Preliminary results of clinical trials of Moderna’s COVID-19 vaccine have shown that it safely produces a “strong” antibody response in children aged 6 to 12.
According to details, these findings are part of the highly anticipated large-scale clinical trials in which over 5,700 children between the ages of 6 months and 12 years participated.
Over 4,700 children aged 6 to 12 years were administered two 50-microgram doses of Moderna’s Coronavirus vaccine 28 days apart. All children produced a strong immune response one month after receiving the second dose.
The 50-microgram dose was well tolerated among the children and the same side effects were witnessed that were previously observed in adolescents and adults. While the intensity of the most of adverse events was mild or moderate, the most common side effects observed were fatigue, headache, fever, and injection site pain.
Moderna will continue to monitor all participants of the trials for the next 12 months after receiving the second dose to assess the long-term protection and safety of the Coronavirus vaccine.
The US-based company is now preparing to submit the findings of the trials to the US Food and Drug Administration (FDA) to seek Emergency Use Authorization (EUA) for the vaccine among the said age group. The FDA is expected to issue EUA in a few weeks once Moderna officially applies for it.
Moderna is only approved for use in individuals aged 18 years and above. It has already applied for EUA among children aged 12 to 17 years but has not yet received it.
On the other hand, Pfizer, one of the two mRNA COVID-19 vaccines in the world along with Moderna, has already applied for the EUA among children aged 5 to 11 years.
Pfizer’s vaccine was initially approved for use in individuals aged 16 and above. Later, it was authorized for use among children aged 12 to 15 years.
Both Moderna and Pfizer ultimately aim to receive regulatory approval for the use of their Coronavirus vaccines among children as young as 6 months.