The Danish biochemistry firm Bavarian Nordic announced on Saturday it would expand the supply and manufacture of its smallpox and mpox vaccine to Africa, where an outbreak of a severe variant of the disease has claimed hundreds of lives in the Democratic Republic of Congo, and resulted in the Africa CDC and WHO declaring continental and international Public Health Emergencies.
So far in 2024, more than 8,700 mpox cases and over 400 deaths have been reported across seven African countries, 96 percent of which have occurred in the Democratic Republic of Congo, according to a report in June from the Africa Centres for Disease Control and Prevention.
On Friday, Bavarian Nordic had sought approval from the European Medicines Agency (EMA) to extend its smallpox and mpox vaccine to children from 12 to 17 years, after a clinical study showed similar immune and safety results in children as adults.
Bavarian Nordic is preparing for a clinical trial to assess the mpox vaccine viability in children from 2 to 12 years of age in the DRC and Uganda later this year, said the company in a press release.
The mpox vaccine is not available in African countries, but Bavarian Nordic said that this trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), may eventually support the vaccine’s approval in the region.
“Children and adolescents are disproportionally affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic in a press release.
Bavarian Nordic’s Copenhagen-listed shares jumped 18.5 percent to 285 Danish crowns after the announcement. Over the last five sessions, the stock is up 46 percent.
During the 2022-2023 mpox outbreak, Bavarian Nordic’s mpox vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents, and the company expanded access to the vaccine, supplying more than 15 million doses to 76 countries.
Since, the Danish firm has built a vaccine inventory that can provide a surge capacity for potential outbreaks. The company has told Africa CDC that it can manufacture 10 million doses by the end of 2025, in addition to current orders, and could already supply up to 2 million doses this year.
Africa is currently tackling one of the largest and deadliest known mpox outbreak to date, with children accounting for the majority of infections and deaths. Along with DRC, cases have also been confirmed in Cameroon, Central African Republic, Ghana, Liberia and South Africa.
Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms – typically fever and headache, followed by painful lesions – resolve within a few weeks.
However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, or death. The mpox virus strain behind the current outbreak, known as clade I, is estimated to be fatal in up to 10 percent of cases.
Bavarian Nordic specializes in the development, production and distribution of vaccines against infectious diseases in connection with cancer treatment, as well as Ebola and cervical cancer.
Their biggest market is in Europe and North America and they are headquartered in Kvistgaard, Denmark.
Bavarian Nordic’s is the only mpox vaccine approved in the U.S., Canada, Switzerland, the EU/EEA and the UK, where it is part of the countries’ national biological preparedness.
The Centers for Disease Control and Prevention (CDC) currently recommends two vaccines to prevent mpox: one by Bavarian Nordic and one by U.S. pharmaceutical company Emergent Biosolutions.
Bavarian Nordic will announce its second quarter results on 22 August.
