Analysis-New mpox vaccines for Congo's children held up by old problem

By Jennifer Rigby, Ange Kasongo and Sonia Rolley

Adults started getting vaccinations against mpox in Democratic Republic of Congo's capital this week. But there were no shots available for children, the most vulnerable group, after a key dose donation was held back by an old legal hurdle.

Japan pledged in September to donate three million doses from its national stockpile of LC16m8 vaccines, first developed by local firm KM Biologics for smallpox.

It is the only vaccine effective against mpox that is approved for use in children, and the pledge was the biggest single donation yet to fight the disease anywhere.

But the two countries took time to negotiate over a common issue in global health: who pays if there are unexpected side effects caused by the vaccine.

Congo said the issue has now been resolved. But the delay once again showed the need for a better system, global health experts said, to stop the seemingly technical point holding up life-saving responses.

Without clear terms, governments of poorer countries fear being left on the hook for claims. Donor governments are also often unwilling. But the payouts can be so huge, in the rare cases of problems, that an agreement over who is responsible needs to be signed before doses can be shipped.

Similar worries held up vaccine programmes during COVID-19.

“When I read the (donation) contract, I added that both countries must be responsible if any side effects occur,” Congo’s health minister Samuel Roger Kamba Mulamba said in a press conference in Kinshasa earlier this month.

“That's why it took so long, because it went back to Japan." Now "all the formalities have been completed," he added.

'EMERGENCY USE' CLEARANCE

Japan's government told Reuters earlier this month there was no current dispute about liability, without going into further detail, and that discussions over deliveries were ongoing. KM Biologics, the Japanese company that produced the vaccine, declined to comment.

Global health experts and industry representatives said there should be a better system set up in advance of major outbreaks to cover the liability issue.

“During a pandemic, well-designed no-fault compensation systems are essential,” said Paula Barbosa, associate director of vaccine policy at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), an industry trade body.

Negotiating liability is a particular challenge during a crisis, when there is pressure to give new products quicker “emergency use” authorisations.

LC16m8 got emergency clearance from the World Health Organization on Tuesday last week, and from Congo's government in June. But vaccine manufacturers’ insurers will not cover side-effects claims for medicines that receive such expedited approvals.

The other vaccine being used for adults, developed by Bavarian Nordic, has received fuller approvals, so liability has not been an issue. Around three million doses of this shot have been pledged to Congo by governments including the U.S., and around 375,000 doses have arrived in the country - still far short of what African health officials say is needed.

But vaccinations with this shot have started slowly, with some at-risk communities in the vast country seemingly unaware of the push.

This may also be an issue for the Japanese donation for children, health officials in Congo and internationally said, although the need is urgent: children have made up the majority of the more than 1,100 suspected mpox deaths in Africa this year.

"It's important for these vaccines to arrive quickly," one doctor working on the response in Congo said. But, the doctor added, before widespread use, there should be tests of how to administer the vaccine, and a plan for where it would be most effective.

LC16m8 is given using a bifurcated needle, a technique that involves pricking the skin 15 times to deliver the vaccine, which will require some training of health workers. The needles are also being donated by Japan.

The Japanese government said on Tuesday it was "tackling and coordinating to solve these problems", without giving further detail.

"We cannot tell you how to solve them immediately," added Tatsuki Sato from the Ministry of Health.