The CDC has approved Moderna’s vaccine for kids 6 to 17

Editor’s note: Follow our updates on vaccines for kids age 6 and under here.

The CDC has approved Moderna’s vaccine for kids 6 to 17

June 28: On Friday, June 24, Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky signed off on Moderna’s vaccine for kids between the ages of 6 and 17, hours after the agency’s advisory panel unanimously recommended the vaccine based on its efficacy and safety profile.

The recent CDC approval provides families with another option to get their children—of any age—fully vaccinated against the SARS-CoV-2 virus. Moderna has already received approval for its vaccine for kids under 6 and its vaccine for adults 18 and up. At this point, just 29.6% of kids ages 5 to 12 have received two doses of a Covid vaccine.

Kids ages 6 to 11 will get two 50-microgram doses of the Moderna vaccine, whereas kids 12 to 17 will get two 100-microgram doses, the same dosage used in adults. The two shots should be spaced four weeks apart, though the CDC recommends stretching out spacing up to eight weeks for the second dose, to reduce the already-low risk of myocarditis.

It’s important to note that the risk of myocarditis is higher from Covid infection than it is as a side effect of the vaccine.

“Extending the interval between dose one and dose two of these mRNA COVID vaccines to eight weeks may further lower the myocarditis risk,” says Sara Oliver, M.D., M.S.P.H., who leads ACIP’s COVID-19 vaccines work group.

The CDC also recommends that children who receive the first dose of a Moderna vaccine should continue with the Moderna series, not switch vaccines and receive a second dose of Pfizer. The Moderna vaccine can be given alongside other childhood vaccinations, the CDC states.

“It is critical that we protect our children and teens from the complications of severe COVID-19 disease. Today, we have expanded the options available to families by recommending a second safe and effective vaccine for children ages 6 through 17 years,” Dr. Walensky says in a statement. “Vaccinating this age group can provide greater confidence to families that their children and adolescents participating in childcare, school, and other activities will have less risk for serious COVID-19 illness.”

The CDC has officially approved Pfizer’s vaccine for kids 5 to 11

November 2: Just hours after the Centers for Disease Control and Prevention’s (CDC) advisory panel unanimously voted to recommend Pfizer’s vaccine for kids ages 5 to 11, CDC Director Dr. Rochelle Walensky issued her endorsement, clearing the way for shots to be distributed immediately.

President Biden released a statement marking the decision, calling it “a turning point in our battle against COVID-19,” and declaring it “a major step forward for our nation in our fight to defeat the virus.”

The Biden administration has been working on a rollout plan in partnership with 25,000 pediatric offices, children’s hospitals, pharmacies and schools in order to make shots available without delay after FDA and CDC approval.

Fifteen million shots have already been shipped to vaccination sites around the country, and the administration said they have purchased enough of the Pfizer low-dose vaccine “for every child in America.”

While some shots may be available starting Wednesday this week, health officials expect the federal rollout program to be fully up and running by Nov. 8.

For every 1 million doses delivered to kids, experts at the CDC expect vaccinations to prevent 58,000 cases and 226 hospitalizations in the pediatric group. Vaccinating the 28 million kids in this age group is expected to prevent 600,000 new cases in general across the country between now and March 2022, reports The New York Times.

“COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history,” the CDC says in a media statement. Officials from both the FDA and the CDC have rigorously reviewed the data from Pfizer’s clinical trials, and determined the vaccine to be safe and effective for the 5 to 11 age group.

Addressing the safety concerns some parents have, Dr. Walensky remarked, “As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.” 

Moderna reports their vaccine is safe and highly effective in kids 6 to 11

October 25: In a statement released Monday, Moderna announced that their vaccine for kids ages 6 to 11 had produced a powerful antibody response in clinical trials.

The results showed that two 50-microgram shots (half of the adult dose) 28 days apart led to a “robust” antibody response in kids that was 1.5 times higher than that seen in young adults.

The side effects reported were “generally well tolerated,” and primarily included fatigue, fever, headache and pain at the injection site. The company plans to submit the trial results to the Food and Drug Administration (FDA) soon.

“We are encouraged by the immunogenicity and safety profile of [the vaccine] in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” says Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

Pfizer’s vaccine is 90.7% effective in kids 5 to 11, even at a lower dose

October 22: Pfizer-BioNTech reported to the Food and Drug Administration (FDA) today that their vaccine for kids ages 5 to 11 is 90.7% effective at reducing symptomatic Covid.

The findings are promising, as the 5 to 11 age group will receive a much smaller dose than the 12 and up age group, at 10 micrograms versus 30 micrograms. The companies also report a high rate of safety and that only mild side effects were seen in the trial participants.

