Morbidity and Mortality Weekly Report

Weekly / Vol. 73 / No. 16 April 25, 2024

Use of Ebola Vaccines — Worldwide, 2021–2023

Ruth Kallay, MPH1; Reena H. Doshi, PhD2; Pierre Muhoza, PhD1; Mary J. Choi, MD3; Anaïs Legand, MPH4; Emma Aberle-Grasse1;
Aminata Bagayoko, MD4; Terri B. Hyde, MD1; Pierre Formenty, DVM4; Alejandro Costa, MSc4

Abstract [Johnson & Johnson]) (2). ERVEBO was licensed by

Ebola virus disease (Ebola) is a rare but severe illness in the European Medicines Agency and the Food and Drug
humans, with an average case fatality rate of approximately Administration in 2019 and is indicated for use in persons aged
50%. Two licensed vaccines are currently available against >12 months (2,3). It has a shelf life of 3 years. The vaccine
Orthoebolavirus zairense, the virus that causes Ebola: the 1-dose has also been approved in Burundi, Central African Republic,
rVSVΔG-ZEBOV-GP (ERVEBO [Merck]) and the 2-dose Côte d’Ivoire, Democratic Republic of the Congo (DRC),
regimen of Ad26.ZEBOV and MVA-BN-Filo (Zabdeno/ Ghana, Guinea, Republic of the Congo, Rwanda, Sierra Leone,
Mvabea [Johnson & Johnson]). The Strategic Advisory Group Uganda, and Zambia (Merck regulatory department, personal
of Experts on Immunization recommends the use of 1-dose communication, December 6, 2023) (2). In 2021, the Strategic
ERVEBO during Ebola outbreaks, and in 2021, a global Advisory Group of Experts on Immunization recommended
stockpile of ERVEBO was established to ensure equitable, using ERVEBO in ring vaccination during Ebola outbreaks,
timely, and targeted access to vaccine doses for future Ebola because it confers protection after 1 dose (4). Zabdeno/Mvabea
outbreaks. This report describes the use of Ebola vaccines
and the role of the stockpile developed and managed by
the International Coordinating Group (ICG) on Vaccine INSIDE
Provision during 2021–2023. A total of 145,690 doses have
365 SARS-CoV-2 Viral Shedding and Rapid Antigen Test
been shipped from the ICG stockpile since 2021. However,
Performance — Respiratory Virus Transmission
because outbreaks since 2021 have been limited and rapidly Network, November 2022–May 2023
contained, most doses (139,120; 95%) shipped from the ICG 372 Investigation of Presumptive HIV Transmission
stockpile have been repurposed for preventive vaccination of Associated with Receipt of Platelet-Rich Plasma
high-risk groups, compared with 6,570 (5%) used for outbreak Microneedling Facials at a Spa Among Former Spa
response. Repurposing doses for preventive vaccination could Clients — New Mexico, 2018–2023
be prioritized in the absence of Ebola outbreaks to prevent 377 Use of an Additional Updated 2023–2024 COVID-19
transmission and maximize the cost-efficiency and benefits Vaccine Dose for Adults Aged ≥65 Years:
of the stockpile. Recommendations of the Advisory Committee on
Immunization Practices — United States, 2024
Introduction 382 Notes from the Field: Group A Streptococcus
Orthoebolavirus zairense, the virus responsible for Ebola Bacteremia in Persons Who Inject Drugs — Northern
virus disease (Ebola), has caused the largest filovirus outbreaks Vermont, January 2020–October 2023
worldwide; the average Ebola case fatality rate is approximately 385 QuickStats
50% (1). Currently, two licensed vaccines are recommended
for the prevention of Ebola caused by Orthoebolavirus zairense:
Continuing Education examination available at
the 1-dose rVSVΔG-ZEBOV-GP (ERVEBO [Merck]) and the https://www.cdc.gov/mmwr/mmwr_continuingEducation.html
2-dose Ad26.ZEBOV and MVA-BN-Filo (Zabdeno/Mvabea

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention
 Morbidity and Mortality Weekly Report

is recommended for preventive vaccination in areas at lower stockpile, ICG has approved requests for targeted preventive
risk for Ebola (or areas neighboring an outbreak) because the vaccination of high-risk groups, including health care workers
full regimen requires 2 doses administered 56 days apart (4). and frontline workers in countries at risk for Ebola outbreaks.
ERVEBO was shown to be safe and effective during clinical This report describes the use of Ebola vaccines and the role of
trials and has likely played an important role in limiting Ebola the ICG vaccine stockpile during 2021–2023.
morbidity and mortality during outbreaks since it was first
introduced (2). In a study conducted in Ebola treatment facili- Methods
ties in DRC, 56% of unvaccinated patients died from Ebola, Data on past Ebola outbreaks were obtained from the World
compared with 25% of patients vaccinated before symptom Health Organization (WHO) Regional Office for Africa’s
onset (5). Ensuring timely availability of Ebola vaccine doses weekly Outbreak and Emergencies situation reports (1).
in the event of a major Ebola outbreak is crucial to limiting Information on Ebola vaccine stockpile requests and deliveries
its spread and protecting global health security. during 2021–2023 was obtained from the ICG Secretariat.
In 2021, a global stockpile of ERVEBO was established Data on the stockpile size were obtained from UNICEF Supply
under the International Coordinating Group (ICG) on Vaccine Division’s ICG Ebola vaccine stockpile report dated January 19,
Provision to ensure equitable and timely access to vaccine doses 2024 (7). This activity was reviewed by CDC, deemed not
for Ebola outbreaks* (6). Upon the establishment of the ICG research, and was conducted consistent with applicable federal
stockpile, the global agreement was to maintain the stockpile law and CDC policy.†
at 500,000 doses (6). Gavi, the Vaccine Alliance (https://www.
gavi.org), supports the procurement of vaccine and operational Results
costs to countries for vaccination (6). Whereas the availability Ebola vaccine was first used during clinical trials in the
of doses for outbreak response is the primary objective of the 2014–2015 West African outbreak, then under a compas-
sionate use protocol in Guinea during 2015, and again in the
* The ICG Ebola vaccine stockpile is managed by the ICG on Vaccine Provision 2018–2020 eastern DRC outbreak. Since 2015, when Ebola
comprising Médecins sans Frontières, the International Federation of Red Cross vaccines were first deployed in outbreak response, recorded
and Red Crescent Societies, UNICEF, and the World Health Organization.
These organizations support maintenance and decisions regarding vaccine
allocations from the ICG on Vaccine Provision’s stockpile of Ebola vaccine. † 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect.
https://www.who.int/groups/icg/about 552a; 44 U.S.C. Sect. 3501 et seq.

The MMWR series of publications is published by the Office of Science, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human
Services, Atlanta, GA 30329-4027.
Suggested citation: [Author names; first three, then et al., if more than six.] [Report title]. MMWR Morb Mortal Wkly Rep 2024;73:[inclusive page numbers].
Centers for Disease Control and Prevention
Mandy K. Cohen, MD, MPH, Director
Debra Houry, MD, MPH, Chief Medical Officer and Deputy Director for Program and Science
Samuel F. Posner, PhD, Director, Office of Science

MMWR Editorial and Production Staff (Weekly)

Charlotte K. Kent, PhD, MPH, Editor in Chief Phyllis H. King, Symone Hairston, MPH,
Rachel Gorwitz, MD, MPH, Acting Executive Editor Acting Lead Health Communication Specialist Acting Lead Health Communication Specialist
Jacqueline Gindler, MD, Editor Alexander J. Gottardy, Maureen A. Leahy, Kiana Cohen, MPH,
Paul Z. Siegel, MD, MPH, Associate Editor Stephen R. Spriggs, Armina Velarde, Tong Yang, Leslie Hamlin, Lowery Johnson,
Mary Dott, MD, MPH, Online Editor Visual Information Specialists Health Communication Specialists
Terisa F. Rutledge, Managing Editor Quang M. Doan, MBA, Dewin Jimenez, Will Yang, MA,
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Glenn Damon, Jacqueline Farley, MS, Information Technology Specialists
Tiana Garrett, PhD, MPH, Ashley Morici,
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Technical Writer-Editors

MMWR Editorial Board

Timothy F. Jones, MD, Chairman
Matthew L. Boulton, MD, MPH David W. Fleming, MD Patrick L. Remington, MD, MPH
Carolyn Brooks, ScD, MA William E. Halperin, MD, DrPH, MPH Carlos Roig, MS, MA
Virginia A. Caine, MD Jewel Mullen, MD, MPH, MPA William Schaffner, MD
Jonathan E. Fielding, MD, MPH, MBA Jeff Niederdeppe, PhD Morgan Bobb Swanson, MD, PhD
Patricia Quinlisk, MD, MPH

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 Morbidity and Mortality Weekly Report

