A Danish biotech, which until recently had only six customers for a monkeypox vaccine, is now inundated with demand — and it’s researching how to meet the demand.
Scandinavian Bavarian Imvanex is the world’s only anti-monkey pox shot. It is licensed against smallpox and monkeypox in the United States (where it is known as Jynneos), and Canada (as Imvamune). In the European Union, it has been approved for smallpox and work is underway to license monkeypox.
As cases of monkeypox exceed 1,000 in 29 non-endemic countries, governments are scrambling for doses of the vaccine, which until recently was mostly stockpiled in the United States and Canada in case of a health emergency.
Media reports from across Europe revealed that contracts for tens of thousands of doses were recently signed in Germany, Italy, Sweden and the United Kingdom. Some of these countries are already administering the vaccine off-label to contacts of confirmed cases. Many requests are expected.
“People are really desperate to get Imvanex or Jynneos or Imvamune because of the increased safety over other vaccines,” Paul Chaplin, chief executive of Bavaria Nordic, said during a conference call on Tuesday.
Chaplin noted that many people cannot receive another buffered smallpox vaccine, known as ACAM2000, due to the risk of rare but severe side effects, which include heart inflammation and a widespread rash that can cause fatal organ damage. (People who are immune to one of the orthopoxviruses, which includes smallpox and monkeypox, are often protected from other viruses in the family.)
The rush to demand is unprecedented – and it comes at an inopportune time. The company has not been able to manufacture any vaccine ingredients since last fall as its facilities in Denmark have been closed for expansion and will not reopen until August. Once it reopens, it will take six months to produce the first batch of vaccines that are ready to be put into vials.
The company is now looking at how best to use its own stockpile of mass-manufactured vaccines to meet these demands — including the current large orders for the United States and Canada.
Chief Financial Officer Henrik Juuel said on the call that he is exploring working with the six existing customers to “change manufacturing schedules,” as well as short-term capacity expansion at the company’s bottling facility.
Analysts at Jefferies Financial Group suggested that the Danish company would need to defer US orders to counter the rush in spot demand.
The Biomedical Advanced Research and Development Authority (BARDA) has a long-term contract of up to 13 million doses, which have already been manufactured in large quantities and will be placed in vials and delivered on demand.
“The first options were exercised just three weeks ago to fill the bulk in flasks,” said Rolf Sass Sorensen, the company’s head of investor relations and communications. That covers nearly 5 million doses that will be delivered as of 2023, he said.
The United States announced on Monday that it had 36,000 doses in stock and instructed the biotech to deliver an additional 36,000 doses “this week.”
Jefferies analysts said in their research note last week that the additional deliveries are likely to be “conditional on US approval of some diversion/delay of their intended doses in storage.”
But the company strongly refuted this suggestion.
“We will not delay orders or deliveries to Canada or the United States,” Sorensen told Politico in an interview. He said the facility closure “has no impact” on the company’s ability to meet demand for its vaccine in the short term, given that there is a “sufficient volume” of the bulk vaccine already made.
Chaplin added that media reports that the company would fulfill orders for large numbers of vaccines destined for the United States or Canada were also wrong.
“The greater part of Barda is the greater part of Barda. The greater part of Canada is the greater part of it,” he said.
He emphasized that these “several million” doses are what the company has to sell to the rest of the world until the new facility manufactures more products next year.
This includes any EU application, if signed.
Sorensen said EU discussions on joint purchase of the vaccine are continuing. “They indicated the number of doses, but that’s it,” he told Politico.
The company also does not know which countries are party to the EU talks, which are being conducted by the Health Emergency Response and Preparedness Authority (HERA). “We actually don’t know who is providing these doses, and who this contract will cover,” Sorensen said.
HERA has not signed a new joint purchase contract for a medical emergency countermeasures procedure since it came into operation last fall — including COVID-19 antivirals, about which talks are still ongoing.
A spokesperson for the European Commission said they could not comment on ongoing talks on Imvanex, but confirmed in a previous exchange that HERA was involved in discussions to buy a monkeypox vaccine and treatment for interested EU countries.
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