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This article has been reviewed and updated as of May 13, 2021.
On Monday, May 10, 2021 the U.S. Food and Drug Administration (FDA) amended the emergency use authorization for the Pfizer COVID-19 vaccine, allowing it to be given to children between the ages of 12 and 15. Prior to this, the Pfizer COVID-19 vaccine could be administered only to individuals 16 years and older. Following the FDA’s amendment, an advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) voted unanimously to recommend giving Pfizer’s COVID-19 vaccine to 12- to 15-year-olds, saying the benefits of vaccinating children and teens outweigh any risks from the vaccine.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Janet Woodcock, MD, acting FDA commissioner, said in a press release. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
But parents and guardians of children with inflammatory or autoimmune diseases like juvenile arthritis may still be cautious about signing up their young ones for a vaccine appointment. As of now, there has been limited information as to how effective the vaccine is in adults with compromised immune systems, let alone how it works in children.
Ultimately, experts believe the Pfizer COVID-19 vaccine is safe for children who are immunocompromised or are taking a medication that affects the immune system — and they are recommending that children with juvenile arthritis get the vaccine when it is available to them.
“We do think that the COVID-19 vaccine is safe and really encourage it for children with juvenile arthritis, regardless of what treatment they’re on,” says Dawn Wahezi, MD, Chief of Pediatric Rheumatology at the Children’s Hospital at Montefiore in New York City.
That said, you should talk to your child’s doctor before making an appointment, and alert your vaccination provider about your child’s condition and medications.
Here’s everything you need to know about the emergency use authorization for the Pfizer COVID-19 vaccine for children ages 12 to 15, especially if your child has juvenile arthritis.
Is the Pfizer COVID-19 Vaccine FDA-approved for My Child?
Emergency use authorization (EUA) is not the same thing as FDA approval, which typically takes much longer to obtain. Instead, according to the FDA, an EUA is used to make treatments like vaccines available during public health emergencies, such as the COVID-19 pandemic.
EUA allows the use of unapproved medical products (or unapproved uses of approved medical products) to diagnose, treat, or prevent serious or life-threatening diseases.
Manufacturers decide whether and when to submit an EUA request, which the FDA then evaluates. If certain criteria have been met — including that there are no adequate, approved, and available alternatives — and scientific evidence supports the product in question, the FDA may grant EUA. The FDA sets forth vigorous standards to determine safety and effectiveness for vaccines, including large clinical trials involving thousands of participants.
Pfizer recently submitted an application for full FDA approval for the COVID-19 vaccine in those age 16 and older.
Is It Safe for Children with Juvenile Arthritis to Get the COVID-19 Vaccine?
Yes — and rheumatologists recommend it. Patients with juvenile idiopathic arthritis are prone to infections, particularly when disease activity is high, per an April 2020 review in Pediatric Rheumatology. Disease-modifying antirheumatic drugs (DMARDs) used to treat juvenile arthritis, including biologics, may further increase this susceptibility. Because of this, it is especially important for them to be protected against COVID-19.
“We know that the vaccine has been looked at in healthy children. We don’t really have data yet on the vaccine for children with rheumatic disease, but from what they’re looking at in adults with rheumatic disease so far, we don’t have any evidence to think that our patients would be at any increased risk from the vaccine,” says Dr. Wahezi.
Pfizer released preliminary results from a Phase 3 trial of 2,260 U.S. volunteers ages 12 to 15 in late March. The data showed that the vaccine provided 100 percent efficacy and robust antibody responses for this younger group — exceeding those of vaccinated 16- to 25-year-old participants in an earlier analysis. The 12- to 15-year-olds experienced side effects similar to those of the young adults. The side effects included pain, fever, chills, and fatigue, especially after the second dose.
In the trial, 18 cases of COVID-19 were observed in the placebo group (1,129 participants) versus none in the vaccinated group (1,131 participants).
The COVID-19 vaccine is not a live vaccine, which is typically not recommended for juvenile arthritis patients. Live vaccines use a weakened form of the virus that causes a disease, and people with weakened immune systems need to talk to their doctor before receiving them, per the United States Department of Health and Human Services. Examples of live vaccines include those against measles, smallpox, chickenpox, and yellow fever.
Will the Pfizer COVID-19 Vaccine Be Less Effective in Children with Juvenile Arthritis?
More research is needed to determine this. It’s believed that adults with inflammatory arthritis who take immunosuppressant medication may not garner the same protection from the vaccine as otherwise healthy adults, but experts still believe it’s important to receive it. Some protection is better than none. The same applies to children — but it’s important to know that their immune systems may act differently.
“We know that children’s immune responses might be different than those of adults, so I think we really have to wait for some data on this to see how the children will respond to the vaccine,” says Dr. Wahezi. “That said, even though there is concern for potentially reduced immune response, we don’t know if this translates to people actually getting more infections.”
In other words, just because people might generate a less robust response to the vaccine if they’re taking immunosuppressant medications doesn’t necessarily mean that they might get sick with COVID if exposed. More data is needed to understand this.
Should Children Stop Immunosuppressant Medication Before Getting the Pfizer COVID-19 Vaccine?
This will be a case-by-case basis and it’s important to speak to your child’s doctor for recommendations specific to their situation.
In its clinical guidance on the COVID-19, the American College of Rheumatology (ACR) recommends that certain medications be held in advance of an adult receiving the COVID-19 vaccine. (The guidance does not specifically address pediatric patients at this time.)
