NEWS ANALYSIS

The Pfizer COVID-19 Vaccine is Now Approved for Kids Ages 5 to 11

girl getting vaccine

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Key Takeaways

  • The Pfizer COVID-19 vaccine is approved for children aged 5 to 11 and will be available shortly.
  • Children will receive a smaller dose of the vaccine, which research has shown that the shot is safe and effective in ages 5 to 11.
  • Vaccinating children is an important step towards curbing the COVID-19 pandemic.

Pfizer's COVID-19 vaccine has been approved for children aged 5 to 11. On October 26, the FDA advisory committee voted to recommend the vaccine. Soon after on October 29, the FDA authorized the vaccine under emergency use authorization (EUA). Now that the CDC has recommended the vaccine, children can begin receiving the shot.

Finally, after months of waiting—including a summer of surging pediatric cases and hospitalizations—parents now have a safe and effective vaccine to protect their elementary-aged children.

Although the news is a welcome relief to many, some parents also have questions and concerns about the vaccines. According to a September survey from the Kaiser Family Foundation, about one-third of parents would get their 5 to 11-year-old vaccinated as soon as the vaccine was approved, and another third would take a “wait and see” approach.

Whether you are planning to get your child vaccinated right away, or need some more time to decide, the more up-to-date, accurate information you have, the better. We have compiled answers to parents’ most frequently asked questions about the COVID-19 vaccine for children, along with some expert advice about how to make the best decisions for your family.

What the COVID-19 Vaccine Approval Means for Parents

The pandemic has been a very stressful time for parents. First, parents faced the enormous strain of school closures and isolation, oftentimes balancing working while caring for their children with no outside help. As the country has opened up and vaccines have become available for adults and teenagers, children have still not been able to get protected by vaccines.

Although COVID-19 continues to be generally milder in children than it is in adults, children can still suffer severe cases of COVID-19. Though rare, children have died of the virus. As the Delta variant surged in the summer of 2021, we saw an unprecedented number of children infected with COVID-19, resulting in the highest number of pediatric hospitalizations so far in the pandemic, according to the Academy of American Pediatrics (AAP).

This was scary news for parents to take in, and many will breathe a deep sigh of relief knowing that their children are protected by the vaccine. Even if the likelihood that your child gets a severe case of COVID-19 is small, knowing that it could happen is the kind of thing that keeps parents up at night.

But the benefit isn’t just for your individual child or children. According to Sunil Sood, MD, a pediatric infectious disease specialist at Northwell Health/South Shore University Hospital, immunizing young children will bring us one step further to ending the pandemic. As Dr. Sood points out, the age 5 to 11 cohort represents about 28 million Americans. Vaccinating as many of that population as possible will increase our overall population immunity.

As Dr. Sood describes it, elementary-aged children easily acquire respiratory infections like COVID-19 and often pass these along to others. As such, they are a key factor in breaking the chain of transmission and keeping our families, schools, and communities safer.

“It will be very important to accelerate the pace before the onset of the cold weather this year, given the high likelihood of a surge in infections this winter,” Dr. Sood adds.

Why Is a COVID Vaccine for Children Needed?

Parents have continued to be assured throughout the pandemic that children usually suffer mild cases of COVID-19, and rarely die from the virus. While this continues to be the case, COVID-19 can be severe for children. According to the AAP, between 0.1 and 2% of COVID-19 cases in children result in hospitalization, and 0.00%-0.03% of the cases in children have resulted in death.

These may sound like small numbers, These may sound like small numbers, but as of October 28th, 6.8 million children have tested positive for COVID-19 since the beginning of the pandemic. During peak periods of transmission, this means thousands of children are hospitalized with COVID-19, and many die as well. According to AAP data looking at 24 states and NYC, over 22,000 children have been hospitalized with COVID-19. Tragically, 520 children have died as of September 30th.

As the AAP points out, there are other considerations, too, when it comes to COVID-19 and children, including the long-term effects of infections. “[T]here 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,” the AAP wrote in a recent report.

The positive effects of COVID-19 vaccines in pediatric populations have already been seen in the 12 to 17 age group. For example, adolescents who were vaccinated with Pfizer’s COVID-19 vaccine were strongly protected during this summer’s Delta surge. A study published by the CDC found that 12 to 17 year-olds who were not vaccinated were 10 times more likely to be hospitalized in July than those who had been vaccinated.

What to Know About the Vaccine

The vaccine that has been approved under EUA for children is the COVID-19 vaccine put out by Pfizer. Already, Pfizer’s COVID-19 vaccine has been fully approved for adults aged 16 and older. Pfizer’s COVID-19 vaccine for tweens and teens, aged 12 to 15, is also already approved under emergency use authorization.

Pfizer’s COVID-19 vaccine for children aged 5 to 11 contains the same vaccine ingredients and formulation as the vaccine for adults and teenagers but in a different dosage. Here’s what we know so far about the COVID-19 vaccine for younger children.

