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1.
MMWR Morb Mortal Wkly Rep ; 71(13): 495-502, 2022 Apr 01.
Article in English | MEDLINE | ID: covidwho-1771891

ABSTRACT

CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted.


Subject(s)
COVID-19 , Influenza Vaccines , Adolescent , Adult , Ambulatory Care , COVID-19/prevention & control , COVID-19 Vaccines , Emergency Service, Hospital , Hospitalization , Humans , Immunization, Secondary , SARS-CoV-2 , Vaccines, Synthetic
2.
MMWR Morb Mortal Wkly Rep ; 71(9): 352-358, 2022 Mar 04.
Article in English | MEDLINE | ID: covidwho-1727017

ABSTRACT

The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17 years (referred to as adolescents in this report) have also indicated high levels of protection against SARS-CoV-2 (the virus that causes COVID-19) infection and COVID-19-associated hospitalization (4-6); however, data on VE against the SARS-CoV-2 B.1.1.529 (Omicron) variant and duration of protection are limited. Pfizer-BioNTech VE data are not available for children aged 5-11 years. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations† among persons aged 5-17 years with COVID-19-like illness across 10 states during April 9, 2021-January 29, 2022,§ to estimate VE using a case-control test-negative design. Among children aged 5-11 years, VE against laboratory-confirmed COVID-19-associated ED and UC encounters 14-67 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 83% and 76%, respectively; VE ≥150 days after dose 2 was 38% and 46%, respectively. Among adolescents aged 16-17 years, VE increased to 86% ≥7 days after dose 3 (booster dose). VE against COVID-19-associated ED and UC encounters was substantially lower during the Omicron predominant period than the B.1.617.2 (Delta) predominant period among adolescents aged 12-17 years, with no significant protection ≥150 days after dose 2 during Omicron predominance. However, in adolescents aged 16-17 years, VE during the Omicron predominant period increased to 81% ≥7 days after a third booster dose. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19-associated hospitalization among children aged 5-11 years was 74% 14-67 days after dose 2, with wide CIs that included zero. Among adolescents aged 12-15 and 16-17 years, VE 14-149 days after dose 2 was 92% and 94%, respectively; VE ≥150 days after dose 2 was 73% and 88%, respectively. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 12-17 years.


Subject(s)
/administration & dosage , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , SARS-CoV-2/immunology , /statistics & numerical data , Adolescent , Ambulatory Care/statistics & numerical data , Child , Child, Preschool , Emergency Service, Hospital/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Immunization, Secondary , Male , United States
3.
MMWR Morb Mortal Wkly Rep ; 71(7): 255-263, 2022 Feb 18.
Article in English | MEDLINE | ID: covidwho-1689713

ABSTRACT

CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after 2 doses of mRNA vaccine has been observed during the period of the SARS-CoV-2 B.1.617.2 (Delta) variant predominance† (1-5), but little is known about durability of protection after 3 doses during periods of Delta or SARS-CoV-2 B.1.1.529 (Omicron) variant predominance. A test-negative case-control study design using data from eight VISION Network sites§ examined vaccine effectiveness (VE) against COVID-19 emergency department/urgent care (ED/UC) visits and hospitalizations among U.S. adults aged ≥18 years at various time points after receipt of a second or third vaccine dose during two periods: Delta variant predominance and Omicron variant predominance (i.e., periods when each variant accounted for ≥50% of sequenced isolates).¶ Persons categorized as having received 3 doses included those who received a third dose in a primary series or a booster dose after a 2 dose primary series (including the reduced-dosage Moderna booster). The VISION Network analyzed 241,204 ED/UC encounters** and 93,408 hospitalizations across 10 states during August 26, 2021-January 22, 2022. VE after receipt of both 2 and 3 doses was lower during the Omicron-predominant than during the Delta-predominant period at all time points evaluated. During both periods, VE after receipt of a third dose was higher than that after a second dose; however, VE waned with increasing time since vaccination. During the Omicron period, VE against ED/UC visits was 87% during the first 2 months after a third dose and decreased to 66% among those vaccinated 4-5 months earlier; VE against hospitalizations was 91% during the first 2 months following a third dose and decreased to 78% ≥4 months after a third dose. For both Delta- and Omicron-predominant periods, VE was generally higher for protection against hospitalizations than against ED/UC visits. All eligible persons should remain up to date with recommended COVID-19 vaccinations to best protect against COVID-19-associated hospitalizations and ED/UC visits.


