Moderna's COVID-19 Vaccine Approved For Kids Under 6

After what has seemed like an eternity of waiting for parents of young children, there is finally a COVID-19 vaccine available for kids 6 and under. On June 17th, the FDA authorized Moderna’s Spikevax for emergency use authorization (EUA). CDC advisors gave the green light for the vaccine on June 18th, and CDC director Rochelle Walensky signed off soon after. Parents can now get the vaccine for their children at their healthcare provider, local pharmacy, clinic, or health department.

We reached out to experts to help parents understand why this vaccine is needed for their little ones, what the trial data showed about the vaccine, what side effects to expect, and what to do if you have any concerns about getting your child vaccinated.

What the Moderna COVID-19 Vaccine Approval Means for Parents

Approval of this vaccine means that 19 million children in the 6 months to 5-year-old age group now have some extra protection against COVID-19, points out Jonathan Blau, MD, FAAP, director of neonatology at Staten Island University Hospital. “Pediatricians and families have been awaiting a pediatric vaccine against COVID-19 for children under age 5 years for the past two years of the pandemic,” says Dr. Blau.

Although the Pfizer vaccine has been available to children aged 5 and up since November 2021, younger children and babies have gone unprotected. This has been very challenging for young children and their parents. Young kids have endured exposure, testing, and quarantines at school and daycare, as well as COVID-19 infections. This has meant missed work, stress, and anxiety for parents who still find themselves navigating the pandemic, even as many others have been able to move closer to normalcy.

Why Is a COVID-19 Vaccine for Kids Under 6 Needed?

Most young children do not get severe cases of COVID-19, says Behnoosh Afghani, MD, pediatric infectious disease specialist at UCI Health. But that doesn’t mean COVID-19 is something parents should take lightly.

“While COVID-19 tends to be milder in children than adults, children who get infected can get very sick and get hospitalized and even die from the infection,” says Dr. Afghani. “Vaccinating young children can help protect them from getting a severe COVID-19 infection and also spreading it to others if they get infected.” 

During the Omicron surge, the American Academy of Pediatrics (AAP) reported over 4.9 million COVID-19 cases in children. Sadly, hospitalizations of children rose dramatically during this period as well. This was particularly true when it came to the youngest cohort. The CDC reports that hospitalizations of kids aged 0 to 4 were higher during the Omicron surge as compared to the Delta surge.

“Most of the children I take care of in my practice are immunocompromised and most parents of these children are eager to have their children vaccinated,” Dr. Kanthula shares. “A lot of immunocompromised children have been ‘living in a bubble’ to prevent severe disease.” A vaccine will mean that these kids can safely return to school and socialize again.

What the Vaccine Trial Data Showed

Moderna tested their COVID-19 vaccine in two different groups: kids aged 2 to 6, and babies and toddlers aged 6 months to 2 years. A total of 11,700 children have been enrolled overall in Moderna’s trials, including 4,200 kids aged 2 to 6, and 2,500 kids 6 months to 2 years.

Both the young kids (2 to 6) and babies/toddlers (6 months to 2 years) received two 25 μg doses of Moderna’s COVID-19 vaccine, spaced 28 days apart. This is a quarter of the dose given to adults, who are given two 100 µg doses.

The study researchers measured the immune response in the children who received the vaccine. According to Moderna, the response in young kids was excellent and produced “robust neutralized antibody titers” that were similar to levels observed with adults who had received the vaccine.

The efficacy of the vaccine—how well it prevented transmission—was a little different. Among the 6-month to 2-year cohort, protection against infection was 51%. Protection against infection for kids aged 2 to 6 was 37%.

However, as Jacqueline Miller, MD, Moderna’s senior vice president of infectious diseases, notes, this trial was done during the Omicron period, when vaccine efficacy was lowered for everyone who had been vaccinated.

“Omicron is much more transmissible than the original strain of the virus and resulted in lower effectiveness among adults who received only two doses of the vaccine (the primary series) compared to what we saw when the original virus was circulating,” Miller explains. “The findings of this study are aligned with what we’ve seen in the real world among adults who haven’t been boosted or received a third dose.”

Dr. Blau agrees that lower efficacy was likely because the trial happened during the omicron surge. He points out that none of the children enrolled in the Moderna trial developed severe illness or needed to be hospitalized. “The trial did not expect to eliminate Omicron infections in young kids, but this reduced infection risk still translates to a significant reduction in severe illness, hospitalization, and death,” Dr. Blau notes.

What Is Known About Side Effects

Parents are understandably concerned about side effects when it comes to getting their kids vaccinated against COVID-19. Thankfully, the vaccines were well tolerated in the children who received them and Moderna did not note any safety issues.

“There were no new safety concerns identified in either age group,” says Dr. Miller. “The safety and tolerability profiles among children 6 months to under 12 years were generally consistent with what’s been observed across all age groups in the adult studies.”

Importantly, Dr. Blau pointed out, none of the kids in the trial developed myocarditis or pericarditis, inflammatory heart conditions that have, in rare cases, impacted teenagers and young adults receiving mRNA vaccines.

If You Are Having Concerns About the Vaccine

It’s common for parents to have misgivings about getting their kids vaccinated. Dr. Afghani wants to assure parents that childhood vaccines are extensively studied and scrutinized and that even after a vaccine is approved, it continues to be monitored and analyzed.

Moreover, COVID-19 vaccines really are necessary for young kids, no matter how bulletproof you may think your child is. “Although children typically get mild disease, occasionally they can get severe disease or die from it,” Dr. Afghani reminds. She also points out that even though the efficacy of this vaccine is lower than some, it will still prevent the worst outcomes, and it will also help protect a child’s family and community by limiting its spread to others.

Some families may choose to forgo vaccination because their child has recently been infected with COVID-19, says Dr. Kanthula. But it’s not possible to know how long protection from COVID-19 will last, and it’s possible that your child could become reinfected, Dr. Kanthula points out.

The CDC notes that protection from vaccines is more robust than protection from natural infection, sharing a study that found that people who were infected but not vaccinated were five times as likely to become infected with COVID-19. Vaccinations also are better able to prevent infection by any new COVID-19 variants that emerge, according to a recent study by Stanford Medicine.