FRANKFURT (Reuters) – The European Union’s drug regulator said on Thursday it was in talks with vaccine maker Bavarian Nordic over trial data that could underpin an extension of the approved use of the Imvanex shot beyond smallpox to include monkeypox.
“The EMA emergency task force is in talks with the market authorisation holder to prepare for the submission of data that could support an extension of the indication to include the prevention of monkeypox,” the European Medicines Agency’s (EMA) head of vaccines strategy, Marco Cavaleri, said in a press briefing.
Imvanex is approved for smallpox in Europe, but has been provided for off-label use in response to monkeypox cases. In the United States, where the shot is called Jynneos, it is already approved against both smallpox and monkeypox.
Cavaleri added that the drug Tembexa, also known as brincidofovir and developed by Chimerix, might be a therapeutic option to treat monkeypox infections.
Tembexa has U.S. approval to treat smallpox but it is so far not authorised in the European union.
“We will explore possible rapid regulatory actions,” said Cavaleri.
(Reporting by Ludwig Burger; Editing by Kirsten Donovan)
