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Can Babies and Toddlers Get a COVID-19 Vaccine?

illustration of baby getting vaccine

Alex Dos Diaz / Verywell

Key Takeaways

  • The COVID-19 vaccine is not yet approved for children under the age of 17.
  • Moderna, one of the pharmaceutical companies working on a vaccine, has listed an upcoming clinical trial on ClinicalTrials.gov that will include 3,000 healthy adolescents. However, it is not clear when that trial will begin.
  • 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, the Food and Drug Administration (FDA) approved an emergency use authorization submitted by Pfizer, giving the pharmaceutical company the green light to begin distributing its COVID-19 vaccine. On the 18th, Moderna's vaccine candidate received the same authorization. The initial doses of each vaccine went to millions of American frontline healthcare works, first responders, and residents of long-term care facilities. 

The approval is a significant milestone in the ongoing COVID-19 pandemic, but many people are wondering when they can expect to get a vaccine. Parents will want to know where their 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.

— Yvonne Maldonado, MD

According to the Centers for Disease Control and Prevention (CDC), the COVID-19 vaccine was only tested on non-pregnant adults, and more recently, on teenagers. The vaccine is currently not being recommended for children under the age of 12 because there is a lack of evidence-based data verifying that it is safe and effective in pediatric populations.

“COVID-19 vaccines have not been studied at all in children under 12 and in very limited numbers of children between 12 and 17 years of age,” 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. “At this time, babies and toddlers should not receive COVID-19 vaccines until they have been studied in older children.”

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 children than in adults.

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. Pfizer currently has around 1,000 12 to 15 year olds enrolled in trials, with further enrollment slated once this group is analyzed after its second dose of the vaccine.

When Will Kids Be Included in Clinical Trials?

As of December 21, Pfizer had enrolled more than 700 participants ages 16 and 17 and more than 1,000 participants ages 12 to 15 in its trials. It is still enrolling additional children ages 12 to 15.

The other pharmaceutical companies working to present clinical trial data on their vaccines to the FDA—AstraZeneca, Johnson & Johnson, and Moderna—have not included children in their clinical trials, but plan to in the future.

A proposed study posted by Moderna to the ClinicalTrials.gov website on December 2 revealed that the company plans to start a COVID-19 vaccination clinical trial that will include 3,000 healthy adolescents ages 12 through 17, and is currently recruiting.

Moderna has not announced when it will start recruiting for the trial, but the study states that it should be completed around June of 2022.

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 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 study recently 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 have not included individuals younger than 12 and only recently began including those younger than 16. Therefore, there is not enough safety data to support giving the COVID-19 vaccine to babies and children.

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