Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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COVID-19 Vaccine Safety Technical (VaST) work group: Enhancing vaccine safety monitoring during the pandemic
Markowitz LE , Hopkins RH Jr , Broder KR , Lee GM , Edwards KM , Daley MF , Jackson LA , Nelson JC , Riley LE , McNally VV , Schechter R , Whitley-Williams PN , Cunningham F , Clark M , Ryan M , Farizo KM , Wong HL , Kelman J , Beresnev T , Marshall V , Shay DK , Gee J , Woo J , McNeil MM , Su JR , Shimabukuro TT , Wharton M , Keipp Talbot H . Vaccine 2024 During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners. |
Recommended adult immunization schedule, United States, 2024
Murthy N , Wodi AP , McNally VV , Daley MF , Cineas S . Ann Intern Med 2024 In October 2023, the Advisory Committee on Immunization Practices (ACIP) voted to approve the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2024. The 2024 adult immunization schedule, available at www.cdc.gov/vaccines/schedules/hcp/imz/adult.html, summarizes ACIP recommendations in the cover page, tables, notes, appendix, and addendum (Figure). The full ACIP recommendations for each vaccine are available at www.cdc.gov/vaccines/hcp/acip-recs/index.html. The 2024 schedule has also been approved by the director of the Centers for Disease Control and Prevention (CDC) and by the American College of Physicians (www.acponline.org), the American Academy of Family Physicians (www.aafp.org), the American College of Obstetricians and Gynecologists (www.acog.org), the American College of Nurse-Midwives (www.midwife.org), the American Academy of Physician Associates (www.aapa.org), the American Pharmacists Association (www.pharmacist.com), and the Society for Healthcare Epidemiology of America (www.shea-online.org). |
Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older - United States, 2024
Murthy N , Wodi AP , McNally VV , Daley MF , Cineas S . MMWR Morb Mortal Wkly Rep 2024 73 (1) 11-15 At its October 2023 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2024. The adult immunization schedule, which can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), is published annually to consolidate and summarize updates to ACIP recommendations on the vaccination of adults and to assist health care providers in implementing current ACIP recommendations. The 2024 immunization schedule includes several changes to the cover page, tables, notes, and appendix from the 2023 immunization schedule.(†) In addition, the 2024 adult immunization schedule includes a new addendum section that summarizes new or updated ACIP recommendations that will occur before the next annual update to the adult immunization schedule. Health care providers are advised to use the cover page, tables, notes, appendix, and addendum together to determine recommended vaccinations for patient populations. |
Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger - United States, 2024
Wodi AP , Murthy N , McNally VV , Daley MF , Cineas S . MMWR Morb Mortal Wkly Rep 2024 73 (1) 6-10 At its October 2023 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2024. The child and adolescent immunization schedule, which can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), is published annually to consolidate and summarize updates to ACIP recommendations on the vaccination of children and adolescents and to assist health care providers in implementing current ACIP recommendations. The 2024 immunization schedule includes several changes to the cover page, tables, notes, and appendix from the 2023 immunization schedule.(†) In addition, the 2024 child and adolescent immunization schedule includes a new addendum section to summarize new or updated ACIP recommendations that will occur before the next annual update to the child and adolescent immunization schedule. Health care providers are advised to use the cover page, tables, notes, appendix, and addendum together to identify the recommended immunizations for patient populations. |
Bystander CPR and long-term survival in older adults with out-of-hospital cardiac arrest
