Last data update: Sep 23, 2024. (Total: 47723 publications since 2009)
Records 1-30 (of 71 Records) |
Query Trace: Janssen J [original query] |
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Minimally invasive blood collection for an mpox serosurvey among people experiencing homelessness
Waddell CJ , Pellegrini Gj Jr , Persad N , Filardo TD , Prasad N , Carson WC , Navarra T , Townsend MB , Satheshkumar PS , Lowe D , Borne D , Okoye N , Janssen J , Bejarano A , Mosites E , Marx GE . J Appl Lab Med 2024 BACKGROUND: People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group are needed. METHODS: In late 2022, the Centers for Disease Control and Prevention conducted an mpox serological survey using venipuncture among PEH in San Francisco, California. Blood collection by a minimally invasive device was offered if venipuncture was not possible or preferred. Participants who had a successful blood draw using the device were asked about device acceptability. RESULTS: Of the 209 successful blood collections, 137 (66%) were among participants who underwent venipuncture and 72 (34%) were among participants who used the device. Use of the device increased overall blood collection participation by 53%. Participants reported high acceptability and preference for the device over venipuncture. CONCLUSIONS: Minimally invasive blood collection devices may increase participation and representation of PEH in serosurveys. |
Reducing hospitalizations and multidrug-resistant organisms via regional decolonization in hospitals and nursing homes
Gussin GM , McKinnell JA , Singh RD , Miller LG , Kleinman K , Saavedra R , Tjoa T , Gohil SK , Catuna TD , Heim LT , Chang J , Estevez M , He J , O'Donnell K , Zahn M , Lee E , Berman C , Nguyen J , Agrawal S , Ashbaugh I , Nedelcu C , Robinson PA , Tam S , Park S , Evans KD , Shimabukuro JA , Lee BY , Fonda E , Jernigan JA , Slayton RB , Stone ND , Janssen L , Weinstein RA , Hayden MK , Lin MY , Peterson EM , Bittencourt CE , Huang SS . Jama 2024 IMPORTANCE: Infections due to multidrug-resistant organisms (MDROs) are associated with increased morbidity, mortality, length of hospitalization, and health care costs. Regional interventions may be advantageous in mitigating MDROs and associated infections. OBJECTIVE: To evaluate whether implementation of a decolonization collaborative is associated with reduced regional MDRO prevalence, incident clinical cultures, infection-related hospitalizations, costs, and deaths. DESIGN, SETTING, AND PARTICIPANTS: This quality improvement study was conducted from July 1, 2017, to July 31, 2019, across 35 health care facilities in Orange County, California. EXPOSURES: Chlorhexidine bathing and nasal iodophor antisepsis for residents in long-term care and hospitalized patients in contact precautions (CP). MAIN OUTCOMES AND MEASURES: Baseline and end of intervention MDRO point prevalence among participating facilities; incident MDRO (nonscreening) clinical cultures among participating and nonparticipating facilities; and infection-related hospitalizations and associated costs and deaths among residents in participating and nonparticipating nursing homes (NHs). RESULTS: Thirty-five facilities (16 hospitals, 16 NHs, 3 long-term acute care hospitals [LTACHs]) adopted the intervention. Comparing decolonization with baseline periods among participating facilities, the mean (SD) MDRO prevalence decreased from 63.9% (12.2%) to 49.9% (11.3%) among NHs, from 80.0% (7.2%) to 53.3% (13.3%) among LTACHs (odds ratio [OR] for NHs and LTACHs, 0.48; 95% CI, 0.40-0.57), and from 64.1% (8.5%) to 55.4% (13.8%) (OR, 0.75; 95% CI, 0.60-0.93) among hospitalized patients in CP. When comparing decolonization with baseline among NHs, the mean (SD) monthly incident MDRO clinical cultures changed from 2.7 (1.9) to 1.7 (1.1) among participating NHs, from 1.7 (1.4) to 1.5 (1.1) among nonparticipating NHs (group × period interaction reduction, 30.4%; 95% CI, 16.4%-42.1%), from 25.5 (18.6) to 25.0 (15.9) among participating hospitals, from 12.5 (10.1) to 14.3 (10.2) among nonparticipating hospitals (group × period interaction reduction, 12.9%; 95% CI, 3.3%-21.5%), and from 14.8 (8.6) to 8.2 (6.1) among LTACHs (all facilities participating; 22.5% reduction; 95% CI, 4.4%-37.1%). For NHs, the rate of infection-related hospitalizations per 1000 resident-days changed from 2.31 during baseline to 1.94 during intervention among participating NHs, and from 1.90 to 2.03 among nonparticipating NHs (group × period interaction reduction, 26.7%; 95% CI, 19.0%-34.5%). Associated hospitalization costs per 1000 resident-days changed from $64 651 to $55 149 among participating NHs and from $55 151 to $59 327 among nonparticipating NHs (group × period interaction reduction, 26.8%; 95% CI, 26.7%-26.9%). Associated hospitalization deaths per 1000 resident-days changed from 0.29 to 0.25 among participating NHs and from 0.23 to 0.24 among nonparticipating NHs (group × period interaction reduction, 23.7%; 95% CI, 4.5%-43.0%). CONCLUSIONS AND RELEVANCE: A regional collaborative involving universal decolonization in long-term care facilities and targeted decolonization among hospital patients in CP was associated with lower MDRO carriage, infections, hospitalizations, costs, and deaths. |
Social and demographic factors associated with receipt of a COVID-19 vaccine initial booster dose and with interval between primary series completion and initial booster dose uptake among persons aged ≥ 12 years, United States, August 2021-October 2022
Meng L , Harris L , Shaw L , Lymon H , Reses H , Bell J , Lu PJ , Gibbs-Scharf L , Chorba T . Vaccine 2024 COVID-19 booster dose vaccination has been crucial in ensuring protection against COVID-19 including recently predominant Omicron variants. Because vaccines against newer SARS-CoV- 2 variants are likely to be recommended in future, it will be valuable to understand past booster dose uptake among different demographic groups. Using U.S. vaccination data, this study examined intervals between primary series completion and receipt of first booster dose (monovalent or bivalent) during August 2021 - October 2022 among persons ≥12 years of age who had completed a COVID-19 vaccine primary series by October 2021. Sub-populations who were late booster recipients (received a booster dose ≥12 months after the primary series) or received no booster dose included persons <35 years old, Johnson & Johnson/Janssen vaccine primary dose recipients, persons in certain racial and ethnic groups, and persons living in rural and more socially vulnerable areas, and in the South region of the United States; these groups may benefit the most from public health outreach efforts to achieve timely COVID-19 vaccination completion in future. |
Mortality risk after COVID-19 vaccination: A self-controlled case series study
Xu S . Vaccine 2024 BACKGROUND: Although previous studies found no-increased mortality risk after COVID-19 vaccination, residual confounding bias might have impacted the findings. Using a modified self-controlled case series (SCCS) design, we assessed the risk of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes after primary series COVID-19 vaccination. METHODS: We analyzed all deaths between December 14, 2020, and August 11, 2021, among individuals from eight Vaccine Safety Datalink sites. Demographic characteristics of deaths in recipients of COVID-19 vaccines and unvaccinated individuals were reported. We conducted SCCS analyses by vaccine type and death outcomes and reported relative incidences (RI). The observation period for death spanned from the dates of emergency use authorization to the end of the study period (August 11, 2021) without censoring the observation period upon death. We pre-specified a primary risk interval of 28-day and a secondary risk interval of 14-day after each vaccination dose. Adjusting for seasonality in mortality analyses is crucial because death rates vary over time. Deaths among unvaccinated individuals were included in SCCS analyses to account for seasonality by incorporating calendar month in the models. RESULTS: For Pfizer-BioNTech (BNT162b2), RIs of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes were below 1 and 95 % confidence intervals (CIs) excluded 1 across both doses and both risk intervals. For Moderna (mRNA-1273), RI point estimates of all outcomes were below 1, although the 95 % CIs of two RI estimates included 1: cardiac-related (RI = 0.78, 95 % CI, 0.58-1.04) and non-COVID-19 cardiac-related mortality (RI = 0.80, 95 % CI, 0.60-1.08) 14 days after the second dose in individuals without pre-existing cancer and heart disease. For Janssen (Ad26.COV2.S), RIs of four cardiac-related death outcomes ranged from 0.94 to 0.98 for the 14-day risk interval, and 0.68 to 0.72 for the 28-day risk interval and 95 % CIs included 1. CONCLUSION: Using a modified SCCS design and adjusting for temporal trends, no-increased risk was found for non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes among recipients of the three COVID-19 vaccines used in the US. |
