COMIRNATY - BioNTech Manufacturing GmbH — Competitive Intelligence Brief

COMIRNATY - BioNTech Manufacturing GmbH (COMIRNATY - BioNTech Manufacturing GmbH) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mRNA vaccine. Area: Immunology / Infectious Disease.

marketed mRNA vaccine SARS-CoV-2 spike protein (S protein) Immunology / Infectious Disease Biologic

Target snapshot

COMIRNATY - BioNTech Manufacturing GmbH (COMIRNATY - BioNTech Manufacturing GmbH) — Jens D Lundgren, MD. COMIRNATY is an mRNA vaccine that instructs cells to produce the SARS-CoV-2 spike protein, triggering an immune response to prevent COVID-19 infection.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
COMIRNATY - BioNTech Manufacturing GmbH TARGET	COMIRNATY - BioNTech Manufacturing GmbH	Jens D Lundgren, MD	marketed	mRNA vaccine	SARS-CoV-2 spike protein (S protein)
BNT162b5 Bivalent (Original/OMI BA.4/BA.5)	bnt162b5-bivalent-original-omi-ba-4-ba-5	Pfizer	marketed	mRNA vaccine	Spike protein of SARS-CoV-2
Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose	variant-adapted-bnt162b2-omicron-xbb-1-5-10-microgram-dose	Pfizer	marketed	mRNA vaccine	SARS-CoV-2 spike protein
BNT162b2 (Omi KP.2)	bnt162b2-omi-kp-2	Pfizer Inc.	marketed	mRNA vaccine	Spike protein of SARS-CoV-2
BNT162b2 BA.4/5 bivalent	bnt162b2-ba-4-5-bivalent	Pfizer	marketed	mRNA vaccine	SARS-CoV-2 virus
Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose	variant-adapted-bnt162b2-omicron-xbb-1-5-3-microgram-dose	Pfizer	marketed	mRNA vaccine	SARS-CoV-2
Combination BNT162b2 and BNT162b2 OMI	combination-bnt162b2-and-bnt162b2-omi	Pfizer	marketed	mRNA vaccine	SARS-CoV-2 spike protein

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (mRNA vaccine class)

1. Pfizer · 12 drugs in this class
2. ModernaTX, Inc. · 11 drugs in this class
3. BioNTech SE · 5 drugs in this class
4. Jules Bordet Institute · 5 drugs in this class
5. Tan Tock Seng Hospital · 2 drugs in this class
6. Clover Biopharmaceuticals AUS Pty · 1 drug in this class
7. CanSino Biologics Inc. · 1 drug in this class
8. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
9. CSPC Megalith Biopharmaceutical Co.,Ltd. · 1 drug in this class
10. Jens D Lundgren, MD · 1 drug in this class