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EMA’s Emergency Task Force (ETF) has given national authorities in the EU permission to use the Imvanex vaccine as an intradermal injection while supplies of the vaccine remain limited. In a statement, the ETF described the decision as a “temporary measure.”
The FDA recently reached a similar decision but authorized the intradermal use of the Imvanex vaccine from Bavarian Nordic A/S (OMX:BAVA, OTC:BVNRY) in adults with an elevated risk of contracting monkeypox.
The Imvanex vaccine is known as Jynneos in the U.S.
While the EMA has only authorized subcutaneous injection of the vaccine, the ETF acknowledged that the intradermal use of the vaccine supports dose sparing, allowing a fraction of the vaccine to be administered than conventionally.
Supplies of the vaccine remain limited throughout the world.
Increased risk of side effects for intradermal Imvanex?
The ETF also concluded that the intradermal (ID) use of the vaccine was associated with an elevated risk of the vaccine than with subcutaneous (SC) injections.
“Around 30% more subjects for ID vs. SC administration reported symptoms of local reactogenicity after the first dose and around 20% more subjects after the second dose,” concluded a document from the European Medicines Agency.
For healthcare providers administering the vaccine intradermally, it is important to rely on professionals experienced with delivering vaccines via that route, the ETF noted.
The task force also concluded there were no data on the maximum number of 0.1 ml doses that can be withdrawn from the 0.5-ml vials with a low-dead volume syringe.
European authorities authorized the vaccine for use in fighting against the monkeypox outbreak on July 22.
Imvanex remains the sole vaccine authorized in the EU for preventing smallpox and monkeypox.
There have been 16,162 confirmed cases of monkeypox in the European Union to date.
According to a recent article in The New York Times, the deployment of monkeypox vaccines in the European Union to date has been uneven.