Moderna's COVID-19 vaccine found to be 100% effective in children ages 12 to 17

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Moderna's COVID-19 vaccine has been found to be safe and effective in children ages 12 to 17, producing an immune response equivalent to what has been found in adults.

While the trial wasn't specifically designed to look at efficacy, observations showed that none of the children who received the vaccine became sick with the virus beginning 14 days after the second dose. Four who received the placebo tested positive for the coronavirus, which Moderna said was consistent with a vaccine efficacy of 100%, though the figure could change as more data comes in.

Because the incidence rate of COVID-19 is lower in adolescents, a secondary case definition based on the Centers for Disease Control and Prevention's definition of the virus was also evaluated to include cases presenting with milder symptoms. Using the CDC definition, which requires only one COVID-19 symptom and a nasopharyngeal swab or saliva sample testing positive, a vaccine efficacy of 93% after the first dose was seen.

No significant safety concerns have been identified to date. Most of the adverse events recorded were mild or moderate in severity, with the most common complaint being pain at the injection site. Other complaints after the second dose ranged from headache and fatigue to myalgia and chills.

Safety data is still coming in, and an independent safety monitoring committee will continue to monitor the study findings. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety, with the results set to be unveiled in a peer-reviewed publication.

WHAT'S THE IMPACT?

The results come at a time when the Biden Administration has set a goal of having adolescents return to in-person school instruction by the fall, if they've not yet done so. Younger children may also be able to get vaccinated soon, as both Pfizer and Moderna are testing the vaccines in children as young as six months old.

Biden has set a goal of having 70% of American adults vaccinated with at least one dose by early July.

In addition to its U.S. filing, Moderna plans to submit this new data on adolescents to regulators across the globe. The company is on track to produce as much as one billion doses this year, and is eyeing three billion doses in 2022. 

THE LARGER TREND

Earlier this month, the Food and Drug Administration approved Emergency Use Authorization for Pfizer's coronavirus vaccine for children ages 12 to 15, making it the first COVID-19 shot available for this age group. 

The approval expands the FDA's EUA for the vaccine in individuals 16 and older that was issued in December 2020. The Pfizer vaccine requires two doses three weeks apart for adolescents, much as with adults. It is expected to be available to middle and high school students in time for back-to-school this fall.

Severe illness due to COVID-19 is rare among children, but deaths have been reported. As of May 6, more than 3.85 million children had tested positive for COVID-19 since the onset of the pandemic, representing 14% of the population, according to the American Academy of Pediatrics.

According to the FDA, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age were reported to the CDC between March 1, 2020, and April 30, 2021.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com