The U.S. pharmaceutical company Moderna has confirmed the efficacy and safety of the new coronavirus vaccine that it has developed in clinical trials targeting 12 to 17 years old, and will include it in this age group as well. In early next month, we announced that we would apply to the FDA = US Food and Drug Administration.
The American pharmaceutical company Moderna's vaccine was approved for emergency use by the FDA last December and is currently being given to people over the age of 18.
Moderna is conducting a clinical trial of approximately 3,700 children aged 12 to 17 with the aim of expanding the target age for vaccination, and announced the results on the 25th.
According to the results, 93% efficacy was shown 2 weeks after the first vaccination, and no one developed infection with the new coronavirus 2 weeks after the second vaccination. That is.
As with the results of clinical trials over the age of 18, no significant concerns were identified regarding safety.
Moderna will continue to observe safety and will apply to the FDA and national regulators early next month to cover 12 to 17 years of age.
Already in the United States, Pfizer and German BioNTech vaccines are available for people over the age of 12.
Chief Cabinet Secretary "Confirming clinical trial data"
Chief Cabinet Secretary Kato said at a press conference on the morning of the 26th, "Basically, when expanding the target age, PMDA = Pharmaceuticals and Medical Devices Agency was consulted to revise the package insert, and its effectiveness and safety were confirmed. At that stage, a report was made to the council of the Ministry of Health, Labor and Welfare, and the package insert was revised promptly. "
On top of that, "Moderna's vaccine has just been approved for special cases for people aged 18 and over, but Takeda Pharmaceutical Company, a regulatory approval holder, has confirmed clinical trial data for people aged 12 to 17 years. I would like to refrain from saying the above at this stage, but if the idea is shown, it is naturally necessary to think about the future of inoculation. "