With nearly 300,000 children in South Carolina on the cusp of becoming eligible for COVID-19 vaccination, pediatric leaders at Medical University of South Carolina are anticipating vaccinations as early as next week in the youngest age group yet.
"A lot of parents have been asking for a long time," said Dr. Elizabeth Mack, chief of pediatric critical care at MUSC. "This has been on a lot of people's radar for a long time. I'm really excited."
Earlier this week, an advisory panel at the Food and Drug Administration reviewed data from clinical trials and voted to approve Emergency Use Authorizations for those ages 6 months to 4 years old for both the Pfizer and Moderna COVID-19 vaccines. Those recommendations and the data will be reviewed by an advisory committee to the Centers for Disease Control and Prevention from June 17-18 and they may vote to recommend the vaccines as well to CDC Director Rochelle Walensky, who would issue a final recommendation and open the door to vaccination.
The U.S. Department of Health and Human Services is already allowing pre-ordering by the states and is prepared to ship 10 million doses initially once there is approval, said Dawn O'Connell, assistant secretary for preparedness and response. The S.C. Department of Health and Environmental Control expects to receive 27,800 doses of Pfizer and 27,800 doses of Moderna, spokesman Derrek Asberry said. Vaccinations could begin early next week and parents will be able to locate clinics that have vaccine through the DHEC vaccine locator, he said.
MUSC could begin vaccinating children as early as June 21 if it has received its vaccine, Mack said.
The vaccines for the smallest children, while a fraction of the dose received by adults and older children, appeared to be just as effective. In clinical tests submitted to the FDA, Moderna's two-dose regimen was 50.6 percent effective in preventing symptoms in those ages 6-23 months and 36.8 percent effective in those ages 2 to 5 years old. The company noted that this clinical trial was during the highly infectious Omicron wave earlier this year and that protection was comparable to what adults experienced during the same surge.
Pfizer's three-dose course showed it was 75.6 percent effective in those 6-23 months and 82.4 percent effective in those 2-4, for an overall effectiveness of 80.4 percent, according to the data the company submitted.
MUSC took part in some of the Moderna vaccine trials that began in June 2021 so they were "very methodically studied," said Dr. Andy Atz, chair of the Department of Pediatrics at MUSC and who oversaw the COVID-19 vaccine trials in children.
"This was very carefully done, specifically for children," he said. "This has been found to be safe and effective" in these young children.
This age group is the last large segment of the population that remains ineligible for COVID-19 vaccination. In the U.S., that is 6 percent of the population or 18,827,338 kids as of July 2021, according to the Census Bureau. It is 5.7 percent of South Carolina's population or roughly 295,870 children, according to Census data and an analysis by The Post and Courier.
Gaining that eligibility would be "an important moment in the pandemic," said White House Coronavirus Response Coordinator Ashish Jha. "It would mean that, for the first time, essentially every American, from our oldest to our youngest, would be eligible for the protection that vaccines provide."
While there is likely pent-up demand from some parents, many are not likely to rush out and have their children under 5 receive shots. A Kaiser Family Foundation survey found 18 percent of parents said they would vaccinate their toddlers this age right away while 38 percent said they would adopt a "wait and see" attitude, and an equal number said they would only do so if required or would "definitely not" vaccinate their children at that age.
While there have been clinical trials, none of those trials compared one against the other so there is nothing that says one is better than another. With a two-dose regimen, a child getting the Moderna shots would have completed the series after 28 days, where a child receiving Pfizer "will take a few months longer" because of the need to wait for the third dose, Atz said.
"It is a good conversation to have" with a health care provider, Atz said. But it is more important to get a child started on immunization than it is to get a particular brand, he said.
"That's a question where we can get the facts and parents can decide," Atz said.
The new approvals come as COVID-19 cases in the state and the area appear to be steadily rising, Mack said. The youngest children have not escaped severe disease from the pandemic: of the nearly 500 children hospitalized at MUSC, 141, or 28 percent, were ages 6 months to 4 years, she said.
"There is definitely a need," Mack said. And as long as those youngest children could not be vaccinated, they remained vulnerable to infections that could then be passed on to other family members as well, Atz said. A chance to get them protected "can in fact help protect the entire family," he said.