NEWS

FDA Committee Will Discuss COVID-19 Vaccines for Kids Next Week

A person's gloved hands holding a syringe with a small child blurred in the background.

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Key Takeaways

  • Pfizer has requested permission from the Food and Drug Administration (FDA) to give a modified version of its COVID-19 vaccine to children ages 5 to 11.
  • The "kid-sized" version of the vaccine provides a smaller dose than the current dose given to people ages 12 and older.
  • In clinical trials with over 2,000 children, Pfizer's vaccine was shown to be effective and safe, with only mild side effects reported (such as redness and pain at the injection site).

Pfizer/BioNTech has formally requested an emergency use authorization (EAU) from the Food and Drug Administration (FDA) for a modified version of its COVID-19 vaccine intended for children ages 5 to 11.

The "kid-sized" vaccine contains about a third of the "adult-sized" dose that is in the original version of the vaccine (which is currently FDA-approved for people ages 12 and older).

The FDA has scheduled an advisory committee meeting for October 26 to discuss the vaccine. A decision by the FDA on the use of the Pfizer vaccine in younger children may come soon after the meeting.  

According to the Centers for Disease Control and Prevention (CDC), there have been 587 deaths from COVID-19 in children ages 0 to 18 since January 2020, including 181 in children ages 0 through 4.

Clinical Trial Results

The FDA recently received the results of a clinical trial testing Pfizer's COVID vaccine in 2,268 children ages 5 to 11. The children were given two 10-microgram doses of the vaccine administered about 21 days apart.

The original version of the vaccine, which is approved for people 12 and older, contains two 30 microgram doses that are given 3 weeks apart). Pfizer says that the smaller 10-microgram dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to [less than] 12 years of age.” 

The results demonstrated both the safety and effectiveness of the modified dose and that it was well-tolerated by most kids in the study.

Moderna and J&J

Moderna and Johnson & Johnson are both conducting clinical trials of their vaccines in children and are expected to apply for authorization in the coming months. Both vaccines are currently approved for people age 18 and older.   

The Rise of COVID In Kids

Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah Health, tells Verywell that it has taken longer for COVID vaccines to be authorized in kids than it did for adults because it's a new vaccine product.

Pavia says that the U.S. Department of Health and Human Services—which includes both the FDA and the Centers for Disease Control and Prevention (CDC)— needs to be sure that it has "a safe vaccine for adults before even launching pediatric trials.”

Andrew Pavia, MD

The decision will be easier in October 2021 than it would have been in April or May.

— Andrew Pavia, MD

According to Pavia, this is often the case with both vaccines and medications; that "only once they are approved in adults, do pediatric studies begin.” 

As the pandemic has evolved, the imperative to vaccinate kids has changed. “When we thought about pediatric vaccines coming out initially, cases of the virus were dropping in the community in the spring and summer," says Pavia, "We thought it might be a close call on the risk of COVID to 5 to 11-year-olds and the benefit might not have been as clear cut."

Vaccines for Infants

Pfizer and the other COVID vaccine manufacturers will likely file for authorization to use their vaccines in children as young as 6 months old by 2022, if not sooner.

According to Pavia, "before the Delta variant appeared, kids were doing relatively well" but now, the situation is different. “There no question anymore they have been hit hard and many have had severe disease," says Pavia. "So, the decision will be easier in October 2021 than it would have been in April or May.” 

According to the American Academy of Pediatrics (AAP), as of September 30, nearly 5.9 million children have tested positive for COVID-19 since the pandemic started. The number of new COVID cases in children also remains exceptionally high.

In a report from October, the AAP stated that while severe illness is uncommon in children, "there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects."

Monitoring for Side Effects

Pavia says that a multilayered system is used to assess for rare vaccine side effects. One is the Vaccine Adverse Event Reporting System (VAERS), which collects data on any adverse outcomes reported in the weeks after a person receives a vaccine.

Pavia says that VARES is "a very sensitive system" that "can find things that follow vaccination that may or may not be related. If there is something out there, there will be a signal."

Sometimes, those signals are important, but they can also be misleading—which is why Pavia says that we need other systems in place.

