Most children under the age of five aren’t vaccinated against COVID-19, but Moderna is trying to change that. The company recently completed a trial that shows its vaccine for children under six is both safe and effective. They are now working on government approval.
This study found that giving two doses of 25 micrograms of the vaccine to babies, toddlers, and preschoolers generated similar levels of antibodies as giving two doses of 100 micrograms of the vaccine to young people aged 18-25. This suggests that there would be similar levels of protection against the virus for both groups.
The only age group in the United States that has not yet gained access to a Covid-19 vaccine are children under six.
Moderna plans to submit requests for authorization to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators in the coming weeks, based on the data.
The results are positive for young children, according to CEO Stephane Bancel. The data collected shows that the vaccine is effective for infants aged six months to adults. However, the company’s trial showed low efficacy against infection during the Omicron wave.
Vaccine efficacy was found to be highest in children aged six months to two years, at 43.7 percent. In the two to five years age group, efficacy was slightly lower, at 37.5 percent. However, the majority of cases in both groups were mild, and the two doses still provided very strong protection against severe outcomes. There were no hospitalizations or deaths.
Moderna stated that their findings were in line with what had been discovered in adults and that they were looking into whether or not a third dose would be necessary to further protect against Omicron infection. The trial included 4,200 children aged two to six years and 2,500 aged six months to two years. The side effects were mild and similar to what has been seen in older age groups.
According to the study, rates of fever greater than 38 degrees Celsius (100.4 Fahrenheit) were around the same in children who received commonly used and recommended pediatric vaccines as those who didn’t.
The company added that, after consulting with the FDA, it is also applying to be authorized among children six to 11 for two doses of 50 micrograms, and updating its application for authorization in kids aged 12 through 17. The EMA and other regulators have already authorized the Moderna vaccine in these age groups.