Ema: 'Yes to smallpox vaccine to counter monkey vaccine'

By Cristiano Antonino On Jul 23, 2022

The Imvanex vaccine, approved in the European Union since 2013, contains an attenuated form of the smallpox virus and the European Medicines Agency recommends it as a ‘potential vaccine for monkeypox’

Imvanex smallpox vaccine, EMA’s indications

The Committee for Medicinal Products for Human Use (Chmp) of the European Medicines Agency (Ema) has recommended extending the indication for smallpox vaccination with Imvanex to include protection of adults against monkeypox.

Vaccine, the medicine has been approved in the European Union since 2013 for the prevention of smallpox

It contains an attenuated (weakened) form of the smallpox virus called ‘modified live Ankara vaccine virus’, which is related to the smallpox virus.

“It has also been considered as a potential vaccine for monkeypox because of the similarity between the monkeypox virus and the smallpox virus,” the Ema statement reads.

The marketing authorisation holder is Bavarian Nordic A/S’.

To confirm its efficacy against monkeypox, ‘the company will collect data from an observational study to be conducted during the ongoing monkeypox epidemic in Europe.

The safety profile of the drug is favourable, with mild to moderate side effects, and Chmp concluded that the benefits of the drug outweigh the risks.

In addition to its use for the prevention of monkeypox, the Chmp recommended that Imvanex be authorised to protect people against diseases caused by the vaccine virus, which leads to similar, but milder, symptoms than smallpox’.