Can Babies and Toddlers Get a COVID-19 Vaccine?

Key TakeawaysA COVID-19 vaccine is not yet authorized for children under the age of 12.Pfizer’s announced on March 31, 2021, that its COVID-19 vaccine was found to be 100% effective and well tolerated in a clinical trial of adolescents ages 12 to 15.Moderna announced on May 25, 2021, that its COVID-19 vaccine was found to be 100% effective and well tolerated in a clinical trial of adolescents ages 12 to 17.Johnson & Johnson announced on April 2, 2021, that it had begun dosing adolescents ages 12 to 17 in a trial.In March 2021, both Moderna and Pfizer announced the start of COVID-19 vaccine trials in children ages 6 months and older.Vaccinating children will be crucial to stopping the spread of COVID-19, but vaccine makers need to ensure that it’s safe and effective to do so.

Key Takeaways

A COVID-19 vaccine is not yet authorized for children under the age of 12.Pfizer’s announced on March 31, 2021, that its COVID-19 vaccine was found to be 100% effective and well tolerated in a clinical trial of adolescents ages 12 to 15.Moderna announced on May 25, 2021, that its COVID-19 vaccine was found to be 100% effective and well tolerated in a clinical trial of adolescents ages 12 to 17.Johnson & Johnson announced on April 2, 2021, that it had begun dosing adolescents ages 12 to 17 in a trial.In March 2021, both Moderna and Pfizer announced the start of COVID-19 vaccine trials in children ages 6 months and older.Vaccinating children will be crucial to stopping the spread of COVID-19, but vaccine makers need to ensure that it’s safe and effective to do so.

On May 10, 2021, the FDA expanded Pfizer’s EUA to ages 12 and older.Moderna is preparing to apply for an expanded EUA for ages 12 and older in June.

COVID-19 Vaccines:Stay up to date on which vaccines are available, who can get them, and how safe they are.

The authorizations are a significant milestone in the ongoing COVID-19 pandemic, but many parents want to know where their younger kids will fit into the vaccination timeline—particularly if infants and young children will be offered the vaccine.

Yvonne Maldonado, MDAt this time, babies and toddlers should not receive COVID-19 vaccines until they have been studied in older children.

Yvonne Maldonado, MD

At this time, babies and toddlers should not receive COVID-19 vaccines until they have been studied in older children.

According to the Centers for Disease Control and Prevention (CDC), the COVID-19 vaccines were initially tested only in non-pregnant adults, andmore recently, on teenagers. There isn’t currently a COVID-19 vaccine authorized in youth under age 12 because there is a lack of evidence-based data verifying that it is safe and effective in these pediatric populations.

“At this time, babies and toddlers should not receive COVID-19 vaccines until they have been studied in older children,“Yvonne Maldonado, MD, Professor of Pediatrics (Infectious Diseases) and of Epidemiology and Population Health at Stanford’s Lucile Packard Children’s Hospital in California, tells Verywell.

How Will the COVID-19 Vaccine Be Distributed?

Why Separate Clinical Trials With Kids Are Necessary

Vaccines that will be given to children need to undergo separate clinical trials because kids' immune systems are very different than adults.How much of a vaccine is given (the dose) as well as how often it is given (the frequency) can also be different for young children than in adults and adolescents.

Older Adults Vulnerable to ‘Twindemic’ of Flu and COVID-19

When Will Kids Be Included in Clinical Trials?

In October the FDA allowedPfizerto include children as young as 12 in its clinical trials, and when Pfizer applied for emergency use authorization, it included preliminary data on a sample of 100 children ages 12 to 15.The company enrolled 16- and 17-year-olds under an earlier FDA approval.

On March 31, 2021, Pfizer announced that its COVID-19 vaccine was found to be 100% percent effective and well tolerated in a clinical trial of 2,260 adolescents ages 12 to 15 years.On May 10, 2021, the FDA expanded Pfizer’s emergency use authorization to ages 12 and older.

Modernaannounced on May 25, 2021, that its COVID-19 vaccine was found to be 100% effective and well tolerated in a clinical trial of more than 3,700 healthy adolescents ages 12 to 17.The company also announced that it plans to apply in early June for an expanded EUA to include ages 12 to 17.

On April 2, 2021,Johnson & Johnsonannounced that it had expanded its COVID-19 vaccine clinical trial to include adolescents ages 12 to 17 and plans to soon initiate a trial in younger children.

