European countries can now administer the Imvanex vaccine just under the upper layer of the skin (intradermally) and no longer deep (subcutaneously) as is currently the case, and thus only use a fifth of the dose, the EMA said in a statement.
This technique which uses a lower dose of vaccine produces the same immunity with an equivalent level of antibodies as the other method, but the risk of skin irritation is higher, the Amsterdam-based watchdog has warned .
"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 said.
European Commissioner Stella Kyriakides stressed that this authorization was an "extremely important decision because it makes it possible to vaccinate five times more people with the stocks of vaccines we currently have".
"This ensures better access to vaccination for people at risk and healthcare professionals," she added in a statement.
Previously limited to Central and West Africa, monkeypox has spread since May to other parts of the world including Europe and the United States.
Same level of antibodies
Developed by Danish group Bavarian Nordic, the Imvanex vaccine was originally approved to fight smallpox, declared eradicated worldwide since 1980.
Studies later showed that this vaccine was also very effective against monkeypox, which is less virulent.
Due to the similarity of the two viruses, the European health authorities approved the extension of its use on July 22, specifying that the injection should be subcutaneous, therefore deeper.
This decision triggered a global rush for this now only authorized vaccine against this disease.
#photo1
The watchdog said on Friday its emergency task force had found that "when given intradermally, a smaller dose of the vaccine may be sufficient".
One way to fight against the currently limited supply of vaccine and thus allow more people to be immunized, added the EMA.
The working group studied data from a clinical trial involving approximately 500 adults and comparing the two types of injection.
"People receiving the vaccine intradermally received one-fifth (0.1ml) of the dose subcutaneously (0.5ml) but produced similar antibody levels as people who received the subcutaneous dose. skin level,” explained the EMA.
She warned, however, that there was a "higher risk of local reactions" such as lasting redness and thickening or discoloration of the skin after the shallower injections.
Bavarian Nordic said it is considering partnerships with other companies to "further increase production capacity to improve global access to the vaccine."
© 2022 AFP