U.S. Domestic Response to the 2022 Monkeypox Outbreak

U.S. Domestic Response to the 2022 Monkeypox Outbreak

August 5, 2022
U.S. Domestic Response to the 2022 Monkeypox Outbreak
Background
have reported cases in children and other populations.
On August 4, 2022, the Department of Health and Human
According to CDC, monkeypox is most commonly spread
Services (HHS) Secretary declared a Public Health
through close personal contact, contaminated materials, and
Emergency for the monkeypox outbreak. Countries in
animals. While scientists are still studying if the current
Africa have reported monkeypox since the first human case
monkeypox virus strain can be sexually transmitted, close
of monkeypox was identified in 1970 (endemic spread).
interpersonal contact, including during sexual activity, with
There have been limited outbreaks in countries outside of
an infected person can facilitate transmission.
Africa. Starting in May 2022, clusters of monkeypox cases
Most monkeypox cases are self-limited and resolve in two
were reported in Europe and the United States. Since then,
to four weeks. According to a study of 528 patients in the
case counts have increased in non-endemic countries—
current outbreak, about 13% were hospitalized. At least 10
representing the largest outbreak in non-endemic countries
deaths have been reported globally in Nigeria, Ghana,
in recent history. According to the Centers for Disease
Spain, Brazil, and India. No deaths have been reported in
Control and Prevention (CDC), as of August 4, 2022, over
the United States.
26,800 cases of monkeypox have been confirmed globally,
with over 26,500 cases in countries that have not
2022 Outbreak Domestic Response
historically reported endemic spread of the virus; over
On June 28, 2022, CDC activated its Emergency Operations
7,000 cases have been confirmed in the United States.
Center for monkeypox response. On August 2, 2022, the
2022 Outbreak
White House appointed a Federal Emergency Management
Agency (FEMA) official as the lead coordinator for the
Monkeypox is a disease caused by infection with the
monkeypox response and assigned a CDC official as his
monkeypox virus, which is part of the same family of
deputy. Other HHS agencies, such as the Administration for
viruses that causes smallpox. There are two types (or
Strategic Preparedness and Response (ASPR; formerly
clades) of monkeypox virus: West African and Congo
Office of the Assistant Secretary of Response) and the Food
Basin. The case fatality rate for those infected with the
and Drug Administration (FDA) are also actively engaged
West African clade is roughly 1%; the case fatality rate of
in response efforts.
the Congo Basin clade is approximately 10%. All cases in
the 2022 outbreak have been linked to the West African
The White House and HHS agencies have initiated response
clade. The 2022 outbreak is distinct from prior monkeypox
activities, including supporting education and awareness
outbreaks in non-endemic countries in two key ways.
and defining federal research priorities. Some key response
activities include the following:
Transmission. Monkeypox is typically transmitted from
animals to humans with limited human-to-human spread. In
Testing
prior outbreaks in non-endemic countries, cases were
HHS reports testing capacity of 80,000 tests per week
mostly linked to travel. In the 2022 outbreak, there is
through public health and CDC-designated commercial
significant person-to-person spread with no links to travel.
laboratories as of July 21, 2022. In 2018, CDC developed a
Clinical Presentation. Monkeypox usually begins with a
test that detects, but does not distinguish between, non-
fever, swollen lymph nodes, malaise, and headache.
variola orthopoxviruses (NVO), the genus that includes
Following this, patients develop a rash, which usually
monkeypox virus. This test received FDA clearance only
spreads throughout the body. In the 2022 outbreak, clinical
for use in the Laboratory Response Network that involves
presentations have varied widely among patients. Some
state, local, and federal laboratories. In June 2022, a new
report no fever or initial symptoms; some report smaller
clearance was issued allowing for expanded use of the test,
and more localized rashes. This may result in misdiagnosis
although its use is still “limited to Centers for Disease
and delays in testing.
Control and Prevention designated laboratories.” Positive
specimens are sent to CDC for characterization as
Scientists are still learning the specifics of this outbreak.
monkeypox virus (response activities begin with the
Researchers in Portugal found that the strain of monkeypox
orthopox result). Some clinical laboratories are also
virus causing the 2022 outbreak shows a significant number
developing laboratory-developed tests for monkeypox
of genetic mutations from the closest known strain detected
generally using CDC’s recently published non-variola PCR
in Nigeria in 2018-2019. Waning smallpox immunity in the
testing procedure. Separate from testing capacity, issues
population and changes in behavior following pandemic
have been reported with access to testing. CDC reports
restrictions may be contributing to this outbreak.
efforts to inform clinicians about test availability and
The majority of initial cases were reported among men who
referral.
have sex with men (MSM). However, MSM are not the
only population susceptible to the disease. Several countries
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U.S. Domestic Response to the 2022 Monkeypox Outbreak
Tracking, Surveillance, and Contact Tracing
clinical benefit. One of these medical countermeasures,
CDC has developed case definitions, or uniform clinical
Tecovirimat (TPOXX), has demonstrated effectiveness
criteria, for reporting monkeypox cases. Requirements for
against orthopoxviruses in animal studies, but there is
