EU drugs watchdog in talks with Bavarian Nordic over wider use of smallpox vaccine
02/06/2022 13:47
FRANKFURT, June 2 (Reuters) - The European Union's drug
regulator said on Thursday it was in talks with vaccine maker
Bavarian Nordic BAVA.CO 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 CMRX.O , 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)
((ludwig.burger@thomsonreuters.com; +49 30 220133634;))