Last data update: Oct 07, 2024. (Total: 47845 publications since 2009)
Records 1-17 (of 17 Records) |
Query Trace: Moulia DL[original query] |
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Use of COVID-19 vaccines for persons aged ≥6 months: Recommendations of the advisory committee on immunization practices - United States, 2024-2025
Panagiotakopoulos L , Moulia DL , Godfrey M , Link-Gelles R , Roper L , Havers FP , Taylor CA , Stokley S , Talbot HK , Schechter R , Brooks O , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2024 73 (37) 819-824 COVID-19 vaccination provides additional protection against severe COVID-19-associated illness and death. Since September 2023, 2023-2024 Formula monovalent XBB.1-strain COVID-19 vaccines have been recommended for use in the United States for all persons aged ≥6 months. However, SARS-CoV-2 continues to evolve, and since winter 2023-2024, Omicron JN.1 lineage strains of SARS-CoV-2, including the JN.1 strain and the KP.2 strain, have been widely circulating in the United States. Further, COVID-19 vaccine effectiveness is known to wane. On June 27, 2024, the Advisory Committee on Immunization Practices (ACIP) recommended 2024-2025 COVID-19 vaccination with a Food and Drug Administration (FDA)-approved or authorized vaccine for all persons aged ≥6 months. On August 22, 2024, FDA approved the 2024-2025 COVID-19 vaccines by Moderna and Pfizer-BioNTech (based on the KP.2 strain) for use in persons aged ≥12 years and authorized these vaccines for use in children aged 6 months-11 years under Emergency Use Authorization (EUA). On August 30, 2024, FDA authorized 2024-2025 COVID-19 vaccine by Novavax (based on the JN.1 strain) for use in persons aged ≥12 years under EUA. ACIP will continue to evaluate new evidence as it becomes available and will update recommendations as needed. |
Use of an additional updated 2023-2024 COVID-19 vaccine dose for adults aged ≥65 years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024
Panagiotakopoulos L , Godfrey M , Moulia DL , Link-Gelles R , Taylor CA , Chatham-Stephens K , Brooks O , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2024 73 (16) 377-381 COVID-19 remains an important public health threat, despite overall decreases in COVID-19-related severe disease since the start of the COVID-19 pandemic. COVID-19-associated hospitalization rates remain higher among adults aged ≥65 years relative to rates in younger adults, adolescents, and children; during October 2023-January 2024, 67% of all COVID-19-associated hospitalizations were among persons aged ≥65 years. On September 12, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommended updated (2023-2024 Formula) COVID-19 vaccination with a monovalent XBB.1.5-derived vaccine for all persons aged ≥6 months to protect against severe COVID-19-associated illness and death. Because SARS-CoV-2 continues to circulate throughout the year, and because of the increased risk for COVID-19-related severe illness in persons aged ≥65 years, the protection afforded by updated vaccines against JN.1 and other currently circulating variants, and the expected waning of vaccine-conferred protection against disease, on February 28, 2024, ACIP recommended all persons aged ≥65 years receive 1 additional dose of the updated (2023-2024 Formula) COVID-19 vaccine. Implementation of these recommendations is expected to enhance immunity that might have waned and decrease the risk for severe COVID-19-associated outcomes, including death, among persons aged ≥65 years. |
Development of COVID-19 vaccine policy - United States, 2020-2023
Oliver SE , Wallace M , Twentyman E , Moulia DL , Godfrey M , Link-Gelles R , Meyer S , Fleming-Dutra KE , Hall E , Wolicki J , MacNeil J , Bell BP , Lee GM , Daley MF , Cohn A , Wharton M . Vaccine 2023 COVID-19 vaccines represent a great scientific and public health achievement in the face of overwhelming pressures from a global pandemic, preventing millions of hospitalizations and deaths due to COVID-19 vaccines in the United States. Over 675 million doses of COVID-19 vaccines have been administered in the United States, and over 80% of the U.S. population has had at least 1 dose of a COVID-19 vaccine. Over the course of the COVID-19 pandemic in the United States, over one million people died from COVID-19, and over six million were hospitalized. It has been estimated that COVID-19 vaccines prevented more than 18 million additional hospitalizations and more than 3 million additional deaths due to COVID-19 in the United States. From the beginning of the COVID-19 pandemic in 2020 through June 2023, ACIP had 35 COVID-19 focused meetings and 24 votes for COVID-19 vaccine recommendations. ACIP had the critical task of rapidly and thoroughly reviewing emerging and evolving data on COVID-19 epidemiology and vaccines, as well as making comprehensive population-based recommendations for vaccine policy and considerations for implementation through a transparent and evidence-based framework. Safe and effective COVID-19 vaccines, recommended through transparent policy discussions with ACIP, remain the best tool we have to prevent serious illness, hospitalization and death from COVID-19. |
