FDA Approves COVID Vaccines for Younger Children

On June 17, the Food and Drug Administration approved the Pfizer and Moderna vaccine for ages six months to five years. Immediately following, the American Academy of Pediatrics, American Academy of Family Medicine, and the Advisory Committee on Immunization Practices (ACIP) strongly recommended the vaccine for this age group. Lancaster Pediatrics providers are enthusiastically encouraging parents to vaccinate their children as it offers protection for this very vulnerable age group.

In the last two years, there have been nearly 170 children admitted to Lancaster General Hospital for illness caused by COVID-19. Most of these hospitalizations were children under the age of five, and 100% of these hospitalizations were comprised of children who were unimmunized. Statistics report that one out of every four children hospitalized during Omicron required the Intensive Care Unit.  Nationwide there have been 442 deaths of children under 5 from COVID. The above statistics reinforce what all pediatricians know: COVID can be dangerous for young children.

While serious COVID disease in young children is thankfully very rare, it is very scary for all when children require oxygen support and IV fluids. This is now preventable. Further, children can get multisystem inflammatory syndrome (MIS-C) from COVID which causes inflammation throughout the body that can affect the heart and other organs. The illness affects children on average about four weeks after COVID infection. To date, there have been 8,525 cases of MIS-C with 69 deaths in the United States.

Beyond illness, we know that our youngest children have suffered from the limitations created by COVID. Nine-month-olds need to see faces and mouth movements to reinforce emotions and language. Three-year-olds need to go to preschool and learn to interact with their peers, follow rules, and participate in group activities. And all children benefit greatly from time with their grandparents without worrying about making them sick.

The above information and statistics reinforce what all pediatricians know: COVID is detrimental to kids in so many ways and can be very dangerous for young children. It is great news that we now have effective, safe protection for everyone but those under 6 months.

Here is what parents need to know before getting the vaccine for their child: 

Both vaccines use the same mRNA vaccine protection that has been used since late 2020 and studied in human trials for well over a decade.

For Pfizer:

• Ages 6 months to 4 years will receive 3mcg of vaccine with each dose. By comparison, 5 to 11-year-olds receive 10 mcg and those aged 12 and older receive 30 mcg.

• It is a series of 3 vaccines, with 3 weeks being recommended between the first and second dose and 8 weeks between the 2nd and 3rd dose.

• It has been shown to be 80% effective in protecting against COVID disease and likely much higher protection against hospitalization and death from COVID.

For Moderna:

• Ages 6 months to 5 years will receive 2 shots at 4 weeks apart.

• The dose is 25 mcg, which is one quarter the size of the adult dose.

• Moderna vaccine was shown to be 40-50% effective in protecting against COVID disease and likely higher protection from hospitalization and death.

• A third booster dose of Moderna vaccine is expected to be approved sometime later this summer.

Side effects for both kinds of vaccine were mainly soreness at the injection site, fever, and irritability for brief time periods. There were no cases of myocarditis reported in the studies of smaller children, but parents and health care providers are still advised to be aware of that rare and treatable possibility. The chances of getting myocarditis from COVID infection are much higher than from getting it from the vaccine.

Both vaccines may be given with other routine immunizations and do not need to be spaced from other shots in any way. Children and teens who have already had COVID should still get vaccinated.

I frequently hear from parents concerned about so many vaccines being given to children who are so small. I understand this concern, but even from birth our immune systems are quite strong and competent, handling a constant onslaught of new germs and exposures. Vaccines are only a tiny blip in the long list of responsibilities that our immune system handles adeptly from a very young age. Furthermore, there are volumes and years of data that supports vaccine safety for children.

A reminder also that “booster doses” or third doses of COVID vaccine are recommended for anyone ages 5 and up who received the second COVID vaccine at least 5 months ago.  The third dose, or booster, has been shown to be critical for protection against newer strains of COVID-19 such as the omicron variant. And a fourth booster has been recommended for everyone age 50 and older and those who are immunocompromised.

According to recent statistics there are close to 222 million people fully vaccinated against COVID-19 in the United States. You have a five times greater risk of being hospitalized for COVID if you are not vaccinated. Most importantly, safety data is very reassuring with adverse events related to the vaccine being very low in all age ranges. Vaccine experts remain confident that there will be no long-term negative effects from the vaccine.

Healthcare providers are reporting that there is a new trend of people seeking vaccination who were initially hesitant but have changed their minds and are now getting vaccinated. It is important that parents hear from their pediatricians that it is okay to change your mind and get your kids vaccinated; we understand that some needed more time to see safety data and to think about it. Pediatric clinicians continue to standby, ready to answer any parental concerns about the vaccine and maintain firmly that it should be a parental choice.

To quote my colleague Dr. Alexandra Solosko, a pediatric hospitalist at Lancaster General: “It’s not hard for people to look away from what is happening when they don’t have to watch patients and families suffering day in and day out. But those who work in healthcare don’t have the luxury of looking away.”

After 27 months of “not looking away,” pediatricians are so grateful that there is now vaccine protection for almost all children. We are looking forward to a safer time for all and, hopefully soon, fewer barriers between all of us.

Sources:
www.cdc.gov
www.aap.org