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Nov 18, 2021
6 min read

COVID vaccine for kids under 12: what are the recommendations?

The Pfizer COVID-19 vaccine has been given FDA Emergency Use Authorization for children over the age of five, while Moderna and Johnson & Johnson’s COVID vaccines are approved for use in adolescents over age 18. The Pfizer vaccine dosage for children under age 12 is one third of the adult dosage. Side effects of the vaccine are similar in children and adults. Children can get the vaccine at the same time as the flu shot or other recommended immunizations. You can get your child a vaccine through a healthcare provider or pharmacy.

steve silvestrochristina varvatsis

Reviewed by Steve Silvestro, MD

Written by Christina Varvatsis, PharmD

Disclaimer

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

While there’s still much to learn about COVID-19, researchers agree that vaccination remains our best protection against severe disease and our best hope of curbing virus spread to end the pandemic. With kids back to school and new variants on the rise, parents are anxious to know if the vaccine can protect their children. Let’s discuss the current recommendations for vaccinating children under 12. 

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When will the COVID vaccine for kids be available?

The Pfizer-BioNTech COVID-19 vaccine is currently available for people ages five years and up. The U.S. Food and Drug Administration (FDA) approved this vaccine for people over age 16, and gave it Emergency Use Authorization (EUA) for use in kids ages 5–15 (FDA, 2021c).

Both Moderna and Johnson & Johnson’s vaccines have FDA Emergency Use Authorization for young adults 18 years and older (CDC, 2021b). They are conducting vaccine trials in people under age 18, but it’s impossible to know precisely when they will be available.  

COVID vaccine trials for children 

In any vaccine trial, researchers work to identify the safest and most effective dosage for a population. They compare the vaccine to a placebo to see how well the vaccine prevents infection and severe disease. They also document any short-term or long-term side effects that occur. The FDA reviews the data for safety and effectiveness and, in the case of the COVID-19 vaccines, grants Emergency Use Authorization if appropriate. 

Pfizer and Moderna began their COVID vaccine clinical trials in children ages six months through 11 years in March of 2021. They studied the vaccine in three separate age groups: 6 months–2 years, 2–5 years, and 5–11 years. Approval for the vaccine in different age groups can be staggered, with groups getting approval first depending on when the studies are complete (Clinicaltrails gov, 2021a; Clinicaltrials.gov, 2021b). 

Currently, Pfizer’s vaccine has EUA for children ages 5–11, and their trials for children under five are ongoing. Moderna’s trials for children under 18 years are also ongoing.  

Is the children’s vaccine the same as the adult vaccine?

The kids’ vaccine and the adults’ vaccine have all of the same ingredients. However, children under 12 years get a smaller dosage, one third the amount of the adult vaccine dose. Their primary vaccine series is two doses given three weeks apart, just like in adults (CDC, 2021d). 

Which children should get a vaccine?

The CDC recommends that all children over the age of five years get a COVID vaccine, unless they have a medical condition (such as severe allergic reaction to vaccine components) that would prevent them from getting it (CDC, 2021b). 

Why should children get a COVID vaccine?

During the early part of the pandemic, adults were more likely than children to get severe COVID-19. However, kids can get very sick from COVID, especially if they have conditions that weaken the immune system, like diabetes, cancer, heart disease, and asthma. They can also carry the virus to others who are at risk. 

Children who get COVID, even those who don’t have symptoms, are also at higher risk for a complication called Multisystem Inflammatory Syndrome associated with COVID-19 (MIS-C). MIS-C causes inflammation in organs like your heart, lungs, brain, and kidneys. It’s not common, but it’s very dangerous and potentially deadly (CDC, 2021c). 

Vaccinating children is also essential for the population-at-large reaching herd immunity. Herd immunity is when enough of the population has immunity that the virus doesn’t have anywhere to land. The result is that the virus dies out—something we’d all like to see happen with COVID-19.

Is the COVID vaccine safe for kids? 

The short answer is: yes. The vaccine has gone through extensive trials, and has been shown to be very safe for kids. It’s essential to be aware of possible side effects, however. 

The most common COVID vaccine side effects in kids are similar to those in adults, like soreness, swelling, or redness in the arm. Some children may get fever, chills, body aches, or stomach upset (CDC, 2021b). These are all relatively mild symptoms that only last a day or so.

Some adolescents who received the COVID vaccine developed myocarditis (heart muscle inflammation) and pericarditis (inflammation of tissue surrounding the heart). The risk was higher in males aged 12–29 after getting their second dose of an mRNA vaccine (Pfizer and Moderna vaccines) (CDC, 2021a). 