The Department of Defense (DOD) also has its own review system of possible side effects, and the CDC's V-Safe program allows people who received the COVID shot to report side effects.

Another avenue that is used to check for side effects is the CDC's Vaccine Safety Data Link, which searches the medical records of tens of millions of people for events that occur post-vaccine, then compares those rates to the rates in people who did not get a vaccine. 

Myocarditis Risk

One concern that is expected to be a high priority for the FDA advisory committee members is a rare side effect that has been seen in a small number of young men who got a COVID vaccine: inflammation of the heart muscle (myocarditis).

Myocarditis can be triggered by an infection or immune response. The CDC says that most patients that experienced it after getting a COVID shot responded well to treatment and rest, and felt better quickly.

The CDC is actively monitoring reports of myocarditis after COVID vaccination, including reviewing medical records to look for any potential link between the condition and the shot.

Several studies that were published at the beginning of October found that cases of myocarditis after a COVID shot are exceedingly rare in girls and women. Cases are slightly higher after the second dose of the vaccine—particularly in young men.

The studies also found that the patients who developed myocarditis generally made a full recovery with no lasting problems.

Earlier this year, the FDA asked both Pfizer and Moderna to increase the number of participants in clinical trials of the COVID vaccine for children to better assess the vaccine's safety.

Information for Caregivers

Claire Boogaard, MD, MPH, medical director of the COVID-19 Vaccine Program at Children’s National Medical Center in Washington, DC, tells Verywell that COVID vaccines for kids are something that “parents want to talk about all the time, so it’s understandable that parents want to put a lot of thought into this.”

Claire Boogaard, MD, MPH

Pediatricians are trained to be able to communicate risks and benefits, and it’s their mission to keep your children safe and healthy.

— Claire Boogaard, MD, MPH

Boogaard says that as new information comes out about vaccines for kids, the best resource for caregivers will be their child's pediatrician.

“Pediatricians are trained to be able to communicate risks and benefits," says Boogaard. "And it’s their mission to keep your children safe and healthy."

Until younger children can be vaccinated, public health experts are stressing the importance of adults getting fully vaccinated, as well as continuing to take precautions, such as making sure that unvaccinated children are masked in public, at school, and any time that they could be exposed to the virus. 

At a White House briefing on October 1, U.S. Surgeon General Vivek Murthy, MD, MBA, told reporters that the COVID-19 vaccines are the FDA’s top priority and that they know the urgency with which our children need to be vaccinated.

“[Reviewers] will be guided by science and safety as they evaluate vaccine data for children. That’s what’s reassuring to me as a parent," said Murthy. "And that is why when a vaccine is available for kids 5 to 11, I will look forward to taking my son to get vaccinated.” 

What This Means For You

Pfizer's modified COVID-19 vaccine could be approved for children ages 5 to 11 as soon as the end of the month. Data on the vaccine's safety and effectiveness will be reviewed by advisory committees to the FDA and the CDC before a decision is made.

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.

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7 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Centers for Disease Control and Prevention (CDC). Provisional COVID-19 Deaths: Focus on Ages 0-18 Years. Updated October 6, 2021.

  2. American Academy of Pediatrics (AAP). Children and COVID-19: State-Level Data Report. Updated October 4, 2021.

  3. Centers for Disease Control and Prevention (CDC). Myocarditis and Pericarditis After mRNA COVID-19 Vaccination. Updated September 8, 2021.

  4. Simone A, Herald J, Chen A, et al. Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or olderJAMA Intern Med. 2021;Epub ahead of print. doi:0.1001/jamainternmed.2021.5511

  5. Guduguntla V, Katz MH. COVID-19 messenger RNA vaccination and myocarditis – a rare and mostly mild adverse effectJAMA Intern Med. 2021;Epub ahead of print. doi:10.1001/jamainternmed.2021.5634

  6. Mevorach D, Anis E, Cedar N, et al. Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in IsraelN Engl J Med. 2021;Epub ahead of print. doi:10.1056/NEJMoa2109730

  7. Witberg G, Barda N, Hoss S, et al. Myocarditis after COVID-19 vaccination in a large health care organizationN Engl J Med. 2021;Epub ahead of print. doi:10.1056/NEJMoa2110737