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Everyone wants Danish firm’s monkeypox jab (but supplies are limited)

A Danish biotech that until recently had just six customers for its monkeypox vaccine is now being inundated with orders — and is figuring out how to meet the demand.

Bavarian Nordic’s Imvanex is the only shot in the world to protect against monkeypox. It’s licensed against smallpox and monkeypox in the U.S. (where it is known as Jynneos), and Canada (as Imvamune). In the EU, it’s approved for smallpox and a monkeypox license is in the works.

As monkeypox cases surpass 1,000 across 29 non-endemic countries, governments are scrambling for doses of the vaccine, which until recently was predominantly stockpiled in the U.S. and Canada in case of a health emergency.

Media reports from across Europe reveal contracts for tens of thousands of doses have recently been signed in Germany, Italy, Sweden and the U.K. Some of these countries are already administering the vaccine off-label to close contacts of confirmed cases. And many more orders are expected.

“People are really desperate to get hold of Imvanex, Jynneos or Imvamune because of the increased safety over other vaccines,” said Paul Chaplin, chief executive officer at Bavarian Nordic, during a conference call on Tuesday.

Chaplin pointed out that many people cannot receive the other stockpiled smallpox vaccine, known as ACAM2000, due to the risk of rare but severe side effects, which include heart inflammation and an extensive rash that can cause fatal organ damage. (People with immunity against one of the orthopoxviruses, which includes smallpox and monkeypox, are often protected against other viruses in the family.)

Limited stocks

The rush for demand is unprecedented — and untimely. The company has been unable to manufacture any vaccine ingredients since last fall as its facility in Denmark is closed for expansion and won’t reopen until August. Once it reopens, it will take six months to produce the first batch of vaccines ready to be put into vials.

The company is now looking at how it can best use its own stockpiles of bulk manufactured vaccines to fill these orders — including large existing orders for the U.S. and Canada.

It’s exploring working with the six existing customers “to move the manufacturing schedules around,” said Chief Financial Officer Henrik Juuel on the call, as well as ramping up the capacity in the short-term at the company’s vial filling facility.

Analysts at financial group Jefferies have suggested that the Danish firm will need to push back U.S. orders to meet the rush in immediate demand.

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has a long-standing contract for up to 13 million doses, which are already manufactured in bulk and will be put into vials and delivered on request.

“The first options were exercised just three weeks ago to fill the bulk into vials,” said Rolf Sass Sørensen, head of investor relations and communications at the company. That covers approximately 5 million doses, he said, that will be delivered from 2023.

The U.S. announced on Monday that it had 36,000 doses in stock and had instructed the biotech to deliver an additional 36,000 doses “this week.”

Further deliveries are likely to be “contingent on the U.S. agreeing to some diversion/delay of its assigned doses in storage,” the Jefferies analysts said in their research note last week.

But the company strongly refuted this suggestion.

“We will not delay orders or deliveries to Canada or to the U.S.,” Sørensen told POLITICO in an interview. He said the facility’s closure was having “no impact” on the company’s ability to fulfill demand for its vaccine in the short term, since there is “sufficient volume” of bulk vaccine already manufactured.

Chaplin added that media reports suggesting the company would fill orders with bulk vaccines reserved for the U.S. or Canada were also wrong.

“BARDA’s bulk is BARDA’s bulk. Canada’s bulk is their bulk,” he said. “What we’re currently offering is bulk that we have as inventory owned by Bavarian Nordic.”

These “several million” doses are what the company has available to sell to the rest of the world until the new facility is manufacturing more product next year, he confirmed.

That includes any order for the EU, if one is signed.

Sørensen said the EU discussions for joint procurement of the vaccine were ongoing. “They’ve indicated the number of doses, but that’s it,” he told POLITICO.

The company also doesn’t know which countries are party to the EU’s talks, carried out by the Health Emergency and Preparedness Response Authority (HERA). “We actually don’t know who they are providing those doses to, who will be covered by that contract,” Sørensen said.

HERA hasn’t signed a new joint procurement contract for a medical countermeasure for a health emergency since it became operational in the fall of last year — that includes the COVID-19 antivirals, for which talks are also ongoing.

A European Commission spokesperson said they could not comment on the ongoing talks for Imvanex, but confirmed in an earlier exchange that HERA is engaged in discussions to buy both a monkeypox vaccine and treatment for interested EU countries.

This article is part of POLITICO Pro

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