The supply of Imvanex vaccine against smallpox is limited in the EU, the EMA said. (representative)
The Hague the Netherlands:
The European Union drug regulator said on Tuesday it had begun a formal review of the use of a smallpox vaccine to treat a growing number of monkeypox cases.
Imvanex was approved by the European Medicines Agency (EMA) for smallpox in 2013, but its maker, the Danish firm Bavarian Nordic, did not apply for its use against monkeypox at the time.
Monkeypox is related to smallpox, which kills millions of people around the world every year before it was eradicated in 1980, but has much less severe symptoms.
The EMA said it had “started a review of data to extend the use of the smallpox vaccine Imvanex to protect people against monkeypox disease”.
It did not say when it could make a decision, adding that it was awaiting a formal request from Bavarian Nordic.
The EMA also said European countries should be able to import the US version of Imvanex, called Jynneos, due to a shortage of supplies.
The US authorities have already approved Jynneos for use against monkey pox.
“Supplies of Imvanex are currently very limited in the EU,” the EMA said.
The World Health Organization said on Saturday that an outbreak of monkeypox that began in May was a very worrisome developing threat, but does not currently constitute a global health emergency.
Since early May, a spate of monkeypox cases have been detected outside of West and Central African countries where the disease has long been endemic. Most of the new cases were in Western Europe.
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