Moderna Therapeutics has recently said that it will urge the Food and Drug Administration (FDA) to approve its low-dose COVID-19 vaccine for children under 6 years old, according to CBS News.
The company seeks FDA approval after interim results from the trials showed some efficacy against COVID infections during the Omicron wave.
On Wednesday, Moderna said vaccine efficacy was 37.5% in children aged between 2 and 6 and 43.7% in children aged 6 months to 2 years old. In the trials, blood samples from participants showed the vaccine had a “robust neutralizing antibody response in both age groups.”
Moderna CEO Stéphane Bancel said, “Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.”
He said the company also would be submitting data to the FDA for vaccinating older age groups of children. Currently, the Moderna COVID vaccine is available for people who are 18 and above.
The FDA had to halt Moderna’s original request to vaccinate adolescents with two 100 mcg doses, the same as adults, due to concerns related to rare heart inflammation side effects. The company then tested the vaccine for younger kids using only 25 mcg per dose. It said the company plans to study a booster dose in kids.
Almost a month ago, Pfizer said it would delay submission of data from its COVID-19 vaccine trials for the youngest age groups, referring to disappointing data against Omicron from two kid-sized doses of their vaccine. Results from testing three doses of that vaccine are expected by the next month.
In February, the Biden administration had planned to distribute around 10 million doses after the FDA’s approval and CDC’s recommendations.
Dr. Anthony Fauci, White House Chief Medical Adviser, said Tuesday, “Unfortunately, it was found that that regimen was not adequate enough to give what was felt to be an appropriate or optimal immune response with protection, and so it looks like this almost certainly will be a three-dose vaccine for children in that age cohort. And that’s the reason why it’s taking so long, as it were.”
Millions of American children under 5 have been infected by COVID-19 and over 400 died, according to CDC. Dr. Fauci said, “Certainly, the FDA, as they always do, want to get it right. So, when they approve something, one can be certain that it’s effective as well as safe.”