Chan PS , Merritt R , McNally B , Chang A , Al-Araji R , Mawani M , Ahn KO , Girotra S . JACC Adv 2023 2 (8) BACKGROUND: Most studies on bystander cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) have focused on in-hospital or short-term survival. OBJECTIVES: The purpose of this study was to examine the association between bystander CPR and long-term survival outcomes for OHCA. METHODS: Within the Cardiac Arrest Registry to Enhance Survival, we identified 152,653 patients with OHCA ≥65 years of age or older. Using multivariable hierarchical logistic regression, we first examined the association between bystander CPR and in-hospital survival. Then, among those surviving to discharge and linked to Medicare files, we evaluated the association between bystander CPR and long-term mortality over 5 years using multivariable Cox regression. RESULTS: Overall, 58,464 (38.3%) received bystander CPR. Patients receiving bystander CPR were more likely to have an OHCA that was witnessed, in a public location, and with an initial shockable rhythm. Bystander CPR was associated with a 24% higher likelihood of surviving to hospital discharge (10.2% vs 5.5%; adjusted relative risk: 1.24 [95% CI: 1.19-1.29]; P < 0.001), and this survival benefit was similar (interaction P = 0.24) for those who were 65 to 74, 75 to 84, and ≥85 years of age. Among patients surviving to hospital discharge (median follow-up of 31 months), bystander CPR was additionally associated with lower long-term mortality vs those without bystander CPR (adjusted hazard ratio: 0.78 [95% CI: 0.73-0.84]; P < 0.001), and this benefit was also consistent across age groups (interaction P = 0.13). CONCLUSIONS: In older adults with OHCA, bystander CPR was associated with higher rates of in-hospital survival. This survival benefit was not attenuated by competing mortality risks but increased in magnitude after hospital discharge. |
Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older - United States, 2023
Murthy N , Wodi AP , McNally V , Cineas S , Ault K . MMWR Morb Mortal Wkly Rep 2023 72 (6) 141-144 At its October 2022 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2023. The 2023 adult immunization schedule summarizes ACIP recommendations, including several changes to the cover page, tables, notes, and appendix from the 2022 immunization schedule.(†) This schedule can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules). Health care providers are advised to use the cover page, tables, notes, and appendix together to determine recommended vaccinations for patient populations. This adult immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), the American Pharmacists Association (https://www.pharmacist.com), and the Society for Healthcare Epidemiology of America (https://shea-online.org). |
Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger - United States, 2023
Wodi AP , Murthy N , McNally V , Cineas S , Ault K . MMWR Morb Mortal Wkly Rep 2023 72 (6) 137-140 At its October 2022 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2023. The 2023 child and adolescent immunization schedule, available on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), summarizes ACIP recommendations, including several changes from the 2022 immunization schedule(†) on the cover page, tables, notes, and appendix. Health care providers are advised to use the tables, notes, and appendix together to determine recommended vaccinations for patient populations. This immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American Academy of Pediatrics (https://www.aap.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (http://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the National Association of Pediatric Nurse Practitioners (https://www.napnap.org). |
Race and ethnicity data in the cardiac arrest registry to enhance survival: Insights from Medicare self-reported data
Chan PS , Merritt R , Chang A , Girotra S , Kotini-Shah P , Al-Araji R , McNally B . Resuscitation 2022 180 64-67 BACKGROUND: For out-of-hospital cardiac arrest (OHCA), assignment of race/ethnicity data can be challenging. Validation of race/ethnicity in registry data with patients' self-reported race/ethnicity would provide insights regarding misclassification. METHODS: Using recently linked 2013-2019 Cardiac Arrest Registry to Enhance Survival (CARES) data with Medicare files, we examined the concordance of race/ethnicity in CARES with self-reported race/ethnicity in Medicare. Among patients with unknown race/ethnicity in CARES, race/ethnicity data from Medicare files were reported. RESULTS: Of 26,875 patients in the linked data, 5757 (21.4%) had unknown race/ethnicity in CARES. Of the remaining 21,118 patients, 14,284 (67.6%) were identified in CARES as non-Hispanic White, 4771 (22.6%) as non-Hispanic Black, 1213 (5.7%) as Hispanic, 760 (3.6%) as Asian or Pacific Islander, and 90 (0.4%) as American Indian or Alaskan Native. The concordance rate for race/ethnicity between CARES and Medicare was 93.4% for patients reported as non-Hispanic White in CARES, 89.1% for non-Hispanic Blacks, 74.6% for Hispanics, 69.6% for Asians and Pacific Islanders, and 37.8% for American Indian or Alaskan Natives. For the 5757 patients with unknown race/ethnicity in CARES, 3973 (69.0%) self-reported in Medicare as non-Hispanic White, 617 (10.7%) as non-Hispanic Black, 425 (7.4%) as Hispanic, 491 (8.5%) as Asian or Pacific Islander, and 52 (0.9%) as American Indian or Alaskan Native. Race/ethnicity remained unknown in 199 (3.5%) of patients. CONCLUSION: Race/ethnicity in CARES was highly concordant with self-reported race/ethnicity in Medicare, especially for non-Hispanic White and Black individuals. For patients with unknown race/ethnicity data in CARES, the vast majority were of White race. |
