The European Commission gave the go-ahead for the company to market a vaccine that protects against monkeypox and the related vaccinia virus.
The vaccine can be used against monkeypox in the U.S. and Canada, but not in Europe.
The European Economic Area, as well as all 27 EU member states, can be used for the marketing of the shot.
The company said the quick approvals highlight the great cooperation between the company and regulators.
The availability of an approved vaccine can greatly improve nations readiness to fight emerging diseases, but only through investment and proper planning, according to the president and CEO of Bavarian Nordic.
The shares of Bavarian Nordic increased in value as the markets opened.
The European Commission's decision is in line with a recommendation from its medicine's regulator to expand the shot's indication. Tedros called on countries to take urgent steps to contain the disease because of the designation. Tedros said that the monkeypox outbreak has spread around the world quickly and through new modes of transmission. Tedros said that the risk of monkeypox is high in the European region. He said that other regions were of moderate risk. Sex between men is the main driver of the disease. While warning against discrimination, officials have urged countries to work with affected communities.
The only vaccine approved for use against monkeypox in the world is the one from Bavarian Nordic. It was made possible by two decades of US investment. It's effectiveness against monkeypox is a result of its intended target, smallpox, a related and now-eradicated virus that is considered a national security issue. Efforts to control the virus have been hampered by the shortage of the vaccine. The company is trying to increase production. Poorer countries are struggling to get a hold of any of the monkeys that are available. Wealthier nations that have been able to secure supplies are facing shortages and are looking at months for them to be delivered. It's against the advice of regulators that experts and health officials adapt their immunization strategies to prioritize first doses to make sure as many high-risk people are protected.
A total of 10,604. Data from the European Center for Disease Prevention and Control and the World Health Organization show how many cases of monkeypox have been identified in the European region. Most cases were reported by men. There are reports that the virus can cause pain so bad that it requires hospitalization. Europe makes up the majority of global cases.
Monkeypox is a global health emergency.
There is a one-dose monkeypox vaccine strategy that could help extend supplies.
Gay men with monkeypox tell their stories.