After more than two years of the COVID-19 pandemic, many were hoping that this would be the summer that they could throw caution to the wind. But along with the COVID threat that refuses to go away, the number of monkeypox virus cases continues to rise. As of August 30, 2022, there are more than 18,000 cases of monkeypox in the United States alone. This, coupled with the short supply of vaccine for the disease, has led to a need for a solution to an increasingly growing public health emergency. Federal officials believe they have come up with a short-term solution in the form of an Emergency Use Authorization (EUA) for the Jyenoes vaccine, modifying the route of administration and dosage. Many in the community are asking if this is EUA safe and does the vaccine actually work?
According to Dr. Wafaa El-Sadr, University Professor Dr. Mathilde Krim-amfAR, chair of Global Health Epidemiology at Columbia University Mailman School of Public Health [Full disclosure: the author of this article is an assistant professor at the Columbia University Mailman School of Public Health but does not work with Dr. El-Sadr], in an interview with AmNews, in order to be infected “somebody has had contact with someone who has monkeypox and particularly what we call close contact, skin-to-skin close contact in particular. . . it takes a couple of weeks and then they come down with some of these symptoms of monkeypox and these could start with a skin rash and the skin rash can occur anywhere in the body and…it has a certain characteristic look some of the skin rashes on the palms and the soles, in the genital area but it’s a very firm kind of skin rash and has a very specific appearance.”
The AmNews also spoke with Dr. Demetre Daskalaskis, the White House National Monkeypox Response deputy coordinator and the CDC’s director of the Division of HIV/AIDS Prevention, about who is most at risk.
According to Daskalakis, “[T]he majority of the cases continue to be seen among gay, bisexual, other men who have sex with men. They continue to be a really important group for us to work with to . . . increase access to [the] vaccine.”
According to an article published earlier this year in the New England Journal of Medicine, that “although the current outbreak is disproportionately affecting gay or bisexual men and other men who have sex with men, monkeypox is no more a ‘gay disease’ than it is an ‘African disease.’ It can affect anyone.” [Emphasis added]
While the outbreak continues to grow, public health officials have implemented a plan to stretch the currently available vaccine in a safe way so that more at-risk people can be protected.
On Aug. 9, 2022, the Biden administration announced a comprehensive plan to expand the number of vaccine doses available to combat the disease. Through an Emergency Use Authorization (“EUA ”), there have been changes to the way the vaccine is administered, thus increasing the number of doses accessible to healthcare providers.
According to the White House, there are currently 400,000 vials of the vaccine available for use and in inventory. These vials could translate into 2 million doses using the new EUA.
In response to the proposed EUA, Paul Chaplin, president & CEO of Bavarian Nordic authored a letter to HHS Secretary Xavier Becerra, and FDA Commissioner Dr. Robert Califf, stating that the company had “some reservations on the [intradermal] approach.”
While he has expressed concerns about the EUA, Chaplin is also one of the co-authors of the 2015 clinical trial of the Jynneos vaccine that the federal government cites specifically to modify the Jynneos dosing. The study specifically speaks to utilizing such a dosing modification during a public health emergency.
According to Daskalakis, “The data really show that the dosing that you give in the skin that’s the one that [the two delivery methods] really elicit the same level of immune protection or immune response in the lab… so they’re equivalent which is really exciting because then one dose goes for five people.”