Moderna says its coronavirus vaccine is effective in teens, and the biotech plans to apply in early June for an expanded OK
- Moderna's coronavirus vaccine most likely works in teens, study results from the biotech indicate.
- The vaccine could become the second OK'd for people as young as 12.
- Teens in Moderna's study had similar immune responses as adults who received the shot.
Moderna's coronavirus vaccine appears to be highly protective in 12- to 17-year-olds, the Massachusetts biotech said Tuesday in a press release, paving the way for the shot to be given widely to adolescents as soon as next month.
If regulators give the green light, Moderna's vaccine would be the second COVID-19 shot to be authorized for people as young as 12 in the US, after the Pfizer-BioNTech vaccine. Both vaccine developers are studying their shots in even-younger populations.
Moderna enrolled more than 3,700 people ages 12 to 17 in a clinical study. Two-thirds of the volunteers received two doses of Moderna's vaccine. The other third received placebo injections.
Adults and children had similar immune responses to the shot, Moderna says
The main goal of the study was to measure the immune responses of participants, comparing their reactions to what was seen in adult volunteers. Moderna said Tuesday that the study was successful in showing those immune responses were comparable among age groups and that it planned to submit that information to regulators early next month.
Pfizer and BioNTech used a similar study to win authorization from the US Food and Drug Administration to provide their shot to adolescents.
The Moderna study counted how many people got sick with symptomatic cases of COVID-19, starting two weeks after the second vaccine dose. Four adolescents had COVID-19 cases in that period, and all of them received the placebo.
The study's results have not yet been published in a peer-reviewed medical journal.
Moderna described the safety and tolerability of the vaccine as "generally consistent" with the adult trial. The most common side effects after the second shot were headache, fatigue, muscle pain, and chills.