Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
Records 1-30 (of 85 Records) |
Query Trace: Baggs J[original query] |
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Epidemiology, clinical characteristics, and diagnostic testing practices for pneumocystis pneumonia-associated hospitalizations, United States, 2019-2022
Benedict K , Baggs J , Gold JAW . Open Forum Infect Dis 2024 11 (2) ofae054 Among 9196 hospitalizations involving Pneumocystis pneumonia, those without HIV had higher in-hospital mortality (24.3% vs 10.5%, P < .001) when compared with those with HIV. These findings underscore the continued importance of Pneumocystis pneumonia clinical awareness and the need for comprehensive prophylaxis guidance, particularly for certain patients without HIV who are immunosuppressed. |
Length of antibiotic therapy among adults hospitalized with uncomplicated community-acquired pneumonia, 2013-2020
McCarthy NL , Baggs J , Wolford H , Kazakova SV , Kabbani S , Attell BK , Neuhauser MM , Walker L , Yi SH , Hatfield KM , Reddy S , Hicks LA . Infect Control Hosp Epidemiol 2024 1-7 OBJECTIVE: The 2014 US National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) aimed to reduce inappropriate inpatient antibiotic use by 20% for monitored conditions, such as community-acquired pneumonia (CAP), by 2020. We evaluated annual trends in length of therapy (LOT) in adults hospitalized with uncomplicated CAP from 2013 through 2020. METHODS: We conducted a retrospective cohort study among adults with a primary diagnosis of bacterial or unspecified pneumonia using International Classification of Diseases Ninth and Tenth Revision codes in MarketScan and the Centers for Medicare & Medicaid Services databases. We included patients with length of stay (LOS) of 2-10 days, discharged home with self-care, and not rehospitalized in the 3 days following discharge. We estimated inpatient LOT based on LOS from the PINC AI Healthcare Database. The total LOT was calculated by summing estimated inpatient LOT and actual postdischarge LOT. We examined trends from 2013 to 2020 in patients with total LOT >7 days, which was considered an indicator of likely excessive LOT. RESULTS: There were 44,976 and 400,928 uncomplicated CAP hospitalizations among patients aged 18-64 years and ≥65 years, respectively. From 2013 to 2020, the proportion of patients with total LOT >7 days decreased by 25% (68% to 51%) among patients aged 18-64 years and by 27% (68%-50%) among patients aged ≥65 years. CONCLUSIONS: Although likely excessive LOT for uncomplicated CAP patients decreased since 2013, the proportion of patients treated with LOT >7 days still exceeded 50% in 2020. Antibiotic stewardship programs should continue to pursue interventions to reduce likely excessive LOT for common infections. |
Antibiotic use among hospitalized patients with COVID-19 in the United States, March 2020-June 2022
Kim C , Wolford H , Baggs J , Reddy S , Hicks LA , Neuhauser MM , Kabbani S . Open Forum Infect Dis 2023 10 (11) ofad503 We conducted a retrospective study to describe antibiotic use among US adults hospitalized with a COVID-19 diagnosis. Despite a decrease in overall antibiotic use, most patients hospitalized with COVID-19 received antibiotics on admission (88.1%) regardless of critical care status, highlighting that more efforts are needed to optimize antibiotic therapy. |
Assessment of hospital-onset SARS-CoV-2 infection rates and testing practices in the US, 2020-2022
Hatfield KM , Baggs J , Maillis A , Warner S , Jernigan JA , Kadri SS , Klompas M , Reddy SC . JAMA Netw Open 2023 6 (8) e2329441 IMPORTANCE: Characterizing the scale and factors associated with hospital-onset SARS-CoV-2 infections could help inform hospital and public health policies regarding prevention and surveillance needs for these infections. OBJECTIVE: To evaluate associations of hospital-onset SARS-CoV-2 infection rates with different periods of the COVID-19 pandemic, hospital characteristics, and testing practices. DESIGN, SETTING, AND PARTICIPANTS: This cohort study of US hospitals reporting SARS-CoV-2 testing data in the PINC AI Healthcare Database COVID-19 special release files was conducted from July 2020 through June 2022. Data were collected from hospitals that reported at least 1 SARS-CoV-2 reverse transcription-polymerase chain reaction or antigen test during hospitalizations discharged that month. For each hospital-month where the hospital reported sufficient data, all hospitalizations discharged in that month were included in the cohort. SARS-CoV-2 viral tests and results reported in the microbiology files for all hospitalizations in the study period by discharge month were identified. Data analysis was conducted from September 2022 to March 2023. EXPOSURE: Hospitalizations discharged in an included hospital-month. MAIN OUTCOMES AND MEASURES: Multivariable generalized estimating equation negative-binomial regression models were used to assess associations of monthly rates of hospital-onset SARS-CoV-2 infections per 1000 patient-days (defined as a first positive SARS-CoV-2 test during after hospitalization day 7) with the phase of the pandemic (defined as the predominant SARS-CoV-2 variant in circulation), admission testing rates, and hospital characteristics (hospital bed size, teaching status, urban vs rural designation, Census region, and patient distribution variables). RESULTS: A total of 5687 hospital-months from 288 distinct hospitals were included, which contributed 4 421 268 hospitalization records. Among 171 564 hospitalizations with a positive SARS-CoV-2 test, 7591 (4.4%) were found to be hospital onset and 6455 (3.8%) were indeterminate onset. The mean monthly hospital-onset infection rate per 1000 patient-days was 0.27 (95 CI, 0.26-0.29). Hospital-onset infections occurred in 2217 of 5687 hospital-months (39.0%). The monthly percentage of discharged patients tested for SARS-CoV-2 at admission varied; 1673 hospital-months (29.4%) had less than 25% of hospitalizations tested at admission; 2199 hospital-months (38.7%) had 25% to 50% of all hospitalizations tested, and 1815 hospital months (31.9%) had more than 50% of all hospitalizations tested at admission. Postadmission testing rates and community-onset infection rates increased with admission testing rates. In multivariable models restricted to hospital-months testing at least 25% of hospitalizations at admission, a 10% increase in community-onset SARS-CoV-2 infection rate was associated with a 178% increase in the hospital-onset infection rate (rate ratio, 2.78; 95% CI, 2.52-3.07). Additionally, the phase of the COVID-19 pandemic, the admission testing rate, Census region, and bed size were all significantly associated with hospital-onset SARS-CoV-2 infection rates. CONCLUSIONS AND RELEVANCE: In this cohort study of hospitals reporting SARS-CoV-2 infections, there was an increase of hospital-onset SARS-CoV-2 infections when community-onset infections were higher, indicating a need for ongoing and enhanced surveillance and prevention efforts to reduce in-hospital transmission of SARS-CoV-2 infections, particularly when community-incidence of SARS-CoV-2 infections is high. |
Candida auris-associated hospitalizations, United States, 2017-2022
Benedict K , Forsberg K , Gold JAW , Baggs J , Lyman M . Emerg Infect Dis 2023 29 (7) 1485-1487 Using a large US hospital database, we describe 192 Candida auris‒associated hospitalizations during 2017-2022, including 38 (20%) C. auris bloodstream infections. Hospitalizations involved extensive concurrent conditions and healthcare use; estimated crude mortality rate was 34%. These findings underscore the continued need for public health surveillance and C. auris containment efforts. |
Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022
Woo EJ , Gee J , Marquez P , Baggs J , Abara WE , McNeil MM , Dimova RB , Su JR . Vaccine 2023 41 (30) 4422-4430 BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis. |
Outbreaks of SARS-CoV-2 infections in nursing homes during periods of Delta and Omicron predominance, United States, July 2021-March 2022
Wilson WW , Keaton AA , Ochoa LG , Hatfield KM , Gable P , Walblay KA , Teran RA , Shea M , Khan U , Stringer G , Ganesan M , Gilbert J , Colletti JG , Grogan EM , Calabrese C , Hennenfent A , Perlmutter R , Janiszewski KA , Brandeburg C , Kamal-Ahmed I , Strand K , Donahue M , Ashraf MS , Berns E , MacFarquhar J , Linder ML , Tran DJ , Kopp P , Walker RM , Ess R , Baggs J , Jernigan JA , Kallen A , Hunter JC . Emerg Infect Dis 2023 29 (4) 761-770 SARS-CoV-2 infections among vaccinated nursing home residents increased after the Omicron variant emerged. Data on booster dose effectiveness in this population are limited. During July 2021-March 2022, nursing home outbreaks in 11 US jurisdictions involving >3 infections within 14 days among residents who had received at least the primary COVID-19 vaccine(s) were monitored. Among 2,188 nursing homes, 1,247 outbreaks were reported in the periods of Delta (n = 356, 29%), mixed Delta/Omicron (n = 354, 28%), and Omicron (n = 536, 43%) predominance. During the Omicron-predominant period, the risk for infection within 14 days of an outbreak start was lower among boosted residents than among residents who had received the primary vaccine series alone (risk ratio [RR] 0.25, 95% CI 0.19-0.33). Once infected, boosted residents were at lower risk for all-cause hospitalization (RR 0.48, 95% CI 0.40-0.49) and death (RR 0.45, 95% CI 0.34-0.59) than primary vaccine-only residents. |
Hospitalizations for unspecified mycoses in a large administrative data set and implications for fungal disease burden estimates, United States, 2019-2021
Benedict K , Baggs J , Wolford H , Jackson BR , Gold JAW . Open Forum Infect Dis 2023 10 (3) ofad100 Fungal diseases are frequently coded as "unspecified mycoses" in data sets used to estimate disease burden. In a large administrative database, 50.9% of unspecified mycosis hospitalizations during 2019-2021 had positive fungal laboratory testing, most commonly Candida (79.1%), highlighting a potential need for improved coding practices and greater fungal laboratory testing. |
Changes in the incidence of invasive bacterial disease during the COVID-19 pandemic in the United States, 2014-2020
Prasad N , Rhodes J , Deng L , McCarthy N , Moline HL , Baggs J , Reddy SC , Jernigan JA , Havers FP , Sosin D , Thomas A , Lynfield R , Schaffner W , Reingold A , Burzlaff K , Harrison LH , Petit S , Farley MM , Herlihy R , Nanduri S , Pilishvili T , McNamara LA , Schrag SJ , Fleming-Dutra KE , Kobayashi M , Arvay M . J Infect Dis 2023 227 (7) 907-916 BACKGROUND: Descriptions of changes in invasive bacterial disease (IBD) epidemiology during the COVID-19 pandemic in the United States are limited. METHODS: We investigated changes in the incidence of IBD due to Streptococcus pneumoniae, Haemophilus influenzae, group A Streptococcus (GAS), and group B Streptococcus (GBS). We defined the COVID-19 pandemic period as March 1-December 31, 2020. We compared observed IBD incidences during the pandemic to expected incidences, consistent with January 2014-February 2020 trends. We conducted secondary analysis of a healthcare database to assess changes in testing by blood and cerebrospinal fluid (CSF) culture during the pandemic. RESULTS: Compared with expected incidences, the observed incidences of IBD due to S. pneumoniae, H. influenzae, GAS, and GBS were 58%, 60%, 28%, and 12% lower during the pandemic period of 2020, respectively. Declines from expected incidences corresponded closely with implementation of COVID-19-associated non-pharmaceutical-interventions (NPIs). Significant declines were observed across all age, race groups and surveillance sites for S pneumoniae and H influenzae. Blood and CSF culture testing rates during the pandemic were comparable to previous years. CONCLUSIONS: NPIs likely contributed to the decline in IBD incidence in the United States in 2020; observed declines were unlikely to be driven by reductions in testing. |
Severe acute respiratory coronavirus virus 2 (SARS-CoV-2) outbreaks in nursing homes involving residents who had completed a primary coronavirus disease 2019 (COVID-19) vaccine series-13 US jurisdictions, July-November 2021.
