US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its COVID-19 vaccine in children under 6 years old after the two-shot regimen was found to be safe and produced a strong immune response.
Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated similar levels of antibodies to two doses of 100 micrograms given to young people aged 18-25, indicating there would be similar levels of protection.
Children under 6 are the only age group that has yet to gain access to a COVID-19 vaccine in the US.
Based on the data, Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators in the coming weeks.
The results “are good news for parents of children under 6 years of age,” said CEO Stephane Bancel.
“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults.”
The company did, however, find relatively low vaccine efficacy against infection, with its trial taking place during the Omicron wave.
Vaccine efficacy in children of 6 months up to 2 years old was 43.7 percent, and efficacy was 37.5 percent in the 2-5-year age group.
The majority of these cases were mild and the two doses still provided very strong protection against severe outcomes.
There were no hospitalizations or deaths.
Moderna said this was consistent with what had been observed among adults, and the company was evaluating a third dose as a booster, to increase efficacy against Omicron infection.
Pedestrians walk in front of a COVID-19 vaccination site in the Brooklyn borough of New York, the United States, Nov 19, 2021. The US Food and Drug Administration (FDA) on Friday authorized boosters of the Pfizer/BioNTech and Moderna COVID-19 vaccines for all adults.Photo:Xinhua