Ebola outbreaks have varied in frequency, size, and origin, with and frontline workers. Preventive vaccination campaigns have
recent outbreaks more often linked to reintroduction through targeted health care workers and frontline workers in at-risk
viral persistence§ (four of five outbreaks since 2021) than to countries, given their increased risk for exposure because
zoonotic spillover (Table 1). of their frequent contact with patients (8). The addition of
The ICG Ebola vaccine stockpile reached the goal of preventive Ebola vaccination of these workers could reduce
500,000 doses in 2022 and, as of December 2023, holds total cases, hospitalizations, and deaths in Ebola outbreaks by
518,890 doses. In total, 208,390 (40%) doses from the cur- an estimated 14%–38% compared with nonpharmaceutical
rent stockpile are scheduled to expire in 2024. Doses from interventions and ring vaccination alone (8).
the ICG stockpile were first deployed in 2021 in DRC for The variability of Ebola outbreak size and time to contain-
outbreak response. During 2021–2023, a total of 145,690 ment makes predicting future vaccine needs challenging.
ERVEBO doses were shipped through requests from the ICG Repurposing doses for preventive vaccination of targeted
stockpile. Among 11 requests to ICG during this period, 10 groups can protect high-risk persons as well as make use of
were approved or partially approved, and one request was doses with a shorter shelf life. More than 200,000 short–shelf-
declined¶ (Table 2). All requests to ICG for outbreak response life doses in the ICG stockpile due to expire in 2024 could be
(three of 11) were delivered within 1 week of being received. redirected for preventive vaccination. In addition to focusing
Longer times to delivery were noted for shipments intended on reactive (outbreak response) vaccination, early planning
for preventive vaccination because of the additional planning for preventive vaccination with short–shelf-life doses could
and engagement around those activities. be incorporated into future stockpile management strategies.
The number of doses shipped from the stockpile has increased Additional studies accounting for the variability in outbreak
annually, from 4,800 doses in 2021, to 13,870 doses in 2022, size could guide planning to maximize the cost-efficiency of
and 127,020 doses in 2023. During this period, 42,620 doses stockpile management.
expired. Most doses shipped (139,120; 95%) were repurposed The frequency of recent outbreaks, especially those linked to
for preventive vaccination. Five percent (6,570) of doses were viral persistence, highlights the need for innovative strategies to
shipped for outbreak response use. DRC has received the largest protect Ebola survivors and prevent reintroductions. One such
number of vaccine doses (111,000; 76%), followed by Uganda strategy is to offer postoutbreak immunization to close contacts
(23,460; 16%) and Guinea-Bissau (11,170; 8%). of survivors, including new sex partners and other groups at
risk for transmission because of viral persistence (9). Additional
Discussion
avenues to expand preventive vaccination among high-risk
The ICG stockpile provides equitable access to vaccines that populations could be explored in countries at risk for outbreaks.
can be shipped quickly in the event of an Ebola outbreak. The Demand-generation activities** incorporating findings from
relatively small number of doses used for outbreak response community engagement and vaccine acceptance studies in
(6,570; 5% of doses shipped) reflects the smaller size and rapid targeted risk groups could accompany vaccination campaigns
containment of Ebola outbreaks since 2021. North Kivu, and help develop targeted engagement plans. Investments and
DRC, has received and administered more doses than any advocacy for preventive vaccination against Ebola are crucial
other geographic area worldwide since 2018, which might have for health system preparedness and resiliency. Currently, Gavi,
contributed to the rapid containment of subsequent outbreaks WHO, and UNICEF are coordinating with other partners to
in that area (1). develop a learning agenda†† to help guide research prioritiza-
After approvals of vaccine for preventive use by ICG in tion and funding decisions for Ebola vaccine use.
2022, WHO, in early 2023, circulated an internal memo on
behalf of ICG informing at-risk countries of the availability Limitations
of vaccines for preventive vaccination of health care workers The findings in this report are subject to at least two limita-
tions. First, whereas the Ebola vaccine has reduced morbidity
§ Person-to-person transmission of Ebola virus that persisted in immunologically and mortality during outbreaks, the impact of Ebola vaccines
privileged sites (sites that are able to tolerate the introduction of antigen without on preventing outbreaks is difficult to ascertain because of the
eliciting an inflammatory immune response, including the eyes, placenta, fetus,
testicles, and central nervous system) or body fluids after recovery from acute
infection in humans, in contrast to outbreaks originating from zoonotic spillover, ** Activities that aim to increase public awareness of and coverage with the
which is the transmission of virus from an animal to a human. vaccine and might include public education campaigns, health care worker
¶ The request to ICG that was not approved lacked justification that the security education and engagement, community outreach, targeted messaging to
forces to be vaccinated were involved in Ebola outbreak response and were at high-risk groups, and increased access to the vaccine.
risk. ICG invited the country to resubmit the application prioritizing staff †† A set of prioritized vaccine implementation research questions and activities
members involved in Ebola response activities. to guide evidence-building and decision-making around the Ebola vaccine.

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 Morbidity and Mortality Weekly Report

TABLE 1. Characteristics of reported Ebola virus disease outbreaks — World Health Organization, African Region, 2014–2023*
Total no. of Total no. of deaths
Start date–end date cases (CFR, %) Country or countries Region/Province Origin
Mar 23, 2014–Jun 10, 2016 28,610 11,308 (40) Guinea, Liberia, and NA Zoonotic spillover
Sierra Leone
Jul 23–Oct 20, 2014 20 8 (40) Nigeria Lagos Human transmission from
West Africa outbreak
Jul 26–Nov 21, 2014 69 49 (71) DRC Equateur Zoonotic Spillover
Aug 23–Oct 17, 2014 8 6 (75) Senegal Dakar Human transmission from
West Africa outbreak
Oct 23–Dec 6, 2014 1 0 (—) Mali Bamako and Kayes Human transmission from
West Africa outbreak
May 11–Jul 2, 2017 8 4 (50) DRC Bas Uele Zoonotic spillover
May 8–Jul 24, 2018 54 33 (61) DRC Equateur Zoonotic spillover
Jun 1–Nov 18, 2020 130 55 (42) DRC Equateur Zoonotic spillover and
viral persistence
Aug 1, 2018–Jun 25, 2020 3,470 2,287 (66) DRC and Uganda North Kivu, South Kivu, Zoonotic spillover
and Ituri
Feb 7–May 3, 2021 12 6 (50) DRC North Kivu Viral persistence
Feb 14–Jun 19, 2021 23 12 (52) Guinea N’Zérékoré Viral persistence
Oct 8–Dec 16, 2021 11 9 (82) DRC North Kivu Viral persistence
Apr 23–Jul 4, 2022 5 5 (100) DRC Equateur Zoonotic spillover†
Aug 22–Sep 27, 2022 1 1 (100) DRC North Kivu Viral persistence§
Abbreviations: CFR = case fatality rate; DRC = Democratic Republic of the Congo; NA = not applicable.
* Outbreak data obtained from the World Health Organization Regional Office for Africa weekly Outbreak and Emergencies situation reports was compared with data
from CDC available online. https://www.cdc.gov/vhf/ebola/history/chronology.html (Accessed January 9, 2024).
† Zoonotic spillover is the transmission of virus from an animal to a human.
§ Person-to-person transmission of Ebola virus from virus that persisted in immunologically privileged sites (sites that are able to tolerate the introduction of antigen
without eliciting an inflammatory immune response, including the eyes, placenta, fetus, testicles, and central nervous system) or body fluids after recovery from
acute infection.

TABLE 2. Requests to the International Coordinating Group on Vaccine Provision for Ebola vaccine deliveries from global stockpile, by country
and year — worldwide, 2021–2023
No. of doses No. of doses Days from request
Country Year requested shipped Vaccination strategy Target groups to delivery Approval status
DRC 2021 4,800 4,800 Outbreak response Ring vaccination 6 Approved
2022 1,570 1,770 Outbreak response Ring vaccination 7 Approved
2022 962 962* Outbreak response Ring vaccination 2 Approved
2023 75,000 21,670 Preventive campaign Frontline workers† 20 Approved
2023 82,647 82,760 Preventive campaign Frontline workers 30 Approved
Uganda 2022 12,000 12,060 Preventive campaign Frontline workers 25 Approved
2023 17,096 11,400 Preventive campaign Frontline workers and 118 Partially approved
security forces
Guinea-Bissau 2023 10,963 11,170 Preventive campaign Health care and frontline 48 Approved
workers and support
staff members
Switzerland 2022 40 40 Preventive campaign International frontline workers 0 Approved
2023 20 20 Preventive campaign International frontline workers 0 Approved
Kenya 2022 2,000 0 Preventive campaign Security forces NA Not approved§

Abbreviations: DRC = Democratic Republic of the Congo; ICG = International Coordinating Group; NA = not applicable.
* Doses shifted from Equateur province to North Kivu province in DRC from previously shipped doses approved by ICG.
† Frontline workers are generally considered to be personnel directly involved in essential, public-facing roles related to health services or outbreak response; countries
might define this group differently.
§ The request to ICG that was not approved lacked justification that the security forces to be vaccinated were involved in Ebola outbreak response and were at risk.
ICG invited the country to resubmit the application prioritizing staff members involved in Ebola response activities.

infrequent occurrence of the disease. Second, important data Implications for Public Health Practice
are lacking regarding the duration of protection, vaccine effec- The availability of licensed Ebola vaccines is an important
tiveness in outbreak situations, and the need for booster doses. advancement in Ebola prevention and global health security. In
These data will be needed to guide decision-making regarding the absence of large-scale outbreaks, the demand for vaccines
vaccination strategies and should be a focus for future research. lags behind the current supply of doses, and preventive vac-
cination could be considered for high-risk groups. Investments,

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 Morbidity and Mortality Weekly Report

References
Summary
1. World Health Organization Regional Office for Africa. Outbreaks
What is already known about this topic? and Emergencies Bulletin. Cité du Djoué, Brazzaville, Republic of
The International Coordinating Group on Vaccine Provision the Congo: World Health Organization Regional Office for Africa;
established an Ebola vaccine stockpile in 2021 to ensure 2024. https://www.afro.who.int/health-topics/disease-outbreaks/
equitable, rapid access to vaccines during an outbreak. outbreaks-and-other-emergencies-updates?page=0
2. World Health Organization. Ebola virus disease vaccines. Geneva,
What is added by this report? Switzerland: World Health Organization; 2023. https://www.who.int/
Since 2021, the absence of large Ebola virus disease (Ebola) news-room/questions-and-answers/item/ebola-vaccines
outbreaks has resulted in fewer vaccine doses being used for 3. Merck. U.S. FDA approves Merck’s ERVEBO (Ebola Zaire Vaccine, Live)
outbreak response. Out of the 145,690 doses shipped from the for use in children 12 months of age and older. [Press release]. Rahway, NJ:
Merck; 2023. https://www.merck.com/news/u-s-fda-approves-mercks-
stockpile through 2023, 95% (139,120) have been repurposed
ervebo-ebola-zaire-vaccine-live-for-use-in-children-12-months-of-age-
for preventive vaccination, and 5% (6,570) were used in and-older/
outbreak response. 4. World Health Organization. Meeting of the Strategic Advisory Group
What are the implications for public health practice? of Experts on Immunization, 22–24 March 2021: conclusions and
recommendations. Geneva, Switzerland: World Health Organization;
Repurposing doses for preventive vaccination could be 2021. https://www.who.int/publications/i/item/meeting-of-the-strategic-
prioritized in the absence of Ebola outbreaks to prevent advisory-group-of-experts-on-immunization-22-24-march-2021-
transmission and maximize the cost-efficiency and benefits of conclusions-and-recommendations
the stockpile. 5. Coulborn RM, Bastard M, Peyraud N, et al. Case fatality risk among
individuals vaccinated with rVSVΔG-ZEBOV-GP: a retrospective cohort
analysis of patients with confirmed Ebola virus disease in the Democratic
advocacy, and additional research to inform preventive vaccina- Republic of the Congo. Lancet Infect Dis 2024. Epub February 7, 2024.
tion are crucial for health system preparedness and resiliency. PMID:38340736 https://doi.org/10.1016/S1473-3099(23)00819-8
Focus on working with countries at risk for Ebola outbreaks to 6. Gavi, The Vaccine Alliance. 500,000 doses of Ebola vaccine to be made
available to countries for outbreak response. Geneva, Switzerland: Gavi,
identify high-risk groups and generate demand for preventive The Vaccine Alliance; 2021. https://www.gavi.org/ne ws/
vaccination is important for optimizing the use of the stockpile. media-room/500000-doses-ebola-vaccine-be-made-available-countries-
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Africa, Brazzaville, Republic of the Congo; 3Division of High-Consequence vaccine.2022.11.036
Pathogens and Pathology, National Center for Emerging and Zoonotic 9. Doshi RH, Fleming M, Mukoka AK, et al. Vaccination of contacts of
Infectious Diseases, CDC; 4Viral Hemorrhagic Fevers team, Health Emergencies Ebola virus disease survivors to prevent further transmission. Lancet Glob
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All authors have completed and submitted the International S2214-109X(20)30454-X
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conflicts of interest. No potential conflicts of interest were disclosed.

