COVID vaccines for kids under five are finally here. Here’s why it took so long

Finally, parents of children under five – many of whom have felt left behind during the pandemic – can breathe a sigh of relief.

Finally, a COVID-19 vaccine for the youngest children is expected to be recommended for Emergency Use Authorization (EUA) in the coming days. The news comes as an FDA advisory panel voted Wednesday to recommend approving the Pfizer and Moderna vaccines for children under age 5 — the first step in a multi-stage process toward full approval.

While the news was greeted with relief, many parents have waited over two years for the opportunity to protect their little ones. In addition, there were several times during this period when rumors circulated that vaccines for children under the age of five would soon be approved; again and again parents found their hope disappointed. In May, mass immunization centers across the country — including Chicago and Seattle — allowed parents to book vaccination appointments for their children, despite a delay.

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In late 2021, health officials in the Biden administration hoped to approve Pfizer and BioNTech vaccines for children between the ages of six months and five years sometime in early 2022, possibly by February 2022. But by the time February 2022 rolled around, the possibility was any permit was being pushed back to spring; Then the Food and Drug Administration (FDA) said it wanted more data on the possibility of a three-dose Pfizer vaccine because of concerns about the Omicron variant, which affects the vaccine’s effectiveness. (Notably, Moderna’s two-dose vaccine appeared to provide more protection against Omicron.)

“It was hard. We have two school-age children and never knew when or what they were bringing home. “Well, honestly, I thought it was about time. We have worked without protection for this age group for so long. It didn’t make any sense.”

“The bar on the safety issue is really high… We know the vaccines don’t protect that well against Omicron, so it’s kind of a moving target in terms of efficacy that you’re aiming for.”

So why has it taken so long to get where we are today? Countries like China, Argentina, Venezuela, Croatia, Germany, Greece, Hungary and Spain have already offered vaccinations for children under the age of five. The answer has to do with emerging variants; the difficulties in conducting clinical trials in children; and unsatisfactory results from clinical trials on how much protection the vaccines offer. To be clear, safety and side effects have never been a reason for delay.

“The bar for security is really high, [but] It’s difficult to do efficacy studies,” Dean Blumberg, associate professor of pediatrics at the University of California-Davis, previously told Salon. “We know the vaccines don’t protect that well against Omicron, so it’s sort of a moving target in terms of effectiveness that you’re aiming for.”

One of the biggest challenges in vaccine development stems from the fact that children have different immune systems than adults, making balancing dose adjustments and immunity a complicated balancing act. This made it increasingly difficult to conduct clinical trials for this cohort.

“Children have a different, less experienced immune system and are also different sizes than adults,” said Blumberg. Essentially, younger children’s immune systems are “less mature,” Blumberg added, and they typically have less body mass than adults. In general, this means adjusting the dose of the vaccine – either more or less than in adults – to produce a healthy and protective immune response. As a result, Pfizer’s dose for children is a tenth of what’s given for adults, and Moderna’s is a quarter of what’s given to adults.

Because clinical trials were being conducted when the Omicron variant began to spread, protection with Pfizer’s two-dose pediatric vaccine was lower, affecting dose calculations. Therefore, a three-dose vaccine is required, which is now expected to be approved.

According to Pfizer’s latest data, the three-dose vaccine offers 75 percent efficacy against COVID-19 in children aged six months to two years and 82 percent efficacy against Omicron in two to four-year-olds.

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However, during Wednesday’s FDA meeting, concerns were raised about the logistics of getting three doses into the arms of children, since the third dose is key to real protection. With just two doses, the vaccine is only 14 percent effective in children under 2 years old and 33 percent effective in children 2 to 4 years old, specifically tested with Omicron. Specifically, while the second dose of Pfizer is given three weeks after the first; the third is given at least eight weeks after the second.

“I’m concerned that parents don’t necessarily realize that after two doses, they might be unprotected at all and engage in the type of activity that would put their child at risk,” Dr. FDA Committee Member Paul Offit, an FDA committee member, said.

Ultimately, the committee agreed that the benefit outweighs the risk.

Moderna’s two-dose Omicron vaccine is estimated to be about 51 percent effective in children ages six to two years and about 37 percent effective in children ages two to five years.

While Wednesday’s meeting was a promising step forward, nothing is certain. Next, a panel of experts advising the Centers for Disease Control and Prevention will meet to make their recommendation. Once that happens, the FDA could issue a final recommendation, which will likely result in CDC Director Rochelle Walensky officially signing off on the recommendations next week. This could mean that children aged between six and five months could start vaccination as early as next week.

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