This is because it’s believed that doing so may increase the body’s response to the COVID-19 vaccine. However, in the case of many immunomodulating medications for rheumatic diseases, the guidance suggests that patients do not stop taking medications before or after getting the vaccine. This is because there is no reason to think, based on available data, that stopping these medications would increase your body’s immune system response to the vaccine.
“For the most part, we are following these recommendations for our patients and we intend to do so for the next age group as well,” says Dr. Wahezi. “But the decision depends on each individual patient, because there might be other factors that go into it.”
Some of the medications for which changes are recommended and that are also used in pediatric patients include:
The ACR guidance advises that abatacept (injectable form) be skipped for one week before and after the first dose of the vaccine only. Meanwhile, the vaccine should be given four weeks after the last infusion of the IV form of abatacept (IV form). Patients should then skip a week and get the next infusion.
The ACR guidance also recommends holding methotrexate for one week after each of the two mRNA vaccine doses (Pfizer and Moderna) for those with well-controlled disease, or for two weeks after single-dose COVID-19 vaccination (Johnson & Johnson).
If a patient’s COVID-19 risk is low or can be mitigated by preventive health measures, the ACR guidance says to schedule vaccination to start about four weeks before the next scheduled rituximab cycle — and to delay rituximab for two to four weeks after the final vaccine dose if disease activity allows.
NSAIDs and Acetaminophen
For patients with stable disease, NSAIDs and acetaminophen should be held for 24 hours before vaccination. No modifications are needed for prednisone timing.
You should speak with your child’s doctor before making any changes to their medication regimen.
Many patients (and their parents) may also be concerned with disease flare-ups as a result of the vaccine, but the risk is likely small.
“With vaccines in general, there is a theoretical risk of disease flare after the vaccine, but we think that it’s very small,” says Dr. Wahezi. “We think the benefits of vaccination still outweigh that risk.”
Are There Any Vaccine Side Effects Children with Juvenile Arthritis Should be Aware Of?
Children are expected to experience the same side effects from the vaccine as adults. According to the CDC, these may include:
- Pain, redness, and swelling near the injection site
- Muscle pain
Some of these symptoms may overlap with those that your child experiences with juvenile arthritis, but they’ll be shorter-lived.
“It’s important to pay attention to when these symptoms are happening, and if they are in the context of a recent vaccine,” says Dr. Wahezi. “Usually vaccine side effects happen most commonly after the second dose, and they go away within a day or two. If that’s the case, it’s more likely to be related to the vaccine than their underlying disease.”
Pain also tends to be more generalized after the COVID-19 vaccine, which may be different from your child experiencing juvenile arthritis pain in one particular joint.
“We don’t have any reason to think our patients with juvenile arthritis would have a higher chance of getting these side effects versus other children,” says Dr. Wahezi.
Because rare allergic reactions are also possible, your child will be monitored for 15 minutes after vaccination (or 30 minutes if they have a history of an immediate allergic reaction of any severity to another vaccine or injectable therapy, have had a contraindication to a different type of COVID-19 vaccine, or have a history of anaphylaxis due to any cause).
How Should I Talk to My Child About Getting the Pfizer COVID-19 Vaccine?
If your child is nervous about getting the vaccine, talk to them about how it can protect them or even relay your own experiences getting vaccinated.
“I think parents should really encourage their kids to obtain the vaccine and to help provide reassurance that it is safe,” says Dr. Wahezi. “They should feel supported by our rheumatology community that these vaccines are safe and they’re really important to protect their child.”
It can also be very helpful to relate to your child through your own experiences. There are two ways you might do this:
- Get the vaccine first. You can then set an example for your child and tell them what to expect. “I’ve had several parents say they specifically got the vaccine first because they wanted to experience it and any potential side effects prior to giving it to their children,” says Dr. Wahezi.
- Get the vaccine together. If you haven’t gotten the vaccine yet, get it with your child so you can support each other through the experience — and your child isn’t alone in it. “I think that’s also a great option,” says Dr. Wahezi.
Can I Accompany My child to Get Their Pfizer COVID-19 Vaccine?
Yes — and in fact, you’ll need to. Anyone under the age of 18 must have a parent or legal guardian present to receive the vaccine.
When Will Other COVID-19 Vaccines Become Available to Children 12-15 Years Old?
Pfizer and Moderna have enrolled children as young as six months in clinical trial studies. Moderna has released initial results of its clinical trials for teens, which show its COVID-19 vaccine is 96 percent effective among children ages 12 to 17, with no serious safety concerns identified to date. Full results are expected in the coming weeks.
Johnson & Johnson is also now studying its vaccine in adolescents ages 12 to 17 in a Phase 2 study.
When Will the Pfizer COVID-19 Vaccine Become Available to Children Younger than 12?
Pfizer plans to request authorization for the COVID-19 vaccine for children ages 2 to 11 in September, per a May 2021 quarterly earnings call from the company.
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Advisory Committee on Immunization Practices Presentation. U.S. Centers for Disease Control and Prevention. May 12, 2021. https://www.cdc.gov/vaccines/acip/meetings/slides-2021-05-12.html.
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Interview with Dawn Wahezi, MD, chief of pediatric rheumatology at the Children’s Hospital at Montefiore
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Moderna Reports First Quarter Fiscal Year 2021 Financial Results and Provides Business Updates. Moderna. May 6, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-reports-first-quarter-fiscal-year-2021-financial-results.
Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. Pfizer. March 31, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal.
Vaccine Types. United States Department of Health and Human Services. https://www.hhs.gov/immunization/basics/types/index.html.