Subject(s)
Ambulatory Care/statistics & numerical data , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Hospitalization/statistics & numerical data , SARS-CoV-2/immunology , /administration & dosage , Adult , Aged , Aged, 80 and over , Case-Control Studies , Emergency Service, Hospital , Female , Humans , Male , Middle Aged , Time Factors , United States , Young Adult
5.
MMWR Morb Mortal Wkly Rep ; 70(44): 1553-1559, 2021 Nov 05.
Article in English | MEDLINE | ID: covidwho-1502903

ABSTRACT

Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately 3% of the U.S. adult population (1). Immunocompromised adults are at increased risk for severe COVID-19 outcomes (2) and might not acquire the same level of protection from COVID-19 mRNA vaccines as do immunocompetent adults (3,4). To evaluate vaccine effectiveness (VE) among immunocompromised adults, data from the VISION Network* on hospitalizations among persons aged ≥18 years with COVID-19-like illness from 187 hospitals in nine states during January 17-September 5, 2021 were analyzed. Using selected discharge diagnoses,† VE against COVID-19-associated hospitalization conferred by completing a 2-dose series of an mRNA COVID-19 vaccine ≥14 days before the index hospitalization date§ (i.e., being fully vaccinated) was evaluated using a test-negative design comparing 20,101 immunocompromised adults (10,564 [53%] of whom were fully vaccinated) and 69,116 immunocompetent adults (29,456 [43%] of whom were fully vaccinated). VE of 2 doses of mRNA COVID-19 vaccine against COVID-19-associated hospitalization was lower among immunocompromised patients (77%; 95% confidence interval [CI] = 74%-80%) than among immunocompetent patients (90%; 95% CI = 89%-91%). This difference persisted irrespective of mRNA vaccine product, age group, and timing of hospitalization relative to SARS-CoV-2 (the virus that causes COVID-19) B.1.617.2 (Delta) variant predominance in the state of hospitalization. VE varied across immunocompromising condition subgroups, ranging from 59% (organ or stem cell transplant recipients) to 81% (persons with a rheumatologic or inflammatory disorder). Immunocompromised persons benefit from mRNA COVID-19 vaccination but are less protected from severe COVID-19 outcomes than are immunocompetent persons, and VE varies among immunocompromised subgroups. Immunocompromised persons receiving mRNA COVID-19 vaccines should receive 3 doses and a booster, consistent with CDC recommendations (5), practice nonpharmaceutical interventions, and, if infected, be monitored closely and considered early for proven therapies that can prevent severe outcomes.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Hospitalization/statistics & numerical data , Immunocompromised Host/immunology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/immunology , COVID-19/therapy , COVID-19 Vaccines/immunology , Female , Humans , Immunization Schedule , Laboratories , Male , Middle Aged , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , United States/epidemiology , Vaccines, Synthetic/administration & dosage , Young Adult
6.
MMWR Morb Mortal Wkly Rep ; 70(44): 1539-1544, 2021 Nov 05.
Article in English | MEDLINE | ID: covidwho-1502901

ABSTRACT

Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared the odds of receiving a positive SARS-CoV-2 test result, and thus having laboratory-confirmed COVID-19, between unvaccinated patients with a previous SARS-CoV-2 infection occurring 90-179 days before COVID-19-like illness hospitalization, and patients who were fully vaccinated with an mRNA COVID-19 vaccine 90-179 days before hospitalization with no previous documented SARS-CoV-2 infection. Hospitalized adults aged ≥18 years with COVID-19-like illness were included if they had received testing at least twice: once associated with a COVID-19-like illness hospitalization during January-September 2021 and at least once earlier (since February 1, 2020, and ≥14 days before that hospitalization). Among COVID-19-like illness hospitalizations in persons whose previous infection or vaccination occurred 90-179 days earlier, the odds of laboratory-confirmed COVID-19 (adjusted for sociodemographic and health characteristics) among unvaccinated, previously infected adults were higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine with no previous documented infection (adjusted odds ratio [aOR] = 5.49; 95% confidence interval [CI] = 2.75-10.99). These findings suggest that among hospitalized adults with COVID-19-like illness whose previous infection or vaccination occurred 90-179 days earlier, vaccine-induced immunity was more protective than infection-induced immunity against laboratory-confirmed COVID-19. All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2.


