COVID Vaccine For Children Under 12 Could Get Emergency Approval By Winter

Emergency approval for COVID-19 vaccines in children under 12 years of age in the United States may come by mid-winter, a Food and Drug Administration (FDA) official reportedly said Thursday.

NBC reported that the FDA looks to pursue full approval of vaccines for kids under 12 shortly after the emergency authorization is issued. The issue of approving a vaccine for children under 12 has gained urgency as the new surge in coronavirus cases across the country, fueled by the aggressive Delta variant of the virus, has hit children and unvaccinated young people more. Earlier this week Mississippi reported seven children in hospital, with two on life support, from the virus.

The FDA official, who wasn't named in the report, added that the agency is requesting for up to six months of safety follow-up studies for a biologics license application (BLA) for kids below 12 years of age. The agency has required only two months of follow-up data for the vaccine clinical trials in adults.

The additional months of follow-up data collection is expected to make the process for full approval easier. Pfizer and Moderna are still holding clinical trials to determine how their COVID-19 vaccines will work in children below the age of 12.

So far coronavirus vaccines for people ages 12 and above have only emergency use authorization for in the United States; no vaccine has been fully approved, which is a concern for some people and contributed to vaccine hesitancy.

Pfizer told CNN that results for the clinical trials among children aged 5 to 11 years will likely be available in September. The company said it is possible to request emergency authorization from the FDA within the same month.

The company added that trial data for kids ages 2-5 could come shortly after, with the timeline set at October or November.

The issue about vaccines for children has escalated as the new school year nears. Speaking to USA Today, a father of two from Delaware, Daniel Horowitz, told USA Today that it appears re-opened spaces “don’t seem to be taking the kids into account too much.”

Some parents who believe there is a lack of attention for unvaccinated children have urged the U.S. Centers for Disease Control and Prevention to provide more detailed guidance on dealing with the matter.

Some parents have opted to enrol their children in vaccine studies so they can get vaccines quicker. Jennifer Barsi of Long Island, whose three children under age 12 have received their second shots as part of a local clinical study, told ABC flagship station WABC-TV that allowing her kids to enrol in the trials “is how we can keep our kids safe.”

"This is how we can keep our kids safe, because I do worry, especially with the Delta variant, I don't want our children to suffer ill effects from COVID," she said.

Not everyone gets a vaccine shot in such studies; two-thirds of the children in the trial got the Pfizer vaccine and the other third got a placebo.

The clinical study at the Stony Brook Children’s Hospital is just one of the 100 facilities around the world to take part in Pfizer’s clinical trials. More than 4,000 children have been enroled in these studies.