The Danish pharmaceutical company Bavarian Nordic Monday received the green light from the European Commission to use the Imvanex vaccine against monkeypox in the European Union, as well as in Iceland, Liechtenstein, and Norway.
Brussels' approval follows the July 22 nod from the European Medicines Agency (EMA), through the Committee for Medicinal Products for Human Use in Europe (CHMP), to extend the application of the smallpox drug Imvanex to as prevention against monkeypox due to the similarity between the virus.
The CHMP has also recommended authorizing Imvanex to protect people against the disease caused by the 'vaccinia' virus, which causes symptoms similar to, but milder than, those of smallpox.
Specifically, this vaccine had been approved in the EU in 2013 to prevent smallpox but had not been prescribed for monkeypox although many European countries are already administering it for that purpose following the current outbreak of the malady that is more common in African countries.
Bavarian Nordic president and CEO Paul Chaplin said his laboratory's vaccine can significantly improve the preparedness of countries against emerging diseases through structured planning. To confirm the efficacy of the monkeypox vaccine, Bavarian Nordic will collect data from an observational study to be conducted during the ongoing monkeypox outbreak in Europe.
Bavarian Nordic has been flooded with orders for the vaccine over the past few days following the increase in the number of confirmed cases in at least 70 countries. The drug marketed under the name Imvanex in Europe is known as Jynneos in the United States. It is the world's only licensed vaccine against monkeypox. Meanwhile, orders for the inoculant soared in recent weeks in line with the increase in cases that have already been reported in at least 70 countries, with Western Europe being the most affected region.
The Danis pharmaceutical company is specialized in the development, manufacture, and marketing of vaccines against infectious diseases as well as in cancer immunotherapies, according to its website. It is headquartered in the city of Hellerup, Denmark, and has offices in Germany, Switzerland, and the United States.
Imvanex contains a modified live form of the monkeypox virus. It is a third-generation serum consisting of a live vaccine that does not replicate in the human body. It is administered by subcutaneous injection, preferably in the upper arm. The dose will depend on whether or not the person has been vaccinated against smallpox. Those not previously vaccinated should receive two doses with an interval of 28 days, while in the other cases a single application serves as a booster.
Bavarian Nordic has an annual production capacity of 30 million doses. According to the drugmaker's Vice President Sass Sørensen, the vaccine is in stock in numerous countries and can be given before or after exposure to the disease. If you get vaccinated a few days after being exposed, you can still be protected, he told reporters from Copenhagen. The laboratory announced that deliveries will start this year and the vast majority of vaccines will be distributed during 2023.
This drug had been cleared for use in the United States since 2019. Sørensen insisted last week that the company would be able to absorb the increasing demand despite having only a single production facility. With the current demand, we can easily supply the global market. We have a few million doses in bulk, we can put them in vials and ensure that the current epidemic is treated, he told AFP.
Monkeypox is transmitted to people from a variety of wild animals, such as rodents and primates, but can also be transmitted from person to person through direct or indirect contact.