We’re officially in year two of the COVID-19 pandemic, and despite early warnings that vaccines could take years to develop, there are now three approved by the U.S. Food and Drug Administration (FDA) for emergency use in adults. The CDC reports that more than 296 million doses have already been administered.
So when will it be approved for kids? Older teens are already eligible in some areas. The Pfizer vaccine has been authorized for use in people ages 12 and older, and the Moderna vaccine is approved to vaccinate those ages 18 and up. Administration of the single-dose Johnson and Johnson vaccine was paused by the FDA and CDC on April 13 to review side effects concerning blood clots, but the pause was then lifted on April 23, resuming J&J shots.
Doses for younger children could be approved by late summer, or perhaps sooner.
Latest News & Clinical Trial Results
Following their phase three clinical trial of 2,260 participants ages 12 to 15, Pfizer reported 100% efficacy in this teenage age group when administered the same two-shot vaccine approved for adults. On May 10, The New York Times reported the vaccine was officially approved for 12 to 15-year-olds.
When it comes to vaccinations, safety is a top concern for parents. Romper previously reported that “a vaccine safety group from the CDC is looking into reports of heart conditions developing in vaccinated teens.” Though the CDC report detailed presentations of myocarditis, or heart inflammation, in adolescents following vaccination, stating that “relatively few” experienced the side effect, that most cases are mild, and it is more common in males than females.
Pfizer also recently announced that they will enroll 4,500 children as young as 6 months old into their latest vaccine trial for kids, per ABC News. The trial will be done in three phases, the first to determine the ideal dosage for children in this age group, and the following two to study the vaccine’s efficacy and safety.
As Romper previously reported, Moderna announced in late May that their vaccine trials show a 100% efficacy in children ages 12 to 18. Moderna CEO Stéphane Bancel has said that they plan to seek Emergency Use Authorization (EUA) approval for this age group in early June, USA Today reported.
When Can Kids Under 12 Get Vaccinated?
Ultimately there may be a longer wait for the youngest children. “What we do know, even in the context of vaccines, is that we will likely not have vaccines for children less than 12 for at least through 2021,” CDC director Dr. Rochelle Walensky said in a Fireside Chat with Covid Collaborative on April 23. Walensky added that she does believe schools should be fully open in the fall, and that anyone in the community who is most at risk — older adults — should be vaccinated. “We owe that to our children,” she said about getting students and teachers back in school.
But on May 4, just after the announcement of Pfizer’s EUA filing for kids ages 12 to 15 hit the news, Pfizer CEO Albert Bourla said, “We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2 to 5 years of age and 5 to 11 years of age, in September.” Apparently the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021, reported The Mercury News.
Moderna has recently initiated a children’s vaccine trial study through the National Institute of Allergy and Infectious Diseases that includes kids ages 6 months to 12 years old, NPR reported. The trial will include 6,750 children in the U.S. and Canada to measure the impact and efficacy of the vaccine’s two-dose shots, as well as monitor the effects of the vaccine on this age group.
Experts Weigh In On Vaccines & Kids
The high efficacy rates shown in trial phases for adults by the currently available vaccines and the beginning of vaccine trials for children mark a promising turn in the fight against COVID-19. However, the speed at which these vaccines have been developed and tested means that there is still much that researchers and physicians alike do not know about the long-term impacts of a vaccine. Questions also still remain about vaccine manufacturing and distribution.
To help address some of the concerns parents may have about COVID-19 vaccines and kids, Romper asked experts to weigh in on some of the biggest questions we have about the vaccine and kids.
At what age is it safe to get a COVID-19 vaccine?
Now that the Pfizer vaccine has been approved for EUA for ages 12 and older, the CDC recommends that anyone aged 12 or older be vaccinated.
For kids under 12, it is unclear at this point what the official recommendation will be for the age of administration of a COVID-19 vaccine, but experts point to other childhood vaccines to make an educated guess. "Some vaccines, like hepatitis B, are safe enough to get close to birth while others, like the influenza vaccine, are given to babies when they are over 6 months old," Los Angeles-based physician Dr. Bita Nasseri tells Romper. She says that since the COVID vaccine is so new, and as far as statistics are concerned, children are affected by the coronavirus differently than adults, it may be advised for kids to wait until they're a bit older to receive the vaccine. But again, there's not yet any official recommendation on this.
The CDC director did say that she doesn’t believe vaccines for children younger than 12 will happen in 2021. Some doctors have offered predictions that, based on current vaccine distribution and EUAs, children ages 5 to 12 and 6 months to 5 may be vaccinated by the end of the year. The Pfizer CEO recently said they’ll be filing for EUAs for children ages 2 to 11 by September.
What are the potential immediate side effects of a COVID-19 vaccine for kids?