Subject(s)
COVID-19/diagnosis , COVID-19/immunology , SARS-CoV-2/isolation & purification , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/therapy , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/immunology , Female , Hospitalization/statistics & numerical data , Humans , Laboratories , Male , Middle Aged , SARS-CoV-2/immunology , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/immunology , Young Adult
7.
N Engl J Med ; 385(15): 1355-1371, 2021 10 07.
Article in English | MEDLINE | ID: covidwho-1397961

ABSTRACT

BACKGROUND: There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department or urgent care clinic. METHODS: We conducted a study involving adults (≥50 years of age) with Covid-19-like illness who underwent molecular testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed 41,552 admissions to 187 hospitals and 21,522 visits to 221 emergency departments or urgent care clinics during the period from January 1 through June 22, 2021, in multiple states. The patients' vaccination status was documented in electronic health records and immunization registries. We used a test-negative design to estimate vaccine effectiveness by comparing the odds of a positive test for SARS-CoV-2 infection among vaccinated patients with those among unvaccinated patients. Vaccine effectiveness was adjusted with weights based on propensity-for-vaccination scores and according to age, geographic region, calendar time (days from January 1, 2021, to the index date for each medical visit), and local virus circulation. RESULTS: The effectiveness of full messenger RNA (mRNA) vaccination (≥14 days after the second dose) was 89% (95% confidence interval [CI], 87 to 91) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization, 90% (95% CI, 86 to 93) against infection leading to an ICU admission, and 91% (95% CI, 89 to 93) against infection leading to an emergency department or urgent care clinic visit. The effectiveness of full vaccination with respect to a Covid-19-associated hospitalization or emergency department or urgent care clinic visit was similar with the BNT162b2 and mRNA-1273 vaccines and ranged from 81% to 95% among adults 85 years of age or older, persons with chronic medical conditions, and Black or Hispanic adults. The effectiveness of the Ad26.COV2.S vaccine was 68% (95% CI, 50 to 79) against laboratory-confirmed SARS-CoV-2 infection leading to hospitalization and 73% (95% CI, 59 to 82) against infection leading to an emergency department or urgent care clinic visit. CONCLUSIONS: Covid-19 vaccines in the United States were highly effective against SARS-CoV-2 infection requiring hospitalization, ICU admission, or an emergency department or urgent care clinic visit. This vaccine effectiveness extended to populations that are disproportionately affected by SARS-CoV-2 infection. (Funded by the Centers for Disease Control and Prevention.).


Subject(s)
Ambulatory Care/statistics & numerical data , COVID-19 Vaccines , COVID-19/prevention & control , Hospitalization/statistics & numerical data , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19 Vaccines/immunology , Female , Humans , Intensive Care Units/statistics & numerical data , Male , Middle Aged , Patient Readmission/statistics & numerical data , United States/epidemiology
8.
MMWR Morb Mortal Wkly Rep ; 69(29): 960-964, 2020 07 24.
Article in English | MEDLINE | ID: covidwho-1389848