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 Morbidity and Mortality Weekly Report

SARS-CoV-2 Viral Shedding and Rapid Antigen Test Performance —

Respiratory Virus Transmission Network, November 2022–May 2023
Sarah E. Smith-Jeffcoat, MPH1; Alexandra M. Mellis, PhD2; Carlos G. Grijalva, MD3; H. Keipp Talbot, MD3; Jonathan Schmitz, MD, PhD3;
Karen Lutrick, PhD4; Katherine D. Ellingson, PhD4; Melissa S. Stockwell, MD5,6,7; Son H. McLaren, MD8; Huong Q. Nguyen, PhD9;
Suchitra Rao, MBBS10; Edwin J. Asturias, MD10; Meredith E. Davis-Gardner, PhD11; Mehul S. Suthar, PhD11; Hannah L. Kirking, MD1;
RVTN-Sentinel Study Group

Abstract Authorization early during the COVID-19 pandemic.* These

As population immunity to SARS-CoV-2 evolves and new tests were initially rolled out broadly in the United States to
variants emerge, the role and accuracy of antigen tests remain diagnose cases and isolate persons who received positive test
active questions. To describe recent test performance, the detec- results to aid in preventing onward spread at a time when
tion of SARS-CoV-2 by antigen testing was compared with that population SARS-CoV-2 immunity was low, and rates of
by reverse transcription–polymerase chain reaction (RT-PCR) severe COVID-19–associated outcomes were high. In addition,
and viral culture testing during November 2022–May 2023. demands for testing exceeded supply, and long turnaround times
Participants who were enrolled in a household transmission for reverse transcription–polymerase chain reaction (RT-PCR)
study completed daily symptom diaries and collected two test results contributed to ongoing transmission. Wide access
nasal swabs (tested for SARS-CoV-2 via RT-PCR, culture, and to antigen tests was made possible through U.S. government
antigen tests) each day for 10 days after enrollment. Among initiatives implemented to prevent transmission.†,§ After the
participants with SARS-CoV-2 infection, the percentages of emergence of the Omicron variant in late 2021, at-home antigen
positive antigen, RT-PCR, and culture results were calculated test use began to increase sharply (1,2).
each day from the onset of symptoms or, in asymptomatic Studies conducted during circulation of SARS-CoV-2 pre-
persons, from the date of the first positive test result. Antigen Delta and Delta variants illustrated that antigen tests have
test sensitivity was calculated using RT-PCR and viral culture high specificity, but lower sensitivity when compared with
as references. The peak percentage of positive antigen (59.0%) RT-PCR tests, thereby missing a substantial number of infec-
and RT-PCR (83.0%) results occurred 3 days after onset, and tions but correlating more closely with viral culture results
the peak percentage of positive culture results (52%) occurred (3–6). Viral culture, although not frequently used for routine
2 days after onset. The sensitivity of antigen tests was 47% patient care, is able to detect actively replicating virus (thus
(95% CI = 44%–50%) and 80% (95% CI = 76%–85%) using identifying when a person is likely to be infectious), whereas
RT-PCR and culture, respectively, as references. Clinicians RT-PCR cannot distinguish between replicating virus and viral
should be aware of the lower sensitivity of antigen testing fragments. Most of these studies included few participants
compared with RT-PCR, which might lead to false-negative with vaccine- or infection-induced immunity. SARS-CoV-2
results. This finding has implications for timely initiation variants and population immunity have evolved since many
of SARS-CoV-2 antiviral treatment, when early diagnosis is of the studies assessing antigen tests were performed; thus, the
essential; clinicians should consider RT-PCR for persons for role that antigen tests should play in diagnosing SARS-CoV-2
whom antiviral treatment is recommended. Persons in the infection remains an active question. The objective of this
community who are at high risk for severe COVID-19 illness investigation was to reevaluate the performance characteristics
and eligible for antiviral treatment should seek testing from of SARS-CoV-2 antigen tests with those of RT-PCR and viral
health care providers with the goal of obtaining a more sensi- culture tests during a period with greater population immunity
tive diagnostic test than antigen tests (i.e., an RT-PCR test). and more recently circulating SARS-CoV-2 Omicron variants.

* h t t p s : / / w w w. f d a . g o v / n e w s - e v e n t s / p r e s s - a n n o u n c e m e n t s /
Introduction coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-
SARS-CoV-2 rapid antigen tests were developed and detection-virus-causes
† https://www.covid.gov/tools-and-resources/resources/tests
received Food and Drug Administration Emergency Use § https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-
for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf

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 Morbidity and Mortality Weekly Report

Methods Among participants who ever received a positive RT-PCR

This evaluation included participants enrolled in an antigen test result and had one or more paired RT-PCR and antigen
test substudy within a case-ascertained household transmission results reported, the percentage of positive antigen, RT-PCR,
study during November 2022–May 2023¶ (7). Index patients and viral culture results was calculated for each day relative
with confirmed SARS-CoV-2 infection and their household to onset. The percentage of positive antigen test results was
contacts were enrolled within 7 days of illness onset in the index stratified by symptom and fever status. Sensitivity of antigen
patient. Participants completed baseline surveys including testing among paired samples collected from 2 days before
demographic characteristics, COVID-19 signs or symptoms until 10 days after onset was computed using two references:
(symptoms),** vaccination,†† and self-reported previous infec- 1) same-day positive RT-PCR result and 2) same-day positive
tion. Participants (index patients and contacts) also provided a culture result, stratified by overall symptom status and pres-
blood specimen for SARS-CoV-2 anti-N antibody detection§§ ence of fever alone or fever or cough. Wilson score intervals
(8,9). For 10 days after enrollment, all participants completed were used for calculating 95% CIs around percentage of
daily COVID-19 symptom diaries and collected two nasal positive test results. Cluster-robust bootstrapping was used to
swabs each day. One swab was self-collected in viral transport calculate 95% CIs around sensitivity to account for within-
media, stored in refrigerator for up to 72 hours, then collected participant correlation. All analyses were performed in RStudio
by a study team member and stored at −12°F (−80°C) until (version 4.2.3; RStudio). This study was reviewed and approved
aliquoted for automated RT-PCR (Hologic Panther Fusion)¶¶ by the Vanderbilt University Institutional Review Board.§§§
and viral culture,*** and the other swab was used for at-home
antigen testing.††† Participants interpreted and reported their Results
antigen test results in their daily symptom diary. For this analy- Characteristics of Study Participants
sis, SARS-CoV-2 infection was defined as at least one positive Among 354 participants in 129 households, 236 (67%)
RT-PCR test result during the study period; onset was defined received a positive SARS-CoV-2 RT-PCR test result and
as the first day of symptoms or, if the participant remained were included in this investigation (Table). Participants
asymptomatic, day of first positive test result. ranged in age from 2 months to 83 years (median = 36 years;
IQR = 17–50 years), 133 (56%) were non-Hispanic White
¶ The Respiratory Virus Transmission Network sites that participated in the persons, and 140 (59%) were female. Ninety-two (40%) par-
antigen substudy were located in Arizona, Colorado, New York, Tennessee, ticipants reported receipt of a COVID-19 vaccine ≤12 months
and Wisconsin. Persons who received test results positive for SARS-CoV-2
were recruited from participating medical centers, community testing sites, before enrollment; 82 (35%) had received ≥2 doses, but the
actively surveilled cohorts, and public health registries at five sites. most recent dose was >12 months before enrollment; 57 (24%)
** Elicited COVID-19 symptoms included fever (including feeling feverish
and chills), cough, sore throat, runny nose, nasal congestion, fatigue
were unvaccinated (including those who had only ever received
(including feeling run-down), wheezing, trouble breathing (including 1 dose); and vaccination status was unknown for five par-
shortness of breath), chest tightness (including chest pain), loss of smell or ticipants. A total of 102 (43%) participants had self-reported
loss of taste, headache, abdominal pain, diarrhea, vomiting, and muscle or
body aches. or serologic evidence of previous SARS-CoV-2 infection. At
†† Vaccination history was self-reported and then verified by study team using least one COVID-19 symptom was reported by 219 (93%)
state vaccination registries, electronic medical records, and pharmacy records. participants, including 182 (77%) who reported cough and
§§ Detection of antinucleocapsid antibodies from a dried blood spot collected
at baseline was considered serological evidence of previous SARS-CoV-2 156 (66%) who reported fever.
infection. Simultaneous detection and differentiation of total binding
antibody (immunoglobulin [Ig]M, IgG, and IgA) to SARS-CoV-2 2019- SARS-CoV-2 Test Results
nCoV WHU02 strain nucleocapsid protein, Wuhan-Hu-1 strain spike
protein receptor binding domain, and Wuhan-Hu-1 strain spike protein Among the 236 SARS-CoV-2–infected participants (i.e.,
trimer in capillary (finger stick) dried blood was performed using the those who received a positive RT-PCR test result), 2,244 anti-
ProcartaPlex Immunoassay multiplex custom panel (Invitrogen) deployed
on the MAGPIX System (Luminex).
gen results were reported and included in analyses. Overall,
¶¶ RT-PCR results were interpreted as categorically positive or negative 143 (61%) participants received one or more positive culture
according to the FDA-authorized parameters of the Hologic Panther Fusion result, and 164 (69%) received one or more positive antigen
SARS-CoV-2 assay, as utilized for in vitro diagnostic purposes. https://www.
fda.gov/media/136156/download?attachment test result.
*** Viral culture was performed on Vero E6 cells expressing both ACE2 and The highest percentage of positive antigen (59%;
TMPRSS2. Cells were infected with serial dilutions of virus in Dulbecco’s 95% CI = 51%–67%) and RT-PCR (83%; 95% CI = 76%–88%)
Modified Eagle Medium (DMEM) containing ciprofloxacin, and cytopathic
effect (CPE) was visually observed during a period of 5 days. Observation test results occurred 3 days after onset (Figure 1). The
of CPE was considered positive for viral culture.
††† Quidel QuickVue At-Home COVID-19 Test (available as over-the-counter). §§§ 45 C.F.R. part 46.114; 21 C.F.R. part 56.114.
https://www.fda.gov/media/146312/download

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 Morbidity and Mortality Weekly Report