"All vaccines have potential side effects, but we have only just begun trials with children, so we don’t know yet," Dr. Susan V. Lipton, MD, MPH, Chief of Pediatric Infectious Diseases at Sinai Hospital of Baltimore tells Romper. "The object of any vaccine is to limit side effects while preventing the virus or disease."
Based on the current trial research available, Dr. Nasseri explains, "Just like any vaccine, it is expected to cause minor symptoms of a viral infection, including low-grade fever, fatigue, body aches, and muscle soreness." Not because you're being injected with any kind of virus, but because there is a shot site where muscle soreness can occur, and because there is also some research that suggests your immune system is reacting to the vaccine and may have some of these side effects.
The CDC has reported that “relatively few” adolescents have experienced heart inflammation called myocarditis following vaccination, but still recommends that kids ages 12 and up receive the vaccine. More information should be available as the vaccine trials continue and FDA approval is sought. "Most vaccines that have been FDA-approved do not have very commonly occurring serious or life threatening side effects at anything more that one per 100,000 or one per million doses," Nasseri tells Romper.
Are there any known long-term effects of a COVID-19 vaccine?
"Since the vaccines are very new, it is possible that there are either rare reactions or also undiscovered long-term effects," Nasseri tells Romper. "Without proper long-term studies, it's hard to say what those may be and how often they occur."
With the vaccine (and even the virus itself) still in its infancy, it may be some time before any answers to this question are available. "It’s such a new virus that the vaccine has not been studied long term in anyone," Lipton says. "No one can know for sure right now."
Will a vaccine effectively protect children from contracting COVID-19?
"This is a hard answer as most vaccine trials need to demonstrate at least a 50% effect in preventing illness, or alternatively demonstrate at least a 50% decrease in transmission by people who contract the virus. It will also depend on what the rest of the research and each of the clinical trials demonstrate," Nasseri tells Romper.
Despite the promising news of high efficacy rates for both the Pfizer and Moderna vaccine trials, neither company has released study results that directly address either vaccine's efficacy in children specifically.
Nasseri says that there really isn't extensive research on how COVID affects children, except for the rare MIS-C, which occurs in less than one in 10,000 to one in 100,000 children and appears weeks after a COVID-19 infection. "It is therefore difficult to demonstrate that children will have adequate and lasting immunity from any of the vaccines yet," she explains. "Once the trials are completed and a good number of children have received the vaccine and been followed closely for any of the potential side effects, the medical and scientific community can weigh in properly."
As vaccine trials for children begin, data found that the Pfizer-BioNTech COVID-19 vaccine demonstrated 100% efficacy in a phase 3 clinical trial involving 2,260 adolescents aged 12 to 15 years old. Not a single child in the vaccinated group became infected with the virus, and the vaccine apparently produced “robust antibody responses” in the children.
Can kids continue getting their routine vaccinations whether or not they receive the COVID-19 vaccine?
"Kids should absolutely get their routine vaccinations whether or not they receive the COVID-19 vaccine," Lipton tells Romper.
Since current vaccine trials have mostly been administered to adults, these subjects have likely had their adult and childhood vaccinations. "There is limited to no data currently on the interactions with other vaccinations, and the COVID-19 vaccine will come with its own safety protocols," Dr. Niket Sonpal, a New York-based internist and gastroenterologist, tells Romper.
Instrumental in protecting children from illness, it's imperative to continue vaccinations as recommended by your child's pediatrician. Nasseri calls the resurgence of infections such as measles and whooping cough "a realistic concern," to stress the importance of continuing with routine vaccinations.
Can my teenager get the COVID-19 vaccine?
Both your teenager’s age, as well as the type of vaccine, will determine whether they are eligible to get vaccinated in the near future. The Pfizer vaccine is currently the only shot on the market that is approved for EAU in kids ages 12 and older, and the CDC does recommend that everyone ages 12 and older get vaccinated.
Prior to vaccination, your kid would be asked the usual screening questions about potential allergic reactions to the vaccine as well as previous COVID-19 exposure. Remember that all vaccine info is changing, and researchers are working to make the shot available for all teenagers as soon as possible. “Pfizer and Moderna have trials at clinicaltrials.org that are ongoing to enroll children ages 12 years and up to see how they respond to vaccination,” Zachary Hoy, MD, a pediatric infectious disease specialist at Pediatrix affiliate, Nashville Pediatric Infectious Disease, tells Romper in an email.
How long will the vaccine protect children for?
Although there is no data available to answer this particular question, it is worth discussing with your child's physician prior to vaccine administration. "The most important question will be how long does this vaccine confer immunity, and if it will require a repeat booster or yearly injection for new strains," Sonpal explains. As Romper previously reported, research about booster requirements for the COVID-19 vaccine is ongoing.
How can parents approach their pediatricians with questions about a COVID-19 vaccine?