ABSTRACT

Population prevalence of persons infected with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), varies by subpopulation and locality. U.S. studies of SARS-CoV-2 infection have examined infections in nonrandom samples (1) or seroprevalence in specific populations* (2), which are limited in their generalizability and cannot be used to accurately calculate infection-fatality rates. During April 25-29, 2020, Indiana conducted statewide random sample testing of persons aged ≥12 years to assess prevalence of active infection and presence of antibodies to SARS-CoV-2; additional nonrandom sampling was conducted in racial and ethnic minority communities to better understand the impact of the virus in certain racial and ethnic minority populations. Estimates were adjusted for nonresponse to reflect state demographics using an iterative proportional fitting method. Among 3,658 noninstitutionalized participants in the random sample survey, the estimated statewide point prevalence of active SARS-CoV-2 infection confirmed by reverse transcription-polymerase chain reaction (RT-PCR) testing was 1.74% (95% confidence interval [CI] = 1.10-2.54); 44.2% of these persons reported no symptoms during the 2 weeks before testing. The prevalence of immunoglobulin G (IgG) seropositivity, indicating past infection, was 1.09% (95% CI = 0.76-1.45). The overall prevalence of current and previous infections of SARS-CoV-2 in Indiana was 2.79% (95% CI = 2.02-3.70). In the random sample, higher overall prevalences were observed among Hispanics and those who reported having a household contact who had previously been told by a health care provider that they had COVID-19. By late April, an estimated 187,802 Indiana residents were currently or previously infected with SARS-CoV-2 (9.6 times higher than the number of confirmed cases [17,792]) (3), and 1,099 residents died (infection-fatality ratio = 0.58%). The number of reported cases represents only a fraction of the estimated total number of infections. Given the large number of persons who remain susceptible in Indiana, adherence to evidence-based public health mitigation and containment measures (e.g., social distancing, consistent and correct use of face coverings, and hand hygiene) is needed to reduce surge in hospitalizations and prevent morbidity and mortality from COVID-19.


Subject(s)
Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Public Health Surveillance/methods , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19 , Child , Coronavirus Infections/ethnology , Female , Humans , Indiana/epidemiology , Male , Middle Aged , Pandemics , Pneumonia, Viral/ethnology , Prevalence , Young Adult
9.
PLoS One ; 16(3): e0241875, 2021.
Article in English | MEDLINE | ID: covidwho-1148240

ABSTRACT

BACKGROUND: Prior studies examining symptoms of COVID-19 are primarily descriptive and measured among hospitalized individuals. Understanding symptoms of SARS-CoV-2 infection in pre-clinical, community-based populations may improve clinical screening, particularly during flu season. We sought to identify key symptoms and symptom combinations in a community-based population using robust methods. METHODS: We pooled community-based cohorts of individuals aged 12 and older screened for SARS-CoV-2 infection in April and June 2020 for a statewide prevalence study. Main outcome was SARS-CoV-2 positivity. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for individual symptoms as well as symptom combinations. We further employed multivariable logistic regression and exploratory factor analysis (EFA) to examine symptoms and combinations associated with SARS-CoV-2 infection. RESULTS: Among 8214 individuals screened, 368 individuals (4.5%) were RT-PCR positive for SARS-CoV-2. Although two-thirds of symptoms were highly specific (>90.0%), most symptoms individually possessed a PPV <50.0%. The individual symptoms most greatly associated with SARS-CoV-2 positivity were fever (OR = 5.34, p<0.001), anosmia (OR = 4.08, p<0.001), ageusia (OR = 2.38, p = 0.006), and cough (OR = 2.86, p<0.001). Results from EFA identified two primary symptom clusters most associated with SARS-CoV-2 infection: (1) ageusia, anosmia, and fever; and (2) shortness of breath, cough, and chest pain. Moreover, being non-white (13.6% vs. 2.3%, p<0.001), Hispanic (27.9% vs. 2.5%, p<0.001), or living in an Urban area (5.4% vs. 3.8%, p<0.001) was associated with infection. CONCLUSIONS: Symptoms can help distinguish SARS-CoV-2 infection from other respiratory viruses, especially in community or urgent care settings where rapid testing may be limited. Symptoms should further be structured in clinical documentation to support identification of new cases and mitigation of disease spread by public health. These symptoms, derived from asymptomatic as well as mildly infected individuals, can also inform vaccine and therapeutic clinical trials.


