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While mpox has low transmission in the US currently, outbreaks are still occurring in other regions of the world. Image credit: Shutterstock / Melnikov Dmitriy. The US Biomedical Advanced Research and Development Authority (BARDA) has requested Bavarian Nordic manufacture more of the product used in its smallpox/mpox vaccine Jynneos, as the company aims to replenish stocks that were used in the 2022 measles outbreak. In the form of a $156.8m contract to the Danish vaccine specialist, the new order is necessary to fulfil the existing contract to supply a next-generation, freeze-dried version of the vaccine for US smallpox preparedness. In 2017, BARDA awarded Bavarian Nordic a contract to develop a freeze-dried version of the vaccine with a longer shelf-life to replace the stockpile. The US had around 20 million Jynneos doses in its stockpile at the time of the 2022 mpox outbreak, the majority of which had expired, according to a report in The New York Times . BARDA duly requested a liquid-frozen version supply of the vaccine, which reduced Bavarian Nordic’s inventory of bulk products. To fulfil its contract for the freeze-dried version, the drug manufacturer was first awarded a contract to replenish stock last year. See Also: Takeda’s ADZYNMA gains EU approval for cTTP treatment Amneal’s CREXONT gains FDA approval for Parkinson’s treatment While $139.7m of the most recent US contract value will go towards partly replenishing the inventory used to manufacture Jynneos vaccines, the remaining $17m will be used to store vaccine doses between 2025 and 2027. Part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, BARDA uses Jynneos as part of its smallpox and mpox medical countermeasure framework, which also includes the antivirals Tpoxx (tecovirimat) and Tembexa (brincidofovir). Jynneos is a US Food and Drug Administration (FDA)-approved vaccine for both smallpox and mpox, as both belong to the same virus family and exhibit similar preventive features. Although the World Health Organization (WHO) declared that smallpox was eradicated in 1980, mpox continues to pose a threat to global health. Jynneos, the only FDA-approved vaccine for mpox, was instrumental in fighting the infectious disease during the 2022 outbreak. During the peak of the flare-up, there were 447 cases over a seven-day average in the US. There has been a total of just over 32,000 cases in the country, and though there is only low-level transmission at the moment, the disease is still being reported in other parts of the world, such as the Democratic Republic of the Congo (DRC). Bavarian Nordic, which previously relied on the US Government to stockpile and distribute Jynneos, rolled out the vaccine itself into the market earlier this year. Financial outlook for Bavarian Nordic Bavarian Nordic said the contract would not impact its overall financial guidance for the year, but it did say that its “public preparedness business value” would increase by DKr900m ($131.8m). The company added that a “few additional government contracts” anticipated later this year would bring the business revenue to a range of $730m-$780m. Bavarian Nordic reported record financial results in 2023 , earning a preliminary revenue of $1bn compared to $456m in 2022. The company’s revenue growth was propelled by surges in sales of smallpox and mpox vaccine brands, as countries continued to purchase orders to mitigate the risks of new outbreaks. Jynneos, also known under the brands Imvamune and Imvanex outside the US, generated sales of $725m last year.

Purdue Pharma has drawn heavy criticism in the past and has been the subject of numerous lawsuits as many accuse the company of being responsible in large part for the US’ current opioid epidemic. Credit: Shutterstock / JHVEPhoto. Purdue Pharma ’s opioid overdose reversal injection, Zurnai, was granted clearance by the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older to combat overdose due to synthetic opioids. Coming in the form of an auto-injector pen that provides 1.5mg of nalmefene hydrochloride per actuation, it is the longest-acting opioid antagonist currently approved for opioid overdose reversal. The company hopes the system is simple enough to be used by anyone. The approval comes as data published by the Centers for Disease Control (CDC) for over 12 months until February 2024 indicates approximately 90% of opioid overdose deaths were from synthetic opioids, mostly fentanyl. At the same time, research published in the New England Journal of Medicine found that opioid overdose deaths in the US have doubled among teenagers with 22 high school-age adolescents dying each week from overdoses driven by fentanyl-laced prescription pills. Purdue president and CEO Craig Landau said: “Zurnai can be an important new tool to save lives in critical moments. We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the company.” Purdue Pharma has drawn heavy criticism in the past and has been the subject of numerous lawsuits. Many parties have accused the company of being responsible in large part for the US’ current opioid epidemic when it engaged in deceptive marketing practices to sell Oxycontin (oxycodone hydrochloride), an opioid painkiller. See Also: Takeda’s ADZYNMA gains EU approval for cTTP treatment Amneal’s CREXONT gains FDA approval for Parkinson’s treatment Purdue says that less than 5% of those administered nalmefene hydrochloride through its Zurnai injector pen saw some adverse effects such as nausea, headache, dizziness and vomiting, among others. The company insists that it is producing the device US-wide at no profit to itself while continuing the production of its nalmefene hydrochloride injection in single-dose vials. Elsewhere, researchers at Canada’s University of Waterloo have developed a new blood testing technique that can identify the presence of potent opioids including the highly potent fentanyl in less than three minutes. At the same time, the FDA has issued a complete response letter to Orexo regarding a new drug application for its high-dose naloxone rescue medication, OX124.