Implications Of Monkeypox Being Declared A Public Health Emergency In U.S.

On August 4th, the Biden Administration declared monkeypox a public health emergency. The announcement comes on the heels of the World Health Organization declaring monkeypox a public health emergency of international concern in July. This implies monkeypox poses a global public health risk through international spread, which requires a coordinated international response.

In the U.S., prior to the Biden Administration’s declaration, a number of municipalities and even several states – California, Illinois, and New York – had declared monkeypox a public health emergency.

More than 27,600 monkeypox cases have been reported across 87 countries. With approximately 8,300 confirmed cases, the U.S. comprises 30% of confirmed infections worldwide. Furthermore, test positivity is very high in the U.S., which reflects undertesting.

A Public Health Declaration allows the Secretary of Health and Human Services (HHS) to take certain actions to address the threat to public health from a disease or a crisis of some kind. Public health emergencies aren’t just declared in the event of infectious disease outbreaks such as Covid-19 and monkeypox. For example, in October 2017, President Trump declared the “opioid crisis” to be a “public health emergency.”

Importantly, a public health emergency declaration releases resources earmarked for an actual (or emerging) public health crisis. In the case of monkeypox, the federal government can now significantly scale the production and availability of vaccines, expand testing capacity, and make testing more convenient. The declaration also facilitates coordination among federal, state, and local authorities, specifically in relation to improving access to testing and treatment. Furthermore, funding is directed at coordinating (across jurisdictions) awareness and prevention outreach campaigns that target members of the at-risk communities and the public at large, aimed at curbing spread of the virus.

Additionally, the declaration allows the Secretary of HHS to conduct and support investigations into the cause, treatment, or prevention of the disease or crisis, in addition to supporting advanced research and development and biosurveillance necessary to address the problem at hand. Finally, it enables the CDC to access the Infectious Diseases Rapid Response Reserve Fund to prevent, prepare for, or respond to an infectious disease emergency.

No monkeypox deaths have yet been reported in the U.S., but in the latest worldwide outbreak, which began in May of this year, at least 6 fatalities have occurred outside the U.S. Moreover, estimates on numbers of confirmed cases that have been hospitalized vary between 3% and 13%. Most hospitalizations are for severe pain management. Patients often suffer debilitating pain from the skin rash caused by the virus. Skin lesions can occur anywhere on the body. Common systemic features preceding the rash include fever (62%), lethargy (41%), muscle aches (31%), headache (27%), and enlarged lymph nodes (56%).

Besides pain management, the reasons cited for hospitalizations have included pharyngitis limiting oral intake, encephalitis (brain inflammation), eye lesions, acute kidney injury, and myocarditis (heart inflammation).

Men who have sex with men are currently at highest risk, but anyone can contract monkeypox. And, in fact a growing number of women and children have tested positive for the virus.

What is definitively known is that monkeypox spreads through direct contact with body fluids or sores on the body of someone who has monkeypox, or with direct contact with material, such as clothing and linens, that have touched body fluids or sores. It may also spread through respiratory droplets when people have close, face-to-face contact.

The U.S. has increased testing capacity to 80,000 per week. Nevertheless, current demand for testing exceeds present capacity in the U.S. in terms of testing supplies.

In 2019, the Food and Drug Administration (FDA) approved a vaccine called Jynneos for adults ages 18 and older who are at high risk of exposure to monkeypox or smallpox. Jynneos is the only FDA-approved monkeypox vaccine in the U.S. It is administered in two doses 28 days apart. On July 15, 2022, HHS’s Administration for Strategic Preparedness and Response announced that it had ordered an additional 2.5 million doses of Jynneos to bolster monkeypox preparedness, which will increase the federal government’s ​available supply to more than 6.9 million doses by the middle of ​2023.

Thus far, HHS has made 786,000 doses of Jynneos available for state and local authorities. But lawmakers and local communities have criticized the pace of the response. And due to shortages in supply, the FDA is now considering dividiing Jynneos doses into fifths.

Centers for Disease Control and Prevention Director Dr. Walensky has acknowledged that demand for the vaccine is outstripping supply. An additional 11.1 million doses are in storage in Denmark with the manufacturer Bavarian Nordic. However, these doses need to be “filled and finished” before they can be administered, which will require additional funding from Congress.

The U.S. also has more than 100 million doses of an older generation smallpox vaccine, called ACAM2000, that is likely effective against monkeypox. But, ACAM2000 can have serious side effects and is not recommended for those with compromised immune systems, such as HIV patients, pregnant women, and people with autoimmune disorders.

As far as other treatments are concerned, the U.S. has 1.7 million courses of the antiviral treatment tecovirimat in its strategic national stockpile. Some physicians are using tecovirimat to treat monkeypox patients. But, this drug has only been approved by the FDA for smallpox.

It is hoped that the declaration of a public health emergency will soon lead to a ramping up of testing and treatment of monkeypox, but also increased use of public health messaging on prevention of spread of the disease, particularly in vulnerable communities.