Notes from the Field: The National Wastewater Surveillance System's Centers of Excellence contributions to public health action during the respiratory virus season - four U.S. Jurisdictions, 2022-23
Valencia D , Yu AT , Wheeler A , Hopkins L , Pray I , Horter L , Vugia DJ , Matzinger S , Stadler L , Kloczko N , Welton M , Bertsch-Merbach S , Domakonda K , Antkiewicz D , Turner H , Crain C , Mulenga A , Shafer M , Owiti J , Schneider R , Janssen KH , Wolfe MK , McClellan SL , Boehm AB , Roguet A , White B , Schussman MK , Rane MS , Hemming J , Collins C , Abram A , Burnor E , Westergaard R , Ricaldi JN , Person J , Fehrenbach N . MMWR Morb Mortal Wkly Rep 2023 72 (48) 1309-1312 Wastewater surveillance (WWS), the systematic detection of infectious agents in wastewater, provided a valuable tool for monitoring SARS-CoV-2 circulation during the COVID-19 pandemic; surveillance has expanded from 20 to 53 jurisdictions across the United States, with increasing capacity to test for more respiratory pathogens (1,2). This report highlights the use of wastewater data by the four National Wastewater Surveillance System’s (NWSS) Centers of Excellence (California; Colorado; Houston, Texas; and Wisconsin) to guide public health action during the 2022–23 respiratory disease season. This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.* |
Mpox vaccine acceptability among people experiencing homelessness in San Francisco - October-November 2022
Filardo TD , Prasad N , Waddell CJ , Persad N , Pellegrini GJ Jr , Borne D , Janssen J , Bejarano A , Marx GE , Mosites E . Vaccine 2023 41 (39) 5673-5677 Mpox has affected many communities in the United States (U.S.), including people experiencing homelessness (PEH). Mpox vaccination has been an important tool to disrupt transmission and protect communities at risk of infection. To better understand mpox vaccine knowledge and attitudes, we surveyed 273 PEH and people accessing homeless service sites in San Francisco. Among 64 participants previously offered mpox vaccination, 38 (59 %) had received the vaccine. Among 209 participants not previously offered mpox vaccination, 108 (52 %) reported they would receive the vaccine. Vaccine acceptance was higher among transgender female participants and among male participants who reported male sex partner preference (MSM). Half of participants who declined vaccination identified that perception of personal risk and vaccine education may increase their likelihood of receiving an mpox vaccine. Leveraging trusted information sources to provide risk communication and vaccine education may increase vaccine uptake among PEH. |
A summary of the Advisory Committee for Immunization Practices (ACIP) use of a benefit-risk assessment framework during the first year of COVID-19 vaccine administration in the United States
Wallace M , Rosenblum HG , Moulia DL , Broder KR , Shimabukuro TT , Taylor CA , Havers FP , Meyer SA , Dooling K , Oliver SE , Hadler SC , Gargano JW . Vaccine 2023 41 (44) 6456-6467 To inform Advisory Committee for Immunization Practices (ACIP) COVID-19 vaccine policy decisions, we developed a benefit-risk assessment framework that directly compared the estimated benefits of COVID-19 vaccination to individuals (e.g., prevention of COVID-19-associated hospitalization) with risks associated with COVID-19 vaccines. This assessment framework originated following the identification of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination in April 2021. We adapted the benefit-risk assessment framework for use in subsequent policy decisions, including the adverse events of myocarditis and Guillain-Barre syndrome (GBS) following mRNA and Janssen COVID-19 vaccination respectively, expansion of COVID-19 vaccine approvals or authorizations to new age groups, and use of booster doses. Over the first year of COVID-19 vaccine administration in the United States (December 2020-December 2021), we used the benefit-risk assessment framework to inform seven different ACIP policy decisions. This framework allowed for rapid and direct comparison of the benefits and potential harms of vaccination, which may be helpful in informing other vaccine policy decisions. The assessments were a useful tool for decision-making but required reliable and granular data to stratify analyses and appropriately focus on populations most at risk for a specific adverse event. Additionally, careful decision-making was needed on parameters for data inputs. Sensitivity analyses were used where data were limited or uncertain; adjustments in the methodology were made over time to ensure the assessments remained relevant and applicable to the policy questions under consideration. |
Identifying and alleviating bias due to differential depletion of susceptible people in post-marketing evaluations of COVID-19 vaccines (preprint)
Kahn R , Schrag SJ , Verani JR , Lipsitch M . medRxiv 2021 2021.07.15.21260595 Recent studies have provided key information about SARS-CoV-2 vaccines’ efficacy and effectiveness (VE). One important question that remains is whether the protection conferred by vaccines wanes over time. However, estimates over time are subject to bias from differential depletion of susceptibles between vaccinated and unvaccinated groups. Here we examine the extent to which biases occur under different scenarios and assess whether serologic testing has the potential to correct this bias. By identifying non-vaccine antibodies, these tests could identify individuals with prior infection. We find in scenarios with high baseline VE, differential depletion of susceptibles creates minimal bias in VE estimates, suggesting that any observed declines are likely not due to spurious waning alone. However, if baseline VE is lower, the bias for leaky vaccines (that reduce individual probability of infection given contact) is larger and should be corrected by excluding individuals with past infection if the mechanism is known to be leaky. Conducting analyses both unadjusted and adjusted for past infection could give lower and upper bounds for the true VE. Studies of VE should therefore enroll individuals regardless of prior infection history but also collect information, ideally through serologic testing, on this critical variable.Competing Interest StatementDr. Lipsitch reports consulting/honoraria from Bristol Myers Squibb, Sanofi Pasteur, and Merck, as well as a grant through his institution, unrelated to COVID-19, from Pfizer. He has served as an unpaid advisor related to COVID-19 to Pfizer, One Day Sooner, Astra-Zeneca, Janssen, and COVAX (United Biomedical). Dr. Kahn discloses consulting fees from Partners In Health.Funding StatementThis work was supported by the U.S. National Cancer Institute Seronet cooperative agreement U01CA261277. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:N/AAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesCode is available on github. https://github.com/rek160/spurious-waning |
A Remote Household-Based Approach to Influenza Self-Testing and Antiviral Treatment (preprint)
Heimonen J , McCulloch DJ , O'Hanlon J , Kim AE , Emanuels A , Wilcox N , Brandstetter E , Stewart M , McCune D , Fry S , Parsons S , Hughes JP , Jackson ML , Uyeki TM , Boeckh M , Starita LM , Bedford T , Englund JA , Chu HY . medRxiv 2021 2021.02.01.21250973 Background Households represent important settings for transmission of influenza and other respiratory viruses. Current influenza diagnosis and treatment relies upon patient visits to healthcare facilities, which may lead to under-diagnosis and treatment delays. This study aimed to assess the feasibility of an at-home approach to influenza diagnosis and treatment via home testing, telehealth care, and rapid antiviral home delivery.Methods We conducted a pilot interventional study of remote influenza diagnosis and treatment in Seattle-area households with children during the 2019-2020 influenza season using pre-positioned nasal swabs and home influenza tests. Home monitoring for respiratory symptoms occurred weekly; if symptoms were reported within 48 hours of onset, participants collected mid-nasal swabs and used a rapid home-based influenza immunoassay. An additional home-collected swab was returned to a laboratory for confirmatory influenza RT-PCR testing. Baloxavir antiviral treatment was prescribed and delivered to symptomatic and age-eligible participants, following a telehealth encounter.Results 124 households comprising 481 individuals self-monitored for respiratory symptoms, with 58 home tests administered. 