The U.S. Food and Drug Administration (FDA) has 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 determined to be at high risk of monkeypox infection. This will increase the total number of doses available for use by up to five-fold.
The monkeypox vaccine can now be given to high-risk adults intradermally, meaning between the layers of the skin, rather than subcutaneously, or under the skin, as it has been given up until now.
This decision was made independently by the FDA based on compelling, science-based evidence that a fifth of the dose, when given intradermally on the same two-dose schedule as currently administered, produced a similar immune response to the current vaccination approach.
The Louisiana Department of Health has communicated to healthcare providers that this guidance is effective immediately 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 on clinical data
Data from a 2015 clinical study of the JYNNEOS vaccine evaluated a two-dose series given intradermally compared to subcutaneously. Individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously. The results of this study demonstrated that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way.
Vaccination by the intradermal route resulted in more redness, firmness, itchiness and swelling at the injection site, but less pain, and these side effects were mild and manageable.
Current vaccine eligibility in Louisiana
There are three groups of individuals currently 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 contract monkeypox and the current eligibility criteria are only limited to the above groups because they are most at risk based on the first diagnoses we have seen. However, the criteria will be expanded as additional vaccine becomes available and/or demographics of the current outbreak change.
Those who meet the above eligibility criteria can find a list of vaccine locations in Louisiana that have received monkeypox vaccine by visiting LDH’s webpage (ldh.la.gov/monkeypox) or calling 211. We recommend you call ahead.