News item | 19-08-2022 | 15:30
It is a possibility to give monkeypox vaccine Imvanex in the skin, instead of under the skin. In this way it is possible to elicit a comparable immune response with a smaller amount of vaccine. This way more people can be vaccinated. That says the Emergency Task Force (ETF) of the European medicine agency EMA. The ETF also includes experts from the MEB medicine authority.
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Imvanex is an approved vaccine against monkeypox virus. The product information states that the injection must be administered subcutaneously, ie under the skin. With intradermal administration (in the skin) a much smaller amount of vaccine is needed. This could be beneficial, as the current stock of vaccines is limited.
Clinical research
The expert group looked at the results of a clinical study involving about 500 adults. They each received 2 shots 4 weeks apart. The two methods of administration were compared for the vaccine. People who received the prick in the skin received only one fifth of the amount of the vaccine. The amount of antibodies produced in the body was the same in both groups.
Slightly more local side effects
No new safety concerns emerged from the study. However, the ETF warns that after a skin puncture there is a higher risk of local reactions, such as redness or thickening of the skin.
Correct injection needles and administration
The ETF has no information on the maximum number of doses that can be obtained from one vial. The Task Force does recommend the use of so-called low-dead volume syringes. It is also important to ensure the correct administration of intradermal injections. The advice is therefore that only healthcare providers who have experience with intradermal injections should administer the vaccine in this way.
Advice ETF
The ETF’s ruling is advice based on a clinical trial due to the current limited availability of the vaccine. The advice is not directly incorporated into Imvanex’s product information and package leaflet. With this information, national governments can decide whether to give Imvanex (temporarily) intradermally to people at higher risk of monkeypox. The expert council (organized by RIVM) prepares an advice for the Ministry of Health, Welfare and Sport. The minister will then make a decision. |
About the vaccine
Imvanex has been approved in the European Union since 2013 to prevent smallpox. The vaccine contains a weakened form of the vaccinia virus. This is a virus similar to the smallpox virus. The vaccine will protect against smallpox and has mild to moderate side effects. Since July 2022, it has also been approved for use against monkey pox.