(GNB Desk)- Moderna said Tuesday that its COVID-19 vaccine is “highly effective” for adolescents in the age group — 12-17 years. It is hoping to get regulatory approval for the same by June.
The company said it plans to ask the Food and Drug Administration to expand the emergency use of its Covid vaccine for teens early next month. If approved, it would expand the number of shots available to middle and high school students ahead of the next school year. Pfizer and German partner BioNTech were cleared to use their vaccine for 12- to 15-year-olds earlier this month.
The company conducted its Phase 2/3 trial on the age 12-17 with a sample size of 3,732 children and none of them had any COVID-19 symptoms 14 days after the second shot. This showed that the vaccine efficacy rate was 100 percent. The reports indicated that the vaccine was 93 percent effective after the first dose. Four children in the placebo group were infected with the coronavirus.
The researchers applied the same definitions that were used in adult trials, in the definition of a COVID-19 case. However, adolescents are less likely to get infected with the coronavirus. So, the trial included a second, more expansive definition that had been set by the Centers for Disease Control. The definition included milder cases, as it required only one symptom of COVID-19 and a positive test. Even after this expansive definition was applied, the efficacy rate stayed at 93 percent after the first dose.
According to a statement from Stephane Bancel CEO of Moderna, mRNA-1273 vaccine was highly effective in preventing COVID-19 in the age group of 12-17 and the results of the adolescent trials would be sent to the FDA and other global regulators in early for June for approval. The statement also reiterated the commitment of Moderna to help end the COVID-19 pandemic.
Moderna also reported that there were mild side effects. These included headaches, fatigue myalgia and chills. These symptoms appeared after the administration of the second dose of the vaccine.
On May10, Pfizer-BioNTech, got authorization from federal regulators for their COVID-19 vaccine to be used for ages 12-15.
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