American biotech firm Moderna said on May 26 (2021) that clinical trials have shown that its Covid-19 vaccine is “highly effective” in adolescents aged 12 to 17 years old.
The company will seek healthcare regulators’ approval next month (June 2021).
“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 (Food and Drug Administration) and regulators globally in early June and request authorisation.”
If greenlit as expected, it would be the second Covid-19 vaccine authorised for use in American adolescents after Pfizer/BioNTech’s, which began rolling out this month for 12- to-15-year-olds.
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The Moderna study enrolled 3,732 adolescents aged 12 to 17 and randomly assigned two-thirds to receive the two doses of the vaccine and the rest to receive a placebo.
After two doses, no cases of symptomatic Covid-19 were observed in the vaccine group, compared to four cases in the placebo group.
This means that the shots were 100% effective in preventing symptomatic Covid-19.
Adolescents are less likely than adults to contract the illness.
Therefore, the study also examined efficacy according to a more stringent definition of Covid-19, which requires just one symptom, in addition to a positive test.
Under this definition, the vaccine was 93% 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-19 than adults, experts believe they are important to reach in order to help achieve population or herd immunity against the disease. – AFP Relaxnews
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