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Bavarian Nordic ramps up monkeypox vaccine manufacturing capacity, reopens bulk facility

Bavarian Nordic has been scrambling to ramp up the supply of the only approved monkeypox vaccine, Jynneos, to meet growing global demand. The Danish company’s latest efforts include exploring reusing technically expired doses and shifting production of other vaccines to contractors.

Bavarian Nordic now expects to only manufacture Jynneos until around the end of next year, CEO Paul Chaplin told investors during a call Wednesday. The company also markets a rabies vaccine Rabipur and a tick-borne encephalitis shot called Encepur, but those have been deprioritized.

“We have completely changed gears within the company in terms of […] manufacturing,” Chaplin said.

The company just reopened its Danish bulk facility, which has been shut down since last August for an upgrade. Before the first reported cases in the latest monkeypox outbreak, BN was working to add an additional line at its Danish bulk facility to allow for simultaneous production of different products.

Now facing increased Jynneos demand, the company is hiring more people to boost bulk production and fill-finish capacity, which was just endorsed by the FDA. It’s also working to outsource production of its RSV vaccine candidate, which is currently in phase 3 testing.

The measures are helping BN double bulk yield to four batches a week by the end of this year, Chaplin said. The Danish company also recently contracted Grand River Aseptic, which Chaplin said could double the fill-finish capacity of Jynneos, with the potential for further increase.

The company expects to deliver about four million doses of the vaccine by the end of the year.

Meanwhile, governments around the world have developed dose-sparing tactics to maximize their limited stock so that more people can be vaccinated. These include shifting to single vaccination series or delaying the booster shot.

In the U.S., the FDA earlier this month asked that healthcare professionals use only one-fifth of the original dose strength from a vial and give the vaccine by intradermal injection rather than subcutaneously. But doctors have found it difficult to extract the ideal five doses from one vial, Stat reports.

Despite all of these efforts, BN is clearly still struggling to resolve supply constraints and meet demand. Chaplin noted that the vaccine takes about six months to manufacture, including about five months of release time when tests are run to ensure quality.

“We’re not finished yet,” Chaplin said. “It’s clear that we need even more capacity to meet the demand moving forward into 2023.”

Looking forward, BN hopes to expand both bulk and fill-finish capacity by partnering up, Chaplin said on the Wednesday call. The company expects to unveil additional manufacturing partnerships in the coming weeks, Chaplin told Reuters.

Another method to expand capacity involves using technically expired doses. BN supplied millions of vaccine doses to the U.S. over the past few years under a previous contract, but many have expired. Existing testing showed that about half of a million doses are still active, Chaplin said, according to Reuters. But it’s up to the U.S. government to decide whether to use those doses.

In May, the U.S. government exercised an option to place a $119 million order for 13 million freeze-dried doses of Jynneos as part of a contract awarded in 2017. In June, the Biden administration ordered 500,000 doses for delivery in 2022, to be filled with existing bulk vaccines, and in July ordered an additional five million doses for 2022 and 2023.