This risk has given some people pause, causing uncertainty about whether vaccinating their kids is safe. However, the overall risk is very low compared to the risk of severe COVID. Plus, the risk of myocarditis and pericarditis from COVID infection is actually much higher than the risk of these conditions after the vaccine (AAP, 2021b; CDC, 2021d). Therefore, the vaccine is still strongly recommended in this age group.

Where can kids get a COVID vaccine? 

Many healthcare providers can administer the COVID vaccine in their offices, so call your pediatrician to find out. Some national pharmacy chains like CVS and Walgreens are also giving the COVID vaccine to children. 

Can kids get a COVID vaccine with a flu shot? 

The American Academy of Pediatrics (AAP) reports that it’s safe to give the COVID vaccine at the same time as the flu shot, or as any other pediatric vaccine (AAP, 2021b). 

What about kids under 5?

Unfortunately, kids under five still have to wait before they can get a COVID vaccine. Waiting is hard—especially when we want to do everything possible to protect our children. But doing so safely is critical. 

Since the FDA granted approval for Pfizer’s vaccine in certain age groups, pediatricians and other healthcare providers have been under increased pressure from parents to administer the vaccine “off-label” to younger children. FDA-approved drugs are often used “off-label” by prescribers—meaning for other uses not approved by the FDA—if the prescriber feels it is the best treatment for their patient. However, safe and effective dosages in children are often different in younger age groups, so the AAP strongly discourages this practice for the COVID-19 vaccine (AAP, 2021a). 

The FDA has stated they are prepared to review data as quickly as possible—without compromising thoroughness and safety—once they receive an application from the drug companies (FDA, 2021b). So while there is no available vaccine for younger kids under five yet, that may change at any time.  

All children over the age of five can now receive a COVID-19 vaccine. Parents should continue to follow the latest CDC recommendations and continue to have their children mask and social distance when indicated. Vaccines are our best chance for getting through this pandemic and will be worth the wait once they are available for everyone. 

References

  1. American Academy of Pediatrics (AAP). (2021a, August). Academy of Pediatrics cautions against off-label use of COVID-19 vaccines in children under 12. Retrieved on Sept. 12, 2021 from 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/
  2. American Academy of Pediatrics (AAP). (2021b, November). About the COVID-19 Vaccine: Frequently Asked Questions. Retrieved on Nov. 10, 2021, from https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/covid-19-vaccine-for-children/about-the-covid-19-vaccine-frequently-asked-questions/ 
  3. Centers for Disease Control and Prevention (CDC). (2021a, July). Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the advisory committee on immunization practices — United States, June 2021. Retrieved on Sept. 12, 2021 from https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm
  4. Centers for Disease Control and Prevention (CDC). (2021b, November). COVID-19 Vaccines for Children and Teens. Retrieved on Nov. 9, 2021, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html?s_cid=11370:cdc%20covid%20vaccine%20children:sem.ga:p:RG:GM:gen:PTN:FY21
  5. Centers for Disease Control and Prevention (CDC). (2021c, November). MIS and COVID-19. Retrieved on Nov. 10, 2021, from https://www.cdc.gov/mis/index.html 
  6. Centers for Disease Control and Prevention (CDC). (2021d, November). Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Retrieved on Nov. 10, 2021, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html?s_cid=11374:cdc%20covid%20vaccine%20heart%20inflammation:sem.ga:p:RG:GM:gen:PTN:FY21
  7. ClinicalTrials.gov. (2021a, August). Study to evaluate the safety, tolerability, and immunogenicity of an RNA vaccine candidate against COVID-19 in healthy children <12 years of age. Retrieved on Sept. 12, 2021 from https://clinicaltrials.gov/ct2/show/NCT04816643
  8. ClinicalTrials.gov. (2021b, August). A study to evaluate safety and effectiveness of mRNA-1273 COVID-19 vaccine in healthy children between 6 months of age and less than 12 years of age. Retrieved on Sept. 12, 2021 from https://clinicaltrials.gov/ct2/show/NCT04796896
  9. Pfizer. (2021). Pfizer and BioNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age. Retrieved Sept. 29, 2021, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal
  10. U.S. Food & Drug Administration (FDA). (2021a, August). FDA approved first COVID-19 vaccine. Retrieved on Sept. 14, 2021 from https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
  11. U.S. Food & Drug Administration (FDA). (2021b, September). FDA will follow the science on COVID-19 vaccines for young children. Retrieved on Sept. 14, 2021 from https://www.fda.gov/news-events/press-announcements/fda-will-follow-science-covid-19-vaccines-young-children
  12. U.S. Food & Drug Administration (FDA). (2021c, October). FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. Retrieved on Nov. 9, 2021 from https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age