Trials In Young ChildrenOn March 16, 2021, Moderna announced that it began giving the first doses in a COVID-19 vaccine clinical trial in children ages 6 months to 11 years. The trial, which is called KidCOVE, will enroll approximately 6,750 healthy participants and will have two parts: The first part will evaluate two different vaccine dosage options in children ages 2 to 11 and three dosage options in children ages 6 months to under 2 years old.After dosages are evaluated and selected, the second part of the trial will compare the vaccine to a placebo.On March 31, 2021, Pfizer announced it also has also started giving the first doses in a trial of children ages 6 months to 11 years.

Trials In Young Children

On March 16, 2021, Moderna announced that it began giving the first doses in a COVID-19 vaccine clinical trial in children ages 6 months to 11 years. The trial, which is called KidCOVE, will enroll approximately 6,750 healthy participants and will have two parts: The first part will evaluate two different vaccine dosage options in children ages 2 to 11 and three dosage options in children ages 6 months to under 2 years old.After dosages are evaluated and selected, the second part of the trial will compare the vaccine to a placebo.On March 31, 2021, Pfizer announced it also has also started giving the first doses in a trial of children ages 6 months to 11 years.

On March 16, 2021, Moderna announced that it began giving the first doses in a COVID-19 vaccine clinical trial in children ages 6 months to 11 years. The trial, which is called KidCOVE, will enroll approximately 6,750 healthy participants and will have two parts: The first part will evaluate two different vaccine dosage options in children ages 2 to 11 and three dosage options in children ages 6 months to under 2 years old.After dosages are evaluated and selected, the second part of the trial will compare the vaccine to a placebo.

On March 31, 2021, Pfizer announced it also has also started giving the first doses in a trial of children ages 6 months to 11 years.

How Do Vaccines Become Approved for Children?

According to a 2015 study onclinical trialsin children, safety and efficacy data on many medicines administered to children is remarkably scarce.Some of the reasons for the paucity of data include a lack of funding, the uniqueness of children, and ethical concerns.

Children are a vulnerable and protected population that must be safeguarded. Kids cannot make decisions for themselves, which is one reason why a clinical trial that involves children cannot be rushed.

The immunizations that are currently on the recommended vaccination schedule for children—such aspolio,measles, mumps, and rubella (MMR),varicella (chickenpox),hepatitis B, anddiphtheria, tetanus, & acellular pertussis (DTaP)vaccinations—were created over several decades.Each went through a highly-regulated schedule of clinical trials.

Pfizer’s Inclusion of Kids In Vaccine Trials Is a Sign of Progress, Experts Say

Clinical trials for vaccinations intended for children (or eventually intended for children) follow three phases of strict protocol to determine they are safe and effective with minimal side-effects.

After Phase 3 of a clinical trial is complete and successful, the sponsor company sends its results to the FDA for review and approval.

The clinical trial process has traditionally taken several years—if not decades—to complete.

Why Vaccination Is Important

Making sure that infants and children are included in COVID-19 vaccination efforts will be critical to controlling the spread of the virus.

A 2020 study published in theInfectious Diseases Society of Americareported that delaying clinical trials in children will delay our recovery from COVID-19, further impacting our children’s education, health, and emotional well-being. The authors of the study suggested that Phase 2 clinical trials of the COVID-19 vaccine involving children should start immediately.

Back in September of 2020, the American Association of Pediatrics (AAP) sent a letter to the FDA outlining concerns that children had yet to be included in COVID-19 vaccine trials.The authors note that approximately 10% of all COVID-19 cases have been children, and 109 had died from the infection at the time of publication.

The AAP’s letter stated that it is unethical to allow children to take on the burdens of the COVID-19 pandemic yet not have the opportunity to benefit from a vaccine.

What This Means For YouChildren are not yet on the vaccination distribution timeline because clinical trials are just beginning for those younger than 12. Therefore, there is not enough safety data to support giving the COVID-19 vaccine to babies and children.

What This Means For You

Children are not yet on the vaccination distribution timeline because clinical trials are just beginning for those younger than 12. Therefore, there is not enough safety data to support giving the COVID-19 vaccine to babies and children.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

13 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food & Drug Administration.Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic.Moderna.Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June.Salazar JC.When will the COVID-19 vaccine be available for kids, and will it be safe? Connecticut Children’s.Pfizer.Pfizer and BioNTech to submit emergency use authorization request today to the U.S. FDA for COVID-19 vaccine.Pfizer.Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents.Johnson & Johnson.Johnson & Johnson expands Phase 2a clinical trial of COVID-19 vaccine candidate to include adolescents.Moderna.Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in pediatric population.Joseph P, Craig J, Caldwell P.Clinical trials in children.British Journal of Clinical Pharmacology.Bcp.12305. doi:10.1111/bcp.12305Cleveland Clinic.Why a COVID-19 vaccine for children may take a while.Centers for Disease Control and Prevention (CDC).Birth-18 years immunization schedule.History of Vaccines.Vaccine development, testing, and regulation. College of Physicians of Philidelphia.Anderson E, Campbell J, Creech C, Frenck R, Kamidani S, Munoz F, et al.Warp speed for COVID-19 vaccines: why are children stuck in neutral?Clinical Infectious Diseases.Ciaa1425. doi:10.1093/cid/ciaa1425American Academy of Pediatrics.AAP letter to HHS and FDA children COVID vaccine trials.