12 home tests were positive for influenza, of which 8 were true positives confirmed by RT-PCR. The sensitivity and specificity of the home influenza test was 72.7% and 96.2%, respectively. There were 8 home deliveries of baloxavir, with 7 (87.5%) occurring within 3 hours of prescription, and all within 48 hours of symptom onset.Conclusions We demonstrate the feasibility of self-testing combined with rapid home delivery of influenza antiviral treatment. This approach may be an important control strategy for influenza epidemics and pandemics.Summary In this pilot study, 481 individuals self-monitored for respiratory symptoms. Of 58 home tests, 12 were influenza-positive. There were 8 baloxavir home deliveries within 48 hours of illness onset. A home-based approach to influenza diagnosis and treatment could be feasible.Competing Interest StatementH.Y.C. has received research support from GlaxoSmithKline, Novavax, and Sanofi Pasteur; J.A.E. has received research support from AstraZeneca, GlaxoSmithKine, Merck, and Pfizer and served as a consultant for Sanofi Pasteur and Meissa Vaccines. M.L.J. has received research support from Sanofi Pasteur. M.B. receives research support and serves as a consultant for Ansun Biopharma, Gilead Sciences, Janssen, and Vir Biotechnology; and serves as a consultant to GlaxoSmithKline, ReViral, ADMA, Pulmocdie and ModernaClinical TrialNCT04141930Funding StatementThe Seattle Flu Study is funded by Gates Ventures. The funder was not involved in the design of the study, does not have any ownership over the management and conduct of the study, the data, or the rights to publish.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:University of Washington Institutional Review Board (STUDY00008200)All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData and code used for analyses may be available upon request. |
Clinical Trends Among U.S. Adults Hospitalized with COVID-19, March-December 2020 (preprint)
Garg S , Patel K , Pham H , Whitaker M , O'Halloran A , Milucky J , Anglin O , Kirley PD , Reingold A , Kawasaki B , Herlihy R , Yousey-Hindes K , Maslar A , Anderson EJ , Openo KP , Weigel A , Teno K , Ryan PA , Monroe ML , Reeg L , Kim S , Como-Sabetti K , Bye E , Shrum Davis S , Eisenberg N , Muse A , Barney G , Bennett NM , Felsen CB , Billing L , Shiltz J , Sutton M , Abdullah N , Talbot HK , Schaffner W , Hill M , Chatelain R , Wortham J , Taylor C , Hall A , Fry AM , Kim L , Havers FP . medRxiv 2021 2021.04.21.21255473 Background The COVID-19 pandemic has caused substantial morbidity and mortality.Objectives To describe monthly demographic and clinical trends among adults hospitalized with COVID-19.Design Pooled cross-sectional.Setting 99 counties within 14 states participating in the Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET).Patients U.S. adults (aged ≥18 years) hospitalized with laboratory-confirmed COVID-19 during March 1-December 31, 2020.Measurements Monthly trends in weighted percentages of interventions and outcomes including length of stay (LOS), intensive care unit admissions (ICU), invasive mechanical ventilation (IMV), vasopressor use and in-hospital death (death). Monthly hospitalization, ICU and death rates per 100,000 population.Results Among 116,743 hospitalized adults, median age was 62 years. Among 18,508 sampled adults, median LOS decreased from 6.4 (March) to 4.6 days (December). Remdesivir and systemic corticosteroid use increased from 1.7% and 18.9% (March) to 53.8% and 74.2% (December), respectively. Frequency of ICU decreased from 37.8% (March) to 20.5% (December). IMV (27.8% to 8.7%), vasopressors (22.7% to 8.8%) and deaths (13.9% to 8.7%) decreased from March to October; however, percentages of these interventions and outcomes remained stable or increased in November and December. Percentage of deaths significantly decreased over time for non-Hispanic White patients (p-value <0.01) but not non-Hispanic Black or Hispanic patients. Rates of hospitalization (105.3 per 100,000), ICU (20.2) and death (11.7) were highest during December.Limitations COVID-NET covers approximately 10% of the U.S. population; findings may not be generalizable to the entire country.Conclusions After initial improvement during April-October 2020, trends in interventions and outcomes worsened during November-December, corresponding with the 3rd peak of the U.S. pandemic. These data provide a longitudinal assessment of trends in COVID-19-associated outcomes prior to widespread COVID-19 vaccine implementation.Competing Interest StatementDr. Evan Anderson reports grants from Pfizer, grants from Merck, grants from PaxVax, grants from Micron, grants from Sanofi-Pasteur, grants from Janssen, grants from MedImmune, grants from GSK, personal fees from Sanofi-Pasteur, personal fees from Pfizer, personal fees from Medscape, personal fees from Kentucky Bioprocessing, Inc, personal fees from Sanofi-Pasteur, outside the submitted work. Dr. William Schaffner reports personal fees from VBI Vaccines, outside the submitted work. Funding StatementThis work was supported by the Centers of Disease Control and Prevention through an Emerging Infections Program cooperative agreement (grant CK17-1701) and through a Council of State and Territorial Epidemiologists cooperative agreement (grant NU38OT000297-02-00).Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. Sites participating in COVID-NET obtained approval from their respective state and local Institutional Review Boards, as applicable.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting check ist(s) and other pertinent material as supplementary files, if applicable.YesPublicly available data referred to in this analysis can be found at: https://gis.cdc.gov/grasp/covidnet/covid19_3.html https://gis.cdc.gov/grasp/covidnet/covid19_3.html |
COVID-19-associated hospitalizations among vaccinated and unvaccinated adults ≥18 years – COVID-NET, 13 states, January 1 – July 24, 2021 (preprint)
Havers FP , Pham H , Taylor CA , Whitaker M , Patel K , Anglin O , Kambhampati AK , Milucky J , Zell E , Chai SJ , Kirley PD , Alden NB , Armistead I , Yousey-Hindes K , Meek J , Openo KP , Anderson EJ , Reeg L , Kohrman A , Lynfield R , Como-Sabetti K , Davis EM , Cline C , Muse A , Barney G , Bushey S , Felsen CB , Billing LM , Shiltz E , Sutton M , Abdullah N , Talbot HK , Schaffner W , Hill M , George A , Murthy BP , McMorrow M . medRxiv 2021 2021.08.27.21262356 Background As of August 21, 2021, >60% of the U.S. population aged ≥18 years were fully vaccinated with vaccines highly effective in preventing hospitalization due to Coronavirus Disease-2019 (COVID-19). Infection despite full vaccination (vaccine breakthrough) has been reported, but characteristics of those with vaccine breakthrough resulting in hospitalization and relative rates of hospitalization in unvaccinated and vaccinated persons are not well described, including during late June and July 2021 when the highly transmissible Delta variant predominated.Methods From January 1–June 30, 2021, cases defined as adults aged ≥18 years with laboratory-confirmed Severe Acute Respiratory Coronavirus-2 (SARS-CoV-2) infection were identified from >250 acute care hospitals in the population-based COVID-19-Associated Hospitalization Surveillance Network (COVID-NET). Through chart review for sampled cases, we examine characteristics associated with vaccination breakthrough. From January 24–July 24, 2021, state immunization information system data linked to both >37,000 cases representative cases and the defined surveillance catchment area population were used to compare weekly hospitalization rates in vaccinated and unvaccinated individuals. Unweighted case counts and weighted percentages are presented.Results From January 1 – June 30, 2021, fully vaccinated cases increased from 1 (0.01%) to 321 (16.1%) per month. Among 4,732 sampled cases, fully vaccinated persons admitted with COVID-19 were older compared with unvaccinated persons (median age 73 years [Interquartile Range (IQR) 65-80] v. 59 years [IQR 48-70]; p<0.001), more likely to have 3 or more underlying medical conditions (201 (70.8%) v. 2,305 (56.1%), respectively; p<0.001) and be residents of long-term care facilities [37 (14.5%) v. 146 (5.5%), respectively; p<0.001]. From January 24 – July 24, 2021, cumulative hospitalization rates were 17 times higher in unvaccinated persons compared with vaccinated persons (423 cases per 100,000 population v. 26 per 100,000 population, respectively); rate ratios were 23, 22 and 13 for those aged 18-49, 50-64, and ≥65 years respectively. For June 27 – July 24, hospitalization rates were ≥10 times higher in unvaccinated persons compared with vaccinated persons for all age groups across all weeks.Conclusion Population-based hospitalization rates show that unvaccinated adults aged ≥18 years are 17 times more likely to be hospitalized compared with vaccinated adults. Rates are far higher in unvaccinated persons in all adult age groups, including during a period when the Delta variant was the predominant strain of the SARS-CoV-2 virus. Vaccines continue to play a critical role in preventing serious COVID-19 illness and remain highly effective in preventing COVID-19 hospitalizations.Competing Interest StatementAll authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Evan J. Anderson reports grants from Pfizer, grants from Merck, grants from PaxVax, grants from Micron, grants from Sanofi-Pasteur, grants from Janssen, grants from MedImmune, grants from GSK, personal fees from Sanofi-Pasteur, personal fees from Pfizer, personal fees from Medscape, personal fees from Kentucky Bioprocessing, Inc, personal fees from Sanofi-Pasteur, personal fees from Janssen, outside the submitted work; and his institution has also received funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines. Ruth Lynfield reports Associate Editor for American Academy of Pediatrics Red Book (Committee on Infectious Diseases), donated fee to Minnesota Department of Health. Laurie M. Billing reports grants from Council of State and Territorial Epidemiologists (CSTE), during the conduct of the study; grants from Centers for Disease Control and Prevention (CDC) outside the submitted work. William Schaffner reports personal fees from VBI Vaccines, outside the submitted work. No other potential conflicts of interest were disclosed.Funding StatementThis work was supported by the Centers of Disease Control and Prevention through an Emerging Infections Program cooperative agreement (grant CK17-1701) and through a Council of State and Territorial Epidemiologists cooperative agreement (grant NU38OT000297-02-00).Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (see e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesPublicly available data referred to in this analysis can be found at: https://gis.cdc.gov/grasp/covidnet/covid19_3.html https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html https://gis.cdc.gov/grasp/covidnet/covid19_3.html https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html |
Improving reporting standards for polygenic scores in risk prediction studies (preprint)
Wand H , Lambert SA , Tamburro C , Iacocca MA , O'Sullivan JW , Sillari C , Kullo IJ , Rowley R , Dron JS , Brockman D , Venner E , McCarthy MI , Antoniou AC , Easton DF , Hegele RA , Khera AV , Chatterjee N , Kooperberg C , Edwards K , Vlessis K , Kinnear K , Danesh JN , Parkinson H , Ramos EM , Roberts MC , Ormond KE , Khoury MJ , Janssens Acjw , Goddard KAB , Kraft P , MacArthur JAL , Inouye M , Wojcik GL . medRxiv 2020 2020.04.23.20077099 Polygenic risk scores (PRS), often aggregating the results from genome-wide association studies, can bridge the gap between the initial discovery efforts and clinical applications for disease risk estimation. However, there is remarkable heterogeneity in the reporting of these risk scores. This lack of adherence to reporting standards hinders the translation of PRS into clinical care. The ClinGen Complex Disease Working Group, in a collaboration with the Polygenic Score (PGS) Catalog, have updated the Genetic Risk Prediction (GRIPS) Reporting Statement to the current state of the field and to enable downstream utility. Drawing upon experts in epidemiology, statistics, disease-specific applications, implementation, and policy, this 22-item reporting framework defines the minimal information needed to interpret and evaluate a PRS, especially with respect to any downstream clinical applications. Items span detailed descriptions of the study population (recruitment method, key demographic and clinical characteristics, inclusion/exclusion criteria, and outcome definition), statistical methods for both PRS development and validation, and considerations for potential limitations of the published risk score and downstream clinical utility. Additionally, emphasis has been placed on data availability and transparency to facilitate reproducibility and benchmarking against other PRS, such as deposition in the publicly available PGS Catalog. By providing these criteria in a structured format that builds upon existing standards and ontologies, the use of this framework in publishing PRS will facilitate translation of PRS into clinical care and progress towards defining best practices.Summary In recent years, polygenic risk scores (PRS) have increasingly been used to capture the genome-wide liability underlying many human traits and diseases, hoping to better inform an individual’s genetic risk. However, a lack of adherence to existing reporting standards has hindered the translation of this important tool into clinical and public health practice; in particular, details necessary for benchmarking and reproducibility are underreported. To address this gap, the ClinGen Complex Disease Working Group and Polygenic Score (PGS) Catalog have updated the Genetic Risk Prediction (GRIPS) Reporting Statement into the 22-item Polygenic Risk Score Reporting Statement (PRS-RS). This framework provides the minimal information expected of authors to promote the validity, transparency, and reproducibility of PRS by encouraging authors to detail the study population, statistical methods, and potential clinical utility of a published score. The widespread adoption of this framework will encourage rigorous methodological consideration and facilitate benchmarking to ensure high quality scores are translated into the clinic.Competing Interest StatementMIM is on the advisory panels Pfizer, Novo Nordisk, and Zoe Global; Honoraria: Merck, Pfizer, Novo Nordisk, and Eli Lilly; Research funding: Abbvie, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Pfizer, Roche, Sanofi Aventis, Servier & Takeda. As of June 2019, he is an employee of Genentech with stock and stock options in Roche. No other authors have competing interests to declare.Funding StatementClinGen is primarily funded by the National Human Genome Research Institute (NHGRI), through the following three grants: U41HG006834, U41HG009649, U41HG009650. ClinGen also receives support for content curation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the following three grants: U24HD093483, U24HD093486, U24HD093487. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additionally, the views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Research reported in this publication was supported by the National Human Genome Research Institute of the National Institutes of Health under Award Number U41HG007823 (EBI-NHGRI GWAS Catalog, PGS Catalog). In addition, we acknowledge funding from the European Molecular Biology Laboratory. Individuals were funded from the following sources: MIM was a Wellcome Investigator and an NIHR Senior Investigator with funding from NIDDK (U01-DK105535); Wellcome (090532, 098381, 106130, 203141, 212259). MI, SAL, and JD were supported by core funding from: the UK Medical Research Council (MR/L003120/1), the British Heart Foundation (RG/13/13/30194; RG/18/13/33946) and the National Institute for Health Research (Cambridge Biomedical Research Centre at the Cambridge University Hospitals NHS Foundation Trust). SAL is supported by a Canadian Institutes of Health Research postdoctoral fellowship (MFE-171279). JD holds a British Heart Foundation Personal Chair and a National Institute for Health Research Senior Investigator Award. This work was also supported by Health Data Research UK, which is funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation and Wellcome.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:N/AAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesN/A |
Tracing the origin of SARS-CoV-2 Omicron-like Spike sequences detected in wastewater (preprint)
Shafer MM , Bobholz MJ , Vuyk WC , Gregory D , Roguet A , Haddock Soto LA , Rushford C , Janssen KH , Ries HJ , Pilch HE , Mullen PA , Fahney RB , Wei W , Lambert M , Wenzel J , Halfmann P , Kawaoka Y , Wilson NA , Friedrich TC , Pray IW , Westergaard R , O'Connor DH , Johnson MC . medRxiv 2022 31 Background: The origin of divergent SARS-CoV-2 spike sequences found in wastewater, but not in clinical surveillance, remains unclear. These "cryptic" wastewater sequences have harbored many of the same mutations that later emerged in Omicron lineages. We first detected a cryptic lineage in municipal wastewater in Wisconsin in January 2022. Named the "Wisconsin Lineage", we sought to determine this virus's geographic origin and characterize its persistence and evolution over time. Method(s): We systematically sampled maintenance holes to trace the Wisconsin Lineage's origin. We sequenced spike RBD domains, and where possible, whole viral genomes, to characterize the evolution of this lineage over the 13 consecutive months that it was detectable. Finding(s): The persistence of the Wisconsin Lineage signal allowed us to trace it from a central wastewater plant to a single facility, with a high concentration of viral RNA. The viral sequences contained a combination of fixed nucleotide substitutions characteristic of Pango lineage B.1.234, which circulated in Wisconsin at low levels from October 2020 to February 2021, while mutations in the spike gene resembled those subsequently found in Omicron variants. Interpretation(s): We propose that prolonged detection of the Wisconsin Lineage in wastewater represents persistent shedding of SARS-CoV-2 from an infected individual, with ongoing within-host viral evolution leading to an ancestral B.1.234 virus accumulating "Omicron-like" mutations. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license. |
Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021 (preprint)
Salvatore PP , Lee CC , Sleweon S , McCormick DW , Nicolae L , Knipe K , Dixon T , Banta R , Ogle I , Young C , Dusseau C , Salmonson S , Ogden C , Godwin E , Ballom T , Ross T , Wynn NT , David E , Bessey TK , Kim G , Suppiah S , Tamin A , Harcourt JL , Sheth M , Lowe L , Browne H , Tate JE , Kirking HL , Hagan LM . medRxiv 2021 19 Background The extent to which vaccinated persons who become infected with SARS-CoV-2 contribute to transmission is unclear. During a SARS-CoV-2 Delta variant outbreak among incarcerated persons with high vaccination rates in a federal prison, we assessed markers of viral shedding in vaccinated and unvaccinated persons. Methods Consenting incarcerated persons with confirmed SARS-CoV-2 infection provided mid-turbinate nasal specimens daily for 10 consecutive days and reported symptom data via questionnaire. Real-time reverse transcription-polymerase chain reaction (RT-PCR), viral whole genome sequencing, and viral culture was performed on these nasal specimens. Duration of RT-PCR positivity and viral culture positivity was assessed using survival analysis. Results A total of 978 specimens were provided by 95 participants, of whom 78 (82%) were fully vaccinated and 17 (18%) were not fully vaccinated. No significant differences were detected in duration of RT-PCR positivity among fully vaccinated participants (median: 13 days) versus those not fully vaccinated (median: 13 days; p=0.50), or in duration of culture positivity (medians: 5 days and 5 days; p=0.29). Among fully vaccinated participants, overall duration of culture positivity was shorter among Moderna vaccine recipients versus Pfizer (p=0.048) or Janssen (p=0.003) vaccine recipients. Conclusions As this field continues to develop, clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Outbreak of COVID-19 among vaccinated and unvaccinated homeless shelter residents - Sonoma County, California, July 2021 (preprint)
Bukatko A , Lobato MN , Mosites E , Stainken C , Reihl K , Deldari M , Bell JM , Morris MK , Wadford DA , Harriman K , Mase S . medRxiv 2021 08 In July 2021, the Sonoma County Health Department was alerted to three cases of COVID-19 among residents of a homeless shelter in Santa Rosa, California. Among 153 shelter residents, 83 (54%) were fully vaccinated; 71 (86%) vaccinated residents had received the Janssen COVID-19 vaccine and 12 (14%) received an mRNA (Pfizer BioNTech or Moderna) COVID-19 vaccine. Within 1 month, 116 shelter residents (76%) received positive SARS-CoV-2 test results, including 66 fully vaccinated residents and 50 not fully vaccinated. 9 fully vaccinated and 1 unvaccinated were hospitalized for COVID-19. All hospitalized cases had at least one underlying medical condition. Two deaths occurred, one in a vaccinated resident and one in a non-vaccinated resident. Specimens from 52 residents underwent whole genome sequencing; all were identified as SARS-CoV-2, Delta Variant AY.13 lineage. Additional mitigation measures are needed in medically vulnerable congregate setting where limited resources make individual quarantine and isolation not feasible. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Guillain-Barre Syndrome after COVID-19 Vaccination in the Vaccine Safety Datalink (preprint)
Hanson KE , Goddard K , Lewis N , Fireman B , Myers TR , Bakshi N , Weintraub E , Donahue JG , Nelson JC , Xu S , Glanz JM , Williams JTB , Alpern JD , Klein NP . medRxiv 2021 05 Importance: Post-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barre syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years. Objective(s): To 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design(s): Interim analysis of surveillance data from the Vaccine Safety Datalink. Setting(s): Eight participating integrated healthcare systems in the United States. Participant(s): 10,158,003 individuals aged >=12 years. Exposures: Receipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine. Main Outcomes and Measures: GBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day. Result(s): From December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66). Conclusions and Relevance: In this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license. |
Case series of thrombosis with thrombocytopenia syndrome following COVID-19 vaccination-United States, December 2020-August 2021 (preprint)
See I , Lale A , Marquez P , Streiff MB , Wheeler AP , Tepper NK , Woo EJ , Broder KR , Edwards KM , Gallego R , Geller AI , Jackson KA , Sharma S , Talaat KR , Walter EB , Akpan IJ , Ortel TL , Walker SC , Yui JC , Shimabukuro TT , Mba-Jonas A , Su JR , Shay DK . medRxiv 2021 14 Background: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. TTS presents similarly to autoimmune heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis following Janssen/Johnson & Johnson (Ad26.COV2.S) COVID-19 vaccination have been described. Objective(s): Describe surveillance data and reporting rates of TTS cases following COVID-19 vaccination. Design(s): Case series. Setting(s): United States Patients: Case-patients reported to the Vaccine Adverse Event Reporting System (VAERS) receiving COVID-19 vaccine from December 14, 2020 through August 31, 2021, with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction). If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for anti-platelet factor 4 antibody was required. Measurements: Reporting rates (cases/million vaccine doses) and descriptive epidemiology. Result(s): 52 TTS cases were confirmed following Ad26.COV2.S (n=50) or mRNA-based COVID-19 (n=2) vaccination. TTS reporting rates were 3.55 per million (Ad26.COV2.S) and 0.0057 per million (mRNA-based COVID-19 vaccines). Median age of patients with TTS following Ad26.COV2.S vaccination was 43.5 years (range: 18-70); 70% were female. Both TTS cases following mRNA-based COVID-19 vaccination occurred in males aged >50 years. All cases following Ad26.COV2.S vaccination involved hospitalization including 32 (64%) with intensive care unit admission. Outcomes of hospitalizations following Ad26.COV2.S vaccination included death (12%), discharge to post-acute care (16%), and discharge home (72%). Limitation(s): Under-reporting and incomplete case follow-up. Conclusion(s): TTS is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the two cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
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. |
Tanzania's COVID-19 vaccination strategy: lessons, learning, and execution
Mfinanga SG , Gatei W , Tinuga F , Mwengee WMP , Yoti Z , Kapologwe N , Nagu T , Swaminathan M , Makubi A . Lancet 2023 401 (10389) 1649 Tanzania has taken an unusual route in the COVID-19 pandemic response. In early 2021, Tanzania was reported to have refused COVID-19 vaccines.1 In response, the Tanzanian Government explained the country's position, arguing there were concerns with initial vaccine safety but pointing out that the country was ready to work with the international community in the fight against COVID-19.2 After the appointment of a presidential task force in April, 2021, to establish the country's direction on COVID-19 response, as initially recommended by an expert committee,3 Tanzania joined COVID-19 Vaccines Global Access (COVAX), and the first batch of US-donated Janssen (Johnson & Johnson) COVID-19 vaccines arrived on July 24, 2021. By then, many countries in Africa were on their third round of COVAX consignments. The Tanzanian Government quickly undertook the task of mass vaccinations by starting with priority populations and thereafter resumed sharing COVID-19 epidemiological data with WHO. However, initial vaccine uptake was extremely low due to scepticism. Some assessment studies reported COVID-19 vaccine hesitancy of up to 65% in the general population4 and low vaccine confidence, especially in health-care workers. Another study reported hesitancy of 62% in western Tanzania.5 |
Notes from the field: Prevalence of previous dengue virus infection among children and adolescents - U.S. Virgin Islands, 2022
