low volume intradermal syringes
The European Medicines Agency (EMA) Emergency Working Group (ETF) has recommended the use of low-volume syringes if the monkeypox vaccine is administered intracutaneously, as well as for it to be performed by professionals experienced with these types of injections.
The ETF analyzed existing data on the intradermal use of the Imvanexthe vaccine authorized against monkeypox, so that the public health authorities of the Member States have all the necessary information about its safety and efficacy and can take measures in the face of the current epidemiological situation.
Invamex is licensed for subcutaneous administration of two doses of 0.5 milliliters spaced at least four weeks apart. However, a clinical study in 500 adults concluded that giving lower doses intradermal (under the outermost layer of skin) may be just as effective.
Prior to the worldwide shortage of these drugs and the inability to achieve sufficient production in the short term to meet demand, this change in the route of administration meant that more people could be vaccinated, even.
Similar antibodies when 1/5 of the usual dose is received
low volume intradermal syringes
The ETF, to which various technicians from the Spanish Agency for Medicines and Health Products (AEMPS) are affiliated, did a comprehensive review of the data from this study to assess the safety and efficacy of this new indication: subjects who received one-fifth of the usual dose (0.1 ml) produced similar intradermal antibody levels. For those who have received the usual subcutaneous dose (0.5 ml). In terms of safety, this administration has not produced any hitherto undetected adverse reactions.
Despite this, the ETF cautions that this study “does not provide data on generated cellular immunity and that intradermal administration increases the risk of redness and pain rather than administration.
If the intradermal route is chosen, the ETF recommends the use of low dead volume injections to obtain the maximum number of intradermal administration doses from the licensed presentation of Invamex, ensuring that each dose reaches the recommended dose (0.1 mL). Likewise, for safety, it is recommended that it only be taken by healthcare professionals with previous experience with this type of injection.
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