EMA will allow more doses to be taken from each vial of monkeypox by making it intramuscular

The European Medicines Agency (EMA) accepted the proposal of several Spanish institutions to approve the intradermal application (under the top layer of the skin) of Imvanex vaccine against monkeypox.

The request, which came first from the Community of Madrid and hours later from the Ministry of Health, allows the injected monkey to be replaced, leaving behind the subcutaneous tissue (under the skin), in order to use a smaller dose and thus vaccinate more people.

The EMA’s Emergencies Task Force (ETF) recommended its use low dead volume syringes in case the monkeypox vaccine is administered intradermally, as well as performed by professionals experienced in this type of injection.

[Madrid propone dividir las vacunas de la viruela del mono en cinco dosis ante la escasez de viales]

Right now, Invamex It is approved for subcutaneous administration in two doses of 0.5 mL at an interval of at least four weeks. However, clinical trial in 500 adults concluded that intradermal (under the outermost layer of the skin) administration of lower doses may be equally effective.

In the case of Spain, on August 10 the health authorities of the Community of Madrid proposed a vaccination in which the doses were reduced by a fifth in order to reach a larger number of infected people.

Initially, the Ministry of Health preferred not to approve the option until it “received an opinion from the authorities of the European Union”. But hours later, he asked the European authorities from ASpanish Agency for Medicines and Health Products (AEMPS) the aforementioned use.

The approval for Spain is very important, as it is one of the countries with the most cases of monkeypox in Europe (second) and first in the world ranking. Only after the US that has enough vaccines.

The company in charge of producing the vaccine has already informed member states months ago that there is a lack of stock and an inability to achieve sufficient production in the short term to meet demand. Therefore, the method of application suggests that more people can be vaccinatedup to five with the same vaccine.

[La falta de vacunas complica el control de la viruela del mono, que sigue cebándose en España]

The study, supported by European authorities, showed that people who received one fifth of the usual dose (0.1 ml) intradermally produced antibody levels similar to those who received the usual subcutaneous dose (0.5 ml). In terms of safety, this route of administration did not lead to any previously undetected side effects.

However, the ETF cautions that this study “does not provide data on the cellular immunity generated and that intradermal administration increases the risk of redness and pain at the application site.”

In the case of choosing the intradermal route andl ETF recommends using syringes with low dead volume to obtain the maximum number of intradermal doses from the authorized presentation of Invamex, ensuring that each dose reaches the recommended dose (0.1 ml). These needles are the same ones that have been used in Covid-19 vaccines, such as the one produced by Pfizer.

Likewise, in the interest of safety, it is recommended that it be administered only by medical professionals with previous experience in this type of injection. I mean the nurses.

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