TABLE. Characteristics of participants infected with SARS-CoV-2* highest percentage of positive viral culture results (52%;
(N = 236) — Respiratory Virus Transmission Network, November 95% CI = 43%–61%) occurred 2 days after onset. Among
2022–May 2023
the 219 symptomatic participants, the highest percentage of
Characteristic No. (%)
positive antigen test results was 65% (95% CI = 57%–73%)
Age at enrollment, yrs, median (IQR) 36 (17–50)
at 3 days after onset among those who experienced any
Age group, yrs
0–4 22 (9) COVID-19 symptom and 80% (95% CI = 68%–88%) at
5–11 15 (6) 2 days after onset among those who reported fever.
12–17 23 (10)
18–49 114 (48)
50–64 44 (20)
Sensitivity of Antigen Testing
≥65 18 (7) Compared with same-day collected RT-PCR and culture
Gender results, the overall sensitivities of daily antigen test results were
Female 140 (59)
Male 95 (40)
47% (95% CI = 44%–50%) and 80% (95% CI = 76%–85%),
Nonbinary/Transgender 1 (<1) respectively (Figure 2) (Supplementary Table, https://stacks.
Race and ethnicity† cdc.gov/view/cdc/153544). When stratified by symptoms
Black or African American 17 (7) experienced on the day of specimen collection, antigen test
White 133 (57)
Hispanic or Latino 69 (29) sensitivity increased with occurrence of any COVID-19 symp-
Other 14 (6) toms (56% and 85% compared with RT-PCR and culture,
Unknown/Refused 3 (1)
respectively) and peaked on days that fever was reported (77%
SVI, median (IQR)§ 0.43 (0.19–0.80)
Any chronic medical condition 110 (47)
and 94% compared with RT-PCR and culture, respectively).
Vaccination status¶
Compared with RT-PCR and culture results, sensitivity of
Unvaccinated 57 (24) antigen testing was low on days when no symptoms were
Vaccinated >12 mos before enrollment 82 (35) reported (18% and 45%, respectively).
Vaccinated ≤12 mos before enrollment 92 (40)
Unknown 5 (<1)
Any previous SARS-CoV-2 infection** 102 (43) Discussion
Any COVID-19 symptoms†† 219 (93) Among participants enrolled in a household transmission
Any cough 182 (77)
Any fever 156 (66)
study during a period of increased disease- and vaccine-induced
One or more positive viral cultures 143 (61) immunity, and when circulating viruses differed antigenically
One or more positive antigen tests 164 (69) from the ancestral SARS-CoV-2 strain, antigen and culture
Abbreviations: RT-PCR = reverse transcription–polymerase chain reaction; tests detected a similar proportion of SARS-CoV-2 infections,
SVI = social vulnerability index.
* SARS-CoV-2 infection defined as having received at least one positive RT-PCR
but detection by RT-PCR was higher than that by either
result during study testing. antigen or culture. Similarly, paired antigen test sensitivity
† Persons of Hispanic or Latino (Hispanic) origin might be of any race but are
was low compared with RT-PCR (47%), but relatively high
categorized as Hispanic; all racial groups are non-Hispanic.
§ SVI was determined using the 2020 U.S. Census Bureau decennial tract compared with culture (80%). The sensitivity of antigen testing
location of the home. SVI uses 16 census variables to indicate the relative was higher when symptoms were present on the test day and
vulnerability of every census tract to a hazardous event with values closer to
1 representing highly vulnerable areas and values closer to 0 representing peaked on days when participants reported fever. Although
least vulnerable areas.
¶ Vaccination history was self-reported and then verified by study team.
viral culture is not an absolute marker of transmissibility, this
Participants were considered vaccinated within 12 months before enrollment pattern suggests that positive antigen test results could indicate
if they had received ≥2 doses and the most recent dose was received between transmissible virus; thus, antigen tests might aid persons with
14 days and 12 months before enrollment; vaccinated >12 months before
enrollment if they had received ≥2 doses and the most recent dose was
COVID-19 in determining when they are no longer infectious
received >12 months before enrollment; and unvaccinated if they received once symptoms begin to resolve.
<2 doses before enrollment. The findings from this investigation remain similar to those
** By self-report or serologic evidence. Previous SARS-CoV-2 infection was
defined as self-report of a previous infection ≥1 month before enrollment or reported in other studies throughout the COVID-19 pandemic
by detection of antinucleocapsid antibodies from a dried blood spot collected (3–6). For example, considering the current study’s sensitivity
at baseline.
†† Elicited COVID-19 signs and symptoms included fever (including feeling results, an early 2021 study comparing antigen testing with
feverish or chills), cough, sore throat, runny nose, nasal congestion, fatigue RT-PCR and culture found similar antigen test sensitivity
(including feeling run-down), wheezing, trouble breathing (including
shortness of breath), chest tightness (including chest pain), loss of smell or compared with culture (84%), but slightly higher sensitivity
loss of taste, headache, abdominal pain, diarrhea, vomiting, and muscle or compared with RT-PCR (64%) (3). The sensitivity differ-
body aches.
ence between these two studies could be attributed to many

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 Morbidity and Mortality Weekly Report

FIGURE 1. Percentage* of rapid antigen, reverse transcription–polymerase chain reaction, and viral culture test results that were positive for
SARS-CoV-2 (A) and percentage of antigen test results that were positive, by symptom status† (B) and presence of fever (C) each day since
onset§ among participants infected with SARS-CoV-2¶ — Respiratory Virus Transmission Network, November 2022–May 2023

A. 100
RT-PCR
90
Culture
80 Antigen
Percentage positive 70
60
50
40
30
20
10
0
−3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Days since onset
B. 100
90
Asymptomatic
80
Percentage positive

Symptomatic
70
60
50
40
30
20
10
0
−3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Days since onset
C. 100
90
Ever had fever
80 Never had fever
Percentage positive

70
60
50
40
30
20
10
0
−3 −2 −1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Days since onset

Abbreviation: RT–PCR = reverse transcription–polymerase chain reaction.

* With 95% CIs indicated by shaded areas.
† Elicited COVID-19 signs and symptoms included fever (including feeling feverish or chills), cough, sore throat, runny nose, nasal congestion, fatigue (including feeling
run-down), wheezing, trouble breathing (including shortness of breath), chest tightness (including chest pain), loss of smell or loss of taste, headache, abdominal
pain, diarrhea, vomiting, and muscle or body aches.
§ Date of symptom onset or, for asymptomatic persons, date of first positive test result.
¶ SARS-CoV-2 infection defined as having received at least one positive RT-PCR test result during study testing.

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 Morbidity and Mortality Weekly Report

factors, including differences in participant immunity, infect-

Summary
ing variants, the limit of detection of the reference RT-PCR,
What is already known about this topic?
or sampling methods.
During the COVID-19 pandemic, rapid antigen tests were found
Minimizing false negative test results is important because
to detect potentially transmissible SARS-CoV-2 infection, but
additional modalities, including antiviral medications, are antigen tests were less sensitive than reverse transcription–
available to prevent severe outcomes. Antiviral treatments for polymerase chain reaction (RT-PCR) testing.
SARS-CoV-2 infection should be started as soon as possible, What is added by this report?
and within 5–7 days of symptom onset.¶¶¶ Therefore, persons During November 2022–May 2023, among persons infected
who are at higher risk for severe illness and eligible for antiviral with SARS-CoV-2, sensitivity of rapid antigen tests was 47%
treatment would benefit from a more accurate diagnostic test. compared with RT-PCR and 80% compared with viral culture.
In most clinical scenarios in the United States, this approach Antigen tests continue to detect potentially transmissible
means a SARS-CoV-2 RT-PCR test would be a better diagnostic infection but miss many infections identified by positive
RT-PCR test results.
test to minimize the risk for a false-negative result. Alternatively,
if RT-PCR tests are not available or accessible, clinicians and What are the implications for public health practice?
patients should follow FDA’s serial antigen testing recommenda- Rapid antigen tests can aid in identifying infectiousness of
persons infected with SARS-CoV-2 and providing access to
tions to help optimize diagnostic test performance.****
diagnostic testing for persons with COVID-19 symptoms.
Persons in the community eligible for antiviral treatment should
Limitations seek more sensitive diagnostic tests from a health care provider.
The findings in this report are subject to at least three Clinicians should consider RT-PCR testing for persons for whom
limitations. First, participants included in this analysis might antiviral treatment is recommended.
not represent all U.S. persons infected with SARS-CoV-2 and
represent those with mild to moderate illness. These findings tests compared with RT-PCR tests has implications for timely
might not apply to persons with more severe COVID-19 initiation of anti–SARS-CoV-2 treatment when early and
illness. Second, one commercially available antigen test was accurate diagnosis is important. With several treatment options
used in this study; results might not apply to all available available, clinicians should consider more sensitive RT-PCR
antigen tests. Finally, because of the parent study design, onset tests for accurate diagnosis in persons at higher risk for severe
for asymptomatic participants (i.e., the day of the first positive illness to minimize delays in treatment initiation. Persons in the
test result), could be biased if household members were not community who are at high risk for severe COVID-19 illness
enrolled early enough to record the earliest positive test result. and eligible for antiviral treatment should seek testing from
health care providers with the goal of obtaining a more sensi-
Implications for Public Health Practice tive diagnostic test than antigen tests (i.e., an RT-PCR test).
As COVID-19 becomes endemic and public focus shifts
from stopping transmission to preventing severe illness,†††† Acknowledgments
diagnostic testing should emphasize use of the best tests to Supraja Malladi, CDC; Erica Anderson, Marcia Blair, Jorge
identify infection in persons who would benefit from treat- Celedonio, Daniel Chandler, Brittany Creasman, Ryan Dalforno,
ment. The low sensitivity of antigen testing among persons Kimberly Hart, Andrea Stafford Hintz, Judy King, Christopher
with asymptomatic infections illustrates that these tests should Lindsell, Zhouwen Liu, Samuel Massion, Rendie E. McHenry,
only be used once symptoms are present. Conversely, the higher John Meghreblian, Lauren Milner, Catalina Padilla-Azain, Bryan
sensitivity when symptoms are present (especially cough or Peterson, Suryakala Sarilla, Brianna Schibley-Laird, Laura Short,
fever) supports the need to stay at home when symptomatic, Ruby Swaim, Afan Swan, His-nien Tan, Timothy Williams, Paige
Yates, Vanderbilt University Medical Center; Hannah Berger,
irrespective of test result.§§§§ The low sensitivity of antigen
Brianna Breu, Gina Burbey, Leila Deering, DeeAnn Hertel, Garrett
Heuer, Sarah Kopitzke, Carrie Marcis, Jennifer Meece, Vicki Moon,
¶¶¶ https://www.cdc.gov/coronavirus/2019-ncov/your-health/treatments-for- Jennifer Moran, Miriah Rotar, Carla Rottscheit, Elisha Stefanski,
severe-illness.html
**** https://www.fda.gov/medical-devices/safety-communications/ Sandy Strey, Melissa Strupp, Murdoch Children’s Research Institute;
home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative- Lisa Saiman, Celibell Y Vargas, Anny L. Diaz Perez, Ana Valdez
results-fda-safety de Romero, Raul A. Silverio Francisco, Columbia University.
†††† https://www.cdc.gov/respiratory-viruses/whats-new/changing-threat-
covid-19.html
§§§§ https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html

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 Morbidity and Mortality Weekly Report

FIGURE 2. Sensitivity* of rapid antigen tests results for diagnosing SARS-CoV-2 infection compared with reverse transcription–polymerase
chain reaction (A) and viral culture (B), overall and by presence of symptoms† — Respiratory Virus Transmission Network, November 2022–
May 2023

A. Compared with RT-PCR

Overall

Symptomatic

Cough or fever

Fever

Asymptomatic

0 20 40 60 80 100
Sensitivity, %

B. Compared with culture

Overall

Symptomatic

Cough or fever

Fever

Asymptomatic

0 20 40 60 80 100

Sensitivity, %

Abbreviation: RT–PCR = reverse transcription–polymerase chain reaction.