During your child's next visit with their doctor, it's likely the topic of vaccines will come up. When it comes to a COVID-19 vaccine, Nasseri says, "Just like any vaccine, it is important to ask their physician if they know the data about the specific vaccine being offered."
Because the information about this specific vaccine is continuously evolving, inquiring about potential side effects and efficacy rate at the time of your visit is a good idea. Your doctor may have access to new information that you have not yet seen.
"I think the best question to always ask when you are concerned about anything recommended by your doctor is, 'Are you doing this for your own children or grandchildren?'" Lipton tells Romper. Your child's pediatrician is the best direct resource you have for specific questions about a COVID-19 vaccine and your kids.
You can also ask your child’s pediatrician about the best way to prep your child for the vaccine. Make sure they’re hydrated, relaxed, and that they aren’t feeling unwell before they go in for their shot.
When will we know if the vaccine is safe for kids?
Despite many American adults and teens receiving the vaccine in the past few months, parents are still waiting on more information about whether the vaccine is safe for their children, too.
Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital, told Romper in early 2021 that we should have answers by March 2021. And now we do.
“I think it will be very similar to how they did it with adults, where after the second shot we could see that data in as little as three months,” Rathore said. “It all depends on what they find and what the FDA board says, but it could be approved for children 12 and over as early as March.”
Now, the Pfizer vaccine has been approved for children over the age of 12, and Moderna has been approved for children over the age of 18.
Where will children fall in line to receive the vaccine compared to the rest of the population?
James Schneider, M.D., board-certified pediatric critical care specialist at Northwell Health, tells Romper in an interview that kids will probably fall behind other, higher-need populations. “If, and when, an approved vaccine becomes available for children, I'd think we, as a country, would still try to vaccinate the most vulnerable in the population — frontline health care workers, the elderly, those with chronic comorbidities at risk for severe COVID-19 — prior to vaccinating children. However, there are children with comorbidities as well that may deserve earlier vaccination. We also know that children, who may often be asymptomatic carriers, may spread the infection to other vulnerable people, making vaccinating children an important part of the public health strategy for overcoming this pandemic.”
Where can parents take their children to get vaccinated?
Parents may be wondering whether the COVID vaccine will be available by request at their pediatrician’s office, like the flu shot, or if they’ll need to go to a special site for their shot, like a local hospital or health department. Rathore says how the vaccines will be distributed to the public depends on a lot of logistical factors, especially the vaccine’s special storage requirements.
“I think it makes the most sense to have it at the pediatrician’s office of course, but it requires a -73-degree freezer to store it in, so I don’t think many pediatricians will have that. The freezer will be the big thing,” he says.
Currently, anyone 12 and older is eligible to get a COVID-19 vaccine in the U.S.. The CDC recommends that parents search for a vaccine provider in their area by using the Vaccine.gov search portal and your zip code.
Will my child need more than one dose of the vaccine to be protected?
The currently-approved vaccines from Pfizer and Moderna requires two doses to fully protect an adult from COVID, per the CDC. Will this be the same for children? And will they need to get their doses once, or annually, like a flu shot?
Schneider says only time will tell.
“With the currently approved Pfizer and Moderna vaccines, we still don't yet know how long immunity will last. And there are other vaccines currently still in the clinical trial phase that we have yet to determine the safety, efficacy, and therefore the duration of the immunity. That information will likely determine whether or not an annual shot will be required. It is quite possible that we will need an annual COVID shot as we currently get an annual flu shot.”
How can I sign my child up for a vaccine trial?
Currently, both Pfizer and Moderna have active vaccine trials for kids. While each manufacturer’s requirements for trial participation varies, the process typically involves receiving the vaccine through a research facility or participating practitioner and then following up for up to a year afterward to study impacts related to efficacy and safety.
Moderna’s vaccine trial for children, which they call KidCove, has a dedicated website that allows parents to check whether or not their child is eligible for the trial through an online survey. The site details the 14-month study, which includes two injections given 28 days apart, and follow-ups via monthly telehealth appointments and six in-person visits.
Information on Pfizer’s website directs parents to search a directory of available vaccine trials (for COVID-19 and other vaccine trials in progress) to learn about what enrollment entails, view eligibility requirements, and find a designated study facility.
Experts:
Dr. Susan V. Lipton, MPH, Chief, Pediatric Infectious Diseases at Samuelson Children’s Hospital at Sinai Hospital of Baltimore and Chief, Section on Infectious Diseases, Maryland American Academy of Pediatrics
Dr. Bita Nasseri, Los Angeles-based physician
Dr. Niket Sonpal, New York-based internist, gastroenterologist, and adjunct professor at Touro College
Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital
James Schneider, M.D., board-certified pediatric critical care specialist at Northwell Health
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