Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Sponsored ADR Report announced Wednesday that they’re reaching out to the U.S. Food and Drug Administration for full approval of a booster shot of their COVID-19 vaccine for people aged 16 and over.
Earlier this week, the FDA fully approved the duo’s first two shots for people 16 and over.
The companies said in a statement that they have initiated “a supplemental Biologics License Application to the Food and Drug Administration for the approval of a booster (third) dose of Comirnaty (COVID-19 Vaccine, mRNA).”
The duo intend to complete submission of the supplemental BLA by the end of this week.
“The sBLA includes data from a Phase 3 clinical trial of 306 participants 18-55 years of age who received a booster (third) dose of Comirnaty between 4.8 and 8 months after completing the two-dose primary regimen, with a median follow-up time of 2.6 months post-booster,” Pfizer and BioNTech said.
“The booster (third) dose elicited robust neutralizing antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection through one-month post-dose-three.”
A third dose of the Pfizer-BioNTech vaccine isn’t yet authorized for broad use in the U.S. However, on Aug. 12, a third dose was authorized for emergency use to people 12 and over who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
The news didn’t appear to affect either company’s stock. Pfizer shares traded at $47.50, down 1.8% at last check, and BioNTech shares traded at $372.01, up 1%.