Long-term outcomes for out-of-hospital cardiac arrest in elderly patients: An analysis of Cardiac Arrest Registry To Enhance Survival data linked to Medicare files
Chan PS , McNally B , Chang A , Girotra S , Al-Araji R , Mawani M , Ahn KO , Merritt R . Circ Cardiovasc Qual Outcomes 2022 15 (10) 101161circoutcomes122009042 BACKGROUND: Most studies on out-of-hospital cardiac arrest have primarily focused on in-hospital or short-term survival. Little is known about long-term outcomes and resource use among survivors of out-of-hospital cardiac arrest. METHODS: In this observationsl study, we describe overall long-term outcomes for patients from the national Cardiac Arrest Registry to Enhance Survival linked to Medicare files to create the Cardiac Arrest Registry to Enhance Survival: Mortality, Events, and Costs for Cardiac Arrest survivors dataset. Cardiac Arrest Registry to Enhance Survival data between 2013 and 2019 were linked to Medicare data using probabilistic matching algorithms. Overall long-term mortality, readmissions, and index hospitalization costs are reported for the overall cohort. RESULTS: Among 56 425 patients who were 65 years of age or older in Cardiac Arrest Registry to Enhance Survival who survived to hospital admission, 26 875 (47.6%) were successfully linked to Medicare files. Mean (+SD) cost of the index hospitalization was $23 262+$24 199 and the median cost was $14 636 (interquartile range, $9930-$30 033). Overall, 8676 (32.3%) survived to hospital discharge with 38.0% discharged home, 11.8% to hospice care, and the remaining 50.2% to other inpatient, skilled nursing care, or rehabilitation facilities. Mortality after discharge was initially high (27.0% at 3 months) and then increased gradually, with 1- and 3-year mortality of 37.1% and 50.1%, respectively. During the first year, 40.1% were readmitted at least once, with 19.7% readmitted on > 1 occasion. CONCLUSIONS: The Cardiac Arrest Registry to Enhance Survival: Mortality, Events, and Costs for Cardiac Arrest survivors registry includes rich data on postdischarge outcomes and resource utilization. Use of this dataset will enable future investigations on the long-term effectiveness, costs, and cost-effectiveness of various interventions for out-of-hospital cardiac arrest in elderly patients. |
Trends in EMS-attended out-of-hospital cardiac arrest survival, United States 2015-2019
Odom E , Nakajima Y , Vellano K , Al-Araji R , Coleman King S , Zhang Z , Merritt R , McNally B . Resuscitation 2022 179 88-93 AIM: Everyday, nearly 1000 U.S. adults experience out-of-hospital cardiac arrest (OHCA). Survival to hospital discharge varies across many factors, including sociodemographics, location of arrest, and whether bystander intervention was provided. The current study examines recent trends in OHCA survival by location of arrest using a cohort of emergency medical service (EMS) agencies that contributed data to the Cardiac Arrest Registry to Enhance Survival. METHODS: The 2015 CARES cohort (N=122,613) includes EMS agencies contributing data across five consecutive years, 2015-2019. We assessed trends in EMS-attended OHCA survival for the 2015 CARES cohort by location of arrest - public, residential, nursing home. Unadjusted and adjusted percentages were estimated using 3-level hierarchical logistic regression models among cases aged 18-65 years. RESULTS: Overall, survival from EMS-attended OHCA significantly increased from 12.5% in 2015 to 13.8% in 2019 (p=0.001). Survival from bystander witnessed arrests also increased significantly from 17.8% in 2015 to 19.7% in 2019 (p=0.004). The trend for survival increased overall and for bystander witnessed OHCAs occurring in public places and nursing homes. CONCLUSION: Increasing trends for EMS-attended OHCA survival were observed in the overall and bystander witnessed groups. No change in the trend for survival was observed among OHCAs in the groups most likely to have a desirable outcome - bystander witnessed, with a shockable rhythm, and receiving bystander intervention. Reporting and monitoring of OHCA may be an important first step in improving outcomes. Additional community interventions focused on bystander CPR and AED use may be warranted. |
Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older - United States, 2022