Wyatt Wilson W , Keaton AA , Ochoa LG , Hatfield KM , Gable P , Walblay KA , Teran RA , Shea M , Khan U , Stringer G , Colletti JG , Grogan EM , Calabrese C , Hennenfent A , Perlmutter R , Janiszewski KA , Kamal-Ahmed I , Strand K , Berns E , MacFarquhar J , Linder M , Tran DJ , Kopp P , Walker RM , Ess R , Read JS , Yingst C , Baggs J , Jernigan JA , Kallen A , Hunter JC . Infect Control Hosp Epidemiol 2023 44 (6) 1-5 Among nursing home outbreaks of coronavirus disease 2019 (COVID-19) with ≥3 breakthrough infections when the predominant severe acute respiratory coronavirus virus 2 (SARS-CoV-2) variant circulating was the SARS-CoV-2 δ (delta) variant, fully vaccinated residents were 28% less likely to be infected than were unvaccinated residents. Once infected, they had approximately half the risk for all-cause hospitalization and all-cause death compared with unvaccinated infected residents. |
Association between thromboembolic events and COVID-19 infection within 30 days: a case-control study among a large sample of adult hospitalized patients in the United States, March 2020-June 2021.
Huang YA , Yusuf H , Adamski A , Hsu J , Baggs J , Auf R , Adjei S , Stoney R , Hooper WC , Llata E , Koumans EH , Ko JY , Romano S , Boehmer TK , Harris AM . J Thromb Thrombolysis 2022 1-6 The association between thromboembolic events (TE) and COVID-19 infection is not completely understood at the population level in the United States. We examined their association using a large US healthcare database. We analyzed data from the Premier Healthcare Database Special COVID-19 Release and conducted a case-control study. Thestudy population consisted of men and non-pregnant women aged18years with (cases) or without (controls) an inpatient ICD-10-CM diagnosis of TE between 3/1/2020 and 6/30/2021. Using multivariable logistic regression, we assessed the association between TE occurrence and COVID-19 diagnosis, adjusting for demographic factors and comorbidities. Among 227,343 cases, 15.2% had a concurrent or prior COVID-19 diagnosis within 30days of their index TE. Multivariable regression analysis showed a statistically significant association between a COVID-19 diagnosis and TE among cases when compared to controls (adjusted odds ratio [aOR]1.75, 95% CI 1.72-1.78). The association was more substantial if a COVID-19 diagnosis occurred 1-30days prior to index hospitalization (aOR3.00, 95% CI 2.88-3.13) compared to the same encounter as the index hospitalization. Our findings suggest an increased risk of TE among persons within 30days of beingdiagnosed COVID-19, highlighting the need for careful consideration of the thrombotic risk among COVID-19 patients, particularly during the first month following diagnosis. |
Association between history of SARS-CoV-2 infection and severe systemic adverse events after mRNA COVID-19 vaccination among U.S. adults.
Tompkins LK , Baggs J , Myers TR , Gee JM , Marquez PL , Kennedy SB , Peake D , Dua D , Hause AM , Strid P , Abara W , Rossetti R , Shimabukuro TT , Shay DK . Vaccine 2022 40 (52) 7653-7659 BACKGROUND: Risk of experiencing a systemic adverse event (AE) after mRNA coronavirus disease 2019 (COVID-19) vaccination may be greater among persons with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; data on serious events are limited. We assessed if adults reporting systemic AEs resulting in emergency department visits or hospitalizations during days 0-7 after mRNA COVID-19 vaccine dose 1 were more likely to have a history of prior SARS-CoV-2 infection compared with persons who reported no or non-severe systemic AEs. METHODS: We conducted a nested case-control study using v-safe surveillance data. Participants were18years and received dose 1 during December 14, 2020May 9, 2021. Cases reported severe systemic AEs 0-7days after vaccination. Three controls were frequency matched per case by age, vaccination date, and days since vaccination. Follow-up surveys collected SARS-CoV-2 histories. RESULTS: Follow-up survey response rates were 38.6% (potential cases) and 56.8% (potential controls). In multivariable analyses including 3,862 case-patients and 11,586 controls, the odds of experiencing a severe systemic AE were 2.4 (Moderna, mRNA-1273; 95% confidence interval [CI]: 1.89, 3.09) and 1.5 (Pfizer-BioNTech, BNT162b2; 95% CI: 1.17, 2.02) times higher among participants with pre-vaccination SARS-CoV-2 histories compared with those without. Medical attention of any kind for symptoms during days 0-7 following dose 2 was not common among case-patients or controls. CONCLUSIONS: History of SARS-CoV-2 infection was significantly associated with severe systemic AEs following dose 1 of mRNA COVID-19 vaccine; the effect varied by vaccine received. Most participants who experienced severe systemic AEs following dose 1 did not require medical attention of any kind for symptoms following dose 2. Vaccine providers can use these findings to counsel patients who had pre-vaccination SARS-CoV-2 infection histories, experienced severe systemic AEs following dose 1, and are considering not receiving additional mRNA COVID-19 vaccine doses. |
Comparison of the risk of recurrent Clostridioides difficile infections among patients in 2018 versus 2013
Guh AY , Yi SH , Baggs J , Winston L , Parker E , Johnston H , Basiliere E , Olson D , Fridkin SK , Mehta N , Wilson L , Perlmutter R , Holzbauer SM , D'Heilly P , Phipps EC , Flores KG , Dumyati GK , Hatwar T , Pierce R , Ocampo VLS , Wilson CD , Watkins JJ , Korhonen L , Paulick A , Adamczyk M , Gerding DN , Reddy SC . Open Forum Infect Dis 2022 9 (9) ofac422 Among persons with an initial Clostridioides difficile infection (CDI) across 10 US sites in 2018 compared with 2013, 18.3% versus 21.1% had 1 recurrent CDI (rCDI) within 180 days. We observed a 16% lower adjusted risk of rCDI in 2018 versus 2013 (P<.0001). |
Declines in the utilization of hospital-based care during COVID-19 pandemic.
