Bavarian Nordic A/S, the only company with an approved vaccine for monkeypox, said it’s no longer certain it can meet demand as cases continue to rise across the world.
The Danish company is now exploring the possibility of outsourcing some of the production, including technology transfer to a US contract manufacturer, to meet accelerating demand.
“It’s a very dynamic market situation,” Rolf Sass Sorensen, a vice president at the firm, said by phone on Wednesday. “Demand keeps rising and it’s no longer certain that we can continue to meet the demand we’re facing even with the upgrade of our existing manufacturing site in Denmark.”
A move to outsourcing production would mark a shift for Bavarian which until now has said it could deliver on all orders from its Danish facility.
It also previously said a technology transfer to a third-party producer — which would allow bulk production of the vaccine rather than just ‘fill-finish’ where the doses are put into vials and packaging — would be too cumbersome, expensive and take too long.
The flare-up of the virus, which has spread to thousands of people in more than 70 countries in just a few months, was declared a public health emergency of international concern by the head of the World Health Organization last month.
The UK said earlier this week it’s facing a temporary shortage of the vaccine as it awaits further production of doses by the manufacturer.
“We’re looking at ways to get help from partners in all the various production steps of the vaccine,” Sorensen said. “We are also investigating a tech transfer to a contract manufacturer in the US to increase capacity. We don’t have any concrete negotiations in the works with bulk producers, but we’re investigating and looking at what options there are.”
The Danish company has raised its financial outlook several times this year as governments across the globe have spent hundreds of millions of dollars ordering its Jynneos vaccine, which originally was developed for smallpox. Bavarian can currently produce 30 million doses per year at its bulk facility based north of Copenhagen.
Bavarian’s chief executive officer, Paul Chaplin, told Danish newspaper Borsen on Wednesday that a possible tech transfer for Jynneos to a US producer could take about three months if the process is sped up, compared with about nine months under normal circumstances.