Mac VV , Wong JM , Volkman HR , Perez-Padilla J , Wakeman B , Delorey M , Biggerstaff BJ , Fagre A , Gumbs A , Drummond A , Zimmerman B , Lettsome B , Medina FA , Paz-Bailey G , Lawrence M , Ellis B , Rosenblum HG , Carroll J , Roth J , Rossington J , Meeker JR , Joseph J , Janssen J , Ekpo LL , Carrillo M , Hernandez N , Charles P , Tosado R , Soto R , Battle S , Bart SM , Wanga V , Valentin W , Powell W , Battiste Z , Ellis EM , Adams LE . MMWR Morb Mortal Wkly Rep 2023 72 (11) 288-289 In May 2019, the Food and Drug Administration issued approval for Dengvaxia (Sanofi Pasteur), a live-attenuated, chimeric tetravalent dengue vaccine (1). In June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended vaccination with Dengvaxia for children and adolescents aged 9–16 years with laboratory confirmation of previous dengue virus infection and who live in areas with endemic dengue transmission, such as the U.S. Virgin Islands (USVI)† (2). Confirming previous dengue virus infection before vaccine administration (prevaccination screening) is important because 1) although Dengvaxia decreases hospitalization and severe disease from dengue among persons with a previous infection, it increases the risk for these outcomes among persons without a previous infection; 2) many dengue virus infections are asymptomatic; and 3) many patients with symptomatic infections do not seek medical attention or receive appropriate testing (3). Sufficient laboratory evidence of previous dengue virus infection includes a history of laboratory-confirmed dengue§ or a positive serologic test result that meets ACIP-recommended performance standards for prevaccination screening, defined as high specificity (≥98%) and sensitivity (≥75%). A seroprevalence of 20% in the vaccine-eligible population (corresponding to a positive predictive value of ≥90% for a test with minimum sensitivity of 75% and minimum specificity of 98%) is recommended to maximize vaccine safety and minimize the risk for vaccinating persons without a previous dengue virus infection (2). |
Possible undetected Mpox infection among persons accessing homeless services and staying in encampments - San Francisco, California, October-November 2022
Waddell CJ , Filardo TD , Prasad N , Pellegrini GJ Jr , Persad N , Carson WC , Navarra T , Townsend MB , Satheshkumar PS , Lowe D , Borne D , Janssen J , Okoye N , Bejarano A , Marx GE , Mosites E . MMWR Morb Mortal Wkly Rep 2023 72 (9) 227-231 Monkeypox (mpox) is a disease caused by an Orthopoxvirus. The 2022 multinational outbreak, which began in May 2022, has spread primarily by close skin-to-skin contact, including through sexual contact. Persons experiencing homelessness have been disproportionately affected by severe mpox (1). However, mpox prevalence and transmission pathways among persons experiencing homelessness are not known, and persons experiencing homelessness have not been specifically recommended to receive mpox vaccine during the 2022 outbreak (2,3). During October 25-November 3, 2022, a CDC field team conducted an orthopoxvirus seroprevalence survey among persons accessing homeless services or staying in encampments, shelters, or permanent supportive housing in San Francisco, California that had noted at least one case of mpox or served populations at risk. During field team visits to 16 unique sites, 209 participants completed a 15-minute survey and provided a blood specimen. Among 80 participants aged <50 years who did not report smallpox or mpox vaccination or previous mpox infection, two (2.5%) had detectable antiorthopoxvirus immunoglobulin (Ig) G antibody. Among 73 participants who did not report mpox vaccination or previous mpox infection and who were tested for IgM, one (1.4%) had detectable antiorthopoxvirus IgM. Together, these results suggest that three possible undetected mpox infections occurred among a sample of persons experiencing homelessness, highlighting the need to ensure that community outreach and prevention interventions, such as vaccination, are accessible to this population. |
Reports of Guillain-Barr Syndrome after COVID-19 vaccination in the United States
Abara WE , Gee J , Marquez P , Woo J , Myers TR , DeSantis A , Baumblatt JAG , Woo EJ , Thompson D , Nair N , Su JR , Shimabukuro TT , Shay DK . JAMA Netw Open 2023 6 (2) e2253845 IMPORTANCE: Because of historical associations between vaccines and Guillain-Barré syndrome (GBS), the condition was a prespecified adverse event of special interest for COVID-19 vaccine monitoring. OBJECTIVE: To evaluate GBS reports to the Vaccine Adverse Event Reporting System (VAERS) and compare reporting patterns within 21 and 42 days after vaccination with Ad26.COV2.S (Janssen), BNT162b2 (Pfizer-BioNTech), and mRNA-1273 (Moderna) COVID-19 vaccines. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted using US VAERS reports submitted during December 2020 to January 2022. GBS case reports verified as meeting the Brighton Collaboration case definition for GBS in US adults after COVID-19 vaccination were included. EXPOSURES: Receipt of the Ad26.COV2.S, BNT162b2, or mRNA-1273 COVID-19 vaccine. MAIN OUTCOMES AND MEASURES: Descriptive analyses of GBS case were conducted. GBS reporting rates within 21 and 42 days after Ad26.COV2.S, BNT162b2, or mRNA-1273 vaccination based on doses administered were calculated. Reporting rate ratios (RRRs) after receipt of Ad26.COV2.S vs BNT162b2 or mRNA-1273 within 21- and 42-day postvaccination intervals were calculated. Observed-to-expected (OE) ratios were estimated using published GBS background rates. RESULTS: Among 4 651 785 COVID-19 vaccine doses, 17 944 515 doses (3.7%) were Ad26.COV2.S, 266 859 784 doses (54.7%) were BNT162b2, and 202 847 486 doses (41.6%) were mRNA-1273. Of 295 verified reports of individuals with GBS identified after COVID-19 vaccination (12 Asian [4.1%], 18 Black [6.1%], and 193 White [65.4%]; 17 Hispanic [5.8%]; 169 males [57.3%]; median [IQR] age, 59.0 [46.0-68.0] years), 275 reports (93.2%) documented hospitalization. There were 209 and 253 reports of GBS that occurred within 21 days and 42 days of vaccination, respectively. Within 21 days of vaccination, GBS reporting rates per 1 000 000 doses were 3.29 for Ad26.COV.2, 0.29 for BNT162b2, and 0.35 for mRNA-1273 administered; within 42 days of vaccination, they were 4.07 for Ad26.COV.2, 0.34 for BNT162b2, and 0.44 for mRNA-1273. GBS was more frequently reported within 21 days after Ad26.COV2.S than after BNT162b2 (RRR = 11.40; 95% CI, 8.11-15.99) or mRNA-1273 (RRR = 9.26; 95% CI, 6.57-13.07) vaccination; similar findings were observed within 42 days after vaccination (BNT162b2: RRR = 12.06; 95% CI, 8.86-16.43; mRNA-1273: RRR = 9.27; 95% CI, 6.80-12.63). OE ratios were 3.79 (95% CI, 2.88-4.88) for 21-day and 2.34 (95% CI, 1.83-2.94) for 42-day intervals after Ad26.COV2.S vaccination and less than 1 (not significant) after BNT162b2 and mRNA-1273 vaccination within both postvaccination periods. CONCLUSIONS AND RELEVANCE: This study found disproportionate reporting and imbalances after Ad26.COV2.S vaccination, suggesting that Ad26.COV2.S vaccination was associated with increased risk for GBS. No associations between mRNA COVID-19 vaccines and risk of GBS were observed. |
Absolute and relative vaccine effectiveness of primary and booster series of COVID-19 vaccines (mRNA and adenovirus vector) against COVID-19 hospitalizations in the United States, December 2021-April 2022
Lewis NM , Murray N , Adams K , Surie D , Gaglani M , Ginde AA , McNeal T , Ghamande S , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hager DN , Ali H , Prekker ME , Frosch AE , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Lauring AS , Khan A , Hough CL , Busse LW , Bender W , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Chappell JD , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Lindsell CJ , Hart KW , Rhoads JP , McMorrow ML , Tenforde MW , Self WH , Patel MM . Open Forum Infect Dis 2023 10 (1) ofac698 BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccine effectiveness (VE) studies are increasingly reporting relative VE (rVE) comparing a primary series plus booster doses with a primary series only. Interpretation of rVE differs from traditional studies measuring absolute VE (aVE) of a vaccine regimen against an unvaccinated referent group. We estimated aVE and rVE against COVID-19 hospitalization in primary-series plus first-booster recipients of COVID-19 vaccines. METHODS: Booster-eligible immunocompetent adults hospitalized at 21 medical centers in the United States during December 25, 2021-April 4, 2022 were included. In a test-negative design, logistic regression with case status as the outcome and completion of primary vaccine series or primary series plus 1 booster dose as the predictors, adjusted for potential confounders, were used to estimate aVE and rVE. RESULTS: A total of 2060 patients were analyzed, including 1104 COVID-19 cases and 956 controls. Relative VE against COVID-19 hospitalization in boosted mRNA vaccine recipients versus primary series only was 66% (95% confidence interval [CI], 55%-74%); aVE was 81% (95% CI, 75%-86%) for boosted versus 46% (95% CI, 30%-58%) for primary. For boosted Janssen vaccine recipients versus primary series, rVE was 49% (95% CI, -9% to 76%); aVE was 62% (95% CI, 33%-79%) for boosted versus 36% (95% CI, -4% to 60%) for primary. CONCLUSIONS: Vaccine booster doses increased protection against COVID-19 hospitalization compared with a primary series. Comparing rVE measures across studies can lead to flawed interpretations of the added value of a new vaccination regimen, whereas difference in aVE, when available, may be a more useful metric. |
Transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021.
