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Emergent joins the fight against MPOX and donates 50,000 vaccine doses to Africa

Emergent's CEO said the company could increase stockpiles by about 40 million doses if needed. Image credit: Shutterstock / Ralf Liebhold.

Emergent BioSolutions said it will donate 50,000 doses of its smallpox vaccine to the Democratic Republic of Congo (DRC) and other countries affected by the current smallpox health crisis, as many cases in the region are attributed to a new variant.

As part of Emergent's commitment, implemented by humanitarian aid organization Direct Relief, Burundi, the Democratic Republic of Congo, Kenya, Rwanda and Uganda will receive vaccine doses, according to an August 19 press release.

The donation follows a call by South African President Cyril Ramaphosa to ensure a fairer distribution of vaccines and therapeutics compared to the previous Mpox outbreak in 2022.

Last week, the Africa Centers for Disease Control and Prevention (CDC) declared a health emergency in light of Mpox outbreaks on the continent, and the World Health Organization (WHO) quickly declared a global health emergency of international concern. Emergent shares have risen 39% since the African CDC declared the health emergency. The U.S. company has a market capitalization of $640 million.

The new variant of the virus, known as clade Ib, has spread rapidly in Africa. Last week, a case was confirmed in Sweden. This was the first time the new variant was observed outside Africa.

Although Emergent's ACAM2000 vaccine is approved for smallpox, it is currently also available for immunization against smallpox under the Expanded Access Investigational New Drug (EA-IND) protocol.

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Emergent has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) in October 2023 requesting an expanded mpox indication for ACAM2000. The FDA aims to review the sBLA in Q3 2024.

Side effects of the vaccine

The FDA has previously highlighted the side effects and risks of ACAM2000. According to the FDA, Emergent's product causes myocarditis and pericarditis – swelling in or around the heart muscle – in one in 175 recipients. People with weakened immune systems, such as HIV patients, may not be suitable for the vaccine. Africa is the region most affected by HIV in the world.

“The risk of experiencing serious side effects must be weighed against the risk of potentially fatal smallpox infection,” the agency previously said in a 2022 fact sheet.

Jynneos from Bavarian Nordic was studied in HIV-infected people and the side effects observed were comparable to those in non-HIV-infected people.

ACAM2000 is derived from vaccinia, a virus closely related to smallpox but causing a milder disease. The live virus is administered not through a conventional syringe, but with a two-pronged needle that pricks the skin several times.

Joe Papa, CEO of Emergent, said: “We currently have additional products in stock and can increase supply by approximately 40 million doses if needed.”

Emergent participates in global efforts

Emergent's 50,000 doses follow Bavarian Nordic's pledge to donate 40,000 doses of its Jynneos vaccine, also known as MVA-BN and Imvamune. The donations will accompany a shipment of around 175,420 doses ordered by the European Health Emergency Preparedness and Response Authority (Hera).

Bavarian Nordic has also submitted data to the European Medicines Agency (EMA) to support an expansion of the vaccine's use among teenagers.

The Danish company is preparing trials to investigate the use of the vaccine in children aged 2 to 12 years. The trial, which is partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is set to begin later this year in the Democratic Republic of Congo and Uganda. Bavarian Nordic said this could also potentially support regulatory approval of the vaccine for this specific age group in African countries.


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