This article appeared in KSAT. Read the full article here.
The Food and Drug Administration could authorize COVID-19 vaccinations for children under the age of 5 in the next couple of weeks allowing the youngest population to get their first doses as soon as June 21, according to the Biden administration.
Dr. Mandie Svatek, a pediatric specialist at University Hospital, said the delay over those shots hasn’t been because of concern with side effects, but with trying to get the dosage correct for effectiveness.
The FDA’s outside panel of advisers will meet on June 14-15 to evaluate the Pfizer and Moderna shots for younger kids.
Moderna is seeking clearance for two low-dose shots for children under age 6 while Pfizer hopes to offer three extra-low doses to kids under age 5 — differences due to how each company studied its vaccine.
Currently the CDC recommends the Pfizer vaccination for everyone age 5 and older. Moderna is approved for adults only in the U.S.
Svatek answered some commonly asked questions about the vaccine for children age 5 and under.
Why don’t we have COVID-19 vaccines for children under 5?
Svatek: So the current studies actually showed that children (from) six months, up to two years showed a robust immune response, but (from) the age of two years to four years, that immune response was not the same as children that were over four. And so they’re currently looking at a third dose. As far as safety, the safety was looked at and it was found to be as safe as in children that were five and above. But as far as effectiveness, that’s where they needed to look a little bit further at that third dose.
When will we be able to vaccinate children under 5 against COVID-19?
Svatek: I hope that we’ll be able to get the FDA approval soon after they look at the studies for children under five with the third dose that they receive and looking at that immune response to assure that is as equal to those that are five and above.
If Omicron doesn’t cause severe illness, why were so many children under 5 hospitalized?
Svatek: So we saw as new variants were coming in, even with the Delta variant that we saw an increased number of children hospitalized. I had more children in the hospital with COVID, fortunately recovering pretty well. And then as Omicron moved in, we found that more individuals were being affected by Omicron. So it was much more easily spread than some of the other variants. And as we had children that were unvaccinated, that spread was much easier. And that number — 25% of children — were being affected by COVID, which was a much higher percentage than in the past. And so with that much higher percentage, we were starting to see much higher numbers in the hospitals for children, even though that’s still less than 1%.
How big will the COVID-19 vaccine dosage be for children under 5?
Svatek: So for children that are 5 to 11, ten micrograms is the current dose, which is less than children 12 and above. For children that are below the age of five that dosing is three micrograms — so significantly less of a dose. And that immune response in the children aged 2 to 4 was not found to be as effective. And so now they’re looking at that third dose to look at that effectiveness, to assure that they are going to have that same robust immune response as children that are five and above.
Did a safety concern cause a delay in the Pfizer COVID-19 vaccine for children under 5?
Svatek: There was no safety concern. There were similar symptoms that they found as far as side effects, the common side effects after you receive a vaccine — pain in the arm, fever, fatigue. But what they were looking at was more on the effectiveness side and how well you built that immune response from COVID.
Why is Pfizer looking at a three-dose series for its COVID-19 vaccine for children under 5?
Svatek: Currently looking at that dose. That’s in comparison for children. That’s five to the age of up to 12. It’s about a third of the dose, so it’s much less. And so that’s when they were looking at how effective that dosing was. It wasn’t found to be as effective. And so that’s why they’re looking at that third dose to assure that it is much more effective in reaching that immune response that’s similar to children five and above.
Have there been any safety concerns related to the vaccine trials in younger children, such as myocarditis?
Svatek: So when we look at the number of cases of myocarditis, you will see commonly what they estimate — 54 cases per million doses received. And so that rate is really low. And if we think about the number of children that have died from COVID, that has been over a thousand children that have died from COVID, and the number of children that have developed MIS-C (multisystem inflammatory syndrome), which is can be associated with myocarditis. There’s over 7,500 children that have had MIS-C and approximately 48 deaths from MIS-C. And so if we compare the two and we know that the number of associated myocarditis cases are self resolved with the vaccine versus you can actually get COVID and myocarditis and associated deaths with that, the risk-benefit has shown that you’re much more safe getting the vaccine and as opposed to getting COVID and putting yourself at risk or your child at risk for developing myocarditis.