Kazakova SV , Baggs J , Parra G , Yusuf H , Romano SD , Ko JY , Harris AM , Wolford H , Rose A , Reddy SC , Jernigan JA . J Hosp Med 2022 17 (12) 984-989 The disruptions of the coronavirus disease 2019 (COVID-19) pandemic impacted the delivery and utilization of healthcare services with potential long-term implications for population health and the hospital workforce. Using electronic health record data from over 700 USacute care hospitals, we documented changes in admissions to hospital service areas (inpatient, observation, emergency room [ER], and same-day surgery) during 2019-2020 and examined whether surges of COVID-19 hospitalizations corresponded with increased inpatient disease severity and death rate. We found that in 2020, hospitalizations declined by 50% in April, with greatest declines occurring in same-day surgery (-73%). The youngest patients (0-17) experienced largest declines in ER, observation, and same-day surgery admissions; inpatient admissions declined the most among the oldest patients (65+). Infectious disease admissions increased by 52%. The monthly measures of inpatient case mix index, length of stay, and non-COVID death rate were higher in all months in 2020 compared with respective months in 2019. |
Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years - United States, May 17-July 31, 2022.
Hause AM , Baggs J , Marquez P , Myers TR , Su JR , Hugueley B , Thompson D , Gee J , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (33) 1047-1051 On May 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine to authorize a homologous* booster dose for children aged 5-11 years ≥5 months after receipt of the second primary series dose(†) (1) based on findings from a clinical trial conducted among 401 children aged 5-11 years (2). To further characterize the safety of booster vaccination in this age group, CDC reviewed adverse events and health impact assessments after receipt of a Pfizer-BioNTech third dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events occurring after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system comanaged by CDC and FDA. During May 17-July 31, 2022, approximately 657,302 U.S. children aged 5-11 years received a third Pfizer-BioNTech dose (either a third primary series dose administered to immunocompromised children or a booster dose administered to immunocompetent children)(§); 3,249 Pfizer-BioNTech third doses were reported to v-safe for children in this age group. Local and systemic reactions were reported to v-safe after a second dose and a third dose with similar frequency; some reactions (e.g., pain) were reported to be moderate or severe more frequently after a third dose. VAERS received 581 reports of adverse events after receipt of a Pfizer-BioNTech third dose by children aged 5-11 years; 578 (99.5%) reports were considered nonserious, and the most common events reported were vaccine administration errors. Three (0.5%) reports were considered serious; no reports of myocarditis or death were received. Local and systemic reactions were common among children after Pfizer-BioNTech third dose vaccination, but reports of serious adverse events were rare. Initial safety findings are consistent with those of the clinical trial (2). |
Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years - United States, March 29, 2022-July 10, 2022.
Hause AM , Baggs J , Marquez P , Abara WE , Baumblatt J , Blanc PG , Su JR , Hugueley B , Parker C , Myers TR , Gee J , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (30) 971-976 The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥5 years receive 1 booster dose of a COVID-19 vaccine after completion of their primary series.* On March 29, 2022, the Food and Drug Administration (FDA) authorized a second mRNA booster dose ≥4 months after receipt of a first booster dose for adults aged ≥50 years and persons aged ≥12 years with moderate to severe immunocompromise (1,2). To characterize the safety of a second mRNA booster dose among persons aged ≥50 years, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) after receipt of a second mRNA booster dose during March 29-July 10, 2022. V-safe is a voluntary smartphone-based U.S. active surveillance system that monitors adverse events occurring after COVID-19 vaccination. VAERS is a U.S. passive surveillance system for monitoring adverse events after vaccination, managed by CDC and FDA (3). During March 29-July 10, 2022, approximately 16.8 million persons in the United States aged ≥50 years received a fourth dose.(†) Among 286,380 v-safe registrants aged ≥50 years who reported receiving a second booster of an mRNA vaccine, 86.9% received vaccines from the same manufacturer for all 4 doses (i.e., homologous vaccination). Among registrants who reported homologous vaccination, injection site and systemic reactions were less frequent after the second booster dose than after the first booster dose. VAERS received 8,515 reports of adverse events after second mRNA booster doses among adults aged ≥50 years, including 8,073 (94.8%) nonserious and 442 (5.1%) serious events. CDC recommends that health care providers and patients be advised that local and systemic reactions are expected after a second booster dose, and that serious adverse events are uncommon. |
Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status - United States, January 12, 2022-March 28, 2022.
