WASHINGTON — As more students, and their families, prepare for the start of another school year, one question looms at the forefront of discussion: Will the spread of the Delta variant cause schools to shut down once again?
For children younger than 12, vaccines are not an option to protect against COVID-19. The FDA has authorized three vaccines -- Moderna, Pfizer and Johnson & Johnson -- to be given only to those ages 12 and older. Dr. Danielle Dooley with Children's National Hospital said more data is needed to know the proper vaccine dose for younger kids.
"We know many medications in children are given on a weight-based dosing algorithm," Dooley said. "So it is critical we get all the data to know what dose is effective for children under 12."
So how much longer will parents have to wait? Dooley estimates that progress could come as early as this fall.
"We know that the trials are underway and that Pfizer has a very large trial for kids under 12," Dooley said. "And at this point, they expect to submit their data, later this fall. We're really trying to make sure children stay at the forefront, now that we're at this stage of the pandemic where children are the large population not eligible for vaccination."
In an interview with NPR, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor to the president, backed up Dooley's estimated timeline. Though he said he doesn’t know for sure when a vaccine would be authorized for kids, based on the timelines for Pfizer trials and approvals, he believes kids aged 5 to 11 could get an Emergency Use Authorization (EUA) by mid to late Fall. But he reiterated that ultimately that decision will be up to the Food and Drug Administration (FDA).
It's unclear if it will take weeks or longer once the FDA receives data from Pfizer's trial to secure emergency approval, but Dr. Dooley said pediatricians are pressing for a quick, but thorough review.
Maryland Gov. Larry Hogan remains one of the loudest voices in the push to approve vaccines for school-age children.
“We continue to call on the federal government to expedite approval so that our 5 to 11-year-olds can begin receiving COVID-19 vaccines," Hogan said Monday, in reaction to the FDA approval of Pfizer's vaccine. "Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away."
As of Monday, Pfizer's COVID-19 vaccine is the only shot to be fully approved by the FDA, though all three vaccine options (Pfizer, Moderna and Johnson & Johnson) have been granted EUA by the FDA.
To get the EUA, the companies submitted thousands of pages of data from clinical trials. This data covered the vaccines safety, side effects, and manufacturing processes
“The safety standards were completely met and they were reviewed rigorously not only by the FDA but also by independent panels who advise the FDA on emergency use,” said Dr. Matthew Laurens, a vaccines expert from the University of Maryland School of Medicine.
To get full approval, the FDA explained the companies must submit a Biologic License Application. To qualify for this application our experts said it follows the same standards for safety and effectiveness.
To put it plainly, full approval looks at more data from a longer period of time than the EUA did. Instead of two months of follow-up data from trials, FDA approval looks at a minimum of six months of data.
However, full approval has the same safety and effectiveness standards.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Acting FDA Commissioner Janet Woodcock. "[This] milestone puts us one step closer to altering the course of this pandemic in the U.S.”