Murthy N , Wodi AP , Bernstein H , McNally V , Cineas S , Ault K . MMWR Morb Mortal Wkly Rep 2022 71 (7) 229-233 At its November 2021 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Adult Immunization Schedule for Ages 19 Years or Older, United States, 2022. The 2022 adult immunization schedule summarizes ACIP recommendations, including several changes to the cover page, tables, and notes from the 2021 immunization schedule.() In addition, the 2022 adult immunization schedule provides an appendix that lists the contraindications to and precautions for all routinely recommended vaccines in the schedule. This schedule can be found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules). Health care providers are advised to use the cover page, tables, notes, and appendix together. This adult immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the Society for Healthcare Epidemiology of America (https://www.shea-online.org). |
Advisory Committee on Immunization Practices recommended immunization schedule for children and adolescents aged 18 years or younger - United States, 2022
Wodi AP , Murthy N , Bernstein H , McNally V , Cineas S , Ault K . MMWR Morb Mortal Wkly Rep 2022 71 (7) 234-237 At its November 2021 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger-United States, 2022. The 2022 child and adolescent immunization schedule, found on the CDC immunization schedule website (https://www.cdc.gov/vaccines/schedules), summarizes ACIP recommendations, including several changes from the 2021 immunization schedule() on the cover page, tables, and notes. The 2022 child and adolescent schedule also includes a newly created appendix that lists the contraindications and precautions for all vaccine types in the schedule. Health care providers are advised to use the tables, notes, and appendix together. This immunization schedule is recommended by ACIP (https://www.cdc.gov/vaccines/acip) and approved by CDC (https://www.cdc.gov), the American Academy of Pediatrics (https://www.aap.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (http://www.acog.org), the American College of Nurse-Midwives (https://www.midwife.org), the American Academy of Physician Associates (https://www.aapa.org), and the National Association of Pediatric Nurse Practitioners (https://www.napnap.org). |
Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.
Oliver SE , Wallace M , See I , Mbaeyi S , Godfrey M , Hadler SC , Jatlaoui TC , Twentyman E , Hughes MM , Rao AK , Fiore A , Su JR , Broder KR , Shimabukuro T , Lale A , Shay DK , Markowitz LE , Wharton M , Bell BP , Brooks O , McNally V , Lee GM , Talbot HK , Daley MF . MMWR Morb Mortal Wkly Rep 2022 71 (3) 90-95 On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines. |
Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021
Paz-Bailey G , Adams L , Wong JM , Poehling KA , Chen WH , McNally V , Atmar RL , Waterman SH . MMWR Recomm Rep 2021 70 (6) 1-16 Dengue is a vectorborne infectious disease caused by dengue viruses (DENVs), which are predominantly transmitted by Aedes aegypti and Aedes albopictus mosquitos. Dengue is caused by four closely related viruses (DENV-1-4), and a person can be infected with each serotype for a total of four infections during their lifetime. Areas where dengue is endemic in the United States and its territories and freely associated states include Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau. This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the Dengvaxia vaccine in the United States. The vaccine is a live-attenuated, chimeric tetravalent dengue vaccine built on a yellow fever 17D backbone. Dengvaxia is safe and effective in reducing dengue-related hospitalizations and severe dengue among persons who have had dengue infection in the past. Previous natural infection is important because Dengvaxia is associated with an increased risk for severe dengue in those who experience their first natural infection (i.e., primary infection) after vaccination. Dengvaxia was licensed by the Food and Drug Administration for use among children and adolescents aged 9-16 years (referred to in this report as children). ACIP recommends vaccination with Dengvaxia for children aged 9-16 having evidence of a previous dengue infection and living in areas where dengue is endemic. Evidence of previous dengue infection, such as detection of anti-DENV immunoglobulin G with a highly specific serodiagnostic test, will be required for eligible children before vaccination. |
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.
Rosenblum HG , Hadler SC , Moulia D , Shimabukuro TT , Su JR , Tepper NK , Ess KC , Woo EJ , Mba-Jonas A , Alimchandani M , Nair N , Klein NP , Hanson KE , Markowitz LE , Wharton M , McNally VV , Romero JR , Talbot HK , Lee GM , Daley MF , Mbaeyi SA , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (32) 1094-1099 In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public. |
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021.
