Spain reserves second dose of ‘monkeypox’ vaccine for immunocompromised

The monkeypox (“monkeypox”) vaccination plan envisages the administration of a single dose until there is greater availability of drugs, except for immunosuppressed people, who will receive the second puncture 28 days after the first to complete the pattern.

These people, as well as pregnant women and children, will receive the normal amount of 0.5 ml of serum for each injection, while other people over the age of 18 will receive the reduced dose of 0.1 ml, in accordance with the recommendations approved yesterday by the Public Health Commission.

In the update to the Strategy released by the Department of Health on Tuesday, the Directors General of Public Health state that “the availability of vaccine doses for preventive purposes, both currently and in the near term, is limited, due to the strong global demand and the difficulties of their manufacture”, since they are only developed by a single laboratory.

While the acquisition of more vaccines is being negotiated, just over 12,000 have arrived in our country, which has recorded 6,284 cases today, to which will be added 5,000 others; Given the evolution of the epidemic, it was necessary to review the recommendations, both for pre-exposure and post-exposure prophylaxis.

Group Prioritization

The strategy continues to prioritize people who engage in high-risk sexual practices, primarily but not exclusively GBMSH (gay, bisexual and men who have sex with men) included in the indications for pre-exposure prophylaxis with HIV (PrEP) or infected with HIV. HIV in the follow-up of hospital consultations.

As a novelty, this update establishes that those who are not already vaccinated and who meet one of the following criteria: have a high exchange of sexual partners (10 or more in the last year or more than three in the past 3 months), going to specific places to have group sex, or had a sexually transmitted infection in the past month.

In addition, people at occupational risk predominate – such as health staff in specialized STI/HIV care clinics who deal with people with high-risk practices and laboratory staff who handle potentially contaminated samples – or who are in charge of disinfection of surfaces in premises where risky sexual relations take place, provided that other means of protection cannot be guaranteed.

Meanwhile, in post-exposure vaccination, close contacts of confirmed cases predominate, especially those at high risk of severe disease (child population, pregnant women, and immunocompromised people), as well as health and laboratory personnel in contact with confirmed cases and which have had some impact on the use of PPE.

Second dose

From now on, one-fifth of the dose administered so far subcutaneously will be injected intradermally, with the exception of pregnant, under 18 and immunocompromised women, to whom the traditional model will continue to be applied.

The recommended vaccination schedule is two doses with an interval of at least 28 days but, “due to existing limitations”, the first will be administered and “the schedule will be completed until a greater number of vaccines available”, except for immunocompromised individuals, who will receive the second injection at the recommended interval.

In people with a history of vaccination against smallpox “it may be considered not to administer the second dose”.

If the vaccine was given after the at-risk contact, a single dose will be given within the first 4 days of the first close contact, although it may be offered for up to 14 days. The latter “will only be offered if they meet the pre-exposure vaccination criteria” described above and “the same recommendations established for this vaccination will be followed”.

How the new strategy will be applied

Vaccine vials are formulated as a single dose of 0.5 ml, from which a maximum of 5 doses of 0.1 ml can be extracted; if the last dose extracted is less than 0.1ml, it should be discarded and will not be topped up “under any circumstances with product from another vial”.

Once thawed, the containers can be kept for 2 months between 2 and 8°C (in the refrigerator). In order to minimize possible contamination by microorganisms, once the first puncture has been made in the stopper, the vial should be at room temperature for as little time as possible and in the refrigerator for a maximum of 8 hours. If people are not vaccinated consecutively, they should also be stored in the refrigerator.

According to the protocol, “it is important that intradermal administration be performed by nursing staff experienced or trained in this administration technique.”

To optimize the use of the vaccine, the use of syringes and needles minimizing dead volume is recommended; In order to avoid residual loss of volume in the needle, the needle can be used for loading and administering the drug.

The plan recommends reporting the expected possibility of induration and erythema or discoloration of the skin at the injection site. These local side effects are self-limiting and reversible.

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