The FDA will be releasing its own report analyzing the vaccine makers’ clinical trial data later today.

The New York Times states that of the 2,268 children in the vaccine clinical trials, 16 kids who received the placebo got Covid-19, as compared to three who received the vaccine. While no vaccine is 100% effective, the mRNA technology used in the Pfizer-BioNTech shot is very successful at preventing illness in many and protecting against severe forms of the disease.

White House rolls out plan to vaccinate kids ages 5 to 11 against Covid

October 20: In a news conference held this morning, the White House Covid-19 Response Team unveiled a plan to move quickly on getting shots in arms for kids ages 5 to 11.

The Biden administration is aiming to set up a “kid-friendly experience that makes sure that we’re getting shots in arms with trusted providers in ways that makes parents feel comfortable,” says Sonya Bernstein, a senior policy adviser for the White House Covid-19 Response Team in The New York Times.

That looks like coordinating with more familiar settings for kids and families, like pediatricians’ offices, primary care offices, pharmacies, children’s hospitals and schools—but no mass vaccination sites will be used, which means shorter lines (and hopefully fewer tears). 

The needles and vaccine vials used will be smaller, too.  

Officials are working to put plans in motion now so that vaccine distribution can start rolling out quickly—within days after the shot becomes authorized. 

While the Pfizer/BioNTech vaccine has not yet been authorized by the Food and Drug Administration (FDA), a meeting is set for October 26 to review the decision, with potential recommendations by the Centers for Disease Control and Prevention (CDC) shortly after.

“We will be ready to begin getting shots in arms in the days following a final CDC recommendation,” the White House said, which could come in the next two weeks.

COVID-19 vaccines for kids under 12 may be available as soon as this fall

August 19: Pfizer expects to have enough data collected by the end of September to support an application for emergency use authorization for its vaccine in kids ages 5 to 11, according to NPR, but full authorization may not be granted until year-end.

For kids ages 12 to 15, shots became available in May 2021 after the vaccine-maker applied to the FDA for emergency use authorization in April. Given that timeline as a model, we can hopefully expect shots to be available for kids ages 5 to 11 sometime in October.

“We’re hoping to have authorization—depending on both results and, of course, a few decisions—not too long after the school year starts,” Dr. Phil Dormitzer, chief scientific officer for viral vaccines at Pfizer, told NPR.

Full FDA approval isn’t expected until the end of the year

In a recent interview with NPR, Dr. Francis Collins, director of the National Institutes of Health (NIH), said that this September timeline is still accurate, but added, “I’ve got to be honest, I don’t see the approval for kids—5 to 11—coming much before the end of 2021.” Full FDA approval may empower more schools to require the COVID-19 vaccine for eligible students.

Vaccine safety data for kids under 5 is coming soon, too

Pfizer has also shared that the data for children between the ages of 2 and 5 should be available shortly after the data is collected for kids ages 5 to 11. They expect data on kids ages 6 months to 2 years to be available by year-end.

Moderna, the maker of another mRNA-based COVID-19 vaccine, is also collecting data on its use of the vaccine in children between the ages of 6 and 11. Currently, the Moderna vaccine is only available to people over the age of 18, but Moderna hopes to apply for emergency use authorization for ages 6 to 11 by year-end, as well.

Cases are increasing among children

With approximately 50 million children under 12 in the U.S., that’s a significant portion of the population walking around unvaccinated. According to the American Academy of Pediatrics, children now make up 26% of COVID cases. And given the fact that the Delta variant now makes up 98.8% of COVID cases and is more than twice as contagious as previous strains, time is of the essence in getting shots in kids’ arms.

Because so many children are ineligible for the vaccine, we’re seeing pediatric cases—and hospitalizations—rising across the country. Currently, the best tool we have for fending off infections is to have as many adults and teens get vaccinated as soon as possible.

Hold on a little longer

With school already in session for thousands of kids across the country, the timing isn’t great—but stay hopeful. It’s also important to remember that both the Pfizer and Moderna vaccines require two shots spaced three or four weeks apart, and that immunity isn’t fully built up until two weeks after the second shot. If shots become available for the 5 to 11 age group in October, that could mean many kids would have full immunity by Thanksgiving—something to be thankful for, indeed.

In the meantime, keeping up with kids’ masking, hand-washing, social distancing and frequent testing can help curb the spread, plus encouraging vaccination for any and all teens and adults in your orbit.

Related Stories

Child

CDC approves both Pfizer and Moderna’s pediatric Covid vaccines for kids under 6

Children's Health

Childhood vaccination rates continue to plummet since the start of the pandemic

Life

Dr. Fauci on the timeline for vaccinations for kids under 12 + why pregnant and breastfeeding women should get vaccinated