Maui Pediatrician Discusses “Safety and Efficacy” of the COVID-19 Vaccine in Kids

A Maui pediatrician provided safety and efficacy information to parents considering the COVID-19 vaccination for children in the 5-11 year age group.

Dr. Irene Papaconstadopoulos, M.D., Medical Director at C.H.A.M.P.S. Pediatrics in Kīhei, where she practices as a private pediatrician said, “As a pediatrician and a mom of two boys that are in this age group, I was anticipating a lot of excitement that we saw already, but also a lot of questions and concerns, which are reasonable from parents.”

She credited state and county officials as well as the Department of Health the Immunization Branch with the speedy distribution of the vaccines upon obtaining Emergency Use Authorization.

“In my office, I have personal experience, but seeing also from other pediatricians’ offices, clinics, pharmacies, and the hospital, we’ve already vaccinated hundreds of kids on Maui with the first dose, and we haven’t seen any adverse effects,” Dr. Papaconstadopoulos noted during a press briefing on Friday hosted by Maui Mayor Michael Victorino.

Dr. Papaconstadopoulos said she is getting a lot of questions from parents, as expected, and weighed in on the most common concerns below:

If children don’t frequently experience severe illness with COVID-19, why do they need to be vaccinated?

Dr. Papaconstadopoulos addressed what she called a “misconception” that COVID-19 in children is rare and not common as in adults, or serious. In doing so, she pointed towards numbers compiled in recent studies.

“From the beginning of the pandemic, up to October 2021, in the 5-11 age group, there have been to date about two million cases of COVID-19 that are confirmed. There are probably more than that. We know from studies now, that by measuring neutralizing antibodies in this age group, that children are just as likely as adults to get COVID-19,” said Dr. Papaconstadopoulos.

“We have had 8,300 hospitalizations in the US in children 5-11 years old. A third of those required pediatric ICU admission. Two-thirds of those have had co-morbidities–the most common of which were asthma and obesity. And one-third of all of those hospitalizations were previously healthy children,” she said.

To put things a little bit into perspective, the total number of children 5-11 in the US is about 25 million. “The total number of deaths per year that we have in that age group prior to COVID is about 2,000-2,300 total. That’s a total number–and the most common cause are accidents in this age group, congenital heart defects, congenital anomalies, and neoplasms (cancer),” said Dr. Papaconstadopoulos.

She described this age group as a healthy age group saying, “It is not expected to be hospitalized or to die. The total number of deaths from COVID-19 from the beginning of the pandemic in this age group is around 100. That puts COVID-19 right now as the eighth leading cause of death in children 5-11 years old. It is more serious, more common than bacterial sepsis.”

“Some people may not remember, but prior to approving the Meningococcal vaccine that we routinely give in children at 11 years old, we had about eight confirmed deaths per year in that age group from meningococcal sepsis or bacterial meningitis. So no amount of death is acceptable in this age as long as we have an effective and safe vaccine,” said Dr. Papaconstadopoulos.

How effective is this vaccine?

Regarding risks, Dr. Papaconstadopoulos said this age group has the unique risk that it’s the highest risk for MIS-C–that’s the Multisystem Inflammatory Syndrome in children, having the most common age presentation of 9 years old.

She noted that MIS-C presents itself about 2-4 weeks after an infection with COVID-19.

“Now these children may not have had severe COVID-19. They may have had very mild symptoms–fever, cough, congestion–and 2-4 weeks later we see that it’s a reaction of their immune system, which causes a systematic inflammatory response. There’s inflammation in multiple organ systems, including the heart, causing a condition commonly known as Myocarditis. So children with MIS-C–60-70% of those required pediatric ICU, and 1-2% of those died. The total number of cases of MIS-C from the beginning of the pandemic are 5,217 as of October 2021–and 40% of those cases were in children 5-11 years old,” she said.

Dr. Papaconstadopoulos said we still do not know the long term effects of COVID-19 in children (long haul COVID).

“Currently there is a study to look into that. I don’t think there is any primary care physician who hasn’t seen the mental health toll that COVID-19 has taken on kids,” she said.

“We can now say that the risk of COVID-19 is similar to pre-COVID influenza rates. So it has the same risk as the influenza prior to COVID for children this age,” said Dr. Papaconstadopoulos.

The FDA Emergency Use Authorization was based on the results from a clinical trial that included about 4,300 children between the ages of 5-11.

“So what they did is they vaccinated about 3,000 of the children and about 1,500 received placebo. They compared the neutralizing antibody titers in this age group to the neutralizing antibody titers from a larger study in 16-25 year olds, and they found that with 1/3 of the dose, they had an equivalent response–an equivalent production of antibodies. Because the study was done during the Delta surge, we know that it protects also from the Delta variant,” said Dr. Papaconstadopoulos.

The vaccine, she said, is 90% effective in preventing COVID-19 infection.

“I found it interesting that 9% of the children in this study already had antibodies–they already had COVID–so they tolerated the vaccine well. It actually boosted their immune responses,” said Dr. Papaconstadopoulos.

Adverse Effects: How safe it is for children?

During the study, the children were monitored for side effects, and they continue to monitor for two months later.

“We know historically that the most common adverse effects from vaccines will be shown within the first two months after vaccination. That is why they put that limit. In medicine at some point, there has to be a decision of when we know enough to start protecting the rest of the decision,” said Dr. Papaconstadopoulos.

“In that amount of children, the side effects were generally mild to moderate. There were less frequent side-effects than the 12 years and older. The most common was pain at the site of the injection (about 70%); 40% experienced fatigue; 28% headache; 12% muscle pain; and about 10% reported chills with fever,” she said.

She noted that cases of myocarditis (inflammation of the heart muscle); and cases pericarditis (inflammation of the outer lining of the heart) have been reported in children after the second dose of the vaccine in ages 12 and above.

“This study had no cases of myocarditis, but the total number of the participants, 4,000, is pretty small to show us very rare adverse effects. So that is why they’re continuing to monitor,” said Dr. Papaconstadopoulos.

“Parents should keep in mind that the virus itself, the actual infection from COVID-19 is more likely to cause myocarditis than the vaccine. And we know by numbers that it is about 37 times more likely in older kids 12 [years] and above, the virus to cause the myocarditis, and a much more severe myocarditis than the vaccine,” she said.

“The vaccine itself has caused in young male adults–and the risk is about 54 cases per 1 million doses of the second dose of the vaccine administered to males ages 12-17. And almost all of those cases resolved completely without leaving permanent sequelae,” she said.

Dr. Papaconstadopoulos said that the FDA, the American Academy of Pediatrics, the Infectious Disease Society of America, and multiple health organizations endorse this vaccine, “because the overall benefits outweigh the risks.”

“Anything we do, and any decision we make has a risk and a benefit, and right now it’s clear that the safest way to protect our children from the complications of COVID, and as Dr. [Lorrin] Pang said previously, we don’t know how much we are going to see in the future, the safest way right now to protect them right now is by vaccinating them. The risk right now to vaccinate is lower than getting COVID in this age group,” said Dr. Papaconstadopoulos.

In speaking, she urged parents to discuss these topics with their pediatrician and family doctor, and make the decision that is best for their family.