US increases supply of monkeypox meds while Bavarian Nordic bolsters supply capability through Grand River

In a blitz of monkeypox news Thursday, the U.S. said it will provide an additional 1.8 million doses of Bavarian Nordic's vaccine Jynneos, while the company revealed it will bolster its capacity to produce the shot through U.S. contract manufacturer Grand River Aseptic. 

The U.S. also said it will provide 50,000 additional doses of Siga’s TPOXX, used to treat those who have been infected.

The news came amid mounting criticism about the government’s response to the outbreak, which was classified a public health emergency earlier this month. More than 13,500 in the U.S. have been infected, said the Centers for Disease Control and Prevention, representing more than one-third of the 39,000 cases reported worldwide.

The new supply of 1.8 million vaccines comes on top of the 1.6 million doses announced in late June, which were to carry the U.S. through the summer.

Tuesday, the Department of Health and Human Services said it would make the final 442,000 of that initial supply available sooner than expected.

The new batch of 1.8 million vaccines will become available Monday of next week. An FDA decision last week to allow administering Jynneos intradermally—between layers of the skin—has increased fivefold the number of doses that can be had from a vial. Bavarian Nordic has expressed consternation over the ruling, citing a lack of data and safety concerns.

The new supply of TPOXX—which comes on top of an initial supply of 20,000—will start next week, the administration said. States will receive allocations based on a formula that includes the number of cases reported and estimates of how many people are considered at high risk.  

In July, Bavarian Nordic revealed that it had agreed to provide 2.5 million doses of Jynneos to the U.S., bringing the company’s total supply to the country to 5.5 million, with delivery due through 2023.  

As for Bavarian's deal with Grand River, the CDMO will perform fill and finish of the vaccine and begin before the end of this year. Tech transfer—which is already underway—is planned to take three months as opposed to the standard nine-month interval, the companies said.

The scale-up will allow Bavarian to expedite delivery of vaccines to the U.S., while also freeing up capacity for other countries, BN said.

Since the outbreak this May, the company also has doubled its filling capacity at its factory in Denmark. In addition, BN said that its bulk manufacturing is operational after a planned shutdown.