On July 25, the European Commission (EC) authorized the Danish pharmaceutical company Bavarian Nordic to extend the label of its Imvanex vaccine against smallpox to include protection against monkeypox, two days after the World Health Organization (WHO) ) declared the disease a public health emergency of international importance.
The green light from Brussels follows that of the European Medicines Agency (EMA), which on July 22 approved the extension to monkeypox of the Imvanex vaccine, authorized since 2013 in the European Union (EU) against human smallpox. in adults over 18 years of age.
However, according to EU legislation, the EMA does not have the authority to allow marketing in the different countries of the bloc, but rather the EC, which is in charge of authorizing and making a legally binding decision based on the EMA recommendation. .
Through a statement, the Bavarian Nordic pharmaceutical company reported the marketing authorization for its Imvanex vaccine as protection against monkeypox:
This approval for monkeypox is an example of good cooperation between the Nordic and European Bavarian regulators, with a work extension that normally takes six to nine months.
Imvanex is a non-replicating smallpox vaccine developed in collaboration with the US government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals.
The Commission’s approval is valid in all 27 EU member states, as well as in Iceland, Liechtenstein and Norway, which are in the European Economic Area. In addition, Imvanex is marketed as Jynneos in the United States, where it has been licensed against monkeypox since 2019, making it the only licensed vaccine for prevention of the disease.
In the middle of this month of July, Bavarian Nordic had announced a new important order in the US, which raised the number of doses requested by the American country to seven million. In addition, an order for 1.5 million doses from an unnamed European country was announced last week.
Within the framework of the declaration of monkeypox as a public health emergency of international importance, the WHO reported that at the end of last week, cases of monkeypox exceeded the 16,000 mark in 75 countries, most of them in Europe.
First detected in humans in 1970, monkeypox is less dangerous and contagious than the human smallpox eradicated in 1980. Until now only endemic in a few African countries, the disease is characterized by rashes that can appear on the genitals or in the mouth. In addition, it can be accompanied by episodes of fever, sore throat and / or pain in the lymph nodes.