Health authorities in Ireland and the rest of Europe have been given permission to change the way the monkeypox vaccine is given so more people can be vaccinated.
The European Medicines Agency’s Emergency Task Force announced today that it has reviewed data on the monkeypox vaccine Imvanex, which is used as an intradermal injection – where it is given just under the top layer of the skin.
The vaccine is only approved for subcutaneous injection – i.e. injection under the skin.
However, when administered intradermally, a lower dose of vaccine can be used.
Given the current limited availability of the vaccine, this means more people can be vaccinated.
The task force reviewed data from a clinical trial involving around 500 adults that compared the vaccine given either intradermally or subcutaneously in two doses with four weeks between each dose.
Individuals who received the vaccine intradermally received one-fifth (0.1 mL) of the subcutaneous dose (0.5 mL), but produced similar antibody levels to those who received the higher subcutaneous dose.
The ETF warned that there is a higher risk of local reactions such as prolonged redness and thickening or discoloration of the skin after intradermal injections.
The HSE has said over 6,000 people here are at increased risk of catching the monkeypox virus, with 113 cases so far.
However, due to the limited supply of the vaccine, it can only be given to about 600 men in the first phase.
EMA noted that no information is available on the maximum number of 0.1mL doses that can be withdrawn from the authorized dosage form (0.5mL suspension) and recommended the use of low dead volume syringes to optimize the number of doses that can be removed.
His task force also stressed the importance of correct intradermal injection and recommended that only healthcare professionals experienced in intradermal injection should administer the vaccine in this manner.
With all of these considerations in mind, national authorities may decide to use Imvanex as an intradermal injection at a lower dose as a temporary measure to protect vulnerable individuals during the current monkeypox outbreak while vaccine supplies remain limited.
Imvanex was first approved for protection against smallpox in exceptional circumstances in 2013.
It was approved for protection against monkeypox disease on July 22, 2022, following a request to extend its use.
The task force’s recommendations were issued to address the monkeypox outbreak in several EU countries as part of their public health emergency response, which includes advice to support regulatory activities and product-related assessments.
https://www.independent.ie/news/new-method-of-giving-monkeypox-jab-will-allow-more-people-be-vaccinated-41923584.html New method of administering monkeypox vaccine will allow more people to get vaccinated