Europe to buy 110k doses of Bavarian Nordic's monkeypox vaccine — as EU-licensed vaccine not easily accessible
Known monkeypox cases rose above the 4,000 mark this week as officials have sought another name for the disease, and Europeans moved forward on stocking up a working vaccine.
The European Medicines Agency announced Monday that it had agreed to buy 110,000 doses of Jynneos, the US-licensed version of Bavarian Nordic’s Imvanex. Imvanex is authorized in the EU for the prevention of smallpox in adults, but only “under exceptional circumstances due to the impossibility to generate efficacy data as smallpox virus is no longer circulating.”
Jynneos, on the other hand, is approved in the US and Canada for infection and disease caused by both smallpox and monkeypox. Both of these viruses are orthopoxviruses and are closely related.
“Since the EU authorised vaccine Imvanex is not immediately available, in order to allow rapid containment of the outbreaks, EU MSs [member states] agreed to the purchasing of close to 110.000 doses of the US made vaccine Jynneos by HERA. Their delivery is foreseen to start to MSs with highest number of cases in the coming days,” the agency said in a statement.
The EMA on Monday said it also kicked off its review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox.
Bavarian Nordic has been busy making deals with numerous entities such as the US government’s BARDA for 500,000 doses and Germany for 40,000 doses, amid reporting “overwhelming interest” in Jynneos from other entities.
“We are obviously still in dialogue with a number of countries from different regions of the world and we are expecting to sign more contracts,” CFO Henrik Juuel said earlier this month on an investor call.
Jynneos is produced at Bavarian Nordic’s manufacturing facility in Denmark, which is not currently authorized for EU production, according to the EMA. At least in the manufacturing process, the difference between Jynneos and Imvanex was not considerable, and “[d]ifferences are deemed to be minor and do not raise any concern regarding immunisation with Jynneos,” the agency added.
One other factor brought up was shelf life — Jynneos can store for three years at -20 ̊C, or -4 ̊F. However, Imvanex is only authorized for two years at that same temperature, plus differing shelf life between the two when thawed and stored in similar conditions. And while initial data seem that the two vaccines could have the same shelf life of three years when frozen, the EMA noted that information is not completely available to confirm the same amount of potency.
Regardless, the agency adds, “It is acceptable to use Jynneos under the stated EU storage conditions for Imvanex as a temporary measure until the EU and US data sets are aligned.”