Moderna, a US biotech group, said Tuesday that trials have shown that its Covid-19 vaccine is “highly successful” in adolescents aged 12 to 17, and that it will seek regulatory approval in June.
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents,” CEO Stephane Bancel said in a statement.
“We will submit these results to the US FDA and regulators globally in early June and request authorization.”
If approved, it will be the second Covid vaccine approved for use in adolescents in the United States, following Pfizer’s, which started rolling out this month for 12-to-15-year-olds.
In the Moderna report, 3,732 adolescents aged 12 to 17 were enrolled and randomized, with two-thirds receiving the two vaccine doses and the remainder receiving a placebo.
After two doses, the vaccine group had no cases of symptomatic Covid-19 compared to four cases in the placebo group, indicating that the shots were 100 percent efficient.
Adolescents have a lower risk of contracting the illness than adults.
As a result, the researchers looked at effectiveness using a more rigorous concept of Covid, which only includes one symptom in addition to a positive test.
After the first dose, the vaccine was 93 percent effective under this description.
The vaccine, known as mRNA-1273, was generally well tolerated, with no major safety issues, as has been observed in adults.
Injection site discomfort, headache, nausea, muscle ache, and chills were among the most common mild to moderate side effects.
Despite the fact that teenagers are much less vulnerable to extreme Covid than adults, experts agree they must be reached in order to help achieve population immunity.
The United States has hit nearly half of its 332 million people with at least one dose, but its vaccine program is slowing due to skepticism.
By July 4, President Joe Biden wants 70 percent of adults to have received at least one dose of the vaccine. The latest percentage is about 62 percent.
SOURCE: THE GUARDIAN