African production of mpox vaccines could secure the continent’s health

As Africa grapples with multiple outbreaks of mpox, public health leaders say locally produced vaccines are vital to end donation dependence and secure the continent's health.

Africa is currently reliant on wealthier nations for vaccines to fight the latest mpox outbreak, which has been declared a continental and global health emergency by the Africa Centres for Disease Control and Prevention (Africa CDC) and the World Health Organization (WHO).

The European Union donated 50,000 doses to allow the Democratic Republic of Congo (DRC) — the epicentre of the outbreak — to begin its vaccination campaign earlier this month (5 October).

As we do not manufacture vaccines in Africa, we are facing the same challenges we encountered during the COVID-19 pandemic."

Jean Kaseya, director general, Africa CDC

Mpox, formerly known as monkeypox, is a viral disease that spreads mainly through close contact with an infected person, causing a painful rash, enlarged lymph nodes, and fever.

In recent months, the disease has been spreading exponentially in the DRC, which has recorded more than 6,000 cases and 25 deaths this year.

There have also been outbreaks in Nigeria, Kenya, Burundi, Uganda and Rwanda.

Despite requesting mpox vaccines two years ago, during a previous outbreak, the DRC and other low-income countries struggled to purchase them due to high costs.

Jean Kaseya, director general of Africa CDC, says the delays reflect the inequities in global health systems. He believes Africa needs to focus on local vaccine production to meet the needs of its people.

The dependency on donations mirrors the challenges Africa faced during the global COVID-19 pandemic when the continent was often last in line for life-saving vaccines, Kaseya told SciDev.Net.

“As we do not manufacture vaccines in Africa, we are facing the same challenges we encountered during the COVID-19 pandemic — relying on external sources for vaccines,” Kaseya told SciDev.Net during a press briefing on mpox.

“Local manufacturing remains critical,” he stressed.

Technology transfer

In a push to increase local manufacturing capacity, Africa CDC is in talks with Bavarian Nordic, a Danish vaccine manufacturer, to transfer mpox vaccine technology to African producers.

In September, Bavarian Nordic committed to increasing production of its JYNNEOS vaccine and said it was exploring the possible transfer of manufacturing to other companies in Africa or elsewhere.

Africa CDC has since shared preliminary information with African manufacturers, of which nine expressed interest, but only one has the potential to produce the vaccine, Kaseya revealed.

According to Kaseya, local production, starting with so-called “fill and finish” processes — filling packaging the vaccines, usually using imported active ingredients, called antigens — is a priority.

Africa’s ability to carry out fill and finish operations far exceeds current demand, according to a 2023 report co-authored by Africa CDC, the Clinton Health Access Initiative, and PATH.

‘Money game’

Amref Health Africa CEO Githinji Gitahi told SciDev.Net that a significant hurdle for African vaccine manufacturers is the uncertain market demand.

He said local manufacturers need strong and sustained demand to make production viable.

“Developing proper vaccine manufacturing in Africa isn’t just about technology or skills, but also having a market to sell the vaccines,” said Gitahi.

“Demand often translates into a market only when the threat crosses African borders into wealthy countries, prompting pharmaceutical companies to scale up production—it’s a money game,” he explained.

To break this cycle, Gitahi advocates for organisations like Gavi, the Vaccine Alliance, a major vaccine purchaser, to commit to buying African-made vaccines.

In May this year, African health ministers committed to purchasing vaccines made within the continent, during a meeting hosted by Africa CDC. The agency is now collaborating with governments to translate these commitments into action.

“The pooled procurement mechanism, approved at the last AU summit, is a key step in generating predictable demand,” Kaseya told SciDev.Net.

“It will allow manufacturers to plan for future production with confidence.”

In September, Africa CDC signed an agreement with the Pan American Health Organization (PAHO) to support the implementation of the pooled procurement system and further promote local manufacturing.

Regulatory hurdles

However, even with increased local manufacturing capacity, regulatory barriers remain a significant challenge for African countries.

Currently, only a few have countries approved the mpox vaccine, and those lacking regulatory capacity rely on WHO approval before beginning vaccination campaigns, even when vaccines are available.

Chimwemwe Chamdimba, head of the African Medicines Regulatory Harmonization (AMRH) programme, acknowledged the regulatory hurdles facing the continent, including lack of skilled professionals and ineffective policies for swift approval during emergencies.

She said AMRH had begun fast-tracking applications from manufacturers to assess and list mpox-related products.

“This process will also support pooled procurement by Africa CDC and its support to countries to respond to mpox,” Chamdimba said.

She added that it may also pave the way for African vaccine manufacturers to access regional markets, a crucial factor for long-term success.

Gitahi agreed, noting that strengthening local manufacturing and regulatory capacity will not only ensure that Africa is not left waiting in line for vaccines during future pandemics, but will develop skills and bring significant economic and social benefits to the continent.