Editor’s Note: Sean T. O’Leary, MD, MPH, is a professor of pediatrics at the University of Colorado School of Medicine and Children’s Hospital Colorado and serves as the vice chair of the Committee on Infectious Diseases for the American Academy of Pediatrics. Yvonne A. Maldonado, MD, is the senior associate dean for faculty development and diversity, the Taube Professor of Global Health and Infectious Diseases, and professor of pediatrics, epidemiology and population health at Stanford University. She also serves as the chair of the Committee on Infectious Diseases for the American Academy of Pediatrics and is the Stanford lead investigator for the Pfizer pediatric Covid-19 vaccine trials. Both serve as liaisons to the Advisory Committee on Immunization Practices. The opinions expressed in this commentary are their own. View more opinion at CNN.
On Friday, the US Food and Drug Administration authorized Pfizer-BioNTech’s Covid-19 vaccine for emergency use in children 5-11. The US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) is expected to make final clinical recommendations soon. This represents an important milestone in this pandemic, as, up to now, children under 12 have not had the protections that vaccines offer. Parents of children 5-11 years should take advantage of this opportunity to both protect them and take us one step closer to ending this pandemic.
Children of all ages have suffered greatly throughout the pandemic, both directly from Covid-19 infections and indirectly from unintended consequences, such as school closures and, for too many, the loss of a parent or other loved one. While it is clear that Covid-19 is more likely to lead to severe illness and hospitalization in adults, it is incorrect to say that it is a benign disease in children. With well over 500 pediatric deaths as of this writing, Covid-19 fits squarely in the top 10 causes of childhood deaths in the United States.
The highly contagious Delta variant has also changed the risk to children. It is so contagious that in the coming months, for many unvaccinated persons, the question is not if they will get infected, but when. In the last few months, we have seen the highest Covid-19 infection rates among children since the start of the pandemic, and many children’s hospitals have recently had overflowing ICUs.
While the Pfizer-BioNTech vaccine has been authorized for use in children 12 and older since May, children under 12 have had no opportunity for vaccination outside of clinical trials. Many of these children are in schools with minimal mitigation measures in place, and are thus at significant risk of infection, particularly when community circulation is high. Emergency authorization of a safe and effective vaccine is a game changer for these children and their families.
A new survey from The Kaiser Family Foundation that was released this week, and conducted before the FDA’s announcement Friday, found that 27% of parents with children in this age group would get their child vaccinated as soon as they were authorized and available (compared to 30% who were firmly opposed to getting their kids vaccinated). Another 33% said they would wait and see and 5% said their kids would get vaccinated only if it were required. For these last two groups of parents, there are several vaccine benefits to consider.
First, the vaccine will offer children protection from infection and related complications, such as hospitalization and long Covid. According to the FDA, the vaccine was found to be 90.7% effective in preventing Covid-19 in kids ages 5 to 11.
Second, many children live in homes with vulnerable caregivers who may not respond as well to vaccination, such as persons who are moderately or severely immunocompromised (estimated to be 3% of the US population, according to data published in the Journal of the American Medical Association).
Third, being fully vaccinated means that if a child is exposed to someone with Covid-19, they don’t have to quarantine. This is critical for preventing school absenteeism, as many children have already been forced to miss school, and many schools have no remote learning options available for this school year. From an equity perspective, vaccination of this age group may alleviate some of the long-standing educational disparities that have been exacerbated by the pandemic.
Finally, there are roughly 28 million children between the ages of 5 and 11 in the US, representing a little over 12% of the US population. The more eligible people who get vaccinated, the fewer Covid-19 cases and deaths the US will experience overall.
On the other side of the equation, what are the potential risks of vaccination? There were no serious adverse events related to the vaccine in kids ages 5-11, based on safety data from clinical trials data reviewed by the FDA. Because the FDA and CDC safety surveillance systems previously identified an increased risk of myocarditis, inflammation of the heart wall, after vaccination, particularly in boys ages 12 to 17, the FDA conducted its own modeling to predict the potential myocarditis cases in younger children and found that overall, the benefits of the vaccine would outweigh its risks.
Parents with questions about the potential risks of vaccination should reach out to their pediatricians, who are consistently shown in polls to be parents’ most trusted source of vaccine information. People of all ages should avoid seeking unproven sources of Covid-19 and vaccine information, including unauthorized internet sources, which may contain substantial mis- and disinformation, even as social media companies attempt to crack down.
Finally, as we await Covid-19 vaccines for even younger children between 6 months and 4 years of age, we must not forget about the importance of maintaining routine childhood vaccines. Globally and within the US, the Covid-19 pandemic was associated with a dramatic drop in vaccination coverage across all ages as a result of lockdowns and shortages in staffing and supply chain, leading to a credible risk of pediatric outbreaks of other vaccine preventable diseases, such as measles and pertussis. Thanks to our robust national vaccination programs, we rarely see many of these diseases, but the risk for resurgence is a threat as long as our nation’s children remain under-vaccinated for these preventable diseases.
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The authorization by the FDA of the Pfizer-BioNTech Covid-19 vaccine for use in children is an important milestone in this historic pandemic. The next step in the approval process is for the Advisory Committee on Immunization Practices (ACIP), on which both of us serve and that advises the CDC on use of vaccines in the US population, to review the data and recommendations released by the FDA in order to make specific clinical recommendations for 5-to-11-year-old children. This meeting is scheduled for November 2 and 3 and is open to the public.
For parents with questions – or even parents who simply want to better understand how these recommendations are made, the meeting will offer an opportunity to see a robust scientific discussion and make a truly informed decision based on the best available evidence. The vaccine recommendation and oversight processes provided by the FDA and CDC are the best in the world, and our children should be allowed to benefit from the protection conferred by Covid-19 vaccines.