Alternative Dosing Regimen for Monkeypox Vaccine Authorized by FDA Increasing Doses Available

The Louisiana Department of Health announced on August 10, 2022, that the US Food and Drug Administration (FDA) had issued an emergency use authorization (EUA) allowing healthcare providers to use an alternative dosing regimen of the JYNNEOS vaccine for individuals 18 years of age and older who have been determined to be at high risk of monkeypox infection. This increases the overall number of accessible dosages by up to fivefold.

The monkeypox vaccination can now be administered intradermally, or between the layers of skin, rather than subcutaneously, or beneath the skin, as it was previously.

The FDA made this determination independently based on convincing, scientific evidence that a fifth of the dose, when administered intradermally on the same two-dose schedule as now used, produced a similar immunological response to the existing immunization strategy.

The Louisiana Department of Health has informed healthcare providers that this advice is now effective in Louisiana.

“We welcome today’s decision from the FDA. This alternative dosing regimen has been shown in prior studies to be safe and elicit an equivalent antibody response. Importantly, it will significantly increase the number of at-risk individuals who can now benefit from protection against monkeypox. This is a potential game changer for our monkeypox response, especially ahead of upcoming large events in Louisiana,” said State Health Officer Dr. Joseph Kanter. “LDH will work with CDC and our healthcare providers to operationalize this new regimen in Louisiana as quickly as possible so we can get more vaccine doses out to more people faster. We must do everything we can to contain monkeypox in our state and keep our at-risk communities safe.”

Background information about clinical data
Data from a 2015 clinical trial of the JYNNEOS vaccine compared a two-dose intradermal series against a subcutaneous series. Individuals who received the vaccination intradermally received one-fifth as much as those who received it subcutaneously. The findings of this study showed that intradermal delivery induced a similar immunological response to subcutaneous treatment, implying that individuals in both groups responded similarly to vaccination.

Intradermal vaccination caused more redness, stiffness, itching, and edema at the injection site, but less discomfort, and these adverse effects were modest and tolerable.

Louisiana’s current vaccine eligibility
Currently, three groups of people are eligible for monkeypox vaccine:

• Individuals with known exposures to monkeypox patients;
• Gay, bisexual, and other (cis or trans) men who have sex with men OR transgender women and nonbinary persons assigned male at birth who have sex with men, AND
• Have had intimate or sexual contact with multiple or anonymous partners in the last 14 days, OR
• Have had intimate or sexual contact with other men in a social or sexual venue in the last 14 days; and
• Individuals (of any sex/gender identity) who have given or received money or other goods/services in exchange for sex in the last 14 days.

Important note: Anyone can get monkeypox, and the present eligibility requirements only apply to the above groups since they are more at risk based on the first diagnoses. However, when more vaccine becomes available and/or the demographics of the present outbreak change, the criteria will be expanded.

Those who satisfy the aforementioned eligibility criteria can obtain a list of monkeypox vaccine locations in Louisiana by visiting LDH’s website by following this link (ldh.la.gov/monkeypox) or dialing 211. We encourage that you call ahead of time.