PCV21 — Competitive Intelligence Brief

PCV21 (PCV21) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Pneumococcal conjugate vaccine. Area: Immunology / Infectious Disease.

phase 3 Pneumococcal conjugate vaccine Streptococcus pneumoniae polysaccharide capsule (21 serotypes) Immunology / Infectious Disease Biologic

Target snapshot

PCV21 (PCV21) — Sanofi Pasteur, a Sanofi Company. PCV21 is a pneumococcal conjugate vaccine that stimulates immune responses against 21 serotypes of Streptococcus pneumoniae to prevent pneumococcal disease.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
PCV21 TARGET	PCV21	Sanofi Pasteur, a Sanofi Company	phase 3	Pneumococcal conjugate vaccine	Streptococcus pneumoniae polysaccharide capsule (21 serotypes)
Prevnar 20	pneumococcal 20-valent conjugate vaccine (PCV20)	Pfizer Inc.	marketed	Pneumococcal conjugate vaccine	Streptococcus pneumoniae capsular polysaccharides (20 serotypes)	2021-06-08
PCV10 full dose	PCV10 full dose	Epicentre	marketed	Pneumococcal conjugate vaccine
Streptococcus pneumoniae serotype 3	Streptococcus pneumoniae serotype 3	University of Oxford	marketed	Pneumococcal conjugate vaccine	Streptococcus pneumoniae serotype 3 capsular polysaccharide
GSK1024850A (SynflorixTM)	GSK1024850A (SynflorixTM)	GlaxoSmithKline	marketed	Pneumococcal conjugate vaccine	Streptococcus pneumoniae polysaccharide antigens (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
PCV13 alone	PCV13 alone	Korea University Guro Hospital	marketed	Pneumococcal conjugate vaccine	Streptococcus pneumoniae polysaccharide capsule (13 serotypes)
Prevnar13	Prevnar13	GlaxoSmithKline	marketed	Pneumococcal conjugate vaccine	Streptococcus pneumoniae polysaccharide capsule (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)

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)

• 2033-06-01 — Prevnar 20 · US 8,895,024 · Composition of matter · US
• 2035-06-01 — Prevnar 20 · US 10,279,033 · Method of use · US

Sponsor landscape (Pneumococcal conjugate vaccine class)

1. GlaxoSmithKline · 12 drugs in this class
2. Sanofi Pasteur, a Sanofi Company · 2 drugs in this class
3. Korea University Guro Hospital · 1 drug in this class
4. Merck Sharp & Dohme LLC · 1 drug in this class
5. Papua New Guinea Institute of Medical Research · 1 drug in this class
6. Pfizer Inc. · 1 drug in this class
7. Sanofi · 1 drug in this class
8. University of Minnesota · 1 drug in this class
9. University of Oxford · 1 drug in this class
10. Vabiotech · 1 drug in this class