reporting monkeypox cases are under state and subfederal
limited efficacy data for its use in human monkeypox.
law. The Council of State and Territorial Epidemiologists
Clinical trials of TPOXX have shown minor side-effects in
voted to make monkeypox a nationally notifiable disease,
humans. These medical countermeasures can be requested
meaning there is formal consensus to collect state data and
by state and territorial health authorities from the CDC
report to CDC (reporting is voluntary). CDC advises that
Emergency Operations Center. The SNS has over 1.7
when an NVO test result returns positive, public health
million TPOXX courses available.
authorities should initiate contact tracing and investigation.
Selected Considerations for Congress
Medical Countermeasures: Vaccines and
Therapeutics
Funding
Vaccines. The Strategic National Stockpile (SNS) hosts
It is uncertain whether the President will submit a formal
two vaccines that may be used for monkeypox: JYNNEOS
supplemental appropriations request for the monkeypox
(which is FDA approved for both smallpox and
response. HHS agencies, such as CDC and APSR, are using
monkeypox) and ACAM2000 (which is FDA-indicated for
available appropriations to respond to the outbreak. CDC
smallpox, but is allowed for use against monkeypox under a
has access to an Infectious Diseases Rapid Response
CDC Expanded Access Investigational New Drug
Reserve Fund (IDRRRF), with funding available based on
protocol). While the SNS hosts a greater supply of
an HHS Secretarial determination of an infectious disease
ACAM2000, there are significant side effects associated
emergency (42 U.S.C. §247d-4a), which can be activated
with that vaccine; therefore, HHS has prioritized
without a PHE declaration. As of July 29, 2022, The
distribution of JYNNEOS. In addition to the existing
IDRRRF had a balance of $609 million. CDC can transfer
JYNNEOS doses stockpiled and scheduled to be distributed
the funding to ASPR and the National Institutes of Health.
over the first weeks of the response, HHS has announced
The PHE Declaration (42 U.S.C. §247d(b)) also activated a
the purchase of an additional 5 million JYNNEOS doses
Public Health Emergency Fund; that fund currently has a
(2.5 million on July 1 and 2.5 million on July 15), which
balance of $56,000.
are to be delivered at the end of 2022 through early 2023.
This would bring the total available supply of the vaccine to
Equity
6.9 million doses. As of August 4, 2022, ASPR had
Given that reported monkeypox cases have been
delivered over 602,000 doses of JYNNEOS to state, local,
concentrated among the MSM population, some have
tribal, and territorial jurisdictions.
expressed concern about potential stigmatization or
mischaracterization of the disease as sexually transmitted.
While the FDA determined the JYNNEOS vaccine is safe
Further, some have expressed equity concerns around
in humans, the efficacy trials relied on animal studies. Thus,
access to testing and the limited supply of vaccines. For
exactly how well it prevents monkeypox in humans remains
Coronavirus Disease 2019 (COVID-19) response, the
undetermined. Based on observational data from those who
federal government supported community-based testing and
received the JYNNEOS vaccine in Africa, CDC estimates
vaccination sites to target underserved populations. The
that the vaccine is 85% effective.
Government Accountability Office (GAO) has reviewed
State, tribal, territorial, and select local health jurisdictions
these efforts (GAO-22-104457). Congress might consider
are currently able to order vaccines through ASPR. The
lessons learned and whether to support similar programs for
ASPR sets a maximum number of doses available for order
the monkeypox response.
through an algorithm that takes into account variables such
as total population, at-risk population, case counts, and
Data Reporting
vaccine uptake. As circumstances change, ASPR may
CDC Director Rochelle Walensky has remarked that CDC
modify the algorithm. Authorities are permitted to
lacks authority to require data collection on monkeypox
redistribute their vaccines to other health jurisdictions,
cases. Instead, CDC relies on data shared by state and local
health care entities, and other appropriate recipients for
health departments. For COVID-19, Congress enacted a
administration to eligible populations.
federal laboratory reporting requirement on test results as a
part of the CARES Act (P.L. 116-136; §18115). Through
Currently, CDC recommends the use of available vaccines
guidance, HHS still mostly directed labs to report through
as pre-exposure prophylaxis (PrEP) for those whose jobs,
state and local channels. Separate data modernization
such as laboratory positions, could expose them to
efforts helped enable real-time reporting on COVID-19
orthopoxviruses. For the 2022 outbreak response, CDC also
results from laboratories to CDC. Congress may consider
recommends use of vaccines post-exposure (PEP) for
whether a similar reporting requirement for monkeypox is
certain individuals at high risk or are presumed exposed.
appropriate, and whether the data infrastructure for
Individual jurisdictions can set their own criteria for
COVID-19 can be leveraged for monkeypox response.
determining eligibility for their allocated vaccines.
Therapeutics. There are no therapeutic products
Taylor R. Wyatt, Analyst in Public Health Emergency
specifically indicated for use in monkeypox. CDC has
Management
identified some anti-viral and antibody medical
Kavya Sekar, Analyst in Health Policy
countermeasures for which evidence of efficacy for use in
Hassan Z. Sheikh, Analyst in Public Health Emergency
monkeypox is limited, but that may provide patients with
Management
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U.S. Domestic Response to the 2022 Monkeypox Outbreak

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