TeamHealth’s Emerging Infectious Disease Taskforce reinforces the FDA’s emergency use authorization of the Pfizer-BioNTech COVID-19 vaccination for children ages 5 to 11 years.
After extensive research and review, the FDA has authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 years for the prevention of COVID-19. This is in addition to the existing EUAs and approvals for the Pfizer product covering ages older than 11. The FDA overwhelmingly voted that the benefits of the Pfizer-BioNTech COVID-19 vaccine for this age group outweigh the known and potential risks of the vaccine.
What is the Impact of COVID-19 on Children Age 5 through 11 Years?
Since the start of the COVID-19 pandemic, about 1.9 million children ages 5 through 11 years have been infected. This accounts for about 9% of all U.S. cases. More than 8,300 of these younger children have been hospitalized and 94 have died. The death toll in the past year puts COVID in the top 10 causes of death for children ages 5 through 11.
The level of short-term and long-term complications in this age range from COVID-19 is mostly unknown but is not insubstantial. In addition, the death rate in children from COVID-19 is up to three times the death rate from seasonal influenza. We regularly recommend influenza vaccination each year for younger children. The Pfizer-BioNTech COVID-19 vaccine is one of the best-studied, most effective and safest vaccines ever developed.
Is the Pfizer BioNTech Vaccine Effective Against COVID-19?
Yes, the immune responses of children ages 5 through 11 years are comparable to people 16 through 25 years of age in previous Pfizer COVID-19 vaccine studies. The vaccine was found to be 90.7% effective in preventing symptomatic COVID-19 in children in the 5 through 11 year age range.
What about the Safety Characteristics of the Pfizer BioNTech Vaccine in Younger Children?
The vaccine’s safety characteristics have been specifically studied in more than 4,600 participants (3,100 received the vaccine and 1,538 a placebo) in ages 5 through 11 years. The study is ongoing at this time. It is being conducted across a wide variety of children in several nations including the United States.
No serious adverse side effects have been detected thus far in any of the children participating in the study. This includes no reports of anaphylaxis, myo/pericarditis or Multisystem Inflammatory Syndrome in Children (MIS-C). Previous studies in older age groups demonstrate that the risk of such events is approximately an order of magnitude higher if one contracts COVID-19 than by receiving the vaccine. In addition, the risk of myo/pericarditis from the COVID-19 vaccine is similar to the risk from other fully approved pediatric vaccines.
What are the Common Side Effects in Children Age 5 through 11 Years?
More children reported side effects after the second dose than the first. Side effects were generally mild to moderate in severity and occurred within two days after vaccination. Most complaints resolved within 24 to 48 hours. Commonly reported side effects in the clinical trial so far include:
- Injection site pain
- Local redness and swelling
- Myalgia and/or arthralgia
- Chills and/or fever
- Nausea and/or decreased appetite
The FDA and CDC safety surveillance systems previously identified possible elevated risks of myocarditis and pericarditis following vaccination with Pfizer-BioNTech COVID-19 vaccine. Due to these previous findings, the CDC conducted its own additional benefit-risk assessment study. In the final analysis, the study predicted that the benefits of the COVID-19 vaccine in the 5 through 11 year age range far outweighed any risks of the vaccine.
What about Continued Safety Monitoring for Children Age 5 Through 11 Years?
The ongoing Pfizer study has specifically been adapted to monitor for myocarditis, pericarditis and other serious adverse events including Multisystem Inflammatory Syndrome (MIS-C). In addition, cases of COVID-19 that result in hospitalization or death in vaccinated individuals are monitored. Both Pfizer and all vaccine providers have a mandatory requirement to report any such events. Both the and the CDC have monitoring and reporting systems in place nationally that continually evaluate vaccine safety. These systems allow for rapid detection and investigation of any potential safety problems. These data are summarized and made available on a monthly basis by the FDA.
Were the Risks of Vaccinating Children Who Have Had Prior COVID-19 Considered?
Yes, the CDC data show up to 42% of children nationally may have had COVID-19. This means they could have at least some level of protection, similar to older people. But also, like others, they are not fully protected by this prior infection. They can still likely transmit the disease to others when reinfected. Based on this, the FDA and CDC recommend the Pfizer COVID-19 vaccine for children with known or suspected prior COVID-19 as well as those with no known prior infection under this EUA.
No cases of serious adverse events were detected in the study patients thus far. Serious adverse events are also very low in the 12 to 18-year cohort from the vaccine. In addition, the lower dose of the vaccine being used for the 5 through 11-year group is thought to additionally reduce the risk of serious adverse events.
What is the Dose and Protocol for the Pfizer-BioNTech COVID-19 Vaccine for Children Age 5 through 11?
The Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age is administered as a two-dose primary series, three weeks apart. However, it uses a lower dose of 10 micrograms rather than the 30 microgram dose used for individuals 12 years of age and older. This dose has been found to be just as effective and is thought to help reduce adverse side effects.
COVID-19 Vaccination for Children
The CDC has created a detailed information packet regarding pediatric COVID-19 vaccinations. Vaccines continue to be the safest and most effective means to prevent COVID-19 and to end the pandemic. Visit the CDC website for more information about the COVID-19 vaccine and current guidance for pregnancy and booster shots.
Find more COVID-19 resources from TeamHealth.