* With 95% CIs indicated by error bars.
† Elicited COVID-19 signs and symptoms included fever (including feeling feverish or chills), cough, sore throat, runny nose, nasal congestion, fatigue (including feeling
run-down), wheezing, trouble breathing (including shortness of breath), chest tightness (including chest pain), loss of smell or loss of taste, headache, abdominal
pain, diarrhea, vomiting, and muscle or body aches.

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 Morbidity and Mortality Weekly Report

RVTN-Sentinel Study Group References

Melissa A. Rolfes, National Center for Immunization and 1. Qasmieh SA, Robertson MM, Rane MS, et al. The importance of
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Vanderbilt University Medical Center, Nashville, Tennessee; Karla org/10.2196/38196
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Doris Duke Charitable Foundation COVID-19 Fund to Retain
Clinician-Scientists. Suchitra Rao reports grant support from
Biofire. Melissa S. Stockwell reports institutional support from the
University of Washington, Boston Children’s Hospital, Westat, and
New York University, and service as the Associate Director of the
American Academy of Pediatrics Pediatric Research in Office Settings
Research Network (payment to the trustees of Columbia University).
Huong Q. Nguyen reports research support from CSL Seqirus,
GSK, and ModernaTX, and an honorarium from ModernaTX for
participating in a consultancy group, outside the submitted work.
No other potential conflicts of interest were disclosed.

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 Morbidity and Mortality Weekly Report

Investigation of Presumptive HIV Transmission Associated with

Receipt of Platelet-Rich Plasma Microneedling Facials at a Spa
Among Former Spa Clients — New Mexico, 2018–2023
Anna M. Stadelman-Behar, PhD1,2,3; Mika N. Gehre, PhD2; Liana Atallah, MD4; Tegan Clarke, MD4; Ana-Alicia Leonso, MD4; Francella Jojola5;
HaoQiang Zheng, PhD3; Hongwei Jia, PhD3; Sheryl B. Lyss, MD3; William M. Switzer, MPH3; Scott P. Grytdal, MPH3; Miranda Durham, MD5;
N. Mariam Salas, MBBCh4; Marla Sievers, MPH2; Chad Smelser, MD2

Abstract test result after the patient’s diagnosis. However, the patient
HIV transmitted through cosmetic injection services via did report exposure to needles during a platelet-rich plasma
contaminated blood has not been previously documented. (PRP) microneedling procedure in spring 2018 at spa A in
During summer 2018, the New Mexico Department of Health New Mexico. The procedure involves drawing a client’s blood,
(NMDOH) was notified of a diagnosis of HIV infection in a separating the blood into its components of plasma and cells,
woman with no known HIV risk factors who reported exposure and using single-use disposable or multiuse sterile equipment
to needles from cosmetic platelet-rich plasma microneedling to inject the PRP into the face for cosmetic purposes, such as
facials (vampire facials) received at a spa in spring 2018. An skin rejuvenation and reducing the appearance of acne scars (1).
investigation of the spa’s services began in summer 2018, and
NMDOH and CDC identified four former spa clients, and Investigation and Results
one sexual partner of a spa client, all of whom received HIV NMDOH and CDC investigated cosmetic injection services
infection diagnoses during 2018–2023, despite low reported as a possible transmission route for HIV. The period for active
behavioral risks associated with HIV acquisition. Nucleotide case finding was from spring 2018, when the initial patient
sequence analysis revealed highly similar HIV strains among received the procedure, to fall 2018 when spa A closed. Spa A’s
all cases. Although transmission of HIV via unsterile injection owner operated without appropriate licenses at multiple loca-
practices is a known risk, determining novel routes of HIV tions and did not have an appointment scheduling system that
transmission among persons with no known HIV risk factors stored client contact information. Investigators compiled and
is important. This investigation identified an HIV cluster cross-referenced names and telephone numbers from spa A
associated with receipt of cosmetic injection services at an client consent forms, handwritten appointment records, and
unlicensed facility that did not follow recommended infec- telephone contacts to create a list of potentially affected clients.
tion control procedures or maintain client records. Requiring The investigative team was not permitted to collect specimens
adequate infection control practices and maintenance of client from spa A at the time of the inspection in September 2018,
records at spa facilities offering cosmetic injection services can because the inspection was conducted under the purview of
help prevent the transmission of HIV and other bloodborne the New Mexico Regulation and Licensing Department, which
pathogens and ensure adequate traceback and notification in did not have authority to collect specimens. This activity was
the event of adverse clinical outcomes, respectively. reviewed by CDC, deemed not research, and was conducted
consistent with applicable federal law and CDC policy.§
Introduction
During summer 2018, the index patient, a woman aged Identification of Clients at Risk
40–50 years, was evaluated after receiving a positive rapid HIV The investigative team identified 59 clients at risk for
test result while abroad. Upon evaluation, the patient received exposure, including 20 who received PRP with microneedling
a positive HIV antigen/antibody rapid test result, with positive at spa A, and 39 who received other injection services (e.g.,
confirmatory results* the same day, indicating stage 1 HIV onabotulinumtoxinA [botox]) during the case-finding period.
infection.† The patient reported no injection drug use, recent Investigators cross-referenced the client list with the New
blood transfusions, or recent sexual contact with anyone other Mexico state HIV registry and identified one spa A client who
than her current sexual partner, who received a negative HIV received a diagnosis of HIV in 2012.
§ 45C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect.
* Positive HIV-1 and HIV-2 antibody plus HIV-1 p24 antigen test, a negative HIV-
1/2 differentiation antibody test, and a detectable HIV-1 RNA qualitative test. 552a; 44 U.S.C. Sect. 3501 et seq.
† https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm?s_cid%20
=%20rr6303a1_w

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 Morbidity and Mortality Weekly Report

During 2018–2023, current and former spa A clients who summer 2018 through spring 2023 (Figure 1) (Table). Two
received new HIV diagnoses were reported to NMDOH from patients had stage 1 disease, and three had stage 3 disease at the
clinical providers throughout the state. During this period, a time of diagnosis** (2). All four female patients had received
spa A–related HIV case was defined as a new HIV diagnosis PRP with microneedling at spa A.
in a patient with previous receipt of blood product or any Four of the five patients with confirmed spa A–related HIV
injection services provided by spa A’s owner¶ from 2017 until infections received at least one PRP with microneedling facial
closure of the unlicensed operation in fall 2018, or who had treatment at spa A during May–September 2018. Two of the
sexual contact with a person who received such spa services. patients in this cluster (a man and a woman) were engaged in
Cases were included only if an HIV nucleotide sequence a sexual relationship before and after their diagnoses. Sexual
demonstrated molecular linkage to other HIV sequences from partners of two other patients received negative HIV test
persons with infections associated with spa A. results after their partners’ diagnoses, and the remaining patient
reported having no sexual partner at the time of diagnosis.
Characteristics of Patients Before receiving a diagnosis of confirmed HIV infection, two
By spring 2023, five patients had been identified, including of the five patients had previously received a positive rapid
four women and one man who was a sexual partner of one of HIV test result during routine evaluations for life insurance,
the four women patients and never received any services from one in summer 2016, and the other in fall 2018; however, only
spa A. Blood specimens from the five patients and a former one patient reported being notified of the positive screening
client with a 2012 HIV diagnosis were submitted to CDC for test result and subsequently had their HIV diagnosis confirmed
nucleotide sequence analysis to ascertain cluster association by a primary care provider in winter 2019. The other patient
and determine case status; all five patients were confirmed to received a confirmed HIV diagnosis after hospitalization with
have spa A–related cases. Medical record reviews and clinician an AIDS-defining illness in fall 2021. One patient received
interviews were conducted for all confirmed patients. Three their HIV diagnosis in spring 2023 after hospitalization with
patients were interviewed by NMDOH. Patients ranged an AIDS-defining illness.
in age from 40–60 years. HIV diagnoses occurred during
** https://www.cdc.gov/mmwr/pdf/rr/rr6303.pdf
¶ Or spa A owner’s associates in a location other than the spa.

FIGURE 1. Receipt of platelet-rich plasma and microneedling facial treatments at spa A and HIV screening and diagnosis test results among
five patients with HIV infection — New Mexico, 2016–2023

PRP with microneedling Positive HIV test result HIV diagnosis

Patient 1

Patient 2
Patient no.

Patient 3

Patient 4

Patient 5

W Sp Su F W Sp Su F W Sp Su F W Sp Su F W Sp Su F W Sp Su F W Sp Su F W Sp Su F
2016 2017 2018 2019 2020 2021 2022 2023

Season and year

Abbreviations: F = fall; PRP = platelet-rich plasma; Sp = spring; Su = summer; W = winter.

