As the only lab producing a licensed monkeypox vaccine, Danish company Bavarian Nordic has filled its order books as the normally rare disease spreads around the world.
“The approval we got in 2019, when we were selling maybe just a few hundred doses, suddenly became very, very relevant to international health,” says company vice president Rolf Sass Sorensen with a smile at the biotech’s headquarters in Copenhagen Harbour.
Bavarian Nordic was caught by surprise by the sudden spread of the disease earlier this year to dozens of countries outside West and Central Africa, where it was previously generally confined.
But Sorensen says he’s confident the company can meet global demand despite having only one manufacturing facility.
“With the current demand, we can easily supply the global market. We have a few million doses in bulk that we can bottle and make sure the current outbreak is managed,” he told AFP in an interview.
Bavarian Nordic has an annual production capacity of 30 million vaccine doses.
The Danish company’s smallpox vaccine, marketed as Imvanex in Europe, Jynneos in the US and Imvamune in Canada, is a third-generation serum (a live vaccine that does not replicate in the human body).
It has been approved in Europe since 2013.
It was developed against adult smallpox, a disease thought to be eradicated about 40 years ago, and requires two doses of vaccine.
– World calls for vaccine –
According to Sorensen, the vaccine is available “in many countries” and can also be used against monkeypox, both before and after contact with the virus.
“If you get vaccinated a few days after exposure, you may also be protected,” he explained.
After receiving the green light from the US Food and Drug Administration (FDA) three years ago to use its smallpox vaccine against monkeypox, Bavarian Nordic is now applying for the same in Europe.
The European Health Emergency Preparedness and Response Authority (HERA), created by the European Commission during the Covid-19 pandemic, has already purchased more than 100,000 doses for the 27 EU countries plus Norway and Iceland.
For the countries classified as priority, the first deliveries are due at the end of June.
The United States has also replenished its supplies with an order for 500,000 doses, in addition to 100 million doses of an older smallpox vaccine previously made by French company Sanofi but known to have some side effects.
Canada and Denmark have also ordered from Bavarian Nordic.
Apart from these announcements by the countries themselves, Bavarian Nordic – which also makes vaccines for tick-borne encephalitis, rabies, Ebola, Covid-19 and the RS respiratory virus – does not disclose which countries have placed orders.
“But I can say that we have procurement requests from all over the world. We have sourcing requests from the US, European countries, Middle East countries and Asian countries,” said Sorensen.
The value of the contracts was also not disclosed, but it was clearly a godsend for Bavarian Nordic, with the company raising its full-year 2022 guidance four times in the space of three weeks.
– Rarely Fatal –
Despite the rise in monkeypox cases worldwide, the World Health Organization did not recommend countries to mass vaccinate their populations at this time.
The United States has previously recommended vaccination of people who have been in close contact with an infected person, while France recommends a single dose for contact cases in high-risk groups who were vaccinated against smallpox before 1980.
The European Medicines Agency approved a smallpox drug, Tecovirimat, to treat monkeypox earlier this year, but it’s not yet widely available.
Most people recover from monkeypox within a few weeks, and the disease has rarely been fatal.
Symptoms include lesions, rashes on the face, palms or soles, scabs, fever, muscle aches and chills.
From January 1 to June 15, the WHO registered more than 2,103 cases and one death in 42 countries.
Europe was the epicenter of the outbreak, with 1,773 confirmed cases, or 84 percent of the global total.
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