- 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 December 11, 2020, the Food and Drug Administration (FDA) approved an emergency use authorization (EUA) submitted by Pfizer, giving the pharmaceutical company the green light to begin distributing its COVID-19 vaccine to people ages 16 and older. Emergency use authorizations followed on December 18, 2020, for Moderna’s COVID-19 vaccine and on February 27, 2021, for Johnson & Johnson’s COVID-19 vaccine, which are each authorized for adults 18 and older.
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.
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, 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, and more 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 Get Meds Info.
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.
When Will Kids Be Included in Clinical Trials?
In October the FDA allowed Pfizer to 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.
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 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 & Johnson announced 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 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.
How Do Vaccines Become Approved for Children?
According to a 2015 study on clinical trials in 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 as polio, measles, mumps, and rubella (MMR), varicella (chickenpox), hepatitis B, and diphtheria, tetanus, & acellular pertussis (DTaP) vaccinations—were created over several decades. Each went through a highly-regulated schedule of clinical trials.
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.
- Phase 1: The first phase involves a small group of adult subjects. If proven safe, the trial will gradually step down the age of individuals until it reaches its target age. The goal of Phase 1 is to determine the immune response triggered by the vaccine as well as its safety. This phase can be non-blinded (researchers know if a subject is getting the vaccination or placebo).
- Phase 2: The second phase tests the vaccine on hundreds of individuals— some of whom might be at a higher risk for contracting the disease. The vaccine is administered in a randomized, highly-controlled environment that also includes a placebo (which might be a saline solution, a vaccination for another disease, or another substance). The goal of Phase 2 is to test safety, proposed doses, schedule of immunizations, as well as how the vaccine will be delivered.
- Phase 3: The third phase recruits a larger group of people (from thousands to tens of thousands). It is a randomized, double-blind study that includes testing the vaccine against a placebo. The goal of Phase 3 is to gather vaccine safety in a large group of people, test the vaccine’s efficiency, and analyze any dangerous side effects that might occur.
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 the Infectious Diseases Society of America reported 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 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 our coronavirus news page.