Topline
A Centers for Disease Control and Prevention committee voted Wednesday to recommend the routine use of Bavarian Nordic’s mpox vaccine in at-risk adults, paving the way for commercialization and issuing people a reminder that the virus is still circulating after last year’s outbreak.
Key Facts
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend adults at risk of mpox infection receive two shots of Bavarian Nordic’s Jynneos vaccine on a routine basis.
The panel had previously endorsed the vaccine for use in people at risk of mpox infection during outbreaks only.
Under the previous recommendation, mpox vaccine delivery was covered by the United States government and there were limited opportunities for Bavarian Nordic to commercialize Jynneos.
The recommendations will now be passed to CDC director Mandy Cohen for final approval.
Pending approval, Danish biotech Bavarian Nordic said it is aiming at a commercial launch for Jynneos in the U.S. “in the first half of 2024.”
Bavarian Nordic CEO Paul Chaplin said the panel’s recommendation “recognizes the significance of maintaining a high awareness of the disease among risk groups and the importance of ensuring broader access to the vaccine beyond an outbreak situation.”
What To Watch For
The ACIP vote, reportedly unanimous at 14-0, is not set to be the committee’s final word on Jynneos. If passed, the group said its recommendation will only provide interim guidance that will be revisited in two to three years. At that point, the virus’ spread will be evaluated and the costs and benefits of vaccination weighed, it said. The group also noted that clinical trials for Jynneos are underway for teens ages 12 to 17 years, as the shot is only authorized for use in adults.
Key Background
Mpox, formerly called monkeypox, was known about for decades but rarely seen apart from sporadic outbreaks in some regions of Africa and occasional cases linked to people—or wildlife—that had been there. The virus, a relative of the eradicated scourge smallpox, largely spreads through close contact with infected people and animals or with contaminated items and surfaces. It can cause painful skin lesions that can last for weeks and, in some cases, kill. It spread globally in the summer of 2022, primarily among men who have sex with men, which revealed a new mode of transmission and symptoms. The World Health Organization declared the outbreak a public health emergency of international concern in July and as the virus had been ignored by much of the world for so long, there were few countermeasures to target mpox directly. Vaccines like Jynneos that were primarily designed with smallpox in mind were deployed to combat the outbreak, though access to these was not equally distributed and supplies were limited. Since the start of last year, there have been more than 30,000 mpox cases in the U.S. and 54 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally. While health agencies have rescinded emergency warnings for mpox, the virus still circulates, particularly in areas with limited access to vaccines and in parts of Africa where outbreaks are still a concern.
Big Number
2 million. That’s how many people Bavarian Nordic say are eligible for mpox vaccination under the panel’s recommendations, citing CDC estimates. Bavarian Nordic said only 23% of this group has received the recommended regimen of two shots during the 2022/2023 outbreak, “leaving a significant number of people vulnerable to infection with mpox.”
Tangent
Guidelines for who is considered at risk of infection are in line with previous advice. Those considered at risk are people who are gay, bisexual and other men who have sex with men or transgender or nonbinary people. Additionally, in the past six months, at-risk people should have had either a new diagnosis for a sexually transmitted infection, more than one sex partner, sex at a commercial sex venue or sex linked to “a large public event in a geographic area where mpox transmission is occurring.” Sexual partners of people who meet these criteria and people who anticipate meeting them are also considered at risk of infection and eligible for vaccination, according to documents from the CDC meeting.
As Monkeypox Spreads, Here’s Who Should Get A Vaccine—And How (Forbes)
The doctor who warned the world of the mpox outbreak of 2022 is still worried (NPR)
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