Editors' (re)View: Supply chains and espionage; Emergent sends mpox vaccines to Africa

Emergent sends mpox vaccines to Africa

In August 2024, the global mpox situation took a worrying turn. Cases have been rising, with over 10,000 new infections reported worldwide just this month. While Central Africa remains the epicenter, outbreaks are now cropping up in Europe, Asia, and the Americas, signaling the virus's spread beyond its initial borders.

The WHO has flagged the situation as increasingly urgent, pushing for tighter surveillance and faster vaccine rollouts. Despite efforts, many countries are struggling with limited vaccine supply and growing public concern, making it clear that mpox is becoming a global health challenge that needs swift action.

As the outbreak in Central Africa shows no signs of slowing down, Emergent BioSolutions has announced a step to help curb the spread. The company is set to donate 50,000 doses of its ACAM2000 vaccine, aiming to offer some much-needed relief in the region. This isn’t just a corporate gesture — it's part of a broader, urgent response coordinated with the WHO and the U.S. government.

The vaccines will reach the Democratic Republic of the Congo (DRC) and surrounding countries like Burundi, Kenya, Rwanda, and Uganda through Direct Relief, a humanitarian organization with deep roots in the region. Direct Relief has been on the ground in these areas for years, delivering essential medicines and supplies, so this partnership makes sense.

Emergent’s ACAM2000 vaccine, originally approved for smallpox back in 2007, is being eyed as a potential tool against mpox, though it’s not without its risks. The vaccine, which uses a live virus, is administered in a way that can cause a noticeable reaction at the injection site — a red, itchy sore that’s a sign the vaccine is working. However, this live virus also means there’s a chance it could spread to others through contact, and it’s not suitable for everyone, especially those with weakened immune systems.

While the ACAM2000 vaccine is stepping into the spotlight, it’s important to note that it doesn’t yet have FDA approval for mpox, though Emergent is pushing for it. The company filed for an expanded indication last October. 

Bavarian Nordic’s Jynneos vaccine, which got FDA approval in 2019 for both smallpox and monkeypox, is also in the mix. The Danish company has promised to increase its production, aiming to deliver 10 million doses by the end of 2025.

With both vaccines in play, the hope is that these efforts will help turn the tide in a region that desperately needs it. With the outbreak still unfolding, only time will tell how effective these interventions will be. — Andrea Corona

Spies and supplies

This week, reports started circulating in various media sources about a Japanese executive from Astellas Pharma who was indicted by the Chinese government on espionage charges. The details are scarce – the individual’s name and specifics of the charges were not made available, only that he had been arrested last October.

But the situation deepens concerns about how foreign companies will conduct business in China, following the country’s tightening of its anti-spying law last July.  The anti-espionage law, which is consistently described as “vaguely worded,” has ignited fears that any information gathering, such as what would occur during a pharma facility inspection, could potentially be criminalized.

The German Pharmaceutical Manufacturers Association voiced concerns back in March, noting that German inspectors are afraid they will be arrested if they travel to China and that this poses a serious problem for the medicines supply chain, antibiotics in particular.

In the U.S., lawmakers have long been questioning FDA inspection practices of sites in both China and India. A GAO report was published in February, evaluating the challenges of foreign inspections for the FDA. According to the report, inspections could not be carried out in over 150 cases since 2021 because they were rejected. 

The pandemic caused considerable inspection and audit delays, as well as broader supply chain issues, so adding strict laws on top of that in China – the top API supplier in the world – is just adding more complexity and more frustration to dealings in China. —Karen Langhauser