Hause AM , Baggs J , Marquez P , Abara WE , Baumblatt JG , Thompson D , Su JR , Myers TR , Gee J , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (28) 899-903 Persons with moderate to severe immunocompromising conditions are at risk for severe COVID-19, and their immune response to COVID-19 vaccination might not be as robust as the response in persons who are not immunocompromised* (1). The Advisory Committee on Immunization Practices (ACIP) recommends that immunocompromised persons aged ≥12 years complete a 3-dose primary mRNA COVID-19 vaccination series followed by a first booster dose (dose 4) ≥3 months after dose 3 and a second booster dose (dose 5) ≥4 months after dose 4.(†) To characterize the safety of first booster doses among immunocompromised persons aged ≥12 years during January 12, 2022-March 28, 2022, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) during the week after receipt of an mRNA COVID-19 first booster dose. V-safe is a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination. VAERS is a passive surveillance system for all vaccine-associated adverse events co-managed by CDC and the Food and Drug Administration (FDA). A fourth mRNA dose reported to v-safe or VAERS during January 12, 2022-March 28, 2022, was presumed to be an mRNA COVID-19 vaccine booster dose administered to an immunocompromised person because no other population was authorized to receive a fourth dose during that period (2,3). In the United States, during January 12, 2022-March 28, 2022, approximately 518,113 persons aged ≥12 years received a fourth dose. Among 4,015 v-safe registrants who received a fourth dose, local and systemic reactions were less frequently reported than were those following dose 3 of their primary series. VAERS received 145 reports after fourth doses; 128 (88.3%) were nonserious and 17 (11.7%) were serious. Health care providers, immunocompromised persons, and parents of immunocompromised children should be aware that local and systemic reactions are expected after a first booster mRNA COVID-19 vaccine dose, serious adverse events are rare, and safety findings were consistent with those previously described among nonimmunocompromised persons (4,5). |
Effectiveness of COVID-19 vaccination against SARS-CoV-2 Infection among Residents of US Nursing Homes, Before and During the Delta variant Predominance, December 2020 - November 2021.
Hatfield KM , Baggs J , Wolford H , Fang M , Sattar AA , Montgomery KS , Jin S , Jernigan J , Pilishvili T . Clin Infect Dis 2022 75 S147-S154 BACKGROUND: Residents of nursing homes experience disproportionate morbidity and mortality related to COVID-19 and were prioritized for vaccine introduction. We evaluated COVID-19 vaccine effectiveness (VE) in preventing SARS-CoV-2 infections among nursing home residents. METHODS: We used a retrospective cohort of 4,315 nursing home residents during December 14, 2020 - November 9, 2021. A Cox proportional hazards model was used to estimate hazard ratios comparing residents with a completed vaccination series to unvaccinated among those with and without prior SARS-CoV-2 infection (identified using positive SARS-CoV-2 tests and/or diagnosis codes), by vaccine product, and by period (before and during Delta variant predominance). VE was estimated as one minus the hazard ratio times 100%. RESULTS: Overall adjusted VE for the completed vaccination series was 58% (95%CI: 44%, 69%) among residents without a history of SARS-CoV-2 infection. During the pre-Delta period, the VE within 150 days of receipt of the second dose of Pfizer-BioNTech (67%, 95%CI: 40%, 82%) and Moderna (75%, 95%CI: 32%, 91%) was similar. During the Delta period, VE measured >150 days after the second dose was 33% (95%CI: -2%, 56%) for Pfizer-BioNTech and 77% (95%CI: 48%, 91%) for Moderna. Rates of infection were 78% lower (95%CI: 67%, 85%) among residents with prior SARS-CoV-2 infection and completed vaccination series compared to unvaccinated residents without a history of SARS-CoV-2 infection. CONCLUSIONS: COVID-19 vaccines were effective in preventing SARS-CoV-2 infections among nursing home residents and history of prior SARS-CoV-2 infection provided additional protection. Maintaining high coverage of recommended doses of COVID-19 vaccines remains a critical tool for preventing infections in nursing homes. |
Antibiotic Resistant Infections among COVID-19 Inpatients in U.S. Hospitals.
Baggs J , Rose AN , McCarthy NL , Wolford H , Srinivasan A , Jernigan JA , Reddy SC . Clin Infect Dis 2022 75 S294-S297 We described bacterial/fungal co-infections and antibiotic resistant infections among inpatients diagnosed with COVID-19 and compared findings with inpatients diagnosed with influenza-like-illness. Less than 10% of COVID-19 inpatients had bacterial/fungal co-infection. Longer lengths of stay, critical care stay, and mechanical ventilation contribute to increased incidence of hospital-onset infections among COVID-19 inpatients. |
Trends in facility-level rates of Clostridioides difficile infections in US hospitals, 2019-2020
Rose AN , Baggs J , Kazakova SV , Guh AY , Yi SH , McCarthy NL , Jernigan JA , Reddy SC . Infect Control Hosp Epidemiol 2022 44 (2) 1-8 OBJECTIVES: The coronavirus disease 2019 pandemic caused substantial changes to healthcare delivery and antibiotic prescribing beginning in March 2020. To assess pandemic impact on Clostridioides difficile infection (CDI) rates, we described patients and trends in facility-level incidence, testing rates, and percent positivity during 2019-2020 in a large cohort of US hospitals. METHODS: We estimated and compared rates of community-onset CDI (CO-CDI) per 10,000 discharges, hospital-onset CDI (HO-CDI) per 10,000 patient days, and C. difficile testing rates per 10,000 discharges in 2019 and 2020. We calculated percent positivity as the number of inpatients diagnosed with CDI over the total number of discharges with a test for C. difficile. We used an interrupted time series (ITS) design with negative binomial and logistic regression models to describe level and trend changes in rates and percent positivity before and after March 2020. RESULTS: In pairwise comparisons, overall CO-CDI rates decreased from 20.0 to 15.8 between 2019 and 2020 (P < .0001). HO-CDI rates did not change. Using ITS, we detected decreasing monthly trends in CO-CDI (-1% per month, P = .0036) and HO-CDI incidence (-1% per month, P < .0001) during the baseline period, prior to the COVID-19 pandemic declaration. We detected no change in monthly trends for CO-CDI or HO-CDI incidence or percent positivity after March 2020 compared with the baseline period. CONCLUSIONS: While there was a slight downward trajectory in CDI trends prior to March 2020, no significant change in CDI trends occurred during the COVID-19 pandemic despite changes in infection control practices, antibiotic use, and healthcare delivery. |
Safety of COVID-19 Vaccination in US Children Ages 5-11 Years.