Gargano JW , Wallace M , Hadler SC , Langley G , Su JR , Oster ME , Broder KR , Gee J , Weintraub E , Shimabukuro T , Scobie HM , Moulia D , Markowitz LE , Wharton M , McNally VV , Romero JR , Talbot HK , Lee GM , Daley MF , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (27) 977-982 In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,(†) and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.(§) In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,(¶) which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis. |
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021.
MacNeil JR , Su JR , Broder KR , Guh AY , Gargano JW , Wallace M , Hadler SC , Scobie HM , Blain AE , Moulia D , Daley MF , McNally VV , Romero JR , Talbot HK , Lee GM , Bell BP , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (17) 651-656 On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS. |
Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger - United States, 2021
Wodi AP , Ault K , Hunter P , McNally V , Szilagyi PG , Bernstein H . MMWR Morb Mortal Wkly Rep 2021 70 (6) 189-192 At its October 2020 meeting, the Advisory Committee on Immunization Practices* (ACIP) approved the 2021 Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger. After Emergency Use Authorization of Pfizer-BioNTech COVID-19 vaccine by the Food and Drug Administration (FDA), ACIP issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years at its December 12, 2020, meeting (1). In addition, ACIP approved an amendment to include COVID-19 vaccine recommendations in the child and adolescent immunization schedule. After Emergency Use Authorization of Moderna COVID-19 vaccine by FDA, ACIP issued an interim recommendation for use of Moderna COVID-19 vaccine in persons aged ≥18 years at its December 19, 2020, emergency meeting (2). |
Plasmodium Parasitemia Associated With Increased Survival in Ebola Virus-Infected Patients.
Rosenke K , Adjemian J , Munster VJ , Marzi A , Falzarano D , Onyango CO , Ochieng M , Juma B , Fischer RJ , Prescott JB , Safronetz D , Omballa V , Owuor C , Hoenen T , Groseth A , Martellaro C , van Doremalen N , Zemtsova G , Self J , Bushmaker T , McNally K , Rowe T , Emery SL , Feldmann F , Williamson BN , Best SM , Nyenswah TG , Grolla A , Strong JE , Kobinger G , Bolay FK , Zoon KC , Stassijns J , Giuliani R , de Smet M , Nichol ST , Fields B , Sprecher A , Massaquoi M , Feldmann H , de Wit E . Clin Infect Dis 2016 63 (8) 1026-33 BACKGROUND: The ongoing Ebola outbreak in West Africa has resulted in 28 646 suspected, probable, and confirmed Ebola virus infections. Nevertheless, malaria remains a large public health burden in the region affected by the outbreak. A joint Centers for Disease Control and Prevention/National Institutes of Health diagnostic laboratory was established in Monrovia, Liberia, in August 2014, to provide laboratory diagnostics for Ebola virus. METHODS: All blood samples from suspected Ebola virus-infected patients admitted to the Medecins Sans Frontieres ELWA3 Ebola treatment unit in Monrovia were tested by quantitative real-time polymerase chain reaction for the presence of Ebola virus and Plasmodium species RNA. Clinical outcome in laboratory-confirmed Ebola virus-infected patients was analyzed as a function of age, sex, Ebola viremia, and Plasmodium species parasitemia. RESULTS: The case fatality rate of 1182 patients with laboratory-confirmed Ebola virus infections was 52%. The probability of surviving decreased with increasing age and decreased with increasing Ebola viral load. Ebola virus-infected patients were 20% more likely to survive when Plasmodium species parasitemia was detected, even after controlling for Ebola viral load and age; those with the highest levels of parasitemia had a survival rate of 83%. This effect was independent of treatment with antimalarials, as this was provided to all patients. Moreover, treatment with antimalarials did not affect survival in the Ebola virus mouse model. CONCLUSIONS: Plasmodium species parasitemia is associated with an increase in the probability of surviving Ebola virus infection. More research is needed to understand the molecular mechanism underlying this remarkable phenomenon and translate it into treatment options for Ebola virus infection. |
Ebola laboratory response at the Eternal Love Winning Africa Campus, Monrovia, Liberia, 2014-2015
