(CN) — Moderna announced Tuesday that it would seek regulatory approval to administer its Covid-19 shot to teens between 12 and 17 years old in June.
Announcing the results of advanced studies of its Covid-19 vaccine that enrolled more than 3,700 participants between ages 12 and 18, Moderna said its vaccine has proved safe and strongly protective in the younger age group.
“No cases of Covid-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine,” the company wrote in a statement Tuesday. Two-thirds of the participants were given two doses of Moderna’s mRNA vaccine, and the remaining third was given a placebo.
Taking into account that teens are less likely to experience severe symptoms of Covid-19, Moderna's study redefined what a mild case of the the virus meant: one symptom and a positive test. Using this definition, “a vaccine efficacy of 93% after the first dose was observed,” the company noted.
CEO Stephane Bancel added that his company has upcoming plans to send the study’s results to the Food and Drug Administration.
"We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents," Bancel said. "We will submit these results to the U.S. FDA and regulators globally in early June and request authorization."
The most common side effect was pain at the injection site, followed by headache, fatigue, muscle pain and chills.
If approved, the vaccine would be the second in the U.S. to be authorized for use in adolescents, coming after Pfizer's drug candidate was approved for use in adolescents 12-15 earlier this month.
While adults were prioritized in the vaccine-development process because older people are more likely than children to develop severe symptoms of Covid-19, doctors and public health officials have underscored that vaccinating younger people will inevitably be part of the fight to curb the pandemic and reach herd immunity as kids make up nearly a quarter of the population.
According to data from early May, children made up 24% of new Covid-19 cases.
Nearly 50% of the American population of 332 million have gotten at least one dose of a Covid-19 vaccine, although numbers are showing far fewer adults in rural counties signing up for their shots as compared with those in urban areas.
President Joe Biden has said he wants to see at least 70% of Americans receive at least one dose of a Covid-19 vaccine by July 4, and at least 160 million Americans fully vaccinated by the same time.
Moderna announced in mid-March it had doled out vaccines to its first set of participants in yet another advanced clinical trial for children under 12 years old, including those as young as 6 months.
Vaccinations will be key in curbing the number of Covid-19 cases. As the Centers for Disease Control and Prevention noted reported Tuesday, cases of Covid-19 in those who have been fully vaccinated remain rare: averaging to about 1 infection in every 10,000 fully vaccinated people.
“Even though FDA-authorized vaccines are highly effective, breakthrough cases are expected, especially before population immunity reaches sufficient levels to further decrease transmission,” the national public health agency wrote. “However, vaccine breakthrough infections occur in only a small fraction of all vaccinated persons and account for a small percentage of all Covid-19 cases.
“The number of Covid-19 cases, hospitalizations, and deaths that will be prevented among vaccinated persons will far exceed the number of vaccine breakthrough cases,” it continued.
The CDC’s conclusions are based on data reported voluntarily by 46 states and territories of “breakthrough infections” that resulted in hospitalization and deaths. These numbers do not suggest a full tally. Among breakthrough infections, nearly two-thirds of cases occurred in women, and the average age of all cases was 58. Asymptomatic cases represented about 25% of the infections. Hospitalizations occurred in 10%, and about 2% died.
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