The COVID-19 vaccine could be approved for emergency use for children under 12 years old as soon as early to midwinter, NBC News reported.
A Food and Drug Administration (FDA) official told the news outlet that children would likely be able to receive the vaccine under the emergency authorization by that time, with a goal to have it fully approved soon afterward.
The official said that the FDA wants four to six months of follow-up data for children under the age of 12. Acquiring follow-up data could make it easier to get the inoculation fully approved, according to NBC. The FDA used two months of follow-up data from clinical trials for adults.
Currently, the COVID-19 vaccine is only authorized in the U.S. for people ages 12 and up.
The news comes amid vaccine hesitancy in the U.S. — a significant portion of the nation remains unvaccinated as the delta variant spreads. States and localities have reported that the majority of people who have been hospitalized or have died from COVID-19 have not been vaccinated.
President BidenJoe BidenPressure grows for breakthrough in Biden agenda talks State school board leaves national association saying they called parents domestic terrorists Sunday shows preview: Supply chain crisis threaten holiday sales; uncertainty over whether US can sustain nationwide downward trend in COVID-19 cases MORE and members of his administration have repeatedly underscored the need to get the jab, and on Thursday, U.S. Surgeon General Vivek MurthyVivek MurthyMore than one-third of eligible seniors have received boosters, White House says Confusion reigns over vaccine booster rollout CDC director partially overrules panel, signs off on boosters MORE made a personal appeal to Americans to get vaccinated. He stated that he had 10 people in his family die from the disease.
The FDA official told NBC News that one factor that may still make families hesitant about getting the vaccine is the fact that they have been used under an emergency use authorization. None of the vaccines available have been fully approved by the agency.
Pfizer and BioNTech announced in May that they started their Biologics License Application to ultimately get their vaccine fully approved for people ages 16 and up.
Additionally, Pfizer and Moderna have already started conducting trials in children under the age of 12 years old. According to NBC, both companies expect data from their clinical trials by the fall.
According to data from the Centers for Disease Control and Prevention, 65 percent of Americans ages 12 and up have gotten at least one dose of the COVID-19 vaccine, and 56 percent of that age group are fully vaccinated.
Among Americans adults ages 18 and up, nearly 68 percent have gotten at least one dose and 59 percent have gotten both doses.
The Hill has reached out to the FDA for more information.