de Wit E , Rosenke K , Fischer RJ , Marzi A , Prescott J , Bushmaker T , van Doremalen N , Emery SL , Falzarano D , Feldmann F , Groseth A , Hoenen T , Juma B , McNally KL , Ochieng M , Omballa V , Onyango CO , Owuor C , Rowe T , Safronetz D , Self J , Williamson BN , Zemtsova G , Grolla A , Kobinger G , Rayfield M , Stroher U , Strong JE , Best SM , Ebihara H , Zoon KC , Nichol ST , Nyenswah TG , Bolay FK , Massaquoi M , Feldmann H , Fields B . J Infect Dis 2016 214 S169-S176 West Africa experienced the first epidemic of Ebola virus infection, with by far the greatest number of cases in Guinea, Sierra Leone, and Liberia. The unprecedented epidemic triggered an unparalleled response, including the deployment of multiple Ebola treatment units and mobile/field diagnostic laboratories. The National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention deployed a joint laboratory to Monrovia, Liberia, in August 2014 to support the newly founded Ebola treatment unit at the Eternal Love Winning Africa (ELWA) campus. The laboratory operated initially out of a tent structure but quickly moved into a fixed-wall building owing to severe weather conditions, the need for increased security, and the high sample volume. Until May 2015, when the laboratory closed, the site handled close to 6000 clinical specimens for Ebola virus diagnosis and supported the medical staff in case patient management. Laboratory operation and safety, as well as Ebola virus diagnostic assays, are described and discussed; in addition, lessons learned for future deployments are reviewed. |
Nanopore Sequencing as a Rapidly Deployable Ebola Outbreak Tool.
Hoenen T , Groseth A , Rosenke K , Fischer RJ , Hoenen A , Judson SD , Martellaro C , Falzarano D , Marzi A , Squires RB , Wollenberg KR , de Wit E , Prescott J , Safronetz D , van Doremalen N , Bushmaker T , Feldmann F , McNally K , Bolay FK , Fields B , Sealy T , Rayfield M , Nichol ST , Zoon KC , Massaquoi M , Munster VJ , Feldmann H . Emerg Infect Dis 2016 22 (2) 331-4 Rapid sequencing of RNA/DNA from pathogen samples obtained during disease outbreaks provides critical scientific and public health information. However, challenges exist for exporting samples to laboratories or establishing conventional sequencers in remote outbreak regions. We successfully used a novel, pocket-sized nanopore sequencer at a field diagnostic laboratory in Liberia during the current Ebola virus outbreak. |
The merits of malaria diagnostics during an Ebola virus disease outbreak
de Wit E , Falzarano D , Onyango C , Rosenke K , Marzi A , Ochieng M , Juma B , Fischer RJ , Prescott JB , Safronetz D , Omballa V , Owuor C , Hoenen T , Groseth A , van Doremalen N , Zemtsova G , Self J , Bushmaker T , McNally K , Rowe T , Emery SL , Feldmann F , Williamson B , Nyenswah TG , Grolla A , Strong JE , Kobinger G , Stroeher U , Rayfield M , Bolay FK , Zoon KC , Stassijns J , Tampellini L , de Smet M , Nichol ST , Fields B , Sprecher A , Feldmann H , Massaquoi M , Munster VJ . Emerg Infect Dis 2016 22 (2) 323-6 Malaria is a major public health concern in the countries affected by the Ebola virus disease epidemic in West Africa. We determined the feasibility of using molecular malaria diagnostics during an Ebola virus disease outbreak and report the incidence of Plasmodium spp. parasitemia in persons with suspected Ebola virus infection. |
A summary of public access defibrillation laws, United States, 2010
Gilchrist S , Schieb L , Mukhtar Q , Valderrama A , Yoon P , Sasson C , McNally B , Schooley M . Prev Chronic Dis 2012 9 E71 INTRODUCTION: On average, less than 8% of people who experience an out-of-hospital cardiac arrest survive. However, death from sudden cardiac arrest is preventable if a bystander quickly retrieves and applies an automated external defibrillator (AED). Public access defibrillation (PAD) policies have been enacted to create programs that increase the public availability of these devices. The objective of this study was to describe each state's legal requirements for recommended PAD program elements. METHODS: We reviewed state laws and described the extent to which 13 PAD program elements are mandated in each state. RESULTS: No jurisdiction requires all 13 PAD program elements, 18% require at least 10 elements, and 31% require 3 or fewer elements. All jurisdictions provide some level of immunity to AED users, 60% require PAD maintenance, 59% require emergency medical service notification, 55% impose training requirements, and 41% require medical oversight. Few jurisdictions require a quality improvement process. CONCLUSION: PAD programs in many states are at risk of failure because critical elements such as maintenance, medical oversight, emergency medical service notification, and continuous quality improvement are not required. Policy makers should consider strengthening PAD policies by enacting laws that can reduce the time from collapse to shock, such as requiring the strategic placement of AEDs in high-risk locations or mandatory PAD registries that are coordinated with local EMS and dispatch centers. Further research is needed to identify the most effective PAD policies for increasing AED use by lay persons and improving survival rates. |