Hause AM , Shay DK , Klein NP , Abara WE , Baggs J , Cortese MM , Fireman B , Gee J , Glanz JM , Goddard K , Hanson KE , Hugueley B , Kenigsberg T , Kharbanda EO , Lewin B , Lewis N , Marquez P , Myers T , Naleway A , Nelson JC , Su JR , Thompson D , Olubajo B , Oster ME , Weintraub ES , Williams JTB , Yousaf AR , Zerbo O , Zhang B , Shimabukuro TT . Pediatrics 2022 150 (2) BACKGROUND AND OBJECTIVES: Limited post-authorization safety data for BNT-162b2 COVID-19 vaccination among children ages 5-11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the US COVID-19 vaccination program in this age group. METHODS: We analyzed data from 3 US safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system co-managed by CDC and FDA; and the Vaccine Safety Datalink (VSD), an active surveillance system that monitors electronic health records for prespecified events, including myocarditis. RESULTS: Among 48,795 children ages 5-11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7,578 adverse event reports; 97% were non-serious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in males after dose 2 (reporting rate 2.2 per million doses). In VSD, no safety signals were detected in weekly sequential monitoring after administration of 726,820 doses. CONCLUSIONS: Safety findings for BNT-162b2 vaccine from 3 US monitoring systems in children ages 5-11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12-15 years. |
Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years - United States, December 9, 2021-February 20, 2022.
Hause AM , Baggs J , Marquez P , Abara WE , Olubajo B , Myers TR , Su JR , Thompson D , Gee J , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (9) 347-351 As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose.(†) During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare. |
Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults - United States, September 22, 2021-February 6, 2022.
Hause AM , Baggs J , Marquez P , Myers TR , Su JR , Blanc PG , Gwira Baumblatt JA , Woo EJ , Gee J , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (7) 249-254 During September 22, 2021-February 6, 2022, approximately 82.6 million U.S. residents aged ≥18 years received a COVID-19 vaccine booster dose.* The Food and Drug Administration (FDA) has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the United States (1-3).(†) The Advisory Committee on Immunization Practices (ACIP) recommended preferential use of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]) for a booster, even for persons who received the Ad26.COV2.S (Janssen [Johnson & Johnson]) COVID-19 vaccine for their single-dose primary series.(§) To characterize the safety of COVID-19 vaccine boosters among persons aged ≥18 years during September 22, 2021-February 6, 2022, CDC reviewed adverse events and health impact assessments following receipt of a booster that were reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. Among 721,562 v-safe registrants aged ≥18 years who reported receiving a booster, 88.8% received homologous COVID-19 mRNA vaccination. Among registrants who reported a homologous COVID-19 mRNA booster dose, systemic reactions were less frequent following the booster (58.4% [Pfizer-BioNTech] and 64.4% [Moderna], respectively) than were those following dose 2 (66.7% and 78.4%, respectively). The adjusted odds of reporting a systemic reaction were higher following a Moderna COVID-19 vaccine booster, irrespective of the vaccine received for the primary series. VAERS has received 39,286 reports of adverse events after a COVID-19 mRNA booster vaccination for adults aged ≥18 years, including 36,282 (92.4%) nonserious and 3,004 (7.6%) serious events. Vaccination providers should educate patients that local and systemic reactions are expected following a homologous COVID-19 mRNA vaccine booster; however, these reactions appear less common than those following dose 2 of an mRNA-based vaccine. CDC and FDA will continue to monitor vaccine safety and provide data to guide vaccine recommendations and protect public health. |
Trimethoprim-sulfamethoxazole resistance patterns among Staphylococcus aureus in the United States, 2012-2018
Ham DC , Fike L , Wolford H , Lastinger L , Soe M , Baggs J , Walters MS . Infect Control Hosp Epidemiol 2022 44 (5) 1-4 We reviewed trimethoprim-sulfamethoxazole antibiotic susceptibility testing data among Staphylococcus aureus using 3 national inpatient databases. In all 3 databases, we observed an increases in the percentage of methicillin-resistant Staphylococcus aureus that were not susceptible to trimethoprim-sulfamethoxazole. Providers should select antibiotic regimens based on local resistance patterns and should report changes to the public health department. |
Identification and description of patients with multisystem inflammatory syndrome in adults associated with SARS-CoV-2 infection using the Premier Healthcare Database.