Subject(s)
COVID-19/diagnosis , COVID-19/epidemiology , Mass Screening/methods , Adolescent , Adult , Aged , Aged, 80 and over , Ageusia/epidemiology , Ageusia/virology , COVID-19/prevention & control , Cough , Cross-Sectional Studies/methods , Dyspnea , Epidemiologic Studies , Female , Fever/epidemiology , Fever/virology , Humans , Indiana/epidemiology , Male , Middle Aged , Prevalence , SARS-CoV-2/metabolism , SARS-CoV-2/pathogenicity , Syndrome
10.
medRxiv ; 2020 Oct 22.
Article in English | MEDLINE | ID: covidwho-900757

ABSTRACT

BACKGROUND: Prior studies examining symptoms of COVID-19 are primarily descriptive and measured among hospitalized individuals. Understanding symptoms of SARS-CoV-2 infection in pre-clinical, community-based populations may improve clinical screening, particularly during flu season. We sought to identify key symptoms and symptom combinations in a community-based population using robust methods. METHODS: We pooled community-based cohorts of individuals aged 12 and older screened for SARS-CoV-2 infection in April and June 2020 for a statewide seroprevalence study. Main outcome was SARS-CoV-2 positivity. We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for individual symptoms as well as symptom combinations. We further employed multivariable logistic regression and exploratory factor analysis (EFA) to examine symptoms and combinations associated with SARS-CoV-2 infection. RESULTS: Among 8214 individuals screened, 368 individuals (4.5%) were RT-PCR positive for SARS-CoV-2. Although two-thirds of symptoms were highly specific (>90.0%), most symptoms individually possessed a PPV <50.0%. The individual symptoms most greatly associated with SARS-CoV-2 positivity were fever (OR=5.34, p<0.001), anosmia (OR=4.08, p<0.001), ageusia (OR=2.38, p=0.006), and cough (OR=2.86, p<0.001). Results from EFA identified two primary symptom clusters most associated with SARS-CoV-2 infection: (1) ageusia, anosmia, and fever; and (2) shortness of breath, cough, and chest pain. Moreover, being non-white (13.6% vs. 2.3%, p<0.001), Hispanic (27.9% vs. 2.5%, p<0.001), or living in an Urban area (5.4% vs. 3.8%, p<0.001) was associated with infection. CONCLUSIONS: Symptoms can help distinguish SARS-CoV-2 infection from other respiratory viruses, especially in community or urgent care settings where rapid testing may be limited. Symptoms should further be structured in clinical documentation to support identification of new cases and mitigation of disease spread by public health. These symptoms, derived from asymptomatic as well as mildly infected individuals, can also inform vaccine and therapeutic clinical trials. RESEARCH IN CONTEXT: Evidence before this study: Using multiple journal articles queried from MEDLINE as well as a Cochrane systematic review, we examined all studies that described symptoms known to be associated with COVID-19. We further examined the guidelines from WHO and CDC on the symptoms those public health authorities consider to be associated with COVID-19. Most of the evidence comes from China, Italy, and the United States. Collectively prior research and guidance suggests there are a dozen symptoms reported by individuals who tested positive for COVID-19 in multiple countries. Symptoms include fever, cough, fatigue, anosmia, ageusia, shortness of breath, chills, myalgias, headache, sore throat, chest pain, and gastrointestinal issues. The evidence is generally of low quality as it is descriptive in nature, and it is biased towards hospitalized patients. Most studies report the proportion of patients hospitalized or testing positive for infection who report one or more symptoms within 3-14 days prior to hospitalization or infection. There has been little validation of symptoms among hospitalized or non-hospitalized patients. Furthermore, according to a Cochrane review, no studies to date assess combinations of different signs and symptoms.Added value of this study: This study employs multiple, rigorous methods to examine the ability of specific symptoms as well as symptom combinations/groups to predict laboratory-confirmed (RT-PCR) infection of SARS-CoV-2. Furthermore, the study is unique in its large sample drawn exclusively from community-based populations rather than hospitalized patients.Implication of all the available evidence: Combining the evidence from this study with prior research suggests that anosmia and ageusia are key symptoms that differentiate COVID-19 from influenza-like symptoms. Clinical screening protocols for COVID-19 should look for these symptoms, which are not commonly asked of patients who present to urgent care or hospital with flu-like symptoms. KEY POINTS: Important symptoms specific to COVID-19 are fever, anosmia, ageusia, and cough. Two-thirds of symptoms were highly specific (>90.0%), yet most symptoms individually possessed a PPV <50.0%. This study confirms using robust methods the key symptoms associated with COVID-19 infection, and it also identifies combinations of symptoms strongly associated with positive infection.

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