The objective is to vaccinate many people in the face of the increase in cases in recent months.
The European Medicines Agency (EMA) Emergency Task Force has reviewed data on the monkeypox vaccine used as an intradermal injection (given just under the top layer of the skin). Until then, the vaccine is only licensed for subcutaneous injection (injection under the skin). However, when given intradermally, a smaller dose of the vaccine can be used.
This Friday, the EMA thus authorized this new technique for injecting the monkeypox vaccine, which will make it possible, given the currently limited supply of vaccines, to immunize more people with a lower dose and to prevent thus a possible shortage.
The EMA says it has reviewed data from a clinical trial 2 involving approximately 500 adults, which compared the vaccine given intradermally or subcutaneously, in 2 doses with an interval of 4 weeks between each dose. People receiving the vaccine intradermally produced similar antibody levels to those who received the highest dose subcutaneously.
However, the EMA has warned that there is a higher risk of local reactions (eg longer lasting redness, and thickening or discolouration of the skin) after intradermal injections.
“National authorities may decide, as a temporary measure, to use Imvanex by intradermal injection at a lower dose to protect those at risk during the current outbreak of monkeypox, as long as the vaccine supply remains limited,” the EMA also said.
This decision will make it possible to vaccinate five times more people with the available vaccine stocks.
The EMA recalls that “monkeypox is a rare disease caused by infection with the monkeypox virus, which causes symptoms similar to those of smallpox. Monkeypox begins with fever, headache, muscle pain, exhaustion and swelling of the lymph nodes A rash usually develops one to three days after the fever starts, first appearing on the face and spreading to other parts of the body, including the hands and feet. Monkeypox can be fatal, although it is usually milder than smallpox.”