KANSAS CITY, Mo. — Children’s Mercy Hospital hopes to begin vaccinating preschool children perhaps as soon as the end of the month, pending approval of an emergency use authorization for Pfizer’s vaccine from federal authorities.
The U.S. Food and Drug Administration announced Tuesday that its Vaccines and Related Biological Products Advisory Committee will meet Feb. 15 to discuss a request for an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine in children ages 6 months to 4 years old.
Children’s Mercy’s Infectious Diseases Division Director Dr. Angela Myers said the FDA committee will review Pfizer’s data and make a decision regarding an emergency use authorization, or EUA, preschool children.
If granted, the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices would consider the application and make a recommendation.
If and when standing orders are granted, vaccines could begin to be administered before the end of February.
“I’m really excited,” Myers said. “This is the last age group of kids that have been unable to be immunized so far. Once this happens, all people, 6 months of age and older, will be eligible for a COVID vaccine. That, to me, is really wonderful news. Along with declining cases, declining hospitalizations as we get over this omicron surge, this will be one more thing to help us keep COVID at lower levels.”
Cases in the Kansas City region as well as across Kansas and Missouri surged to record-shattering levels in January with the arrival of the omicron variant. Infection rates, while still sky high, have trended down in the last 10 days.
Myers said she expects it will be a three-dose regimen, but the initial Pfizer data submitted for review was for two doses.
“I completely understand some concern that parents might have, especially given the fact that it appears that two doses is not going to be enough and that those young children are probably going to need a third dose,” Myers said. “But I would just remind everybody that most childhood vaccines take multiple doses to take effect.”
The standard tetanus, diphtheria and pertussis, or Tdap, vaccine is a five-dose regimen. Pediatric polio, pneumococcal and flu vaccines also are multi-dose, Myers said.
She also hopes an EUA approval for preschool children will renew interest in vaccinated children ages 5 to 11 years old, who have been eligible for vaccination since last November.
The current vaccination rate for that age group is roughly 20%.
Children’s Mercy Hospital has taken part in Pfizer’s clinical trial for preschool children.
“We are doing everything we can to get things in place in order to offer the vaccine as soon as we are approved to give it,” Children’s Mercy’s Chief Emergency Management Medical Officer Dr. Jennifer Watts said. “We are making plans for our mass-vaccination clinics, just as we did for the other two age groups in pediatrics. We will also have our routine vaccine clinics that will be running too that would see these patients.”
Most children would receive vaccines at their pediatrician’s office, which is commonplace for a wide range of vaccines administered to that age range.
After peaking at 37 pediatric COVID-19 patients per day, Children’s Mercy reported 22 patients, including six in intensive care, on Thursday.
Omicron infections appear to be associated with an increase in multisystem inflammatory syndrome, or MIS-C, in children.
MIS-C is a hyper-inflammatory immune response that often shows up weeks after infection, even mild infections, and can affect the liver, heart, lungs and kidneys among other dangers.
“The last time we had MIS-C this high was a year ago, prior to having any vaccine available,” Myers said. “We really didn’t see an increase of MIS-C during (the) delta (wave), which we were thankful for, but we are seeing it again.”
While the omicron surge appears to have peaked, overall rates of infection and the long-term potential dangers associated with illness remain higher than any previous time during the pandemic, Watts said.
“I’m well aware that children overall have more mild disease than adults do, but children still spread disease to adults and adults to children,” Myers said. “The best way to be protected against getting infection altogether is by getting a vaccine.”
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