The Food and Drug Administration (FDA) announced on Thursday that Covid-19 vaccines could become available in the US for children under 12 by midwinter.
Currently, in the US, Covid vaccines have only been authorised for people ages 12 and up, and none has received full approval from the FDA yet.
In March, both Moderna and Pfizer-BioNTech launched trails of their jabs for kids under 12, and results are expected in early autumn, then it will take FDA officials time to review the pharmaceutical companies’ applications.
During one of the Pfizer vaccine trials involving children, 86% of participants suffered an adverse reaction to the jab. Of the 1,127 children who received a first dose of the jab, 86% experienced an adverse reaction ranging from mild to serious, whilst 78.9% of the 1,097 who received a second dose experienced an adverse event.
Despite this, the FDA is hoping to approve vaccines for children as young as six months during the winter months. The regulatory agency is asking for four to six months of safety follow-up data for kids under age 12.
In a statement to NBC News, Pfizer said that it anticipates results on its clinical trials in kids ages 5 to 11 sometime in September, and then could apply for emergency use authorisation. A Pfizer spokesperson said: “Data for kids 2 and under 5 could arrive soon after that,” adding that results on kids ages 6 months up to 2 years may not be released until October or November.
Dr Buddy Creech, a primary researcher for the Moderna KidCOVE clinical trials, which includes children as young as six months, predicted a rollout of pediatric data similar to Pfizer’s.
Dr Creech said: “I can’t imagine, except maybe for the 6- to 11-year-olds, that we’re going to have too much data before the late fall.”
He said that results on kids 5 years old and younger may take longer: “There is still a lot of work left to be done.”