Use of updated COVID-19 vaccines 2023-2024 formula for persons aged ≥6 months: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2023
Regan JJ , Moulia DL , Link-Gelles R , Godfrey M , Mak J , Najdowski M , Rosenblum HG , Shah MM , Twentyman E , Meyer S , Peacock G , Thornburg N , Havers FP , Saydah S , Brooks O , Talbot HK , Lee GM , Bell BP , Mahon BE , Daley MF , Fleming-Dutra KE , Wallace M . MMWR Morb Mortal Wkly Rep 2023 72 (42) 1140-1146 COVID-19 vaccines protect against severe COVID-19-associated outcomes, including hospitalization and death. As SARS-CoV-2 has evolved, and waning vaccine effectiveness has been noted, vaccine formulations and policies have been updated to provide continued protection against severe illness and death from COVID-19. Since September 2022, bivalent mRNA COVID-19 vaccines have been recommended in the United States, but the variants these vaccines protect against are no longer circulating widely. On September 11, 2023, the Food and Drug Administration (FDA) approved the updated (2023-2024 Formula) COVID-19 mRNA vaccines by Moderna and Pfizer-BioNTech for persons aged ≥12 years and authorized these vaccines for persons aged 6 months-11 years under Emergency Use Authorization (EUA). On October 3, 2023, FDA authorized the updated COVID-19 vaccine by Novavax for use in persons aged ≥12 years under EUA. The updated COVID-19 vaccines include a monovalent XBB.1.5 component, which is meant to broaden vaccine-induced immunity and provide protection against currently circulating SARS-CoV-2 XBB-sublineage variants including against severe COVID-19-associated illness and death. On September 12, 2023, the Advisory Committee on Immunization Practices recommended vaccination with updated COVID-19 vaccines for all persons aged ≥6 months. These recommendations will be reviewed as new evidence becomes available or new vaccines are approved and might be updated. |
Use of the Pfizer respiratory syncytial virus vaccine during pregnancy for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
Fleming-Dutra KE , Jones JM , Roper LE , Prill MM , Ortega-Sanchez IR , Moulia DL , Wallace M , Godfrey M , Broder KR , Tepper NK , Brooks O , Sánchez PJ , Kotton CN , Mahon BE , Long SS , McMorrow ML . MMWR Morb Mortal Wkly Rep 2023 72 (41) 1115-1122 Respiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. Nirsevimab (Bevfortus, Sanofi and AstraZeneca) is recommended to prevent RSV-associated lower respiratory tract infection (LRTI) in infants. In August 2023, the Food and Drug Administration (FDA) approved RSVpreF vaccine (Abrysvo, Pfizer Inc.) for pregnant persons as a single dose during 32-36 completed gestational weeks (i.e., 32 weeks and zero days' through 36 weeks and 6 days' gestation) to prevent RSV-associated lower respiratory tract disease in infants aged <6 months. Since October 2021, CDC's Advisory Committee on Immunization Practices (ACIP) RSV Vaccines Pediatric/Maternal Work Group has reviewed RSV epidemiology and evidence regarding safety, efficacy, and potential economic impact of pediatric and maternal RSV prevention products, including RSVpreF vaccine. On September 22, 2023, ACIP and CDC recommended RSVpreF vaccine using seasonal administration (i.e., during September through end of January in most of the continental United States) for pregnant persons as a one-time dose at 32-36 weeks' gestation for prevention of RSV-associated LRTI in infants aged <6 months. Either maternal RSVpreF vaccination during pregnancy or nirsevimab administration to the infant is recommended to prevent RSV-associated LRTI among infants, but both are not needed for most infants. All infants should be protected against RSV-associated LRTI through use of one of these products. |
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. |
Interim recommendations for use of bivalent mRNA COVID-19 vaccines for persons aged 6 months - United States, April 2023