What the Trial Data Showed

According to a press release from Pfizer, 2,268 children aged 5 to 11 years old participated in the vaccine trial. Two-thirds of these children received the Pfizer vaccine, and a third received a placebo.

As shown in data submitted to the FDA from Pfizer, the vaccine had a 90.7% efficiency rate when it came to preventing symptomatic COVID-19 infection in children. A total of 19 children participating in the trial got COVID-19. Of those, 16 had received a placebo, and 3 had received the vaccine.

Strong signs of efficacy and safety were noted. Children in the trial who received the vaccine had similar neutralizing antibody levels as 16-to-25-year-olds in a previous trial. Additionally, no serious or adverse reactions were noted. Importantly, there were no cases of myocarditis, an inflammation of the heart that has been documented as a rare side effect of the Pfizer vaccine, especially in younger males.

Study Methods and Limitations

Children who received the COVID-19 vaccine were given a smaller dosage than teens and adults have been given. Whereas adults and teens are immunized with 30 μg doses, the study researchers found that 10 μg doses produced the best safety and efficacy results in children. These doses were given 21 days apart.

“The 10 μg dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to <12 years of age,” Pfizer explains in their press release.

According to Dr. Sood, there was one limitation with the data, and that is the small number of children studied. “That is the only major limitation because, in contrast, the adult trial enrolled about 44,000 people, and the 12 years of age and older 23,000 children,” he explains.

However, Dr. Sood feels confident about the safety of the vaccine. He also points out that mRNA vaccines have been in development for at least 10 years, and that the lower dosage for children that Pfizer is using was chosen carefully and deliberately, with children’s safety and well-being in mind. 

Dosage and Timing

As per Pfizer’s trial results, it is recommended that children receive two 10 μg doses of the vaccine, spaced about 21 days apart.

Potential Side Effects

Pfizer noted that the side effects in children were "mild to moderate," and most happened within the first one to two days after vaccination. The most common side effects included fatigue, fever, muscle aches, chills, and headaches. These were more likely to happen after the second shot.

Zachary Hoy, MD, a pediatric infectious disease specialist at Nashville Pediatric Infectious Disease in Tennessee, said he expected that the side effects in children would be similar to the ones seen in teenagers and adults. “[This can include] mild soreness at the injection site and mild chills within 24 to 48 hours after the vaccine is given,” he says.

Dr. Sood notes that many decades of childhood vaccines have shown that vaccine side effects in children are usually not severe, especially when compared to adults. Generally, there aren’t any vaccine side effects that are specific or different in children, Dr. Sood explains.

How and Where Children Can Get the Vaccine

Dr. Hoy expects the vaccine for children to be available widely now that it is approved. “I expect it will be available at pediatrician offices, community public health vaccination sites, such as the health department, and pharmacies where COVID-19 vaccines are currently available,” he says.

More and more pediatricians' offices are becoming COVID-19 vaccine providers, says Dr. Sood. He recommends that you contact your pediatrician to see if they are offering the COVID-19 vaccine to patients, or if they plan to in the coming weeks.

If You Are Having Concerns About the Vaccine

It’s understandable that you might have doubts and concerns about the COVID-19 vaccine for your child. Many parents are having similar concerns.

Dr. Hoy says that you should take comfort in the vigorous process of approval that the vaccines have gone through. “When the FDA and CDC give recommendations to include 5- to 11-year-olds in COVID-19 vaccines, it means it was tested appropriately, had minimal side effects, and offered a similar degree of protection from COVID-19 and decreased COVID-19 severity risk as compared to other groups,” he says.

Robert G. Lahita, MD, Director of the Institute for Autoimmune and Rheumatic Disease at Saint Joseph Health, says that, unfortunately, there are many misconceptions floating around about the COVID-19 vaccines and children, including that they cause infertility, will stunt puberty, or affect a child’s growth.

Dr. Lahita wants to assure parents that these are false statements and that the vaccines are safe and effective. “Parents are very protective of their kids, which makes sense,” says Dr. Lahita. But he urges parents to shy away from conspiracy theories and the like. “Kids have vaccines for all sorts of diseases and viruses, and this is no different,” Dr. Lahita emphasizes.

What This Means For You

Even after reviewing the facts and data, you may still feel unsure if the COVID-19 vaccine is right for your family. If you are having doubts, the best person for you to discuss this with is your child’s healthcare provider.

They know your child’s health history and will have insight into this vaccine, as well as the potential risks of COVID-19 in children. It can be helpful to have someone you know and trust listen to your concerns and help you make a decision.

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13 Sources
Verywell Family 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.
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  9. U.S. Food and Drug Administration. FDA Approves First COVID-19 Vaccine. Updated August 23, 2021.

  10. Pfizer Inc. 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. Updated September 28, 2021.

  11. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Document. Updated October 22, 2021.

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