Moderna has asked the U.S. Food and Drug Administration (FDA) to extend the emergency use of its Covid vaccine to American children aged 12 and over. The FDA approved the use of the Pfizer Covid vaccine in children a month ago on Thursday, and earlier this month the U.K.’s medicines regulator did the same for British children. The MailOnline has more.
When the [Moderna] vaccine was originally authorised for use by the FDA in December 2020, it was only for those aged 18 and older.
However, recent Phase Three clinical trial data showed no children who were given the immunisation fell ill with the virus within 14 days 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%”.
It comes exactly four weeks after Pfizer received approval from the FDA to administer its vaccine to children between ages 12 and 15.
As of Thursday, more than seven million U.S. 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 immunise their children right away.
Although children can contract Covid and pass the disease on to others, they tend to not get very ill and make up about 0.1% of deaths.
“We are pleased to announce that we have submitted for an emergency use authorization for our Covid 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 vaccine was highly effective at preventing Covid and SARS-CoV-2 infection in adolescents.”…
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.
Worth reading in full.