As a monkeypox outbreak quietly spreads in the U.S. and abroad, vaccines against the virus have become a hot commodity. Now, Bavarian Nordic, which has been at the forefront of the world’s monkeypox response, has lined up another major supply deal with the U.S.
The U.S. Department of Health and Human Services (HHS) has locked up another 2.5 million doses of Bavarian Nordic’s smallpox and monkeypox vaccine Jynneos, bringing the government’s “rapidly available supply” to more than 4 million shots, HHS said in a recent release.
The order follows Bavarian Nordic’s announcement early last month that the U.S. Biomedical Advanced Research and Development Authority (BARDA) had purchased 500,000 liquid-frozen doses of the shot.
Meanwhile, at the tail end of June, officials with the Centers for Disease Control and Prevention (CDC) outlined a plan to make 1.6 million Jynneos doses available before year-end, according to press reports. Of that total, officials planned to immediately deploy 56,000 doses in areas of high transmission, USA Today reported at the time.
As for the latest order, deliveries will kick off in the fourth quarter and continue into early next year, Bavarian Nordic said.
The deal falls under the Biden-Harris administration’s monkeypox plan of attack, which involves speeding up production and distribution of vaccines, streamlining testing and staying in constant communication with health and community leaders about the outbreak.
As of June 29, the CDC had received reports of around 350 cases of monkeypox in the U.S., which have primarily cropped up among men who have sex with men. Officials have urged people to get vaccinated if they’ve had a sexual partner diagnosed with the illness.
Aside from the doses of Bavarian Nordic’s Jynneos, the U.S. Strategic National Stockpile also has access to more than 100 million doses of Sanofi’s smallpox vaccine ACAM2000, which can be used to prevent monkeypox, too, under an expanded access protocol from the CDC.
On the therapeutic front, the U.S.' Strategic National Stockpile boasts more than 1.7 million courses of the smallpox antiviral med TPOXX, which was developed by Siga Technologies in conjunction with BARDA. Much like Sanofi’s vaccine, the CDC has expanded access to Siga’s drug to tackle the current monkeypox outbreak.
Jynneos, for its part, won U.S. approval in 2019 to prevent smallpox and monkeypox in people determined to be at high risk. In Europe, where the shot carries the Imvanex moniker, Bavarian Nordic’s vaccine is only approved for smallpox.
Amid the current outbreak, Bavarian Nordic entered the global spotlight in May when it forged a vaccine supply contract with an unnamed European country. At the same time, Bavarian Nordic said BARDA had exercised a $119 million option to manufacture freeze-dried Jynneos doses in 2023 and 2024 to replace current stock of bulk vaccine in the U.S.
In mid-June, meanwhile, Bavarian Nordic said the European Health Emergency Preparedness and Response Authority had ordered 110,000 doses of the company’s vaccine bound for Norway and Iceland.
Thanks to that order, plus other smaller supply deals, Bavarian Nordic last month lifted its 2022 financial outlook for the second time after a similar move in May. The company is now eyeing full-year revenues between 1,900 million Danish kroner (about $267 million) and 2,100 million Danish kroner (about $295 million), up from a previous estimate of between 1,800 million Danish kroner ($248 million) and 2,000 million Danish kroner ($275 million).
Because most of the doses under Bavarian’s new 2.5 million dose contract are pegged for delivery in 2023, the company doesn’t expect the new U.S. deal to affect its financial guidance for 2022.