Moulia DL , Wallace M , Roper LE , Godfrey M , Rosenblum HG , Link-Gelles R , Britton A , Daley MF , Meyer S , Fleming-Dutra KE , Oliver SE , Twentyman E . MMWR Morb Mortal Wkly Rep 2023 72 (24) 657-662 Throughout the national public health emergency declared in response to the COVID-19 pandemic, CDC, guided by the Advisory Committee on Immunization Practices (ACIP), has offered evidence-based recommendations for the use of COVID-19 vaccines in U.S. populations after each regulatory action by the Food and Drug Administration (FDA). During August 2022-April 2023, FDA amended its Emergency Use Authorizations (EUAs) to authorize the use of a single, age-appropriate, bivalent COVID-19 vaccine dose (i.e., containing components from the ancestral and Omicron BA.4/BA.5 strains in equal amounts) for all persons aged ≥6 years, use of bivalent COVID-19 vaccine doses for children aged 6 months-5 years, and additional bivalent doses for immunocompromised persons and adults aged ≥65 years (1). ACIP voted in September 2022 on the use of the bivalent vaccine, and CDC made recommendations after the September vote and subsequently, through April 2023, with input from ACIP. This transition to a single bivalent COVID-19 vaccine dose for most persons, with additional doses for persons at increased risk for severe disease, facilitates implementation of simpler, more flexible recommendations. Three COVID-19 vaccines are currently available for use in the United States and recommended by ACIP: 1) the bivalent mRNA Pfizer-BioNTech COVID-19 vaccine, 2) the bivalent mRNA Moderna COVID-19 vaccine, and 3) the monovalent adjuvanted, protein subunit-based Novavax COVID-19 vaccine.* As of August 31, 2022, monovalent mRNA vaccines based on the ancestral SARS-CoV-2 strain are no longer authorized for use in the United States (1). |
Estimated effectiveness of JYNNEOS vaccine in preventing Mpox: A Multijurisdictional Case-Control Study - United States, August 19, 2022-March 31, 2023
Dalton AF , Diallo AO , Chard AN , Moulia DL , Deputy NP , Fothergill A , Kracalik I , Wegner CW , Markus TM , Pathela P , Still WL , Hawkins S , Mangla AT , Ravi N , Licherdell E , Britton A , Lynfield R , Sutton M , Hansen AP , Betancourt GS , Rowlands JV , Chai SJ , Fisher R , Danza P , Farley M , Zipprich J , Prahl G , Wendel KA , Niccolai L , Castilho JL , Payne DC , Cohn AC , Feldstein LR . MMWR Morb Mortal Wkly Rep 2023 72 (20) 553-558 As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions,(†) including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites,(§) to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP),(¶) regardless of administration route or immunocompromise status. |
Vaccine effectiveness of JYNNEOS against mpox disease in the United States
Deputy NP , Deckert J , Chard AN , Sandberg N , Moulia DL , Barkley E , Dalton AF , Sweet C , Cohn AC , Little DR , Cohen AL , Sandmann D , Payne DC , Gerhart JL , Feldstein LR . N Engl J Med 2023 388 (26) 2434-2443 BACKGROUND: In the United States, more than 30,000 cases of mpox (formerly known as monkeypox) had occurred as of March 1, 2023, in an outbreak disproportionately affecting transgender persons and gay, bisexual, and other men who have sex with men. In 2019, the JYNNEOS vaccine was approved for subcutaneous administration (0.5 ml per dose) to prevent mpox infection. On August 9, 2022, an emergency use authorization was issued for intradermal administration (0.1 ml per dose); however, real-world effectiveness data are limited for either route. METHODS: We conducted a case-control study based on data from Cosmos, a nationwide Epic electronic health record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing medically attended mpox disease among adults. Case patients had an mpox diagnosis code or positive orthopoxvirus or mpox virus laboratory result, and control patients had an incident diagnosis of human immunodeficiency virus (HIV) infection or a new or refill order for preexposure prophylaxis against HIV infection between August 15, 2022, and November 19, 2022. Odds ratios and 95% confidence intervals were estimated from conditional logistic-regression models, adjusted for confounders; vaccine effectiveness was calculated as (1 - odds ratio for vaccination in case patients vs. controls) × 100. RESULTS: Among 2193 case patients and 8319 control patients, 25 case patients and 335 control patients received two doses (full vaccination), among whom the estimated adjusted vaccine effectiveness was 66.0% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose (partial vaccination), among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1). CONCLUSIONS: In this study using nationwide EHR data, patients with mpox were less likely to have received one or two doses of JYNNEOS vaccine than control patients. The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection. (Funded by the Centers for Disease Control and Prevention and Epic Research.). |
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. |
Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years - United States, July 2022.
