March 23, 2022, 7:12 pm | Read time: 2 minutes
There is currently no approved COVID-19 vaccine for children under five in the EU. That could soon change. Moderna plans to submit the approval application quickly after successful tests.
The COVID-19 vaccine from U.S. manufacturer Moderna is reportedly safe for children and toddlers aged 6 months to 6 years, according to the company. The two-dose regimen induces robust antibody levels and is well tolerated, the company announced.
According to the data, the vaccine offers limited protection against infection with the Omicron variant, similar to adults, but there have been no severe cases of illness. The company now intends to submit approval applications for this age group to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other relevant authorities “as quickly as possible.”
Only mild side effects of Moderna vaccine observed in children
The interim results presented are based on data from a total of 6,700 children; 4,200 between two and six years old and 2,500 between six months and two years old. They received 25 micrograms of the vaccine—one-quarter of the adult dose—or a placebo, 28 days apart.
The immune response was as strong as in adults despite the lower dose. Adverse effects were mild or moderate and more common after the second dose, such as fever over 100.4 degrees Fahrenheit. There were no deaths or cases of myocarditis or pericarditis, nor any severe inflammatory reactions.
Also of interest: EMA approves BioNTech vaccine for children aged five and up
Protection rate among the youngest at 43.7 percent
At the time of the study, the Omicron variant was circulating in the U.S. The effectiveness of Moderna’s COVID-19 vaccine in preventing infection was 43.7 percent in the youngest group. In the slightly older group, it was 37.5 percent. There were no severe illnesses, hospitalizations, or deaths in the study, so the vaccine’s protection against these events could not be determined.
For children under five, there is currently no approved COVID-19 vaccine in the EU.
With material from dpa