Salvatore PP , Lee CC , Sleweon S , McCormick DW , Nicolae L , Knipe K , Dixon T , Banta R , Ogle I , Young C , Dusseau C , Salmonson S , Ogden C , Godwin E , Ballom T , Rhodes T , Wynn NT , David E , Bessey TK , Kim G , Suppiah S , Tamin A , Harcourt JL , Sheth M , Lowe L , Browne H , Tate JE , Kirking HL , Hagan LM . Vaccine 2022 41 (11) 1808-1818 BACKGROUND: The extent to which vaccinated persons who become infected with SARS-CoV-2 contribute to transmission is unclear. During a SARS-CoV-2 Delta variant outbreak among incarcerated persons with high vaccination rates in a federal prison, we assessed markers of viral shedding in vaccinated and unvaccinated persons. METHODS: Consenting incarcerated persons with confirmed SARS-CoV-2 infection provided mid-turbinate nasal specimens daily for 10 consecutive days and reported symptom data via questionnaire. Real-time reverse transcription-polymerase chain reaction (RT-PCR), viral whole genome sequencing, and viral culture was performed on these nasal specimens. Duration of RT-PCR positivity and viral culture positivity was assessed using survival analysis. RESULTS: A total of 957 specimens were provided by 93 participants, of whom 78 (84 %) were vaccinated and 17 (16 %) were unvaccinated. No significant differences were detected in duration of RT-PCR positivity among vaccinated participants (median: 13 days) versus those unvaccinated (median: 13 days; p = 0.50), or in duration of culture positivity (medians: 5 days and 5 days; p = 0.29). Among vaccinated participants, overall duration of culture positivity was shorter among Moderna vaccine recipients versus Pfizer (p = 0.048) or Janssen (p = 0.003) vaccine recipients. In post-hoc analyses, Moderna vaccine recipients demonstrated significantly shorter duration of culture positivity compared to unvaccinated participants (p = 0.02). When restricted to participants without reported prior infection, the difference between Moderna vaccine recipients and unvaccinated participants was more pronounced (medians: 3 days and 6 days, p = 0.002). CONCLUSIONS: Infectious periods for vaccinated and unvaccinated persons who become infected with SARS-CoV-2 are similar and can be highly variable, though some vaccinated persons are likely infectious for shorter durations. These findings are critically important, especially in congregate settings where viral transmission can lead to large outbreaks. In such settings, clinicians and public health practitioners should consider vaccinated, infected persons to be no less infectious than unvaccinated, infected persons. |
A broad assessment of covid-19 vaccine safety using tree-based data-mining in the vaccine safety datalink.
Yih WK , Daley MF , Duffy J , Fireman B , McClure D , Nelson J , Qian L , Smith N , Vazquez-Benitez G , Weintraub E , Williams JTB , Xu S , Maro JC . Vaccine 2022 BACKGROUND: Except for spontaneous reporting systems, vaccine safety monitoring generally involves pre-specifying health outcomes and post-vaccination risk windows of concern. Instead, we used tree-based data-mining to look more broadly for possible adverse events after Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccination. METHODS: Vaccine Safety Datalink enrollees receiving1 dose of COVID-19 vaccine in 2020-2021 were followed for 70days after Pfizer-BioNTech or Moderna and 56days after Janssen vaccination. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the post-vaccination follow-up period. We used the self-controlled tree-temporal scan statistic and TreeScan software. Monte Carlo simulation was used to estimate p-values; p=0.01 was the pre-specified cut-off for statistical significance of a cluster. RESULTS: There were 4.1, 2.6, and 0.4 million Pfizer-BioNTech, Moderna, and Janssen vaccinees, respectively. Clusters after Pfizer-BioNTech vaccination included: (1) unspecified adverse effects, (2) common vaccine reactions, such as fever, myalgia, and headache, (3) myocarditis/pericarditis, and (4) less specific cardiac or respiratory symptoms, all with the strongest clusters generally after Dose 2; and (5) COVID-19/viral pneumonia/sepsis/respiratory failure in the first 3weeks after Dose 1. Moderna results were similar but without a significant myocarditis/pericarditis cluster. Further investigation suggested the fifth signal group was a manifestation of mRNA vaccine effectiveness after the first 3weeks. Janssen vaccinees had clusters of unspecified or common vaccine reactions, gait/mobility abnormalities, and muscle weakness. The latter two were deemed to have arisen from confounding related to practices at one site. CONCLUSIONS: We detected post-vaccination clusters of unspecified adverse effects, common vaccine reactions, and, for the mRNA vaccines, chest pain and palpitations, as well as myocarditis/pericarditis after Pfizer-BioNTech Dose 2. Unique advantages of this data mining are its untargeted nature and its inherent adjustment for the multiplicity of diagnoses and risk intervals scanned. |
Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink.
Katherine Yih W , Daley MF , Duffy J , Fireman B , McClure D , Nelson J , Qian L , Smith N , Vazquez-Benitez G , Weintraub E , Williams JTB , Xu S , Maro JC . Vaccine 2022 41 (2) 460-466 BACKGROUND: The Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD) has been performing safety surveillance for COVID-19 vaccines since their earliest authorization in the United States. Complementing its real-time surveillance for pre-specified health outcomes using pre-specified risk intervals, the VSD conducts tree-based data-mining to look for clustering of a broad range of health outcomes after COVID-19 vaccination. This study's objective was to use this untargeted, hypothesis-generating approach to assess the safety of first booster doses of Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Ad26.COV2.S) COVID-19 vaccines. METHODS: VSD enrollees receiving a first booster of COVID-19 vaccine through April 2, 2022 were followed for 56 days. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the follow-up period. The self-controlled tree-temporal scan statistic was used, conditioning on the total number of cases for each diagnosis. P-values were estimated by Monte Carlo simulation; p = 0.01 was pre-specified as the cut-off for statistical significance of clusters. RESULTS: More than 2.4 and 1.8 million subjects received Pfizer-BioNTech and Moderna boosters after an mRNA primary series, respectively. Clusters of urticaria/allergy/rash were found during Days 10-15 after the Moderna booster (p = 0.0001). Other outcomes that clustered after mRNA boosters, mostly with p = 0.0001, included unspecified adverse effects, common vaccine-associated reactions like fever and myalgia, and COVID-19. COVID-19 clusters were in Days 1-10 after booster receipt, before boosters would have become effective. There were no noteworthy clusters after boosters following primary Janssen vaccination. CONCLUSIONS: In this untargeted data-mining study of COVID-19 booster vaccination, a cluster of delayed-onset urticaria/allergy/rash was detected after the Moderna booster, as has been reported after Moderna vaccination previously. Other clusters after mRNA boosters were of unspecified or common adverse effects and COVID-19, the latter evidently reflecting immunity to COVID-19 after 10 days. |
Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