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 Morbidity and Mortality Weekly Report

TABLE. Characteristics of patients with confirmed HIV infection associated with receipt of cosmetic injection services at spa A — New Mexico,
2018–2023
Patient no.
Characteristic 1 2 3 4* 5
Sex Woman Woman Woman Man Woman
Age range, yrs† 40–50 40–50 50–60 40–50 40–50
Season and year of HIV screening Summer 2018 Positive screen: Positive screen: Fall 2021 Spring 2023
and diagnosis fall 2018; summer 2016;
diagnosis: diagnosis:
winter 2019 fall 2021
HIV stage†,§ Stage 1 Stage 1 Stage 3 Stage 3 Stage 3
Spa A services received; PRP with PRP with PRP with microneedling None; PRP with
season and year received microneedling; microneedling; (multiple procedures); NA microneedling;
spring 2018 summer 2018 spring and summer 2018 summer 2018
Abbreviations: NA = not available; PRP = platelet-rich plasma.
* This patient was the sexual partner of a spa A client who received a diagnosis of HIV infection after receiving PRP with microneedling at spa A.
† At time of HIV diagnosis.
§ https://www.cdc.gov/mmwr/pdf/rr/rr6303.pdf

The two patients who were engaged in a sexual relationship antiretroviral therapy at the time of specimen collection, did
had stage 3 or chronic HIV infections, indicating that their not cluster with any New Mexico sequences.
infections were likely attributed to exposures before receipt of
cosmetic injection services. The other three patients in this Investigation of Spa A
cluster had no known social contact with one another, and In fall 2018, on-site inspection of spa A revealed multiple
no specific mechanism for transmission among these patients unsafe infection control practices. A centrifuge, a heating dry
was confirmed. Evidence suggests that contamination from bath, and a rack of unlabeled tubes containing blood were
an undetermined source at the spa during spring and summer located on a kitchen counter. Unlabeled tubes of blood and
2018 resulted in HIV-1 transmission to these three patients. medical injectables (i.e., botox and lidocaine) were stored in
the kitchen refrigerator along with food. Unwrapped syringes
Evaluation of HIV Sequences were found in drawers, on counters, and discarded in regular
Whole blood specimens collected from all patients and the trash cans. An autoclave (steam sterilizer) was not found on
former client living with HIV since 2012 were used to generate the premises. Procedure equipment was surface cleaned using
HIV-1 polymerase (pol), gag, and envelope (env) sequences to ammonium chloride disinfecting spray and benzalkonium
evaluate sequence relatedness using established protocols (3,4). chloride disinfecting wipes after each client visit, and dispos-
HIV-1 subtype B was determined using the online subtyping able electric desiccator tips were cleaned by alcohol immersion
tool COMET (5). Maximum likelihood phylogenetic analy- and reused.
sis was employed to compare the pol, gag, and env sequences
from this investigation with genetically similar sequences from Public Health Response
GenBank, the National Institutes of Health genetic sequence Because Spanish was the first language of many spa A cli-
database (https://www.ncbi.nlm.nih.gov/genbank), and with ents, and available client information was limited, NMDOH’s
46 local control sequences from routine HIV surveillance public health response comprised multiple approaches. Direct
in New Mexico in 2018 and 2023 for pol. Additional pol calls were made to known spa A clients to encourage testing
sequences derived from blood specimens collected by com- for bloodborne pathogens. Several Health Alert Notifications
mercial laboratories from three patients within 3 weeks of diag- were sent to providers in New Mexico to ask patients receiving
nosis were included in phylogenetic analyses. HIV-1 subtype J new diagnoses of HIV infection about spa services received
sequences were used as an outgroup†† for the phylogenetic before their diagnosis.§§ NMDOH communicated the risk
analyses. Phylogenetic analyses showed that gag, pol, and env for HIV transmission attributed to spa A’s unsterile injection
sequences from all patients clustered together strongly in a services to the Office of Border Health/Border Infectious
monophyletic clade with high confidence (Figure 2). Sequences Disease Surveillance Group, neighboring jurisdictions through
from the former client living with HIV, who was not receiving CDC’s Epidemic Information Exchange, and published four
†† A more distantly related group that serves as a reference group when §§ https://www.nmhealth.org/publication/view/general/8339/
determining the evolutionary relationships.

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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

FIGURE 2. Maximum likelihood phylogeny* of HIV polymerase sequences† from spa A patients 1–5§ and client receiving diagnosis of
HIV infection in 2012, compared with sequences from GenBank and local HIV surveillance databases — New Mexico, 2018–2023

N1
N1
N2
G40, N24, F2
G5
G2
G2
G4
P5
P5
P5
P2
P2
P1
P1
P3
SH confidence values >0.7 for the branching pattern; P3
SH values <0.7 are not shown. P4
P4
Collapsed nodes.
P4
G2
0.02
G4, N2
G4, N12
G2
G109, N2

R3

Abbreviations: F = former client; G = genetically related; N = New Mexico controls; P = patients 1–5; R = reference sequence; SH = Shimodaira-Hasegawa.
* Collapsed nodes are those with >1 sequence with total number of sequences indicated. Longer branch is associated with higher number of nucleotide substitutions
per site. Scale bar for branch length is shown as the number of nucleotide substitutions per site.
† HIV-1 subtype J reference sequences are used as the outgroup.
§ Each patient had 2 or 3 sequences included in the analysis.

press releases during 2018–2023¶¶ with information on free HIV infections were identified, nor were any hepatitis B or
testing for current and former spa A clients at state public hepatitis C infections detected. Free testing remains available
health offices. NMDOH organized and advertised bloodborne for former spa A clients, and the investigation and public health
pathogen testing events for current and former spa A clients response are continuing.
via social media, radio, newspaper, and television in both
English and Spanish. Members of the NMDOH investigative Discussion
team canvassed community health centers and businesses in This investigation is the first to associate HIV transmission
predominantly Spanish-speaking neighborhoods to distribute with nonsterile cosmetic injection services. A common expo-
testing information for current and former spa A clients. As sure to spa A among clients without behaviors associated with
a result of these activities, 198 former spa A clients and their HIV acquisition helped identify a possible cluster association,
sexual partners were tested during 2018–2023. No additional and analysis of additional data suggested that HIV transmis-
sion likely occurred via receipt of PRP with microneedling
¶¶ September 11, 2018: https://www.nmhealth.org/news/alert/2018/9/?view=709; facial procedures; however, the source of contamination
S e p t e m b e r 2 1 , 2 0 1 8 : h t t p s : / / w w w. n m h e a l t h . o r g / n e w s /
information/2018/9/?view=712; April 29, 2019: https://www.nmhealth.org/ remains unknown. Although the investigative team was not
news/alert/2019/4/?view=762; July 5, 2023: https://www.nmhealth.org/news/ permitted to collect specimens from spa A, evidence from this
alert/2023/7/?view=1988 investigation supports the likely transmission of HIV through

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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

Acknowledgments
Summary
Andrew Gans, Bernadette Gutierrez, Public Health Division, New
What is already known about this topic?
Mexico Department of Health; Shivanna Moriarty, staff members,
Transmission of HIV through cosmetic injection services via
Scientific Laboratory Division, New Mexico Department of Health;
contaminated blood has not been previously documented;
Patricia Joyce, Division of HIV Prevention, National Center for HIV,
however, transmission of HIV via unsterile injection practices is a
known risk. Determining novel routes of HIV transmission Viral Hepatitis, STD, and TB Prevention, CDC; Kaveh Kiani, Anupama
among persons with no known HIV risk factors is important. Shankar, Laboratory Branch, Division of HIV Prevention, National
Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC.
What is added by this report?
Corresponding author: Anna M. Stadelman-Behar, [email protected].
Investigation of multiple HIV infections among persons with no
known HIV risk factors who received platelet-rich plasma with 1Epidemic Intelligence Service, CDC; 2Epidemiology Response Division, New
microneedling (vampire facials) at an unlicensed New Mexico Mexico Department of Health; 3Division of HIV Prevention, National Center
spa revealed likely HIV transmission associated with these for HIV, Viral Hepatitis, STD, and TB Prevention, CDC; 4Division of
cosmetic injection services. Infectious Diseases, Department of Internal Medicine, University of New
Mexico Health Science Center, School of Medicine, Albuquerque, New Mexico;
What are the implications for public health practice? 5Public Health Division, New Mexico Department of Health.

In the absence of known HIV risk factors, clinical and public All authors have completed and submitted the International
health staff members might consider cosmetic injection Committee of Medical Journal Editors form for disclosure of
services as a route of HIV transmission. Requiring adequate
potential conflicts of interest. N. Mariam Salas reports receipt of an
infection control practices at spa facilities offering cosmetic
injection services can help prevent the transmission of HIV and
honorarium for a presentation at the eighth annual HIV conference at
other bloodborne pathogens. Maintenance of client records the University of Texas Medical Branch AIDS Education and Training
could facilitate investigations of suspected transmission at Center, and support for meeting attendance from the University of
such facilities. New Mexico. No other potential conflicts of interest were disclosed.

References
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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

Use of an Additional Updated 2023–2024 COVID-19 Vaccine Dose for Adults

Aged ≥65 Years: Recommendations of the Advisory Committee on
Immunization Practices — United States, 2024
Lakshmi Panagiotakopoulos, MD1; Monica Godfrey, MPH1; Danielle L. Moulia, MPH1; Ruth Link-Gelles, PhD1; Christopher A. Taylor, PhD1;
Kevin Chatham-Stephens, MD1; Oliver Brooks, MD2; Matthew F. Daley, MD3; Katherine E. Fleming-Dutra, MD1; Megan Wallace, DrPH1

Abstract COVID-19 continues to be a public health problem, especially

COVID-19 remains an important public health threat, among older adults. COVID-19–associated hospitalization
despite overall decreases in COVID-19–related severe disease rates remain higher among adults aged ≥65 years relative to
since the start of the COVID-19 pandemic. COVID-19–asso- rates among younger adults, adolescents, and children. During
ciated hospitalization rates remain higher among adults aged October 2023–January 2024, 67% of all COVID-19–associ-
≥65 years relative to rates in younger adults, adolescents, and ated hospitalizations were among persons aged ≥65 years (4).
children; during October 2023–January 2024, 67% of all Further, COVID-19 death rates during January 1, 2023–
COVID-19–associated hospitalizations were among persons January 31, 2024, were highest among adults aged ≥75 years,
aged ≥65 years. On September 12, 2023, CDC’s Advisory followed by adults aged 65–74 years (5,6). Whereas approxi-
Committee on Immunization Practices (ACIP) recommended mately 98%–99% of the U.S. population has measurable
updated (2023–2024 Formula) COVID-19 vaccination with antibody titers against SARS-CoV-2 from infection, vaccina-
a monovalent XBB.1.5-derived vaccine for all persons aged tion, or both (hybrid immunity), adults aged ≥65 years are less
≥6 months to protect against severe COVID-19–associated likely to have immunity resulting from infection (including
illness and death. Because SARS-CoV-2 continues to circu- immunity from infection only or hybrid immunity), compared
late throughout the year, and because of the increased risk for with adults aged 30–49 years and 50–64 years (7). In addition,
COVID-19–related severe illness in persons aged ≥65 years, immunosenescence, the age-related decline in the function-
the protection afforded by updated vaccines against JN.1 and ing of the immune system, results in a less complete immune
other currently circulating variants, and the expected waning of response to novel antigens and a reduced ability to develop
vaccine-conferred protection against disease, on February 28, robust immunity after infections or vaccination (8). The pool
2024, ACIP recommended all persons aged ≥65 years receive of naive T-cells diminishes with age, and this insufficient naive
1 additional dose of the updated (2023–2024 Formula) T-cell pool affects the ability to generate neutralizing antibody
COVID-19 vaccine. Implementation of these recommen- responses and cytotoxic T-cells in response to SARS-CoV-2 (9).
dations is expected to enhance immunity that might have Thus, adults aged ≥65 years are more likely than are younger
waned and decrease the risk for severe COVID-19–associated adults, adolescents, and children to rely upon vaccination to
outcomes, including death, among persons aged ≥65 years. increase immunity that might have waned and might need more
frequent vaccine doses to maintain protection. Coverage with
Introduction the updated COVID-19 vaccine among adults aged ≥65 years
Since June 2020, CDC’s Advisory Committee on was 42% as of February 3, 2024 (10,11). Adults in this age
Immunization Practices (ACIP) has convened 39 public meet- group are more concerned about COVID-19 disease and had
ings to review data and consider recommendations related to higher confidence in COVID-19 vaccine safety and vaccine
the use of COVID-19 vaccines (1). On September 12, 2023, importance than did younger adults (5). A nationally represen-
ACIP recommended that all persons aged ≥6 months receive tative survey conducted during November 2023–January 2024
updated (2023–2024 Formula) monovalent, XBB.1.5 com- indicated that 68.4% of adults aged ≥65 years who had received
ponent (updated) COVID-19 vaccination to protect against an updated COVID-19 vaccine dose definitely would get
severe COVID-19–associated illness and death (2). another updated vaccine if it were recommended, 27.2% prob-
As of February 3, 2024, approximately 6.7 million ably would or are unsure if they would get another updated
COVID-19–associated hospitalizations and 1.1 million vaccine, and 4.4% said they probably or definitely would not.
COVID-19–associated deaths had occurred in the United COVID-19 vaccines are currently on the commercial market,
States (3). Although the overall risk for COVID-19–associated but access-related barriers and disparities in vaccine coverage
hospitalization and death has decreased, severe illness related to remain (5); in the absence of any recommendations for an