Guidelines for the identification of unknown samples for laboratories performing forensic analyses for chemical terrorism
Magnuson ML , Satzger RD , Alcaraz A , Brewer J , Fetterolf D , Harper M , Hrynchuk R , McNally MF , Montgomery M , Nottingham E , Peterson J , Rickenbach M , Seidel JL , Wolnik K . J Forensic Sci 2011 57 (3) 636-42 Since the early 1990s, the FBI Laboratory has sponsored Scientific Working Groups to improve discipline practices and build consensus among the forensic community. The Scientific Working Group on the Forensic Analysis of Chemical, Biological, Radiological and Nuclear Terrorism developed guidance, contained in this document, on issues forensic laboratories encounter when accepting and analyzing unknown samples associated with chemical terrorism, including laboratory capabilities and analytical testing plans. In the context of forensic analysis of chemical terrorism, this guidance defines an unknown sample and addresses what constitutes definitive and tentative identification. Laboratory safety, reporting issues, and postreporting considerations are also discussed. Utilization of these guidelines, as part of planning for forensic analysis related to a chemical terrorism incident, may help avoid unfortunate consequences not only to the public but also to the laboratory personnel. |
Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010
McNally B , Robb R , Mehta M , Vellano K , Valderrama AL , Yoon PW , Sasson C , Crouch A , Perez AB , Merritt R , Kellermann A . MMWR Surveill Summ 2011 60 (8) 1-19 PROBLEM/CONDITION: Each year, approximately 300,000 persons in the United States experience an out-of-hospital cardiac arrest (OHCA); approximately 92% of persons who experience an OHCA event die. An OHCA is defined as cessation of cardiac mechanical activity that occurs outside of the hospital setting and is confirmed by the absence of signs of circulation. Whereas an OHCA can occur from noncardiac causes (i.e., trauma, drowning, overdose, asphyxia, electrocution, primary respiratory arrests, and other noncardiac etiologies), the majority (70%--85%) of such events have a cardiac cause. The majority of persons who experience an OHCA event, irrespective of etiology, do not receive bystander-assisted cardiopulmonary resuscitation (CPR) or other timely interventions that are known to improve the likelihood of survival to hospital discharge (e.g., defibrillation). Because nearly half of cardiac arrest events are witnessed, efforts to increase survival rates should focus on timely and effective delivery of interventions by bystanders and emergency medical services (EMS) personnel. This is the first report to provide summary data from an OHCA surveillance registry in the United States. REPORTING PERIOD: This report summarizes surveillance data collected during October 1, 2005-- December 31, 2010. DESCRIPTION OF THE SYSTEM: In 2004, CDC established the Cardiac Arrest Registry to Enhance Survival (CARES) in collaboration with the Department of Emergency Medicine at the Emory University School of Medicine. This registry evaluates only OHCA events of presumed cardiac etiology that involve persons who received resuscitative efforts, including CPR or defibrillation. Participating sites collect data from three sources that define the continuum of emergency cardiac care: 911 dispatch centers, EMS providers, and receiving hospitals. OHCA is defined in CARES as a cardiac arrest that occurred in the prehospital setting, had a presumed cardiac etiology, and involved a person who received resuscitative efforts, including CPR or defibrillation. RESULTS: During October 1, 2005--December 31, 2010, a total of 40,274 OHCA records were submitted to the CARES registry. After noncardiac etiology arrests and missing hospital outcomes were excluded from the analysis (n = 8,585), 31,689 OHCA events of presumed cardiac etiology (e.g., myocardial infarction or arrhythmia) that received resuscitation efforts in the prehospital setting were analyzed. The mean age at cardiac arrest was 64.0 years (standard