US biotech firm Moderna said Tuesday that trials had shown its Covid-19 vaccine is "highly effective" in adolescents aged 12-17 and the company would seek regulators' 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."
The Moderna study enrolled 3,732 adolescents aged 12 to 17 and randomized, with two-thirds receiving the two doses of the vaccine and the rest receiving a placebo. Adolescents are less likely than adults to contract the illness. President Joe Biden has set a target of having 70 percent of adults vaccinated with at least one dose by July 4. The current figure is almost 62 percent.
A report states, two thirds of the 3,732 individuals aged 12-17 received two doses of the vaccine in Moderna’s latest clinical study. None of them developed serious Covid-19 (equivalent to 100% efficacy) while four developed Covid-19 in the placebo group, the company said.
A single dose of the vaccine resulted in 93% efficacy based on the case definition of the Centers for Disease Control and Prevention (CDC), which is modified, given the lower overall rate of infections in adolescents. The teenagers in the study will be monitored for a year after their second dose, the New York Times reported.
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents,” Moderna CEO Stéphane Bancel said. Some have criticised the U.S. for vaccinating children – who are less susceptible to serious Covid-19 infections -- while more vulnerable adult populations in countries across the world, including India, are yet to be vaccinated.
The Pfizer- BioNTech vaccine was recently approved for emergency use in 12-15 years. Pfizer and Moderna are in the process of conducting vaccine trials on children in the 6 months to 11 years group.
Under this definition, the vaccine was 93 percent effective after the first dose. The vaccine, called mRNA-1273, was generally well tolerated, consistent with what has been observed in adults, with no significant safety concerns.
The majority of side effects were mild or moderate and included injection site pain, headache, fatigue, muscle ache and chills. Although adolescents are much less susceptible to severe Covid than adults, experts believe they are important to reach in order to help achieve population immunity against the disease.
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