Attractive Targeted Sugar Bait Phase III Trial Group , Samuels A , Janssen J , Gimnig J . Trials 2022 23 (1) 640 BACKGROUND: Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) target night-time indoor biting mosquitoes and effectively reduce malaria transmission in rural settings across Africa, but additional vector control tools are needed to interrupt transmission. Attractive targeted sugar baits (ATSBs) attract and kill mosquitoes, including those biting outdoors. Deployment of ATSBs incorporating the insecticide dinotefuran was associated with major reductions in mosquito density and longevity in Mali. The impact of this promising intervention on malaria transmission and morbidity now needs to be determined in a range of transmission settings. METHODS/DESIGN: We will conduct three similar stand-alone, open-label, two-arm, cluster-randomized, controlled trials (cRCTs) in Mali, Kenya, and Zambia to determine the impact of ATSB + universal vector control versus universal vector control alone on clinical malaria. The trials will use a "fried-egg" design, with primary outcomes measured in the core area of each cluster to reduce spill-over effects. All household structures in the ATSB clusters will receive two ATSBs, but the impact will be measured in the core of clusters. Restricted randomization will be used. The primary outcome is clinical malaria incidence among children aged 5-14 years in Mali and 1-14 years in Kenya and Zambia. A key secondary outcome is malaria parasite prevalence across all ages. The trials will include 76 clusters (38 per arm) in Mali and 70 (35 per arm) in each of Kenya and Zambia. The trials are powered to detect a 30% reduction in clinical malaria, requiring a total of 3850 person-years of follow-up in Mali, 1260 person-years in Kenya, and 1610 person-years in Zambia. These sample sizes will be ascertained using two seasonal 8-month cohorts in Mali and two 6-month seasonal cohorts in Zambia. In Kenya, which has year-round transmission, four 6-month cohorts will be used (total 24 months of follow-up). The design allows for one interim analysis in Mali and Zambia and two in Kenya. DISCUSSION: Strengths of the design include the use of multiple study sites with different transmission patterns and a range of vectors to improve external validity, a large number of clusters within each trial site, restricted randomization, between-cluster separation to minimize contamination between study arms, and an adaptive trial design. Noted threats to internal validity include open-label design, risk of contamination between study arms, risk of imbalance of covariates across study arms, variation in durability of ATSB stations, and potential disruption resulting from the COVID-19 pandemic. TRIAL REGISTRATION: Zambia: ClinicalTrials.gov NCT04800055 . Registered on March 15, 2021 Mali: ClinicalTrials.gov NCT04149119 . Registered on November 4, 2019 Kenya: ClinicalTrials.gov NCT05219565 . Registered on February 2, 2022. |
Covid-19 Rates by Time since Vaccination during Delta Variant Predominance
Paz-Bailey G , Sternberg M , Kugeler K , Hoots B , Amin AB , Johnson AG , Barbeau B , Bayoumi NS , Bertolino D , Boulton R , Brown CM , Busen K , Cima M , Drenzek C , Gent A , Haney G , Hicks L , Hook S , Jara A , Jones A , Kamal-Ahmed I , Kangas S , Kanishka FNU , Khan SI , Kirkendall SK , Kocharian A , Lyons BC , Lauro P , McCormick D , McMullen C , Milroy L , Reese HE , Sell J , Sierocki A , Smith E , Sosin D , Stanislawski E , Strand K , Troelstrup T , Turner KA , Vest H , Warner S , Wiedeman C , Silk B , Scobie HM . NEJM Evid 2022 1 (3) BACKGROUND: With the emergence of the delta variant, the United States experienced a rapid increase in Covid-19 cases in 2021. We estimated the risk of breakthrough infection and death by month of vaccination as a proxy for waning immunity during a period of delta variant predominance. METHODS: Covid-19 case and death data from 15 U.S. jurisdictions during January 3 to September 4, 2021 were used to estimate weekly hazard rates among fully vaccinated persons, stratified by age group and vaccine product. Case and death rates during August 1 to September 4, 2021 were presented across four cohorts defined by month of vaccination. Poisson models were used to estimate adjusted rate ratios comparing the earlier cohorts to July rates. RESULTS: During August 1 to September 4, 2021, case rates per 100,000 person-weeks among all vaccine recipients for the January to February, March to April, May to June, and July cohorts were 168.8 (95% confidence interval [CI], 167.5 to 170.1), 123.5 (95% CI, 122.8 to 124.1), 83.6 (95% CI, 82.9 to 84.3), and 63.1 (95% CI, 61.6 to 64.6), respectively. Similar trends were observed by age group for BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccine recipients. Rates for the Ad26.COV2.S (Janssen-Johnson & Johnson) vaccine were higher; however, trends were inconsistent. BNT162b2 vaccine recipients 65 years of age or older had higher death rates among those vaccinated earlier in the year. Protection against death was sustained for the mRNA-1273 vaccine recipients. Across age groups and vaccine types, people who were vaccinated 6 months ago or longer (January-February) were 3.44 (3.36 to 3.53) times more likely to be infected and 1.70 (1.29 to 2.23) times more likely to die from COVID-19 than people vaccinated recently in July 2021. CONCLUSIONS: Our study suggests that protection from SARS-CoV-2 infection among all ages or death among older adults waned with increasing time since vaccination during a period of delta predominance. These results add to the evidence base that supports U.S. booster recommendations, especially for older adults vaccinated with BNT162b2 and recipients of the Ad26.COV2.S vaccine. (Funded by the Centers for Disease Control and Prevention.). |
Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines - United States, October 2022.
Rosenblum HG , Wallace M , Godfrey M , Roper LE , Hall E , Fleming-Dutra KE , Link-Gelles R , Pilishvili T , Williams J , Moulia DL , Brooks O , Talbot HK , Lee GM , Bell BP , Daley MF , Meyer S , Oliver SE , Twentyman E . MMWR Morb Mortal Wkly Rep 2022 71 (45) 1436-1441 Four COVID-19 vaccines are currently approved for primary series vaccination in the United States under a Biologics License Application or authorized under an emergency use authorization (EUA) by the Food and Drug Administration (FDA), and recommended for primary series vaccination by the Advisory Committee on Immunization Practices (ACIP): 1) the 2- or 3-dose monovalent mRNA BNT162b2 (Pfizer-BioNTech, Comirnaty) COVID-19 vaccine; 2) the 2- or 3-dose monovalent mRNA mRNA-1273 (Moderna, Spikevax) COVID-19 vaccine; 3) the single-dose adenovirus vector-based Ad26.COV.S (Janssen [Johnson & Johnson]) COVID-19 vaccine; and 4) the 2-dose adjuvanted, protein subunit-based NVX-CoV2373 (Novavax) COVID-19 vaccine. The number of doses recommended is based on recipient age and immunocompromise status (1). For additional protection, FDA has amended EUAs to allow for COVID-19 booster doses in eligible persons (1). Because COVID-19 vaccines have demonstrated decreased effectiveness during the period when the Omicron variant (B.1.1.529) of SARS-CoV-2 predominated, bivalent booster doses (i.e., vaccine with equal components from the ancestral and Omicron strains) were considered for the express purpose of improving protection conferred by COVID-19 vaccine booster doses (2). During September-October 2022, FDA authorized bivalent mRNA vaccines for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series and removed EUAs for monovalent COVID-19 booster doses (1). Pfizer-BioNTech and Moderna bivalent booster vaccines each contain equal amounts of spike mRNA from the ancestral and Omicron BA.4/BA.5 strains. After the EUA amendments, ACIP and CDC recommended that all persons aged ≥5 years receive 1 bivalent mRNA booster dose ≥2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or monovalent booster doses. |
Booster COVID-19 Vaccinations Among Persons Aged ≥5 Years and Second Booster COVID-19 Vaccinations Among Persons Aged ≥50 Years - United States, August 13, 2021-August 5, 2022.
Fast HE , Murthy BP , Zell E , Meng L , Murthy N , Saelee R , Lu PJ , Kang Y , Shaw L , Gibbs-Scharf L , Harris L . MMWR Morb Mortal Wkly Rep 2022 71 (35) 1121-1125 What is already known about this topic A COVID-19 vaccine booster dose provides enhanced protection against SARS-CoV-2 infection, COVID-19-associated emergency department visits, hospitalization, and death. What is added by this report Among 214 million eligible persons aged 5 years, approximately one half received a booster dose. Among 55 million eligible persons aged 50 years, approximately one third received a second booster dose. Booster and second booster dose coverage rates were lower among the youngest age groups; males; non-Hispanic Black or African American, Hispanic or Latino, and multiracial persons; residents of rural counties; and Janssen (Johnson & Johnson) primary series recipients. What are the implications for public health practice Focused interventions to improve vaccine equity and effectiveness of outreach to populations with low booster and second booster dose coverage should be developed and implemented. 2022 Department of Health and Human Services. All rights reserved. |
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