The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recently granted emergency use authorization (EUA) for the Pfizer COVID-19 vaccine for children ages 5-11. Lyn Nuse, MD, specialty medical director of pediatric primary care at Atrium Health Levine Children’s, answers your questions about vaccines for this new age group.
Question 1: Why do children need a vaccine if they’re less likely to suffer from COVID-19?
Answer 1 | Dr. Nuse: Children seem to have weathered COVID-19 easier, with fewer long-lasting issues and lower death rates than we’ve seen in adults. But not every child has a mild case. Some become severely ill and end up hospitalized, in the ICU, and potentially end up dying. The problem is we can’t determine which population groups are at higher risk; there are no identifying characteristics. We’re also seeing long-haul COVID in children, although not as many. About one-third of adults have long-haul symptoms. Studies in children are showing it can be anywhere from 4% to 10%. But imagine your child still suffering months after an infection and what you would do to prevent that. If you never get the infection, you’re not going to have those potential long-term side effects.
Children can also spread infection. Even if your child has a mild case, they can pass it to someone who might get really sick. Protecting our children really helps all of those around them. One in four pandemic deaths in adults has left a child without a caregiver. We’ve had 140,000 children who’ve lost a caregiver and been orphaned through this pandemic. Every person who gets vaccinated, including our children, brings down the amount of COVID in our communities and reduces the risk that anybody will be exposed to it.
The final reason we need to get children vaccinated is it helps us get closer to herd immunity. We cannot achieve herd immunity without vaccinating our children. If we want to avoid variants that are even worse than the Delta variant or more contagious than Omicron; if we want to prevent our[NL1] children from losing parents and caregivers; if we want people to be protected from those longstanding symptoms or even death, we have to get children vaccinated for themselves and our greater community.
Q2: What do we know about the Pfizer COVID-19 vaccine for those 5-11?
A2 | Dr. Nuse: We know that the vaccine for 5- to 11-year-olds is one-third the dose given to ages 12 and up. It’s still two doses, 21 days apart, and you’re fully vaccinated two weeks after the second dose. Fully vaccinated children ages 5-11 showed an antibody response that’s equal to adult age ranges regarding the levels of protection. Even at lower doses, children have faster and more robust immune systems, so they’re getting the equivalent immune response and equivalent levels of protection.
Q3: What can you tell us about the studies done with this age group?
A3 | Dr. Nuse: Data from studies that started in late winter show that the vaccine is nearly 91% effective in children in this age group. The data submitted to the FDA for emergency use authorization included 2,268 children ages 5-11. One-third initially got a placebo, while the others got the actual vaccine. Even though late winter doesn’t seem very long ago, you have to remember we have lots of data looking at the vaccine itself, how it works, and its safety among ages 12 and up. That data goes back to over a billion doses.
The other things we know about vaccines in general – not just the COVID-19 vaccine – is they get in your system, do the work, and get out of your system. There’s no long-ranging effect over years that we need to track for safety in the manner we would track a new medication. The vast majority of vaccine side effects tend to show up within 48 hours of vaccination, while some appear up to six weeks after doses of the vaccine. There doesn’t tend to be an extended period of potential side effects. Also, parents should be assured that we don’t stop following these children when the studies end. We’re gathering information all the time and looking not just at this population of children, but how they might differ from the huge body of knowledge we’ve collected already.
Q4: Based on the data reviewed for ages 5-11 so far, what are the findings regarding the vaccine’s safety?
A4 | Dr. Nuse: From everything we’ve seen, the vaccine is very safe and effective in preventing COVID-19 for children in this age group. The side effects profile is very similar to 12 and older: mostly mild side effects such as local reaction at the injection site, soreness, redness, fatigue, and maybe fever or chills. Really, they’re side effects we potentially can see with most any vaccine. The FDA did come back to Pfizer and ask them to add more children to the studies and extend the period of time that they’re following the data, so we know we have enough children enrolled to detect extremely rare side effects such as myocarditis. The process we have in the U.S. for approval of new medicines and vaccines is really working the way it’s supposed to. Companies are expanding their studies further to make sure we are looking for those rare side effects.
Q5: What is emergency use authorization, and is it different from being fully approved?
A5 | Dr. Nuse: Emergency use authorization means we know the benefit of the vaccine at this age range outweighs the risk – and not just the risk of the vaccine, although that’s incredibly important from a safety perspective. If we waited for full approval, that would be several more months before we can make it available, and many more children would contract COVID-19 in the meantime. I know there were a lot of people who, with the adult vaccine, wanted to wait until it had full approval. People need to understand that the only difference is timing. All the normal processes and safety procedures are still there with EUA. It’s just a process that lets us get this vaccine to the front lines a little bit faster, because it’s such an imperative to get people protected.
Q6: Are there any concerns regarding the vaccine and immunocompromised children ages 5-11?
A6 | Dr. Nuse: There were no restrictions on the children ages 5-11 who could enroll in the studies. I suspect results will be similar to what we’re seeing in older children who are immunocompromised; their immune systems will not respond as robustly as peers who aren’t immunocompromised, just as we’ve studied additionally in adults. Vaccination for those who are immunocompromised is especially important given the increased risk of severe disease from COVID-19. In January 2022, the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the North Carolina Department of Health and Human Services (NCDHHS) recommended a third dose of Pfizer for children ages 5 to 11 who have compromised immune systems.
Q7: Is a reduced dose for children common in vaccine medicine?
A7 | Dr. Nuse: It depends on how an individual vaccine is designed to work. We do tend to make adjustments for dose or concentration for younger children. The flu vaccine is a great example. Most versions have a lower dose for children under age 3. But there are exceptions, too. There’s a flu vaccine we use that’s specifically designed to give children and adults the same dose. It was actually developed for that.
Q8: Is the lower dose just as beneficial for children who will soon be 12 years old? Should parents wait until then?
A8 | Dr. Nuse: Knowing that the antibody response in children 5-11 is equivalent to the response in adults, there’s no need to wait. The lower dose gives equivalent protection.
Q10: Can children get the flu vaccine and the COVID-19 vaccine at the same time?
A9 | Dr. Nuse: Yes, the CDC says it is safe to receive both the flu and COVID-19 vaccine at the same time, and you do not need to spread out vaccinations.
Q10: What is your advice for parents who might be concerned about the COVID-19 vaccine for their children 5-11?
A10 | Dr. Nuse: If you have questions, talk with your pediatrician, your family physician, or your child’s specialist. That’s what we’re here for. This is a very safe vaccine. We’re excited that we now have protection for this age range. If you have doubts or questions, have a conversation with your trusted healthcare provider. There’s a lot of information available on the internet, but no one ever double-checks to make sure the information is true and accurately reflects the latest details. We can help you sort through that information and partner with you to make the best decision for your child.
Q11: How do I schedule an appointment for my child to receive the vaccine?
A11 | Dr. Nuse: COVID-19 vaccines for children 5-11 are readily available at pediatric and family medicine offices across Atrium Health, allowing children to receive their vaccine in the comfort of their trusted provider’s office. Visit AtriumHealth.org/COVID19Vaccine to schedule or log into your child’s MyAtriumHealth account. Vaccines are available for anyone who is eligible, you do not have to be a current Atrium Health patient. You can also visit our COVID-19 vaccine resource hub online to learn more.