13 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food & Drug Administration.Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic.Moderna.Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June.Salazar JC.When will the COVID-19 vaccine be available for kids, and will it be safe? Connecticut Children’s.Pfizer.Pfizer and BioNTech to submit emergency use authorization request today to the U.S. FDA for COVID-19 vaccine.Pfizer.Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents.Johnson & Johnson.Johnson & Johnson expands Phase 2a clinical trial of COVID-19 vaccine candidate to include adolescents.Moderna.Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in pediatric population.Joseph P, Craig J, Caldwell P.Clinical trials in children.British Journal of Clinical Pharmacology.Bcp.12305. doi:10.1111/bcp.12305Cleveland Clinic.Why a COVID-19 vaccine for children may take a while.Centers for Disease Control and Prevention (CDC).Birth-18 years immunization schedule.History of Vaccines.Vaccine development, testing, and regulation. College of Physicians of Philidelphia.Anderson E, Campbell J, Creech C, Frenck R, Kamidani S, Munoz F, et al.Warp speed for COVID-19 vaccines: why are children stuck in neutral?Clinical Infectious Diseases.Ciaa1425. doi:10.1093/cid/ciaa1425American Academy of Pediatrics.AAP letter to HHS and FDA children COVID vaccine trials.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food & Drug Administration.Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic.Moderna.Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June.Salazar JC.When will the COVID-19 vaccine be available for kids, and will it be safe? Connecticut Children’s.Pfizer.Pfizer and BioNTech to submit emergency use authorization request today to the U.S. FDA for COVID-19 vaccine.Pfizer.Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents.Johnson & Johnson.Johnson & Johnson expands Phase 2a clinical trial of COVID-19 vaccine candidate to include adolescents.Moderna.Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in pediatric population.Joseph P, Craig J, Caldwell P.Clinical trials in children.British Journal of Clinical Pharmacology.Bcp.12305. doi:10.1111/bcp.12305Cleveland Clinic.Why a COVID-19 vaccine for children may take a while.Centers for Disease Control and Prevention (CDC).Birth-18 years immunization schedule.History of Vaccines.Vaccine development, testing, and regulation. College of Physicians of Philidelphia.Anderson E, Campbell J, Creech C, Frenck R, Kamidani S, Munoz F, et al.Warp speed for COVID-19 vaccines: why are children stuck in neutral?Clinical Infectious Diseases.Ciaa1425. doi:10.1093/cid/ciaa1425American Academy of Pediatrics.AAP letter to HHS and FDA children COVID vaccine trials.

Food & Drug Administration.Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic.

Moderna.Moderna announces TeenCOVE study of its COVID-19 vaccine in adolescents meets primary endpoint and plans to submit data to regulators in early June.

Salazar JC.When will the COVID-19 vaccine be available for kids, and will it be safe? Connecticut Children’s.

Pfizer.Pfizer and BioNTech to submit emergency use authorization request today to the U.S. FDA for COVID-19 vaccine.

Pfizer.Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents.

Johnson & Johnson.Johnson & Johnson expands Phase 2a clinical trial of COVID-19 vaccine candidate to include adolescents.

Moderna.Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in pediatric population.

Joseph P, Craig J, Caldwell P.Clinical trials in children.British Journal of Clinical Pharmacology.Bcp.12305. doi:10.1111/bcp.12305

Cleveland Clinic.Why a COVID-19 vaccine for children may take a while.

Centers for Disease Control and Prevention (CDC).Birth-18 years immunization schedule.

History of Vaccines.Vaccine development, testing, and regulation. College of Physicians of Philidelphia.

Anderson E, Campbell J, Creech C, Frenck R, Kamidani S, Munoz F, et al.Warp speed for COVID-19 vaccines: why are children stuck in neutral?Clinical Infectious Diseases.Ciaa1425. doi:10.1093/cid/ciaa1425

American Academy of Pediatrics.AAP letter to HHS and FDA children COVID vaccine trials.

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