most of the machines are named after the engineers that developed the process [02:50] this one is named after Margaret the first patient in the clinical trials to receive the vaccine [02:56] but the beating heart of the lab is this machine a container that uses pressurized ethanol to encase [03:01] the mRNA and special lipid nanoparticles [03:05] those nanoparticles keep the mRNA protected until it [03:08] can jumpstart the immune response in the body's cells [03:38] Speed is essential but inside the lab everyone moves slowly and methodically [03:45] each of the 50,000 steps is logged by one technician confirmed by a second and only then does it actually happen [03:53] it's very important that the quality of the product and all the raw materials is perfect [04:00] here and so no impurities should be present in all raw materials and nothing which we don't [04:06] want to have in our products [04:08] one wrong move has the potential to damage the final product [04:12] if there's any accidental exposure let's say from an ill-timed sneeze [04:17] the entire batch must be thrown out, all eight million doses that's why everyone wears layers [04:23] of protection and they even disinfect their gloved hands repeatedly [04:45] in the lab where we were filming no one had ever told the technicians how many doses were in a batch [04:56] after that they sprayed another application of disinfectant onto their gloves just to be sure [05:13] based on our technology and on the antigen we were using no I wasn't [05:19] I'm very confident in the technology we have [05:22] until now vaccine development has been a slow process [05:26] the BioNtech vaccine uses a new technology based on mRNA it is revolutionizing the way [05:32] vaccines can be produced [06:03] When the COVID-19 pandemic broke out, BioNtech was primarily a cancer vaccine company [06:08] but by using this new mRNA technology it was able [06:11] to quickly pivot to a coronavirus vaccine [06:15] when you look back at any project you've ever done you've [06:17] always looked back at the start and go wow okay if I'd known that now i could have cut you know a few [06:24] hurdles out of my way earlier right but you're in a situation where you're doing something [06:29] especially for us as a smaller company that was unprecedented [06:32] the second part of the process happens at another factory [06:35] where vials are filled and packed into boxes for shipment [06:38] 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":"NewsArticle","@id":"https://time.com/6093670/covid-19-vaccines-kids-younger-12/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6093670/covid-19-vaccines-kids-younger-12/"},"headline":"When Will COVID-19 Vaccines Be Available for Younger Kids?","datePublished":"2021-08-30T14:57:05.000Z","dateModified":"2026-10-14T09:14:38.199Z","description":"There is still not an authorized COVID-19 vaccine for kids younger than 12. 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