Bavarian Nordic Struggles to Supply Monkeypox Shot
Bavarian Nordic has also recently restarted its bulk facility in Copenhagen, which had been offline for about a year, when the biotech began work on an additional line to allow for simultaneous production of different products.
Manufacturer of the world’s only approved monkeypox vaccine, BN also makes the rabies vaccine Rabipur and a vaccine against tick-borne encephalitis, Encepur. In a conference call with investors, CEO Paul Chaplin said these had been deprioritized.
Since May of this year, more than 40,000 cases of monkeypox have been confirmed in more than 80 countries where the virus is not endemic, with about a third of cases currently in the US. The World Health Organization (WHO) has declared an international emergency, and global demand “is "exceeding our ability to deliver," Chaplin told the Reuters newswire.
To meet the market’s increased need for Jynneos, BN is hiring more staff to boost bulk production and has tapped CDMO Grand River Aseptic Manufacturing, based in the US state of Michigan, to handle fill & finish. Technology transfer, already under way, is being accelerated and should be completed within three months rather the standard nine months, the companies said.
With these moves, BN hopes to double the yield to four batches a week and be able to deliver about four million doses of the vaccine by the end of the year. The lion’s share looks likely to go to the US market.
Earlier this month, the US Food and Drug Administration (FDA) asked healthcare workers administering the vaccine to use only one-fifth of the original dose strength from a vial and give the shot by intradermal injection rather than subcutaneously.
Leading pharma journal Stat has reported that doctors are finding it difficult to extract the ideal five doses from one vial, problems also initially seen with the Covid-19 vaccines.
Author: Dede Williams, Freelance Journalist