Parents, educators, and pediatricians can finally breathe a sigh of relief because on March 16, Moderna announced that it had begun a study that will test its vaccine in children under 12 years old, including babies as young as 6 months old. The Moderna vaccine won’t be widely available for kids for quite some time, but this is an important step nonetheless.
In the race to get a safe and effective COVID-19 vaccine approved and distributed, pharmaceutical companies were initially forced to restrict clinical trials to adults. That left a whole segment of the population unprotected from the virus. The Pfizer vaccine was authorized only for people ages 16 and up, and Moderna is available for adults over 18.
Many children will be returning for in-person learning before the end of the 2020-21 school year, but to safely open classroom doors in the fall and to achieve herd immunity, minors need to be vaccinated as quickly as possible. According to a Moderna spokesperson, the study is expected to enroll 6,750 healthy children in the United States and Canada.
A separate Moderna study that may even have results by the summer of 2021 will be testing the vaccine in 3,000 children ages 12-17. However, any vaccine will still require authorization for use in children, so it may take time before it becomes available.
Similar to adults who have received the Moderna vaccine, children participating in the studies will receive two shots 28 days apart. In the first part of the study, children between 2-12 years of age may receive two doses of 50 or 100 micrograms. Children under 2 may receive two shots of 25, 50, or 100 micrograms.
Children in both groups will receive the lowest doses of the vaccine and then be monitored for reactions. Participants in the later trials will then be given higher doses, so researchers can determine which dose is the safest and most protective for each age group.
Young adults tend to have more robust immune systems than older people and therefore experience harsher vaccine side effects, such as sore arms and muscles, fever, and fatigue. Doctors say parents should know what to expect after their children receive vaccinations.
Before clinical trials in children were underway, Moderna previously said it hoped to have data in advance of the 2021 school year—but even now, it seems the timing will be tight.
Pfizer is already testing its vaccine in minors aged 12-15 and is planning to move to younger groups once the product is authorized for use in those 16 and up in the U.S. Johnson & Johnson also has plans to test its vaccine in young children and babies after older children. In February, AstraZeneca began testing its vaccine among children 6 years and older in a U.K. study.
Even before clinical trials were underway, Moderna hoped to have data on its vaccine for kids in advance of the 2021 school year. As of February, the manufacturer didn’t expect to have clinical data for a pending study of children ranging from six months old to 11 years until 2022, so it remains to be seen if this latest development will put the company ahead of schedule.
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