deviation [SD]: 18.2); 61.1% of persons who experienced OHCA were male (n = 19,360). According to local EMS agency protocols, 21.6% of patients were pronounced dead after resuscitation efforts were terminated in the prehospital setting. The survival rate to hospital admission was 26.3%, and the overall survival rate to hospital discharge was 9.6%. Approximately 36.7% of OHCA events were witnessed by a bystander. Only 33.3% of all patients received bystander CPR, and only 3.7% were treated by bystanders with an automated external defibrillator (AED) before the arrival of EMS providers. The group most likely to survive an OHCA are persons who are witnessed to collapse by a bystander and found in a shockable rhythm (e.g., ventricular fibrillation or pulseless ventricular tachycardia). Among this group, survival to discharge was 30.1%. A subgroup analysis was performed among persons who experienced OHCA events that were not witnessed by EMS personnel to evaluate rates of bystander CPR for these persons. After exclusion of 3,400 OHCA events that occurred after the arrival of EMS providers, bystander CPR information was analyzed for 28,289 events. In this group, whites were significantly more likely to receive CPR than blacks, Hispanics, or members of other racial/ethnic populations (p<0.001). Overall survival to hospital discharge of patients whose events were not witnessed by EMS personnel was 8.5%. Of these, patients who received bystander CPR had a significantly higher rate of overall survival (11.2%) than those who did not (7.0%) (p<0.001). INTERPRETATION: CARES data have helped identify opportunities for improvement in OHCA care. The registry is being used continually to monitor prehospital performance and selected aspects of hospital care to improve quality of care and increase rates of survival following OHCA. CARES data confirm that patients who receive CPR from bystanders have a greater chance of surviving OHCA than those who do not. PUBLIC HEALTH ACTIONS: Medical directors and public health professionals in participating communities use CARES data to measure and improve the quality of prehospital care for persons experiencing OHCA. Tracking performance longitudinally allows communities to better understand which elements of their care are working well and which elements need improvement. Education of public officials and community members about the importance of increasing rates of bystander CPR and promoting the use of early defibrillation by lay and professional rescuers is critical to increasing survival rates. Reporting at the state and local levels can enable state and local public health and EMS agencies to coordinate their efforts to target improving emergency response for OHCA events, regardless of etiology, which can lead to improvement in OHCA survival rates. |
Published norms underestimate the health-related quality of life among persons with type 2 diabetes
Norris SL , McNally TK , Zhang X , Burda B , Chan B , Chowdhury FM , Zhang P , Patrick D . J Clin Epidemiol 2011 64 (4) 358-65 OBJECTIVE: To assess health-related quality of life (HRQL) among adults with type 2 diabetes using the Short Form (SF)-36 and to obtain pooled estimates of HRQL for subpopulations defined by demographic characteristics, diabetes-related complications, and comorbidities. STUDY DESIGN AND METHODS: We conducted computerized searches of multiple electronic bibliographic databases, and studies in any language were selected in which HRQL was reported among adults with type 2 diabetes using the SF-36. Estimates were combined using a random-effects model. RESULTS: One hundred eighteen studies fulfilled the inclusion criteria. HRQL was lower in persons with type 2 diabetes, as measured by all the eight component scores of the SF-36 when compared with the existing U.S. population norms and with previously published type 2 diabetes norms. SF-36 component and summary scores were extremely heterogeneous, and subpopulation data were sparse; this precluded obtaining meaningful pooled scores for most populations of interest and made comparisons among subpopulations difficult. CONCLUSION: Our data suggest that previously published norms may underestimate the effect of diabetes on HRQL, and diabetes populations are extremely heterogeneous, making broad population "norms" for HRQL in type 2 diabetes of limited use. Additional research with important subpopulations and individual-level data are needed to further explore the effect of diabetes on HRQL. |
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