DeCuir J , Baggs J , Melgar M , Patel P , Wong KK , Schwartz NG , Bamrah Morris S , Godfred-Cato S , Belay ED . Epidemiol Infect 2022 150 1-22 Multisystem inflammatory syndrome in adults (MIS-A) is a hyperinflammatory illness related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The characteristics of patients with this syndrome and the frequency with which it occurs among patients hospitalised after SARS-CoV-2 infection are unclear. Using the Centers for Disease Control and Prevention case definition for MIS-A, we created ICD-10-CM code and laboratory criteria to identify potential MIS-A patients in the Premier Healthcare Database Special COVID-19 Release, a database containing patient-level information on hospital discharges across the United States. Modified MIS-A criteria were applied to hospitalisations with discharge from March to December 2020. The proportion of hospitalisations meeting electronic health record criteria for MIS-A and descriptive statistics for patients in the potential MIS-A cohort were calculated. Of 34 515 SARS-CoV-2-related hospitalisations with complete clinical and laboratory data, 53 met modified criteria for MIS-A (0.15%). The median age was 62 years (IQR 52-74). Most patients met the severe cardiac illness criterion through either myocarditis (66.0%) or new-onset heart failure (35.8%). A total of 79.2% of patients required ICU admission, while 43.4% of patients in the cohort died. MIS-A appears to be a rare but severe outcome of SARS-CoV-2 infection. Additional studies are needed to investigate how this syndrome differs from severe coronavirus disease 2019 (COVID-19) in adults. |
COVID-19 Vaccine Safety in Children Aged 5-11 Years - United States, November 3-December 19, 2021.
Hause AM , Baggs J , Marquez P , Myers TR , Gee J , Su JR , Zhang B , Thompson D , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2021 70 (5152) 1755-1760 On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5-11 years, administered as 2 doses (10 μg, 0.2mL each) 3 weeks apart (1). As of December 19, 2021, only the Pfizer-BioNTech COVID-19 vaccine is authorized for administration to children aged 5-17 years (2,3). In preauthorization clinical trials, Pfizer-BioNTech COVID-19 vaccine was administered to 3,109 children aged 5-11 years; most adverse events were mild to moderate, and no serious adverse events related to vaccination were reported (4). To further characterize safety of the vaccine in children aged 5-11 years, CDC reviewed adverse events after receipt of Pfizer-BioNTech COVID-19 vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system co-managed by CDC and FDA, and adverse events and health impact assessments reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination,* during November 3-December 19, 2021. Approximately 8.7 million doses of Pfizer-BioNTech COVID-19 vaccine were administered to children aged 5-11 years(†) during this period; VAERS received 4,249 reports of adverse events after vaccination with Pfizer-BioNTech COVID-19 vaccine in this age group, 4,149 (97.6%) of which were not serious. Approximately 42,504 children aged 5-11 years were enrolled in v-safe after vaccination with Pfizer-BioNTech COVID-19 vaccine; after dose 2, a total of 17,180 (57.5%) local and 12,223 systemic (40.9%) reactions (including injection-site pain, fatigue, or headache) were reported. The preliminary safety findings are similar to those from preauthorization clinical trials (4,5). The Advisory Committee on Immunization Practices (ACIP) recommends the Pfizer-BioNTech COVID-19 vaccine for children aged 5-11 years for the prevention of COVID-19 (6). Parents and guardians of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 vaccine should be advised that local and systemic reactions are expected after vaccination. Vaccination is the most effective way to prevent COVID-19. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations. |
Estimation of Coronavirus Disease 2019 Hospitalization Costs From a Large Electronic Administrative Discharge Database, March 2020-July 2021.
Shrestha SS , Kompaniyets L , Grosse SD , Harris AM , Baggs J , Sircar K , Gundlapalli AV . Open Forum Infect Dis 2021 8 (12) ofab561 BACKGROUND: Information on the costs of inpatient care for patients with coronavirus disease 2019 (COVID-19) is very limited. This study estimates the per-patient cost of inpatient care for adult COVID-19 patients seen at >800 US hospitals. METHODS: Patients aged ≥18 years with ≥1 hospitalization during March 2020-July 2021 with a COVID-19 diagnosis code in a large electronic administrative discharge database were included. We used validated costs when reported; otherwise, costs were calculated using charges multiplied by cost-to-charge ratios. We estimated costs of inpatient care per patient overall and by severity indicator, age, sex, underlying medical conditions, and acute complications of COVID-19 using a generalized linear model with log link function and gamma distribution. RESULTS: The overall cost among 654673 patients hospitalized with COVID-19 was $16.2 billion. Estimated per-patient hospitalization cost was $24 826. Among surviving patients, estimated per-patient cost was $13 090 without intensive care unit (ICU) admission or invasive mechanical ventilation (IMV), $21 222 with ICU admission alone, and $59 742 with IMV. Estimated per-patient cost among patients who died was $27 017. Adjusted cost differential was higher among patients with certain underlying conditions (eg, chronic kidney disease [$12 391], liver disease [$8878], cerebrovascular disease [$7267], and obesity [$5933]) and acute complications (eg, acute respiratory distress syndrome [$43 912], pneumothorax [$25 240], and intracranial hemorrhage [$22 280]). CONCLUSIONS: The cost of inpatient care for COVID-19 patients was substantial through the first 17 months of the pandemic. These estimates can be used to inform policy makers and planners and cost-effectiveness analysis of public health interventions to alleviate the burden of COVID-19. |
Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: Findings from the CDC v-safe surveillance system.
