The European Medicines Agency (EMA) on Friday 19 August authorized a new injection technique for the monkeypox vaccine, which will enable more people to be immunized with lower doses and thus prevent a potential shortage.
European countries can now administer the Imvanex vaccine just under the top layer of the skin (intradermal) and no longer deep (subcutaneous) as at present, and thus use only 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 equivalent levels of antibodies as the other method, but the risk of skin irritation is higher, the Amsterdam-based watchdog warned. “National authorities may decide, as an interim measure, to use Imvanex at a lower dose by intradermal injection to protect those at risk during the current outbreak of smallpox while vaccine supplies are limited.EMA said.
European Commissioner Stella Kyriakides emphasized that this authorization was a decision.is extremely important because it makes it possible to vaccinate five times more people with the vaccine stocks we have“currently. “This ensures better access to vaccinations for at-risk people and healthcare professionals“, he added in the press release. Previously confined to Central and West Africa, monkeypox has spread to other parts of the world since May, including Europe and the United States.
The same level of antibodies
The Imvanex vaccine, developed by the Danish group Bavara Nordic, was originally approved to fight smallpox, which has been eradicated worldwide since 1980. Later studies showed that this vaccine was also very effective against chicken pox, which is less contagious. Due to the similarity of the two viruses, European health authorities approved the extension of its use on July 22, stating that the injection should be subcutaneous, therefore deeper. The decision sparked a global rush for the now-only licensed vaccine against the disease.
On Friday, the watchdog said its emergency task force found that “when given intradermally, a smaller dose of vaccine may be sufficient“. One way to combat the currently limited supply of the vaccine and thus enable more people to be immunised, the EMA added. The task force reviewed data from a clinical trial involving approximately 500 adults and compared the two types of injection.
“People receiving the intradermal vaccine received one-fifth (0.1 ml) of the subcutaneous (0.5 ml) dose, but produced the same level of antibodies as people who received the subcutaneous dose. higher:EMA explained. He warned, however, that there is “higher risk of local reactions» such as prolonged redness and thickening or discoloration of the skin after more superficial injections.
“Bavaria Nordic” announced that it is considering cooperation with other companies “further increase production capacity to improve global availability of the vaccine“.
Source: Le Figaro
