Reports are circulating that Pfizer and BioNTech are on the verge of seeking emergency use authorization (EUA) for their COVID-19 vaccine so that it can be used on children younger than five years old.
If those reports are accurate, the companies will ask the U.S. Food and Drug Administration (FDA) to grant EUA for a two-dose regimen of their vaccine as it continues testing three doses in that age group.
The reason why the company is taking two separate steps, the sources said, was because federal regulators might be more likely to approve authorization for two doses sometime this month. However, going for a three-dose regimen approval might push the authorization back until March.
Why a three-shot regimen
The company’s reason for pursuing a three-shot regimen likely stems from a trial it performed on younger children in December. In that trial, two child-sized doses of the vaccine failed to produce the expected immunity in the 2- to 5-year-old age group. However, it did meet expectations for babies up to two years old. At the time, the company said it would "amend" the clinical trial to add a third dose two months after the second one.
Speaking on CBS’ “Face the Nation,” former FDA commissioner and current Pfizer board member Dr. Scott Gottlieb said Pfizer would have better luck going for a two-dose authorization rather than a three-dose authorization.
"I'm hopeful that you could see some movement on trying to entertain that application earlier," Gottlieb said, "Ultimately the decision resides with the FDA, but there is some indication that there may be an earlier action on that application.”
Gottleib said if the goal of the vaccine is to give 2- to 5-year olds baseline immunity and “prevent really bad outcomes," then two doses would do the trick.
"I think that may be why federal health officials are rethinking this. If in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March," he stated.
Moderna has vaccine news of its own
Moderna also announced Tuesday that the FDA has approved its application for SPIKEVAX, another COVID-19 vaccine designed to prevent the disease in individuals 18 years of age and older.
The vaccine’s proof of performance is impressive. Beginning two weeks after the second dose, clinical trials in Canada showed that SPIKEVAX was 94.1% effective in protecting trial participants aged 18 and above against COVID-19. It was also 100% effective in trial participants 12 to 17 years old.