Infectious Europe is already studying a change in dosage for the monkeypox vaccine due to the shortage of doses
The Public Health Commission will study next Monday if the monkeypox vaccine (
monkeypox
) will begin to be administered intradermally, a strategy that already has the endorsement of the European Medicines Agency (EMA) and that
will allow multiplying by five each current dose.
If approved, the intradermal punctures would begin to occur like this next week, as explained from Fuerteventura by the Minister of Health, Carolina Darias, who recalled that this route will allow
not only to increase the number of doses, but also that two separate doses can be inoculated into a period of 28 days to complete the guideline
.
With almost 6,000 confirmed cases -waiting for the Ministry of Health to update the data this afternoon- Spain has a total of 12,420 vaccines to try to stop the outbreak that broke out in non-endemic countries at the beginning of May.
Given the shortage of drugs,
the Spanish Agency for Medicines and Health Products (Aemps) asked the European agency on August 10 to evaluate this new method as soon as possible
, which has been applied in the United States since last week, except in minors. , for which the subcutaneous route has been maintained, since the intradermal route (below the outermost layer of the skin) is a little more complicated in children.
In Europe, the EMA's emergency response group (ETF, for its acronym in English) of the EMA, to which several Aemps technicians belong, has analyzed the existing data on the
intradermal use of Imvanex, which is injected two subcutaneous doses of 0.5 ml.
spaced at least four weeks apart,
although so far only one has been punctured due to lack of vaccines.
However, as the Aemps has recalled in a note issued as soon as the EMA's decision was known, a clinical study in 500 adults has concluded that the intradermal administration of lower doses "may be equally effective."
"Given the shortage of these drugs worldwide and the inability to achieve sufficient production in the short term to meet demand, this change in the route of administration means that a greater number of people could be vaccinated
," explains the agency. Spanish.
In this way, the ETF, after thoroughly reviewing the data from this study to assess the safety and efficacy of this new indication, has concluded that people who received one fifth of the usual dose (0.1 ml .) intradermally produced antibody levels similar to those who received the usual dose subcutaneously (0.5 ml.).
With regard to safety,
this route of administration did not produce any previously undetected adverse reactions
.
However, the EMA warns 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 site of administration.
If this strategy is finally chosen, it
recommends using low dead volume syringes to obtain the maximum number of intradermal administration doses from the authorized presentation of Invamex,
ensuring that each dose reaches the amount of 0.1 ml.
Likewise, "for the sake of safety, it is recommended that
only health professionals with previous experience in this type of injections administer it. "
".
Darias, who spoke before the EMA statement, called for a culture of care and recalled that, in the face of any communicable disease such as monkeypox, it is "very important" to go to a doctor at the first symptom in order to detect it and prevent transmission.
He has also asked to go to the vaccination to those groups for which it is established and those that have been agreed by the Public Health Commission.
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