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BREAKING NEWS: Moderna says its Covid vaccine prevented 100% of cases in children aged 12-to-17 and plans to apply for FDA authorization in June
- Moderna said clinical trials show its COVID-19 vaccine is ‘safe and effective’ in children between ages 12 and 17
- No adolescents given the vaccine fell ill 14 days after their second dose compared to four children who received the placebo
- The company plans to apply for expanded FDA emergency use authorization of its vaccine for use in kids in June.
Moderna Inc says its coronavirus vaccine appears to be safe and effective in children ages 12 to 17.
In a press release on Tuesday, the company said its clinical trial in the US showed that the shot produce an immune response against COVID-19 in adolescents similar to the response seen in adults.
Although the clinical trial did not examine efficacy, none of the children who were given the two-dose immunization fell ill with the virus while four children given the placebo later tested positive.
According to Moderna this is ‘consistent with a vaccine efficacy of 100 percent.’
The firm says it plans to apply to expand U.S. Food and Drug Administration (FDA) emergency use authorization of its vaccine for use in kids in early June.
‘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,’ said Moderna CEO Stéphane Bancel in a statement.
‘We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.’
Moderna said clinical trials show its COVID-19 vaccine is ‘safe and effective’ in children between ages 12 and 17. Pictured: A vial of Moderna’s COVID-19 vaccine, April 7
Moderna’s study included 3,732 adolescents from ages 12 to 17 enrolled at sites across the U.S.
Side effects were mild or moderate with the most common being pain at the site of injection, similar to adults in the clinical trial last year.
Other common symptoms were fatigue, headache, muscle pain and chills, but no serious side effects were reported.
Moderna added that its study looking at COVID-19 vaccines among children ages six months to 11 years, known as KidCOVE, is ongoing.
This is a breaking news story and will be updated.
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