Pfizer says its COVID-19 vaccine to protect young children works, which means the U.S. Food and Drug Administration could approve an emergency use authorization for the vaccine for 5- to 11-year-olds within weeks.
The announcement Monday prompted Cincinnati Children's Hospital Medical Center to offer expert answers and advice about the kids' vaccine from Dr. Robert Frenck, director of the Gamble Center for Vaccine Research at Cincinnati Children’s. Frenck is also the principal site investigator for the Pfizer COVID-19 vaccine trials at the medical center. He was available to news reporters in a Zoom call.
When could approval come?
Question: Pfizer said it provided its data to the FDA, so how long will it be until we see the vaccine available to children 5-11 years old?
Answer: "I'm assuming that it'll take the FDA two to three weeks to review the data and then to make a decision ... so that it's possible, I think, that a vaccine could be available for children 5 years of age and above somewhere in the middle of October to the end of October."
Is the vaccine different than the adult jab?
Q: How is the vaccine for kids this age different from the Pfizer/BioNTech COVID-19 vaccine for teens and adults?
A: "The vaccine itself is the same... The amount of vaccine will be about a third (of the original dose)."
The 10 microgram dose worked just as well in these children as the 30 microgram dose for adolescents and adults, Frenck said. The Cincinnati Children's-based clinical trial for the age group helped determine that dose. The idea was to find a dose that was lower but still could provide the same immune response.
What role did Cincinnati Children's play?
Q. How big a part in the clinical trials for this vaccine did Cincinnati Children's Gamble Center for Vaccine Research play?
A. The local site was one of six sites nationwide that took part in the trials and did dose-finding work.
Are the side effects the same in kids?
Q. What were common side effects from the vaccine?
A. "The side effects in the children really mirrored exactly what we saw in adults. The most common thing is was pain at the injection site, also having headache and maybe fatigue. Fevers and chills were unusual …The side effects lasted a day or two."
What about myocarditis?
Q. Is there a concern about myocarditis?
A. "The myocarditis, which means swelling of the muscles of the heart, we have seen that as a rare side effect ... associated with the second dose. Rare meaning a few (incidents) per 100,000. So it's still like a 99.999% chance that this won't happen. It's been almost all in teenage boys. It's been mild, it's been treated with Motrin (ibuprofen), and they've gotten better."
One shot at a time?
Q. Is it safe to get a flu shot or other vaccine at the same time as the COVID-19 vaccine?
A. "Absolutely yes. You can take any vaccines together. Our immune system can handle all the vaccines at the same time."
My kid isn't 5. What should I do?
Q. What should parents do to protect their children until they can get a vaccine?
A. "Every school district is unique... What we have found nationally is that the masks and the appropriate distancing work well. Using those measures until we have vaccine is effective. (But) they only work well when you're using them."
Advice for vaccine-hesitant parents
Q. What would you tell parents who are hesitant to get their child vaccinated?
A. "While COVID it's less likely to cause severe disease in children, it's not zero. We won't know who are the ones who will be at risk. Beyond the clinical trials now we've given literally hundreds of millions of doses of vaccine to adults and teenagers in the country." He noted investigators saw two unusual side effects: myocarditis and the clotting that happened mostly women in their 30s or older, "and the incidence there was about one in 500,000 The data that we have now, for this vaccine, if we haven't seen anything else with the hundreds of millions of doses we've given, we're not going to see anything (else). I think parents should feel comfortable... It's continuing to show a very good safety profile."