PFE · 8-K · 20260804PR000094

Comirnaty Regulatory Approval

PFIZER INC · 2026-08-04 · Importance 31 · Surprise 42 · In source text

The European Commission granted Pfizer and BioNTech marketing authorization in July 2026 for their 2026-2027 XFG-variant COVID-19 vaccine for individuals aged six months and older. In June 2026, the U.S. Food and Drug Administration approved expanded Hympavzi indications for hemophilia A or B patients aged 12 and older with inhibitors and for pediatric patients aged six to 11. The FDA also approved Ibrance with trastuzumab, with or without pertuzumab and endocrine therapy, for maintenance treatment of adults with HR+/HER2+ locally advanced or metastatic breast cancer. In July 2026, the FDA approved Padcev with pembrolizumab-based regimens for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer regardless of cisplatin eligibility, while a Talzenna supplemental application received priority review with a PDUFA action date in the fourth quarter of 2026.

Key facts

• European Commission granted marketing authorization in July 2026 for Pfizer/BioNTech 2026-2027 Comirnaty XFG-adapted monovalent vaccine for individuals 6 months and older source
• European Commission approved May 2026 update to Comirnaty marketing authorization for children 6 months through 4 years: 10-μg dose for all children 6 months through 11 years and reduces primary series to two doses source

Impact estimates