Monkeypox Vaccine Gets Thumbs Up From EU Regulator Amid Race To Improve Access

Topline

The European Union’s medicines regulator has recommended expanding the label of a smallpox vaccine to include protection against monkeypox, paving the way for expanded access to the shot amid scarce supplies and escalating case numbers.

Key Facts

The company behind the shot—Danish biotech Bavarian Nordic—said the European Medicines Agency (EMA) had adopted a “positive opinion” recommending the company’s smallpox vaccine, Imvanex, be authorized to include protection against monkeypox on its label.

The vaccine is approved for use against monkeypox in the U.S. and Canada—where it is marketed as Jynneos and Imvamune, respectively—but is only authorized for use against smallpox in Europe.

Bavarian Nordic said the regulator asked it to submit more data with a view to expanding its market authorization in light of the growing monkeypox outbreak.

As the EMA, which did not immediately respond to Forbes’ request for comment, is not empowered to permit marketing in different EU countries, its recommendation will now be passed on to the European Commission for final approval.

The Commission will make a binding decision within 67 days of receiving the recommendation and, if authorized, Bavarian Nordic will be able to market the vaccine for use against monkeypox in all 27 EU member states as well as Iceland, Liechtenstein and Norway, which are in the European Economic Area.

Paul Chaplin, president and chief executive of Bavarian Nordic, said the extension of the vaccine’s label “will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox.”

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, 256 were hospitalized (8.1%) and one was admitted to ICU. No cases were reported to have died.

Key Background

Monkeypox has been known to spread in parts of Western and Central Africa for decades, but there are few clinical options to treat the illness specifically. The monkeypox virus is, however, closely related to smallpox, a now eradicated scourge, for which effective vaccines and treatments exist. These likely work against monkeypox as well and have been deployed to help maintain the growing outbreak, though “off label” use can make it more difficult to widen access.

News Peg

Bavarian Nordic’s shot, the only one in the world specifically approved for use against monkeypox, is in critically short supply, which has hampered efforts to control the virus. Poorer countries, notably the African nations where monkeypox has spread for years, are struggling to get a hold of any doses and wealthier nations that have managed to secure supplies face shortages as they wait months for them to be delivered. The accelerating outbreak has experts and health officials considering adapting their immunization strategies to get as many first doses into high-risk people as quickly as possible, eschewing advice from regulators. There have been more than 14,000 cases of monkeypox around the world documented so far this year, the World Health Organization said, a figure that likely underestimates the true scale of the outbreak.

Further Reading

As Monkeypox Spreads, Here’s Who Should Get A Vaccine—And How (Forbes)

A One-Dose Monkeypox Vaccine Strategy Could Help Extend Scarce Supplies As U.S. Outbreak Grows (Forbes)

Struggling To Find A Monkeypox Shot? Severe Shortages And Technical Mishaps Are Slowing Down Rollouts (Forbes)

Lesions, headaches, debilitating pain: Gay men with monkeypox share their stories (NBC News)