FDA ‘eager’ for vaccine for kids, but no firm timeline

The Food and Drug Administration (FDA) said Friday that it is working “around the clock” to authorize COVID-19 vaccines for children under 12, but that it cannot offer a specific timeline for when they will be available.

The lengthy statement from acting FDA Commissioner Janet Woodcock and top vaccine official Peter Marks comes as the agency is facing pressure to move quickly on the issue, given that COVID-19 vaccines are currently unavailable for children under 12.

The FDA sought to address the pressure in Friday’s statement, but also emphasized that it would “follow the science.”

“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” Woodcock and Marks said. “We have to let the science and data guide us.”

“This process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months,” they added.

Clinical trial data must first be submitted to the FDA. National Institutes of Health Director Francis Collins told NPR last month that the data from Pfizer’s trial could come by the end of September.

The FDA said Friday that once the data comes in, the agency will review it “likely in a matter of weeks rather than months.”

The statements from the FDA come after more than 100 lawmakers wrote to the agency last month pressing it for a timeline on when vaccines would be available for children.

The American Academy of Pediatrics has also called on the agency to move “as soon as possible.”

Anthony Fauci, the nation’s top infectious diseases expert, told NBC last month he thinks the authorization could come “hopefully by the mid-late fall and early winter.”

President Biden also stressed in a speech on Thursday laying out the next phase of his pandemic plan that “I’ve made it clear I will do everything within my power to support the FDA with any resource it needs to continue to do this as safely and as quickly as possible.”

He also said, though, that “we can’t take shortcuts with that scientific work.”