Moderna’s COVID-19 vaccine has been granted on Tuesday authorization to expand the use in children and teenagers ages 6 to 17 by the Food and Drug Administration’s (FDA) advisory panel of outside experts.
The panel voted unanimously 22-0 that Moderna’s vaccine, which is currently approved for adults only, is safe and effective enough to be given to kids ages 6 to 17 and recommended the agency expand the authorization making the jab the second option for those children after Pfizer’s vaccine.
Moderna’s two-dose vaccine would be given to children ages 6 to 11 in a smaller 50 microgram shot, while teens ages 12 to 17 would receive the same dose as adults at 100 micrograms.
The same FDA panel is to meet Wednesday to discuss Moderna and Pfizer’s tot-sized shots for kids under 5.
Considering the fact that children and teenagers have had access to Pfizer-BioNTech”s vaccine since last year, the panel’s advice and the expected FDA’s acting upon it ultimately won’t have much of an impact on vaccination rates.
The Centers for Disease Control and Prevention is also scheduled to consider the matter as early as Friday ff the FDA authorizes Moderna’s vaccine.
Although Moderna has asked for FDA’s approval to use the vaccine in adolescents ages 12 to 17 last June, officials were delaying the authorization due to the raised concerns over a rare heart condition.
However, the health officials said on Tuesday that the overall incidence of myocarditis and pericarditis is relatively rare and not statistically significant enough to draw definitive conclusions though the risk might be higher in teen boys and young men.
Although the same risk can occur with the Pfizer vaccine, the extra scrutiny Moderna got is because its shots are a far higher dose.
FDA scientists also emphasized that the vast majority of adolescents that have suffered the side effect have fully recovered.
Be the first to comment