SIOUX FALLS, S.D. (KELO) — Pfizer is claiming that its COVID-19 vaccine offers strong protection for children younger than 5-years-old.

This comes as the company prepares to send data to the FDA, hoping to gain approval for the use of the vaccine for kids older than 6-months in age.

Pfizer’s preliminary data claims that the vaccine, which has been given to children ages 6-months to 4-years in three doses that are 1/10th the strength of an adult dose, has an efficacy rate of 80.3%.

“That’s actually a pretty robust response,” said Dr. David Basel, Avera’s Vice President of Clinical Quality. “What we’ve been seeing in a lot of these vaccines is they’re in that 70% effectiveness range initially.”

Basel says the significance of an 80% efficacy rate also depends on what that 80% is referring to. “It also depends on whether you’re talking about the response to any infection, or to severe hospitalization — maybe an 80% response of preventing any infection, but they’re going to be near 100% protection against severe hospitalization.”

Another noteworthy aspect of Pfizer’s claims is that the vaccine safety profile in their study was similar to that of the placebo. We asked Basel to explain what this means.

“So if you follow a large population over time, a certain percentage of them are going to get rare incidences of things,” said Basel. “[Things] like Guillain-Barre (an immune disorder), or muscle weakness — if you happen to be giving a therapeutic trial of anything, such as a vaccine, then 1% may come up with a muscle weakness.”

Basel says that by also maintaining a placebo group alongside the trial group, researchers can compare the incidence rate of things such as muscle weakness in the trial with that of the placebo group. “If [the incidence rates] are exactly the same, then the vaccine’s not causing any problems,” he explained.

“Let’s say one in a million children goes blind each year. If one in a million children that didn’t get the vaccine went blind, and one in a million people who did get the vaccine went blind, then it’s a pretty good indication that the vaccine isn’t causing blindness,” Basel expounded.

If the Pfizer data is reliable, this implies that there is no statistically relevant rate of adverse reactions to the vaccine in children aged 6-months to 4-years.

Whether or not that data is reliable is the question. Determining this will be the job of the FDA, as the body considers whether or not to allow the use of the Pfizer vaccine in a younger age range. The importance in the role of the FDA in vetting this data was highlighted to KELOLAND News by Dr. Joe Segeleon, Vice President Medical Officer for Sanford Children’s Hospital.

“That’s why we have an FDA board. That’s why we have the analysis that the FDA has to go through as well,” said Segeleon. “It’s looking at the data to make sure that it’s sufficient, and making sure that the data is valid.”

Segeleon acknowledged that if the data proves to be accurate, it would mean that we have a very safe and effective vaccine on our hands for some of the youngest in our society. He emphasized the importance of parents considering the vaccine thoroughly.

“Although most children do well with COVID, and many children have already been infected, there is over 125,000 hospitalizations in children less than age 18. There’s over 1,500 deaths due to COVID, in individuals less than 18, and 477 of those deaths were in individuals less than age 4,” said Segeleon.

Due to this, Segeleon urges parents to make a decision for their child in consultation with their medical provider. “It is appropriate and accurate to say that there is less risk of serious illness in children, but it’s not zero, and we do know that vaccines — looking at the older populations — are effective in decreasing hospitalizations, decreasing deaths and decreasing prolonged COVID.”

While the nation has seen a shift in COVID-19 from a pandemic to an endemic, neither Basel nor Segeleon seem to indicate that we are in a position to just forget about COVID.

“Most experts I hear — and I agree with — think that we’re not totally done with hearing about COVID,” said Basel. “This fall particularly, we’re likely to see at least some resurgence. The only question is, is it going to be mild, or are we going to start having issues again.”

Segeleon also noted the danger of resurgent COVID. “Our cases of positive [COVID-19] have gone up,” he said. “I suspect that we are undercounting in the population, the number of positive cases because of the ability to do home tests,” he said.

While hospitalizations are now below the highest levels we have seen in the pandemic, Segeleon warns that the numbers are once again starting to creep up.

The FDA has said it will move quickly in evaluating the use of the COVID-19 vaccines in ages below 5-years, but that it will also be thorough. Moderna also currently has a vaccine under consideration for this age range.

The FDA has announced tentative plans to examine the data in June.