Moderna asks FDA to expand emergency use of its COVID-19 vaccine to include kids ages 12-17
Moderna Inc has asked the U.S. Food and Drug Administration (FDA) to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 17.
When the vaccine was originally authorized for use by the FDA in December 2020, it was only for those aged 18 and older.
However, recent phase III clinical trial data showed no children who were given the immunization fell ill with the virus within 14 of their second dose while four children given the placebo later tested positive.
According to Moderna, this is ‘consistent with a vaccine efficacy of 100 percent.’
It comes exactly four weeks after Pfizer-BioNTech received approval from the FDA to administer its vaccine to children between ages 12 and 15.
As of Thursday, more than seven million children between ages 12 and 17 have received at least one dose of the vaccine.
Still, only about one in three parents said they would immunize their children right away.
Although children can contract COVID-19 and pass the disease on to others, they tend to not get very ill and make up about 0.1 percent of deaths.
Moderna Inc has asked the FDA to expand emergency use of its COVID-19 vaccine to Americans between ages 12 and 17. Pictured: A healthcare worker holds a vial of the Moderna COVID-19 Vaccine at a pop-up vaccination site in New York City, January 29
Recent clinical trial data found that the vaccine was 100 percent safe and effective in younger teens. Pictured: nurse gives Malikai McPherson, 16, a shot of the vaccine at a vaccination clinic at Health First Medical Center in Melbourne, Florida, May 17
‘We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,’ said Moderna CEO Stéphane Bancel in a statement.
‘We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
‘We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.’
Children are often the last group to be tested during clinical trials because they are not merely little adults.
Their bodies and immune systems behave differently, meaning they might have different treatment needs.
What’s more, children may need different doses or needle sizes depending on their height, weight and age – which is why most children are only vaccinated after safety has been well-documented in the adult population.
Moderna’s study included 3,732 adolescents from ages 12 to 17 enrolled at sites across the U.S.
The vaccine candidate, known as mRNA-1273, was given as two doses four weeks apart with half of the group given the jab and half given the placebo.
In addition to appearing to be 100 percent effective after two doses, the vaccine was found to be 93 percent effective after one dose.
This included against both symptomatic and asymptomatic illness.
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.
Depending on how quickly FDA regulators take to review Moderna’s application, it could mean another option for parents to vaccinate their children before the start of the 2021-22 school year.
It could also help boost vaccination rates with more than 25 million adolescents between ages 12 and 17 in the U.S., according to data from the Census Bureau.
However, despite the promising results, many parents are not enthusiastic about vaccinating their children.
In a recent poll, conducted by the Kaiser Family Foundation, parents were asked if they would get their child immunized once a COVID-19 vaccine is authorized and available for their child’s age group.
Only about three in 10 parents – 29 percent – of children under 18 said they would get their child vaccinated ‘right away.’
The poll also found 15 percent only plan to vaccinate their children if the school requires it and 19 percent said their child will definitely not be getting vaccinated.
What’s more, although children can contract COVID-19 and pass the disease on to others, they tend to not get very will
More than 3.94 million children have tested positive for the virus as of Monday, according to the American Academy of Pediatrics, but only make up 0.1 percent of all deaths.
