The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
AUG 30 2026
APPROVED · 30 DAYS AGO

Pfizer — Comirnaty (Comirnaty) $PFE

for COVID-19

NDA

FDA approved Pfizer and BioNTech's updated Comirnaty COVID-19 vaccine targeting the XFG variant.

About

COVID-19 is a contagious disease caused by the SARS-CoV-2 virus, which led to a global pandemic. Comirnaty is a vaccine that teaches the body's immune system to recognize and fight the virus. This updated vaccine targets a specific variant, potentially helping to protect against severe illness.

Pivotal trial

BOOST-IC Phase 3 active not recruiting NCT05556720

Despite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined. IC hosts were largely excluded from the COVID-19 vaccine registration trials, though many countries recommend additional and booster doses of vaccination in this group

Source: ClinicalTrials.gov

Also in development