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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

additional dose, access to vaccine would be limited among COVID-19–associated emergency department and urgent
persons unable to pay out of pocket for the vaccine.* care visits and hospitalization, compared with receipt of no
On February 28, 2024, ACIP voted to recommend that all updated vaccine dose (12,14). Although these early VE esti-
persons aged ≥65 years receive 1 additional dose of any updated mates show no substantial waning, based on data on effective-
COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer- ness of original and bivalent COVID-19 vaccines, waning of
BioNTech). This recommendation was based on continuing vaccine-conferred immunity is expected. Effectiveness of an
SARS-CoV-2 circulation throughout the year, increased risk additional dose in older adults has been demonstrated for pre-
for severe illness attributable to COVID-19 in adults aged viously recommended additional original COVID-19 vaccine
≥65 years, protection provided by the updated vaccines against doses (15). Among adults aged ≥50 years who were eligible
JN.1 and other currently circulating variants, the expected wan- to receive a second original monovalent mRNA COVID-19
ing of SARS-CoV-2 immunity, and additional implementation vaccine booster dose, VE against COVID-19–associated
considerations, including facilitating clear communication and emergency department and urgent care encounters during the
equitable access to vaccine (5). SARS-CoV-2 Omicron BA.2/BA.2.12.1 period ≥120 days after
the third dose was 32% but increased to 66% ≥7 days after
Methods the fourth dose. VE against COVID-19–associated hospital-
In 2018, ACIP adopted the Evidence to Recommendations ization ≥120 days after the third dose was 55% but increased
framework to guide the development of vaccine recommen- to 80% ≥7 days after the fourth dose (15). In addition, in a
dations. Since November 2023, the ACIP COVID-19 work large cohort of nursing home residents during circulation of
group met seven times to discuss the current policy question, SARS-CoV-2 Omicron subvariants, receipt of a second original
i.e., whether adults aged ≥65 years should receive an additional monovalent mRNA COVID-19 booster dose ≤60 days earlier
dose of updated COVID-19 vaccine. Work group member- was 74% effective against severe COVID-19–related outcomes
ship included ACIP voting members, representatives of ACIP (including hospitalization or death) and 90% effective against
ex officio and liaison organizations, and scientific consultants death, compared with receipt of a single booster dose (16).
with expertise in public health, immunology, medical special- COVID-19 vaccines have a favorable safety profile as
ties, and immunization safety and effectiveness. Work group demonstrated by robust safety surveillance during 3 years of
discussion topics included COVID-19 disease surveillance COVID-19 vaccine use (17). Anaphylactic reactions have
and epidemiology; COVID-19 vaccination coverage; and the rarely been reported after receipt of COVID-19 vaccines
safety, effectiveness, feasibility of implementation, and cost (18). A rare risk for myocarditis and pericarditis exists, pre-
effectiveness of COVID-19 vaccines. This report summarizes dominately in males aged 12–39 years (19). No new safety
the ACIP recommendation for an additional dose of the concerns have been identified for the updated COVID-19
updated COVID-19 vaccine for persons aged ≥65 years and vaccine (5). Among adults aged ≥65 years, overall reactogenicity
the rationale, including evidence reviewed by the work group after COVID-19 vaccination is less frequent and less severe
and presented to ACIP (https://www.cdc.gov/vaccines/acip/ than among adolescents and younger adults (20). A statisti-
recs/grade/covid-19-additional-dose-adults-etr.html). cal signal for ischemic stroke after Pfizer-BioNTech bivalent
mRNA COVID-19 vaccine was detected in the CDC Vaccine
Vaccine Effectiveness and Safety Safety Datalink among persons aged ≥65 years, and informa-
No clinical trial immunogenicity data on an additional tion about this detection has been presented at previous ACIP
dose of the updated COVID-19 vaccines exist; however, the meetings. Ongoing efforts to evaluate the signal have not
initial dose elicits a robust neutralizing antibody response and identified any clear and consistent evidence of a safety concern
provides protection against JN.1 and other circulating variants for ischemic stroke with bivalent mRNA COVID-19 vaccines
(12,13). Early vaccine effectiveness (VE) estimates demonstrate either when given alone or when given simultaneously with
that updated COVID-19 vaccination provided increased influenza vaccines (21). A recent VE study indicated that the
protection against symptomatic SARS-CoV-2 infection and bivalent COVID-19 vaccine was 47% effective in preventing
COVID-19 related thromboembolic events (ischemic stroke,
* Section 2713(a)(2) of the Public Health Service Act, as added by section 1001 myocardial infarction, and deep vein thrombosis) among
of the Affordable Care Act, implemented at 26 CFR 54.9815–2713(a)(1)(ii), persons aged ≥65 years (22).
29 CFR 2590.715–2713(a)(1)(ii), and 45 CFR 147.130(a)(1)(ii). This
requirement does not apply to grandfathered health plan coverage under section
1251 of the Affordable Care Act, implemented at 26 CFR 54.9815–1251, 29
CFR 2590.715–1272, and 45 CFR 147.140.

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US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

Cost Effectiveness
Summary
ACIP considered whether an additional dose of updated
What is already known about this topic?
COVID-19 vaccine in persons aged ≥65 years is a reasonable
In September 2023, the Advisory Committee on Immunization
and efficient allocation of resources. The societal incremen- Practices (ACIP) recommended updated (2023–2024 Formula)
tal cost-effectiveness ratio (ICER) for an additional dose of COVID-19 vaccination for all persons aged ≥6 months.
COVID-19 vaccine in persons aged ≥65 years was $255,122 What is added by this report?
per quality-adjusted life year saved for the base case estimate.
On February 28, 2024, ACIP recommended that all persons
ICER values were sensitive to probability of hospitalizations, aged ≥65 years receive 1 additional dose of any updated
costs, and seasonality assumptions. Estimates of ICER values (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna,
that approximate cost effectiveness for those with higher risk Novavax, or Pfizer-BioNTech).
for COVID-19–associated hospitalization, such as persons What are the implications for public health practice?
with underlying conditions or those aged ≥75 years, were Adults aged ≥65 years should receive an additional dose of the
more favorable (23). updated (2023–2024 Formula) COVID-19 vaccine to enhance
their immunity and decrease the risk for severe COVID-19–
Recommendation for Use of an Additional associated illness.
Updated COVID-19 Vaccine Dose in Persons
Aged ≥65 Years Reporting Vaccine Adverse Events
On February 28, 2024, ACIP recommended that all per- Adverse events after vaccination should be reported to
sons aged ≥65 years receive 1 additional dose of any updated the Vaccine Adverse Event Reporting System (VAERS). For
COVID-19 vaccine (i.e., Moderna, Novavax, or Pfizer- licensed COVID-19 vaccines administered to persons aged
BioNTech).† This additional dose should be administered ≥12 years, reporting is encouraged for any clinically significant
≥4 months after the previous dose of updated COVID-19 vac- adverse event even when whether the vaccine caused the event
cine. For initial vaccination with Novavax COVID-19 vaccine, is uncertain, as well as for vaccination errors. For COVID-19
the 2-dose series should be completed before administration vaccines given under Emergency Use Authorization, vaccina-
of the additional dose. Because Novavax COVID-19 vaccine tion providers are required to report certain adverse events to
is currently authorized under Emergency Use Authorization, VAERS. Additional information is available at https://vaers.
the recommendation for the updated Novavax COVID-19 hhs.gov or by telephone at 1-800-822-7967.
vaccine is an interim recommendation.
Acknowledgments
Persons Aged ≥65 Years with Moderate or Karen Broder, Mary Chamberland, Demetre Daskalakis, Susan
Severe Immunocompromise Goldstein, Aron Hall, Elisha Hall, Fiona Havers, Andrew Leidner,
Pedro Moro, Sara Oliver, Ismael Ortega-Sanchez, Kadam Patel,
Persons aged ≥65 years who are moderately or severely immu- Manisha Patel, Amanda Payne, Huong Pham, Jamison Pike, Lauren
nocompromised, have completed an initial series, and have Roper, Sierra Scarbrough, Tom Shimabukuro, Benjamin Silk, John
received ≥1 updated COVID-19 vaccine dose should receive Su, Evelyn Twentyman, Eric Weintraub, David Wentworth, Melinda
1 additional updated COVID-19 vaccine dose ≥2 months after Wharton, Michael Whitaker, JoEllen Wolicki, Fangjun Zhou, CDC.
the last dose of updated vaccine. Further additional doses may Voting members of the Advisory Committee on Immunization
be administered, guided by the clinical judgment of a health Practices (in addition to listed authors): Wilbur Chen, University of
care provider and personal preference and circumstances. Any Maryland School of Medicine; Sybil Cineas, Warren Alpert Medical
further additional doses should be administered ≥2 months School of Brown University; Camille Kotton, Harvard Medical
after the last COVID-19 vaccine dose. Additional clinical School; James Loehr, Cayuga Family Medicine; Sarah Long, Drexel
considerations, including detailed schedules and tables by age University College of Medicine. Members of the Advisory Committee
on Immunization Practices COVID-19 Vaccines Work Group: Beth P.
for all age groups and vaccination history for those who are
Bell, University of Washington; Edward Belongia, Center for Clinical
or are not moderately or severely immunocompromised, are
Epidemiology & Population Health, Marshfield Clinic Research
available at https://www.cdc.gov/vaccines/covid-19/clinical- Institute; Henry Bernstein, Zucker School of Medicine at Hofstra/
considerations/covid-19-vaccines-us.html. Northwell Cohen Children’s Medical Center; Uzo Chukwuma,
Indian Health Service; Paul Cieslak, Christine Hahn, Council of
† ACIP voted (11 to one with one abstention) to recommend that persons aged State and Territorial Epidemiologists; Richard Dang, American
≥65 years should receive an additional dose of updated (2023–2024 Formula) Pharmacists Association; Jeffrey Duchin, Infectious Diseases Society
COVID-19 vaccine.
of America; Kathy Edwards, Vanderbilt University Medical Center;

