Moderna Applies for Authorization to Give COVID-19 Vaccine Shots to Children Between Ages 2 and 6
© AP Photo / Ted S. Warren
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On Thursday, US pharmaceutical company Moderna announced it had applied to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for its COVID-19 vaccine Spikevax for children between the ages of 2 and 6, even as its vaccine has yet to be authorized for the ages 6-12 cohort.
"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," Moderna CEO Stéphane Bancel said in a news release, adding the company believes its 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."
The vaccine would be delivered in a two-shot series separated by several weeks, similar to how adults receive it, but with a lower dosage for children.
However, according to data published a month prior, while the vaccine produced a similar amount of antibodies in children, it was only about 40% effective at blocking COVID-19 infection. “The majority of cases were mild, and no severe COVID-19 disease was observed in either age group,” it noted.
“That’s not totally out of the realm of what we would have expected,” Dr. Bill Muller of Northwestern University, who helped with the research, told the Associated Press. “Down the road I would anticipate it’s going to be a three-shot series.”
At present, Moderna’s vaccine is only authorized for US adults ages 18 and up. The company has a parallel application with the FDA for authorization for its shot for ages 12 to 18, which has been stalled for months due to concerns over reports of a related inflammatory heart condition. However, the FDA has authorized both first and second booster shots of the vaccine for US adults.
Pfizer’s COVID-19 vaccine, the other mRNA-based shot, has been authorized for months for children above the age of 5, but has been hesitant to allow the shot for children between the ages of 6 months and 4 years. The two vaccines account for the vast majority of American inoculations, with a much smaller number receiving the Johnson & Johnson shot.
Newer variants of COVID-19, such as the Delta and Omicron variants, have proven more potent in children than the original SARS-CoV-2 vaccine that started the global outbreak in 2020. As a result, children in schools are at an increased risk and can become a vector for the illness into the rest of their families.
“There is an important unmet medical need here with these youngest kids,” Paul Burton, Moderna’s chief medical officer, told AP. About 18 million US children are not yet eligible for vaccination against SARS-CoV-2, the virus that causes COVID-19.
Outside the US, other countries have used different vaccines to inoculate children as young as age 2, including Cuba, which has developed six COVID-19 vaccines in spite of US sanctions.
