Vaccine Rollout in Congo Faces Challenges Despite Japan's Generous Donation

The Democratic Republic of Congo (DRC) began vaccinating adults against mpox in its capital this week, yet children—the most vulnerable demographic—remain without access to vaccines. A significant donation from Japan, which pledged three million doses of the LC16m8 vaccine specifically approved for children, has been delayed due to prolonged negotiations over liability for potential side effects.

Legal Hurdles Delay Lifesaving Vaccine

The LC16m8 vaccine, developed by Japan's KM Biologics for smallpox and effective against mpox, is critical for combating the disease in children. However, the shipment was stalled for months as Congo and Japan worked to resolve liability concerns, a common issue in global health crises.

Governments in low-income countries often fear bearing the financial burden of rare but potentially costly claims related to vaccine side effects, while donor nations are similarly cautious. This bureaucratic bottleneck, observed during COVID-19 vaccine rollouts, highlights the urgent need for a global system to address liability during health emergencies.

"We needed both countries to agree on shared responsibility for any side effects," said Congo’s Health Minister Samuel Roger Kamba Mulamba during a press conference. "Now, all formalities have been completed," he added.

Emergency Use Complicates Liability

Japan's government confirmed earlier this month that the liability issue has been resolved, though details were not disclosed. The LC16m8 vaccine received emergency use approval from the World Health Organization (WHO) last week, and from Congo’s government in June. However, vaccines granted emergency authorization are often excluded from manufacturers’ insurance coverage for side effects, further complicating liability discussions.

Global health experts emphasize the need for a pre-emptive system to handle such issues during pandemics. “Well-designed no-fault compensation systems are essential during health emergencies,” said Paula Barbosa of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Urgency in Protecting Vulnerable Children

The urgency of deploying the Japanese vaccines is underscored by the alarming impact of mpox on children in Africa. Of the more than 1,100 suspected mpox deaths reported in the region this year, most were children. However, health officials caution that the rollout must include careful planning and training.

LC16m8 requires administration with a bifurcated needle, a technique involving 15 skin pricks. Japan is donating the specialized needles, but proper training for health workers will be necessary before the vaccine can be widely distributed.

Ongoing Adult Vaccination Efforts

Meanwhile, adults in the DRC are receiving a different vaccine developed by Bavarian Nordic, which has full regulatory approval, eliminating liability concerns. However, uptake has been slow, partly due to a lack of awareness among at-risk communities.

Approximately 375,000 doses of the Bavarian Nordic vaccine have arrived in the DRC out of the three million pledged by international donors, including the U.S. African health officials stress that far more doses are needed to address the outbreak effectively.

Path Forward

Japan’s Ministry of Health has pledged to "coordinate and resolve" remaining issues to expedite vaccine delivery. However, as Congo’s health workers prepare for the rollout, the clock is ticking to protect the country’s most vulnerable citizens.

"We need these vaccines to arrive quickly," said a doctor involved in the response in Congo. "But proper planning and testing are crucial to ensure they are used effectively."