EMA approves Imvanex vaccine against monkeypox in EU

Simon Collins, HIV i-Base

On 22 July 2022, the EU committee responsible for reviewing medicines (CHMP) recommended extending the indication for Imvanex to include monkeypox (MPX). [1]

Imvanex was approved in the EU as a smallpox vaccine in 2013. [2]

Imvanex was approved in the US both for smallpox and monkeypox in 2019 where it is marketed as JYYNEOS. [3]

This included additional information from some studies. [4]

 References

1. EMA News. EMA recommends approval of Imvanex for the prevention of monkeypox disease. (22 July 2022).
   https://www.ema.europa.eu/en/news/ema-recommends-approval-imvanex-prevention-monkeypox-disease
2. EMA. Imvanex product information. (2013).
   https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex
3. US FDA, FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox. (24 September 2019)
   https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox
4. US Office of Vaccines Research and Review (OVRR). Review memorandum for Jynneos vaccine. (2018)
   https://www.fda.gov/media/131870/download

 This report was first published on 27 July 2022.