Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197
As of the edition of 20 October 2026, Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae crm197 is a vaccine component: marketed, first approved in 2021 (US); US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Vaccine component
- Brand name
- Vaxneuvance
- First approved
- 16 July 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 117, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Nervous system; Immune system; Digestive system; Urinary and reproductive
US protection
US protection ends in 2033.
The reference-product exclusivity ends in 2033. The application that gives this date is held by Merck & Co..
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 11 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 20 | 15 | 2 | 2 |
| Phase 3 | 49 | 42 | 5 | 0 |
| Phase 4 | 30 | 24 | 3 | 0 |
| All trials | 117 |