Moderna Asks FDA for Covid-19 Vaccine Authorization for Kids 5 & Under

moderna vaccine authorization, moderna vial lying on paper Ian Hutchinson/Unsplash
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It’s been a long road waiting for vaccines to bring the pandemic to an end and a new announcement from Moderna is another step in the right direction. The vaccine-maker has formally requested authorization from the FDA for its low-dose version of the shot, the first for children under the age of five.

Parents have been cautiously waiting for this development as variants continue to change the landscape of the coronavirus. With babies, toddlers and young children becoming more susceptible and mask mandates dropping off everywhere, the news from Moderna brings a sense of relief.

Stéphane Bancel, Moderna’s chief executive office shares, “We are proud to share that we have submitted for authorization for our COVID-19 vaccine for young children. We believe [the vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers.”


Back in Moderna released the results of Phase 2 of its KidCOVE study for kids six months to five-years-old, which consisted of 6,700 participants ages 6 months to <2 years. The company is requesting for authorization of a two-dose, 25-microgram shot––which is 25% of the first two adult doses.

The KidCOVE study is a randomized, observer-blind, placebo-controlled study that evaluates the efficacy of two doses of mRNA-1273 given to healthy children 28 days apart. It involved 11,700 pediatric participants in three age groups: 6 to <12 years, 2 to <6 years, and 6 months to <2 years.

As of now, the vaccine ranges from 37-51% efficacy, which is lower than most were expecting. However, according to NPR that could be because the testing was done during the time period where Omicron was rampant.

Participants will continued to be monitored over the next 12 month and the company will evaluate the necessity of a booster. For now, the data has been submitted and the world must wait. Originally, NPR reported the end of April would see the vaccine’s approval and implementation. Now, it looks like everyone will need to wait until June.

If there’s one thing the pandemic has taught us, it’s that good things come to those who wait.


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