Trial finds Moderna’s Covid-19 shot to be safe and effective among adolescents, vaccine maker says
May 25, 2021
The American biotech firm Moderna has announced that its trial concerning the safety and effectiveness of its Covid-19 vaccine in adolescents aged 12-17 produced positive efficacy data with no major safety concerns.
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents. It is particularly exciting to see that the Moderna Covid-19 vaccine can prevent SARS-CoV-2 infection,” Stephane Bancel, Moderna CEO, said in a statement on Tuesday.
Bancel noted that the company would shortly be submitting its data to the US Food and Drug Administration (FDA) and regulators globally in early June to request authorization for the vaccine’s use in adolescents.
The study involved 3,732 participants, aged between 12 and 17, who were given either two shots of the vaccine or a placebo. After two doses, no cases of the virus were observed in the vaccine group, compared to four cases in the placebo group. The data suggests efficacy of 100% starting 14 days after the second dose, the company said.
Using another definition of Covid-19 provided by the Centers for Disease Control and Prevention, which only requires patients to show one symptom of the virus and provide a positive PCR test, a vaccine efficacy of 93% was observed after the first dose.
The company said the shot was “generally well tolerated” by the study participants, with results in line with those seen in adults.
“The majority of adverse events were mild or moderate in severity,” Moderna said in a statement. “The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.”
The FDA is expected to take around a month to approve the Moderna jab’s use in adolescents. Pfizer’s shot was authorized for use in those aged 12-15 on May 10 after a month-long review.
0 Comments