Chapin-Bardales J , Myers T , Gee J , Shay DK , Marquez P , Baggs J , Zhang B , Licata C , Shimabukuro TT . Vaccine 2021 39 (48) 7066-7073 BACKGROUND: Post-authorization monitoring of mRNA-based COVID-19 vaccines is needed to better characterize their reactogenicity. We assessed reactions reported during the 2 weeks after receipt of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines. METHODS: We monitored persons who enrolled in v-safe after vaccination health checker(SM), a U.S. smartphone-based vaccine monitoring system, after receiving BNT162b2 or mRNA-1273. V-safe participants received text message prompts to complete web-based surveys. We analyzed responses from persons who received BNT162b2 or mRNA-1273 from December 14, 2020 through March 14, 2021 and completed at least one survey by March 28, 2021. We measured the proportion of participants reporting local and systemic reactions solicited in surveys completed days 0 through 7 post-vaccination. For day 14 surveys, participants described new or worsening symptoms in a free-text response. We assessed the proportion of participants reporting new or worsening local and systemic reactions. RESULTS: One-third of participants were aged <45 years, two-thirds were female, and approximately half received BNT162b2 vaccine. A total of 4,717,908 participants reported during the 7 days after dose 1 and 2,906,377 reported during the 7 days after dose 2. Most reported at least one injection-site reaction (68.5% after dose 1; 72.9% after dose 2) or at least one systemic reaction (50.6% after dose 1; 69.5% after dose 2). Reactogenicity was greater after dose 2 and among mRNA-1273 recipients, persons aged <45 years, and females. New or worsening local and systemic reactions were uncommon during week 2 after either dose; the most frequent were local reactions for dose 1 mRNA-1273 recipients (2.6%). These reactions were reported more often among females after dose 1 mRNA-1273 (3.6%). CONCLUSIONS: During post-authorization monitoring among >4 million vaccinees, local and systemic reactions were commonly reported following mRNA-based vaccines. Reactions were most common during the first week following dose 2 and among persons aged <45 years, females, and mRNA-1273 recipients. |
Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021.
Hause AM , Baggs J , Gee J , Marquez P , Myers TR , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2021 70 (39) 1379-1384 On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose after completion of a primary vaccination series to eligible persons with moderate to severe immunocompromising conditions (1,2). On September 22, 2021, FDA authorized an additional dose of Pfizer-BioNTech vaccine ≥6 months after completion of the primary series among persons aged ≥65 years, at high risk for severe COVID-19, or whose occupational or institutional exposure puts them at high risk for COVID-19 (1). Results from a phase 3 clinical trial conducted by Pfizer-BioNTech that included 306 persons aged 18-55 years showed that adverse reactions after receipt of a third dose administered 5-8 months after completion of a 2-dose primary mRNA vaccination series were similar to those reported after receipt of dose 2; these adverse reactions included mild to moderate injection site and systemic reactions (3). CDC developed v-safe, a voluntary, smartphone-based safety surveillance system, to provide information on adverse reactions after COVID-19 vaccination. Coincident with authorization of an additional dose for persons with immunocompromising conditions, the v-safe platform was updated to allow registrants to enter information about additional doses of COVID-19 vaccine received. During August 12-September 19, 2021, a total of 22,191 v-safe registrants reported receipt of an additional dose of COVID-19 vaccine. Most (97.6%) reported a primary 2-dose mRNA vaccination series followed by a third dose of the same vaccine. Among those who completed a health check-in survey for all 3 doses (12,591; 58.1%), 79.4% and 74.1% reported local or systemic reactions, respectively, after dose 3, compared with 77.6% and 76.5% who reported local or systemic reactions, respectively, after dose 2. These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate. CDC will continue to monitor vaccine safety, including the safety of additional doses of COVID-19 vaccine, and provide data to guide vaccine recommendations and protect public health. |
COVID-19 Vaccine Safety in Adolescents Aged 12-17 Years - United States, December 14, 2020-July 16, 2021.
Hause AM , Gee J , Baggs J , Abara WE , Marquez P , Thompson D , Su JR , Licata C , Rosenblum HG , Myers TR , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2021 70 (31) 1053-1058 As of July 30, 2021, among the three COVID-19 vaccines authorized for use in the United States, only the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine is authorized for adolescents aged 12-17 years. The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine for use in persons aged ≥16 years on December 11, 2020 (1); the EUA was expanded to include adolescents aged 12-15 years on May 10, 2021 (2), based on results from a Phase 3 clinical trial (3). Beginning in June 2021, cases of myocarditis and myopericarditis (hereafter, myocarditis) after receipt of Pfizer-BioNTech vaccine began to be reported, primarily among young males after receipt of the second dose (4,5). On June 23, 2021, CDC's Advisory Committee on Immunization Practices (ACIP) reviewed available data and concluded that the benefits of COVID-19 vaccination to individual persons and the population outweigh the risks for myocarditis and recommended continued use of the vaccine in persons aged ≥12 years (6). To further characterize safety of the vaccine, adverse events after receipt of Pfizer-BioNTech vaccine reported to the Vaccine Adverse Event Reporting System (VAERS) and adverse events and health impact assessments reported in v-safe (a smartphone-based safety surveillance system) were reviewed for U.S. adolescents aged 12-17 years during December 14, 2020-July 16, 2021. As of July 16, 2021, approximately 8.9 million U.S. adolescents aged 12-17 years had received Pfizer-BioNTech vaccine.* VAERS received 9,246 reports after Pfizer-BioNTech vaccination in this age group; 90.7% of these were for nonserious adverse events and 9.3% were for serious adverse events, including myocarditis (4.3%). Approximately 129,000 U.S. adolescents aged 12-17 years enrolled in v-safe after Pfizer-BioNTech vaccination; they reported local (63.4%) and systemic (48.9%) reactions with a frequency similar to that reported in preauthorization clinical trials. Systemic reactions were more common after dose 2. CDC and FDA continue to monitor vaccine safety and provide data to ACIP to guide COVID-19 vaccine recommendations. |
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