Moderna Says Low-Dose Vaccine Is Safe for Kids Under 6 & Offers a 'Strong' Immune Response
On March 23, Moderna shared a promising update on the results of its COVID-19 vaccine trial in kids. According to the pharmaceutical company, a lower-dosage of its MRNA vaccine generated "a strong immune response" in kids ages 6 months to 6 years, and resulted in zero cases of serious illness or death.
The results come after more than a year of extensive study.
While Moderna's adult vaccine was initially approved in December 2020, a kids version took much longer to get right.
In early 2021, the drugmaker said it had officially launched "KidCOVE" — a mid-scale study on children of all ages — but it wasn't until the following fall that the FDA finally approved it in kids 5 and up.
Since then, parents of kids under 6 have been waiting to get an update on when their child might be eligible.
Roughly 6,900 kids under the age of 6 participated in Moderna's trial.
And while some kids did experience side effects after taking the vaccine, researchers said the majority of them were "mild or moderate." (Typically, this refers to things like a mild fever, fatigue, and/or pain at the injection site, according to the Centers for Disease Control and Prevention.)
There were also zero reported cases of myocarditis, a rare but sometimes serious health condition that causes inflammation around the heart. Hopefully, this news puts the minds of many parents at ease, although it should be noted that the link between the COVID-19 vaccine and myocarditis in general is weak, at best.
The chance of kids getting myocarditis from Covid-19 are greater than from the vaccine, says Kizzmekia Corbett, the scientist who helped develop the Moderna vaccine.
— New Day (@NewDay) October 28, 2021
Parents should ask if they prefer their children have "antibodies ready to fight off this virus or not." pic.twitter.com/vOKvS9oSLH
The under-6 vaccine would also be given at a considerably lower dosage than adults currently receive.
But according to Moderna, a little has proven to go a long way.
In fact, the drugmaker saw positive results after giving just two 25 microgram doses of the shot to kids under 6, which is roughly a quarter of the dose given to adults. Children involved in the study also produced an antibody response similar to what was seen in those 18 and older, which is promising.
There was one area of weakness in the study, however.
When it came to omicron variant of the COVID virus, the Moderna vaccine had a lower rate of protection than it did with other variants. Still, the protection it did offer was significant.
For kids 6 months to 2 years old, the efficacy rate was 43.7%, reported NBC News. In kids 2 to 6, it was slightly lower, at 37.5%.
The company also noted that any infections reported post-vaccine were mild and non-life-threatening. In other words, there were no cases of severe illness, hospitalization, or death among any of the children in the study.
The news certainly has many parents breathing a sigh of relief this morning.
(And after a quick scroll through Twitter, pediatricians seem to be pretty psyched about it, too.)
"MRNA vaccines are a miracle of modern science!" one mom tweeted, after reading the news.
"I know a lot of parents who have been anxiously waiting for this moment!" added Miranda van Tilburg, PhD.
Potentially fantastic, hot-off-the-press news for parents: Moderna seeking emergency use auth for its vaccine for kids 5 and under. Stay tuned. 💉✨
— Scott Hadland, MD (@DrScottHadland) March 23, 2022
Good news for parents this morning: Moderna has announced that its vaccine trial of two 25 microgram doses for kids has met the primary endpoint, with similar immune responses to those of adults. It intends to file with the FDA and other global regulators.https://t.co/Fk3AtDxthV
— Benjy Renton (@bhrenton) March 23, 2022
📢 Very exciting news for parents and caregivers of young kids.🎉The #COVID19 vaccine Spikevax (Moderna) has been approved in children 6 -11 years of age! https://t.co/ShSq6sJ6fW
— Dr. Danielle Paes, PharmD (@CdnPharmChief) March 17, 2022
Moderna with a come-from-behind victory, will seek an EUA for vaccine in younger kids. As a parent of a toddler: 🙏🏽 https://t.co/GD6NOGfHfD
— Dr Ed (@notdred) March 23, 2022
Moderna vaccine for 6mo-5yr old kids is meeting targets for safety and efficacy. Now in the hands of the FDA for approval. I know a lot of parents who have been anxiously waiting for this moment! https://t.co/wnnqhl4a1j
— Miranda van Tilburg (@DrvanTilburg) March 23, 2022
With parts of the US now seeing a spike in COVID cases, due to the BA.2 variant, it's no wonder parents are once again on edge. In fact, many hope the FDA will grant a speedy approval, so they can get their kids vaccinated before a new surge hits.
@moderna_tx @DrCaliff_FDA @FDACBER parents of <5s are watching closely and want vaccines to protect their kids BEFORE the next surge! pic.twitter.com/lvVwbjvbYE
— Jen (@Vax4Littles) March 23, 2022
There has, of course, been some backlash to the news.
Aside from the general objections of anti-vaxxers, some people have raised concerns about the shot's protection rates against the omicron variant.
"Only 40 percent efficacy for Pediatrics," tweeted one person, who said it would be "irresponsible" to approve it for young kids.
But plenty of people fired back at this notion.
One person even quoted Moderna's own infectious disease expert, Dr. Jacqueline Miller, who called it "a successful trial," despite the response rates to omicron.
“What I will say is 37.5 percent and 43.7 percent are higher than zero,” Dr. Miller said in an interview, according to The New York Times. “If I were the parent of a young child, I would want there to be some protection on board, especially if we see another wave of infections.”
If approved, a vaccine for kids under 6 could begin to roll out by summer.
But before that happens, Moderna will have to officially submit a request to the FDA for Emergency Use Authorization, which will likely happen in the coming days. After that, it's expected to go through a rigorous review process before the agency even considers giving it the greenlight.
Still, after two years of battling the coronavirus, it seems we're finally heading in the right direction. Despite lingering infection rates, even the nation's top infectious disease expert, Dr. Anthony Fauci, has said the US appears to be leaving its phase of "full-blown" infection. Plus, Moderna may soon be joined by Pfizer, which is rumored to be releasing its own pediatric trial data in April.
Until then, many parents of kids under 6 will continue to wait (and hope) that they'll be able to give their kids the highest level of protection soon.