ECO Animal Health Group (EAH): ECOVAXXIN MS EU approval and launch
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EAH ECO Animal Health Group
10 Nov 2025 · CVMP Positive Opinion received · +13% until the next step
Based on the CVMP's Positive Opinion, the EMA is expected to issue a marketing authorisation during the first quarter of 2026, and ECO Animal Health anticipates making ECOVAXXIN® MS commercially avail
1 Dec 2025 · USDA accepted pivotal efficacy study; UK dossier awaiting submission · +6% until the next step
the key trial (the pivotal efficacy study) has now been accepted by the USDA and marketing approval is now expected by end of CY2026.
22 Dec 2025 · EU marketing authorisation granted; launch planning · −4% until the next step
The Company will issue an update to the market in early 2026 to provide further details on its plans for the EU commercial launch of ECOVAXXIN® MS.
11 Mar 2026 · USDA safety assessment favourable · −4% until the next step
with final regulatory submission for ECOVAXXIN® MG currently anticipated in late 2027
2 Jul 2026 · EU commercial launch completed in Madrid · −7% until the next step
announces the commercial launch of ECOVAXXIN® MS, its poultry vaccine against Mycoplasma synoviae (M. synoviae), across the European Union (EU) with its official launch event in Madrid, Spain.
15 Jul 2026 · EU approved and launched; US approval expected · +8% until the next step
the United States Department of Agriculture (USDA) has now accepted the pivotal efficacy data, with marketing approval expected in the United States by the end of the calendar year.
17 Sep 2026 · USDA-CVB accepted field safety data; US licence pending · −1% since
with US marketing approval expected for ECOVAXXIN® MS by the end of the calendar year.
ECOVAXXIN MS EU approval and launch
USDA-CVB accepted field safety data; US licence pending
DEC31
Next: US marketing approval expected by end of calendar 2026 in 68 days
Every step · 7
- 10 Nov 2025 CVMP Positive Opinion received – Based on the CVMP's Positive Opinion, the EMA is expected to issue a marketing authorisation during the first quarter of 2026, and ECO Animal Health... ↗
- 1 Dec 2025 USDA accepted pivotal efficacy study; UK dossier awaiting submission – the key trial (the pivotal efficacy study) has now been accepted by the USDA and marketing approval is now expected by end of CY2026. ↗
- 22 Dec 2025 EU marketing authorisation granted; launch planning – The Company will issue an update to the market in early 2026 to provide further details on its plans for the EU commercial launch of ECOVAXXIN® MS. ↗
- 11 Mar 2026 USDA safety assessment favourable – with final regulatory submission for ECOVAXXIN® MG currently anticipated in late 2027 ↗
- 2 Jul 2026 EU commercial launch completed in Madrid – announces the commercial launch of ECOVAXXIN® MS, its poultry vaccine against Mycoplasma synoviae (M. synoviae), across the European Union (EU) with its... ↗
- 15 Jul 2026 EU approved and launched; US approval expected – the United States Department of Agriculture (USDA) has now accepted the pivotal efficacy data, with marketing approval expected in the United States by the... ↗
- 17 Sep 2026 USDA-CVB accepted field safety data; US licence pending – with US marketing approval expected for ECOVAXXIN® MS by the end of the calendar year. ↗
What is happening
ECO Animal Health Group: ECOVAXXIN MS EU approval and launch – USDA-CVB accepted field safety data; US licence pending. ['USDA-CVB accepted field safety data; US licence pending']
- In short
- ECOVAXXIN MS was a US and UK approval project, with the USDA accepting the pivotal efficacy study in December 2025. It won EU approval in December 2025, ahead of schedule, and launched in July 2026 with first orders. On 17 Sep 2026 USDA-CVB confirmed the US field safety data fulfils the licensure requirement. US approval is still expected by end of calendar 2026.
- Announced
- 10 Nov 2025 · CVMP Positive Opinion received
- Latest
- 17 Sep 2026 · USDA-CVB accepted field safety data; US licence pending
- US approval
- expected by end of calendar year 2026
- Other filings
- Thailand and Argentina dossiers submitted after year end
- Label data
- 44-week duration of immunity data to be submitted for the label in July
- Next milestone
- US marketing approval expected by end of calendar year 2026
- Field safety data
- USDA-CVB confirmed on 17 Sep 2026 it fulfils the field safety requirements to support licensure
- Trial size
- More than 170,000 commercial laying pullets across three sites in Michigan, Indiana and Wisconsin
- EU status
- Approved December 2025; commercially launched July 2026
- Remaining steps
- Last remaining regulatory requirements towards US marketing authorisation
What comes next
US marketing approval expected by end of calendar 2026 (31 Dec 2026).
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