Key Points
- Liability issues delayed Japan’s mpox vaccine donation to Congo.
- Congo faces logistical hurdles in training health workers for vaccine administration.
- Over 1,100 suspected mpox deaths in Africa highlight the urgent need.
While adults in the Democratic Republic of Congo began receiving vaccinations against mpox this week, children—the most vulnerable group—remain without access to the lifesaving doses.
A significant donation of vaccines from Japan was delayed by legal concerns over liability, exposing once again the challenges in global health systems.
A crucial donation stalled by legal disputes
In September, Japan pledged three million doses of the LC16m8 vaccine from its national stockpile. This vaccine, developed by Japanese firm KM Biologics for smallpox, is the only one approved for use in children against mpox.
The donation was the largest to date in the fight against the disease, but its delivery was stalled due to negotiations over liability for potential side effects.
According to a report by Reuters, Congo’s Health Minister, Samuel Roger Kamba Mulamba, explained during a press conference that both countries had to reach an agreement to share responsibility in the rare event of adverse effects.
“When I read the [donation] contract, I added that both countries must be responsible if any side effects occur,” he said, emphasizing how this extended the delay.
Japan later confirmed that discussions had been resolved, with all formalities completed, paving the way for the vaccines to arrive.
Global lessons on liability in vaccine deployment
The delay in Congo echoes similar issues during the COVID-19 pandemic, where liability concerns slowed vaccine rollouts worldwide. Global health experts, including Paula Barbosa from the International Federation of Pharmaceutical Manufacturers and Associations, stress the need for pre-arranged, no-fault compensation systems during health crises.
LC16m8 was granted emergency use approval by the World Health Organization (WHO) last week, following earlier clearance from Congo’s government in June.
However, vaccines approved under expedited processes often face challenges, as manufacturers’ insurers typically exclude liability for side effects tied to emergency use authorizations.
In contrast, the Bavarian Nordic vaccine being used for adults has full regulatory approvals, enabling faster deployment. Yet even with that, only 375,000 doses have reached Congo, far short of the 1,100 suspected mpox deaths reported across Africa this year, most of which were among children.
Challenges ahead in vaccinating Congo’s children
Health officials in Congo face additional hurdles beyond the legal issues. Administering the LC16m8 vaccine requires specialized training, as it uses a bifurcated needle and a unique technique involving 15 skin pricks. Japan has agreed to donate the needles and is working to address these logistical challenges, but progress remains slow.
Dr. Tatsuki Sato from Japan’s Ministry of Health acknowledged the difficulties, saying, “We cannot tell you how to solve them immediately.”
Congolese health workers stress the urgency of getting the vaccines to the most affected communities but caution that widespread distribution will require careful planning and testing to ensure effectiveness.
Despite the setbacks, the rollout marks a significant step in combating mpox. Experts hope the lessons learned from Congo’s vaccine delays will help streamline future global health responses, saving more lives when every moment counts.
