Topline
The European Commission on Monday has given Danish biotech Bavarian Nordic permission to expand the label of its smallpox vaccine to include protection against monkeypox, days after the World Health Organization sounded the alarm over the accelerating outbreak.
Key Facts
Bavarian Nordic said the European Commission has given the company permission to market its smallpox vaccine, branded as Imvanex in Europe, to include protection from monkeypox and disease caused by the related vaccinia virus.
The vaccine is already approved for use against monkeypox in the U.S. and Canada—where it is marketed as Jynneos and Imvamune, respectively—but could only be used “off label” against monkeypox in Europe, which limits access.
The green light means Bavarian Nordic can market the shot for use against monkeypox in all 27 EU member states as well as Iceland, Liechtenstein and Norway, which are in the European Economic Area.
Bavarian Nordic said the rapid turnaround—such approvals usually take at least six-to-nine months to achieve—highlights the “great cooperation” between the company and European regulators.
Paul Chaplin, president and chief executive of Bavarian Nordic, said the availability of an approved vaccine “can significantly improve nations’ readiness to fight emerging diseases,” but warned this can only be realized through investment and proper planning.
Bavarian Nordic shares jumped nearly 10% as markets opened in Copenhagen Monday morning.
Key Background
The European Commission’s decision is in line with a recommendation from its medicine’s regulator to expand the shot’s indication on Friday and comes days after WHO head Tedros Adhanom Ghebreyesus declared the outbreak a public health emergency of international concern. Such a designation is the organization’s highest level of alert and Tedros called on countries to take urgent steps to contain the disease. The monkeypox outbreak “has spread around the world rapidly” and “through new modes of transmission, about which we understand too little,” Tedros said. In the European region, the risk of monkeypox is “high,” Tedros cautioned, noting a “clear risk of further international spread.” Other regions are of moderate risk, he added. Data suggests the disease is driven overwhelmingly by sex between men, particuarly those with multiple or anonymous partners. Officials have urged countries to work with affected communities to tackle the disease while warning against stigma and discrimination.
News Peg
Bavarian Nordic’s shot is the only vaccine in the world authorized specifically for use against monkeypox. Its development was made possible by two decades of U.S. investment, CEO Chaplin said. Its effectiveness against monkeypox is largely a byproduct of its intended target, smallpox, a related and now-eradicated virus that is treated as a national security issue. The vaccines are in critically short supply, which has hampered efforts to control the virus. Bavarian Nordic told Forbes the company is exploring ways to boost production. These supply issues mean poorer countries, notably the African nations where monkeypox has spread for years, are struggling to get a hold of any doses at all. Wealthier nations that have managed to secure supplies still face shortages and are looking at months for them to be delivered. Experts and health officials are considering adapting their immunization strategies to prioritize first doses to ensure as many high-risk people are protected as possible, though this goes against advice from regulators.
Big Number
10,604. That’s how many cases of monkeypox have been identified throughout the European region (which includes non-EU countries like the U.K. and Russia) as of Tuesday, according to data from the European Center for Disease Prevention and Control and the World Health Organization. Almost all cases, 99.5%, were reported among men. No cases were reported to have resulted in death but there are reports the virus can cause lesions so painful they require hospitalization. Europe makes up the majority of global cases, which now number more than 16,000, Tedros said.
Further Reading
WHO Calls Monkeypox A Global Health Emergency (Forbes)
A One-Dose Monkeypox Vaccine Strategy Could Help Extend Scarce Supplies As U.S. Outbreak Grows (Forbes)
Lesions, headaches, debilitating pain: Gay men with monkeypox share their stories (NBC News)
Source: https://www.forbes.com/sites/roberthart/2022/07/25/monkeypox-vaccine-gets-green-light-in-europe/