379
US Department of Health and Human Services | Centers for Disease Control and Prevention | MMWR | April 25, 2024 | Vol. 73 | No. 16
 Morbidity and Mortality Weekly Report

Sandra Fryhofer, American Medical Association; Jason M. Goldman, 4. Taylor C. COVID-19–associated hospitalizations among adults–
American College of Physicians; Robert Hopkins, University of COVID-NET. Presented at the Advisory Committee on Immunization
Practices meeting, Atlanta, Georgia, February 28, 2024. https://www.
Arkansas for Medical Sciences; Michael Ison, Chris Roberts, National
cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/02-
Institutes of Health; Lisa A. Jackson, Jennifer C. Nelson, Kaiser COVID-Taylor-508.pdf
Permanente Washington Health Research Institute; Denise Jamieson, 5. Wallace M. Evidence to recommendations framework. Presented at the
American College of Obstetricians and Gynecologists; Jeffery Advisory Committee on Immunization Practices meeting, Atlanta,
Kelman, Centers for Medicare & Medicaid Services; Kathy Kinlaw, Georgia, February 28, 2024. https://www.cdc.gov/vaccines/acip/meetings/
downloads/slides-2024-02-28-29/06-COVID-Wallace-508.pdf
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 Morbidity and Mortality Weekly Report

Notes from the Field

Group A Streptococcus Bacteremia in Persons EMR. The remainder of the report focuses on these 38 persons
Who Inject Drugs — Northern Vermont, with 45 cases of GAS bacteremia.
January 2020–October 2023 Twenty-one (55%) of the 38 patients were female; median
Monica J. Raymond, MPH, MS1; Tonda R. Wolfe, MS1;
patient age was 40.5 years (range = 22–63 years). Among 28
Lindsay M. Smith, MD1,2 (62%) of the 45 cases, the patient reported experiencing home-
lessness at the time of GAS bacteremia diagnosis, compared
CDC has recently reported increases in invasive group A with one of the 19 cases among non-PWID. Among 35 (78%)
Streptococcus (GAS) infections.* Injection of illicit drugs and cases, patients reported active injection drug use at the time
homelessness are two documented risk factors for invasive of bacteremia; among the remaining 10 (22%) cases, patients
GAS infections (1). In 2022 and 2023, the University of reported previous injection drug use and current noninjection
Vermont Medical Center (UVMMC) Infection Prevention illicit drug use. Known xylazine exposure before diagnosis was
and Antimicrobial Stewardship programs detected a sub- self-reported in 12 (27%) cases and suspected by a clinician
stantial increase compared with 2020–2021 in community- based on the presence of wounds consistent with xylazine use
acquired GAS bacteremia among adult patients seeking care (2) in an additional seven (16%) cases.
at UVMMC. The programs conducted an investigation to Among 44 of the 45 cases, the patients had concurrent skin
identify opportunities to enhance the delivery of care. and soft tissue infections; in 37 (82%) cases, the patients had
multiple wounds at the time of diagnosis with GAS bacteremia.
Investigation and Outcomes Twenty-one of the 38 patients collectively sought aid 59 times
Cases of invasive GAS infections were identified using reports (range = one to six visits per person) at UVMMC emergency or
in the electronic medical record (EMR), using Epic software. urgent care departments for wound care during the 6 months
A case of GAS bacteremia was defined as Streptococcus pyogenes before their diagnosis of GAS bacteremia.
in a blood culture from a UVMMC patient during January 1, Hospital admission for intravenous antibiotic therapy was
2020–October 31, 2023. A repeat positive culture occurring recommended for all cases. Among 17 (38%) cases, the patient
>30 days after the initial positive culture was considered a underwent wound debridement (12 in an operating room and
recurrent infection and was included in the analysis. Patients five at bedside). Among 23 (51%) cases, the patient declined
meeting the following criteria were excluded: those who admission or left the hospital against medical advice. The aver-
transferred to UVMMC with GAS bacteremia, those who age length of admission was 11 days. Two patients died during
had been admitted to the hospital during the previous 7 days, hospitalization for GAS bacteremia.
and those whose initial positive culture specimen was obtained
≥48 hours after hospital admission, ≤7 days after surgery, or Preliminary Conclusions and Actions
≤7 days postpartum. As a quality improvement project aimed The precipitous increase in GAS bacteremia at UVMMC
at identifying risk factors, developing prevention strategies, followed an increase in involvement of xylazine in fatal opioid
and improving patient care for GAS bacteremia, this activity overdoses in Vermont, first reported in late 2021.§,¶ Xylazine
did not require institutional review board review. causes peripheral vasoconstriction and ischemia and has been
Among UVMMC patients, three cases of GAS bacteremia associated with necrosis at injection sites and noninjection sites
were identified in 2020, four in 2021, 19 in 2022, and 45 (2). Xylazine can be present in both injected and noninjected
during the first 10 months of 2023 (Figure). In comparison, drugs.** Xylazine-related wounds might serve as a portal of
total emergency department patient encounters at UVMMC entry for bacteria into the bloodstream and could, at least
increased by 19% between 2020–2021 and 2022–2023, and in part, explain the increase in GAS bacteremia described in
total admissions increased by <2%. this report. Given the findings of this report and other stud-
Of the 64 cases identified during 2022–2023, a total of 45 ies (1), GAS should be considered in PWID with symptoms
(70%) occurred among 38 patients known to be persons who
inject drugs† (PWID), based on self-report documented in the § https://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP-
XylazineBrief.pdf
¶ https://www.cdc.gov/drugoverdose/fatal/dashboard/index.html
* https://www.cdc.gov/groupastrep/current-activity.html
† Includes persons who actively engaged in injection drug use at the time of GAS ** https://www.cdc.gov/drugoverdose/deaths/other-drugs/xylazine/faq.
bacteremia diagnosis and those who did so previously. html#what

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 Morbidity and Mortality Weekly Report

FIGURE. Cases of community-acquired group A Streptococcus bacteremia, by month of blood culture collection, patient history of injection
drug use, and emergency department encounters — University of Vermont Medical Center, January 2020–October 2023*,†
10 6,000
Current or former injection drug use No known current or former injection drug use ED encounters
No. of cases of group A Streptococcus bacteremia

9
5,000
8

No. of patient ED encounters

7
4,000
6

5 3,000

4
2,000
3

2
1,000
1

0 0
Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep Nov Jan Mar May Jul Sep
2020 2021 2022 2023

Month and year of blood culture collection

Abbreviation: ED = emergency department.
* Infection and ED encounter data are missing for October 28–November 23, 2020, because of a cyberattack that rendered the University of Vermont Medical Center’s
electronic medical records unusable.
† In October 2021, the Vermont Department of Health reported a greater than twofold increase in the percentage of fatal opioid overdoses with xylazine involvement
during the first 7 months of 2021, compared with each of the previous 2 years.

of bacteremia, particularly in persons with wounds. During

Summary
the 6 months before diagnosis with GAS bacteremia, patients
What is already known about this topic?
visited emergency or urgent care departments up to six times
Injection of illicit drugs and homelessness are risk factors for
seeking aid for wound care. Increased access to wound care
invasive group A streptococcal infections. Xylazine has been
services in sites accessible to PWID might result in earlier associated with necrosis, which could facilitate entry of bacteria
treatment and prevent progression to bacteremia. into the bloodstream.
In response to these findings, UVMMC is working to What is added by this report?
improve linkage to care for both opioid use disorder and During 2022–2023, the University of Vermont Medical Center
wound care and is exploring collaborative efforts with local experienced a substantial increase in the number of commu-
nongovernmental organizations and public health authorities nity-acquired group A streptococcal bloodstream infections,
to deliver wound care services in community settings. predominantly in persons who inject drugs. The increase
coincided with the introduction of xylazine into the drug
supply. Many patients sought care for wounds before being
diagnosed with a bloodstream infection.
What are the implications for public health practice?
The availability of wound care services in sites accessible to persons
who inject drugs might help prevent bloodstream infections.

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 Morbidity and Mortality Weekly Report

Acknowledgments References
John Ahern, Cindy Noyes, Angela Ross, Carolyn Terhune, 1. Valenciano SJ, Onukwube J, Spiller MW, et al. Invasive group A
University of Vermont Medical Center. streptococcal infections among people who inject drugs and people
experiencing homelessness in the United States, 2010–2017. Clin Infect
Corresponding author: Monica J. Raymond, [email protected]. Dis 2021;73:e3718–26. PMID:32803254 https://doi.org/10.1093/cid/
1University of Vermont Medical Center, Burlington, Vermont; 2Larner College
ciaa787
2. McFadden R, Wallace-Keeshen S, Petrillo Straub K, et al. Xylazine-
of Medicine, University of Vermont, Burlington, Vermont. associated wounds: clinical experience from a low-barrier wound care
All authors have completed and submitted the International clinic in Philadelphia. J Addict Med 2024;18:9–12. PMID:38019592
https://doi.org/10.1097/ADM.0000000000001245
Committee of Medical Journal Editors form for disclosure of potential
conflicts of interest. No potential conflicts of interest were disclosed.

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 Morbidity and Mortality Weekly Report

QuickStats

FROM THE NATIONAL CENTER FOR HEALTH STATISTICS

Percentage* of Employed Adults Aged ≥18 Years

Who Slept <7 Hours per 24-Hour Period,† by Sex and
Number of Work Hours per Week§ — United States, 2022
100

≤40 Work hours 41–60 Work hours >60 Work hours

60

50
Percentage

40

30

20

10

0
Total Men Women

* Estimates were based on household interviews of a sample of the civilian, noninstitutionalized U.S. population,
with 95% CIs indicated by error bars.
† Based on a response to the question, “On average, how many hours of sleep do you get in a 24-hour period?”
§ Based on a response to the question, “How many hours did you work last week at all jobs or businesses?”

In 2022, the percentage of employed adults who slept <7 hours on average during a 24-hour period increased with the number of hours worked
per week, including 29% among those who worked ≤40 hours, 35% among those who worked 41–60 hours, and 48% among those who worked
>60 hours per week. The patterns were similar for men and women.
Supplementary Table: https://stacks.cdc.gov/view/cdc/153722
Source: National Center for Health Statistics, National Health Interview Survey, 2022. https://www.cdc.gov/nchs/nhis/index.htm
Reported by: Imelda Wong, PhD, [email protected]; Abay Asfaw, PhD; Roger Rosa, PhD.

For more information on this topic, CDC recommends the following link: https://www.cdc.gov/sleep/about_sleep/sleep_hygiene.html

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 Morbidity and Mortality Weekly Report

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