As more than 100 confirmed or suspected monkeypox infections have been identified outside of endemic regions, governments have started preparing for potential bigger outbreaks.
Wednesday, Bavarian Nordic said it has signed a supply contract for its smallpox vaccine, known as Jynneos, with an unnamed country to “ensure sufficient supply to meet the country’s requirements for vaccinating individuals at risk for monkeypox in the short- to medium-term.”
The announcement comes after the U.S. Centers for Disease Control and Prevention (CDC) said it’s in the process of releasing some doses of Jynneos from the national stockpile to a small number of at-risk adults who have been exposed.
The CDC has 1,000 doses readily available, and it expects the supply to “ramp up very quickly in the coming weeks as the company provides more doses to us,” Captain Jennifer McQuiston, deputy director of the CDC’s High Consequence Pathogens Pathology Division, said Monday, as quoted by CNN.
As of Monday, the U.S. had one confirmed monkeypox case in Massachusetts and six suspected cases.
Jynneos is the only vaccine approved anywhere against both smallpox and monkeypox, Bavarian Nordic said. Besides the U.S., the vaccine is also cleared in Canada as Imvamune and in Europe as Imvanex. Its label in Europe doesn't cover the monkeypox indication.
Bavarian Nordic is keeping mum about the identity of the client and the terms of the agreement, but the new deal is big enough to warrant an adjustment to the Danish company’s 2022 financial outlook.
The drugmaker has dialed up its 2022 revenue prediction by 200 million Danish kroner and is now expecting to deliver between 1,300 million Danish kroner ($186 million) and 1,500 million Danish kroner ($215 million). Favorable foreign exchange rates also contributed to the increase, the company said.
Bavarian Nordic said last Thursday that it has secured a contract with an undisclosed European country to supply the vaccine. That order has no major impact on 2022 sales, the company said. Although not specifically approved for monkeypox in Europe, the vaccine has in the past been utilized off-label in response to monkeypox cases.
Shipments of Jynneos under the new contract will start immediately, and Bavarian Nordic said it’s currently talking to several other governments about potential supply of the shot to tackle the monkeypox outbreak and “to explore opportunities for longer-term collaboration to build stockpiles for future preparedness.”
In addition to Jynneos, Emergent BioSolutions has smallpox vaccine ACAM2000, which doesn’t have a monekypox indication. According to the CDC, smallpox vaccine is also supposed to protect against monekypox because the two viruses are close relatives. Emergent hasn’t announced any additional supply contract during the current outbreak. ACAM2000 has a more burdensome side effect profile, according to reports.