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Vaccine bottlenecks threaten to hamper Mpox emergency response

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Urgent efforts to distribute vaccines to address the international public health emergency Mpox in central and eastern Africa risk being hampered by a lack of orders and logistical challenges, a major vaccine maker said as Sweden announced its first case outside Africa.

Cases of the outbreak have been detected in 13 African countries, most of them in the Democratic Republic of the Congo, according to the Africa Centers for Disease Control and Prevention. They said the continent needs 2 million doses of vaccine by the end of the year to help control the outbreak.

Bavarian Nordic, which makes one of two Mpox vaccines recommended by World Health Organization experts, said it has 300,000 doses of its Jynneos vaccine ready and enough production capacity to meet demand. But it faces challenges, including a lack of vaccine approval in some affected countries and the need for a cold supply chain, Chief Executive Paul Chaplin told the Financial Times.

“We have the capacity, but we need people to start placing orders very quickly,” he said. “We need orders by the end of this month if we want to hit 2 million by the end of the year.”

Concerns about vaccine supply and distribution arise aVsceker similar challenges hampered immunization rates in many African countries during the Covid-19 pandemic.

The WHO declared a public health emergency over Mpox on Wednesday. The current outbreak is seen as even more serious than a surge in cases that prompted an earlier declaration in 2022-23, as it is driven by the more dangerous clade 1b virus type.

On Thursday, the Swedish Public Health Agency reported that a person had been diagnosed with Mpox clade 1b in the first such case outside the African continent. The agency said the person had returned from a trip to Africa.

Mpox, formerly known as monkeypox, can cause fever, skin lesions, and sometimes death. It can be more serious among patients with uncontrolled HIV and is spread through contact with infected people or animals, or contaminated materials.

Jacqueline Musengimana sits next to her daughter Sandrine Sibomana undergoing Mpox treatment
Monkeypox, formerly known as Mpox, can cause fever, skin lesions, and sometimes death ©Arlette Bashizi/Reuters

The vaccines are based on smallpox, which has now been eradicated and belongs to the same family of pathogens.

On Tuesday, Bavarian Nordic received an order for more than 175,000 doses from the European Health Emergency Preparedness and Response Authority (HERA) and donated another 40,000 to HERA. On Wednesday, the United States said it would donate 50,000 doses of Jynneos to the DRC.

The company is in talks with other governments to place additional orders that would be distributed in Africa, Chaplin said. Gavi, the vaccine alliance, said it is also discussing direct procurement with the company. If enough orders are booked, Bavarian Nordic can supply 10 million doses by the end of 2025, Chaplin said.

Since Tuesday, shares of the vaccine maker have risen nearly 20 percent.

Another vaccine from Japan’s KM Biologics is also recommended by the WHO’s immunization advisory group, while U.S.-based Emergent BioSolutions also has a smallpox vaccine. The companies did not immediately respond to requests for comment.

But with vaccine supplies expected to be limited, public health experts said other measures will be critical to prevent the spread of the virus, such as contact tracing and testing, and a better understanding of how the new clade spreads. Clade 1b appears to be more virulent than the previously dominant clade, they added.

According to Brian Ferguson, professor of immunology at the University of Cambridge, two-fiVscekhs of cases in the Democratic Republic of Congo involve children under the age of five.

The Democratic Republic of the Congo did not receive vaccines during the previous emergency in 2022, due to a lack of regulatory approvals.

Bavarian Nordic has now received emergency use authorization for its vaccine in the Democratic Republic of Congo and Nigeria, but other affected countries have not yet followed suit.

On Tuesday, Jean Kaseya, director general of the Africa CDC, called on countries to “accelerate the emergency authorization of Mpox vaccines.” There have been 2,863 cases and 517 deaths this year, he said.

Last week, WHO launched a process to allow emergency use of vaccines in countries that have not yet granted national approval, which could speed up their availability in countries and allow Gavi and charities such as UNICEF to procure them.

Gavi also said on Thursday that it could repurpose available funding to support the vaccine and waive independent reviews of new vaccination campaigns.

Ferguson welcomed the WHO’s response, but said: “All these steps take time and the frustration here is that we saw what happened two years ago. There has been very little activity to do these things with a preventative nature in mind to stop the next outbreak.”

Video: Covid-19 and the Vaccine Business

Written by Joe McConnell

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