COVID-19 booster authorized
On May 17, the U.S. Food and Drug Administration (FDA) authorized a Pfizer-made booster—that is, a third mRNA shot—for kids ages five to 11 years old. The Centers for Disease Control and Prevention (CDC) followed suit on May 19.
FDA Commissioner Robert M. Califf explained his agency’s recommendation in a statement acknowledging that COVID-19 has been less severe in children than for adults, but adding that “the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease.”
In a statement following her agency’s recommendation, CDC Director Rochelle Walensky said, “Vaccination with a primary series among this age group has lagged behind other groups, leaving them vulnerable to serious illness. With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected.”
The omicron variant known as BA.2.12.1 is now the dominant coronavirus strain in the U.S. It is even more transmissible than previous variants, which is why public health officials continue to press to get as many Americans as possible vaccinated and boosted.
The Pfizer vaccine, which is the only one approved so far for use in this age group, is a third of the dose given to adults and children ages 12 and up: 10 micrograms vs. 30 micrograms. The booster is recommended for five-to-11-year-olds if it’s been at least five months since they completed the initial two-shot series.
According to clinical trials conducted by Pfizer-BioNTech, a subanalysis of 30 children in the trial found that the third dose provided a 36-fold increase in antibodies against the omicron variant of the virus.
Even though younger children as a group haven’t typically become as sick as adults who contract COVID-19, they are still at risk. According to CDC data, COVID-19 was the fourth leading cause of death in children ages five to 14 as of December 2021. And that was before omicron appeared.
In addition, young children are also at risk of the potentially deadly multisystem inflammatory syndrome in children (MIS-C) as well as long COVID.
Pediatric vaccines coming
This is why parents have been eagerly awaiting a vaccine for their youngest children. Now it seems both the Pfizer-BioNTech and Moderna vaccines for children six months to four years old may be approved as soon as mid-June.
Last month Pfizer announced that its three-dose vaccine regimen was 80 percent effective at preventing symptomatic infections in that age group.
Shortly after that announcement, the FDA said its outside panel of experts would meet to consider Pfizer’s evidence on June 15. If the agency’s panel recommends approval of the vaccine, the CDC would then ask its advisers for a recommendation. Once that happens, the CDC will issue a recommendation, and vaccines would be available as soon as this month.
At the same meeting, the FDA’s panel will also consider approval of Moderna’s pediatric vaccine, which is a two-shot regimen of 25 micrograms, or a quarter of the adult dose. Moderna’s data show that its vaccine was 51 percent effective in preventing illness in children ages six months to two years, and 37 percent effective in the two-to-five-year-old group.
Kavita Patel, a primary care doctor at Mary’s Center in Maryland and the District of Columbia, welcomed the simultaneous FDA review of both pediatric vaccines, telling The Washington Post the process “gives providers a lot of benefit.”
“The most common question we will get from early vaccine recipients is which one is better,” she said. “We will [be able] to say, ‘This is what the data show.’ ”
When asked which vaccine she’d give her own children ages two and four, CNN’s medical advisor Leana Wen said it would be either Pfizer or Moderna, whichever was available first.
“I trust the very thorough regulatory process and believe that both of these vaccines, if and when authorized by the FDA and recommended by the CDC, will be safe and effective,” she told CNN.
Will it be safe?
The question from everyone from the time the vaccines were developed was, “Are they safe?” The data have shown overwhelmingly that coronavirus vaccines are safe for adults. The same has proven true for children who have already been vaccinated.
“There is no reason to expect in this age group [six months to five years] that we’re going to have some kind of different safety profile than what we saw in children, for example, five and older, in whom millions and millions of doses have been given,” Sean O’Leary, vice-chair of the American Academy of Pediatrics’ (AAP) committee on infectious diseases, told ABC’s Good Morning America.
The benefits far outweigh any potential risks, he added.
“I think we all know that the disease is most severe in the elderly and people who have problems with their immune system, but that’s not to say that COVID-19 is a benign illness in children,” he said.
“We’ve seen tens of thousands of hospitalizations in children, and the risk to children under five, actually, for hospitalization is higher than it is for older children, so absolutely there is a need to protect those children with the vaccine,” he added.