Twentyman E , Wallace M , Roper LE , Anderson TC , Rubis AB , Fleming-Dutra KE , Hall E , Hsu J , Rosenblum HG , Godfrey M , Archer WR , Moulia DL , Daniel L , Brooks O , Talbot HK , Lee GM , Bell BP , Daley M , Meyer S , Oliver SE . MMWR Morb Mortal Wkly Rep 2022 71 (31) 988-992 The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike (rS) protein nanoparticle vaccine with Matrix-M adjuvant to protect against infection with SARS-CoV-2, the virus that causes COVID-19. On July 13, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Novavax vaccine for primary COVID-19 immunization of unvaccinated adults aged ≥18 years, administered as 2 doses (5 μg rS and 50 μg Matrix-M adjuvant in each dose) 3 weeks apart (1). On July 19, 2022, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Novavax vaccine in persons aged ≥18 years for the prevention of COVID-19.* In the per-protocol(†) efficacy analysis, vaccine efficacy (VE) against reverse transcription-polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 was 89.6% (95% CI = 82.4%-93.8%). The Alpha variant (B.1.1.7) of SARS-CoV-2 was the predominant circulating variant during the period of case accrual for VE assessments. Cases of myocarditis or pericarditis were reported in temporal association with vaccination, suggesting a possible causal relationship. The ACIP recommendation for the use of the Novavax COVID-19 vaccine is interim and will be updated as additional information becomes available. The adjuvanted, protein subunit-based Novavax COVID-19 vaccine provides an additional option for unvaccinated adults, increasing flexibility for the public and for vaccine providers. Vaccination is important for protection against COVID-19. |
Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months-5 Years - United States, June 2022.
Fleming-Dutra KE , Wallace M , Moulia DL , Twentyman E , Roper LE , Hall E , Link-Gelles R , Godfrey M , Woodworth KR , Anderson TC , Rubis AB , Shanley E3rd , Jones JM , Morgan RL , Brooks O , Talbot HK , Lee GM , Bell BP , Daley M , Meyer S , Oliver SE . MMWR Morb Mortal Wkly Rep 2022 71 (26) 859-868 On June 17, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) amendments for the mRNA-1273 (Moderna) COVID-19 vaccine for use in children aged 6 months-5 years, administered as 2 doses (25 µg [0.25 mL] each), 4 weeks apart, and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine for use in children aged 6 months-4 years, administered as 3 doses (3 µg [0.2 mL] each), at intervals of 3 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3. On June 18, 2022, the Advisory Committee on Immunization Practices (ACIP) issued separate interim recommendations for use of the Moderna COVID-19 vaccine in children aged 6 months-5 years and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-4 years for the prevention of COVID-19.* Both the Moderna and Pfizer-BioNTech COVID-19 vaccines met the criteria for immunobridging, which is the comparison of neutralizing antibody levels postvaccination in young children with those in young adults in whom efficacy had been demonstrated. Descriptive efficacy analyses were also conducted for both Moderna and Pfizer-BioNTech COVID-19 vaccines during the period when the Omicron variant of SARS-CoV-2 (the virus that causes COVID-19) predominated. No specific safety concerns were identified among recipients of either vaccine. ACIP recommendations for the use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-5 years and 6 months-4 years, respectively, are interim and will be updated as additional information becomes available. Vaccination is important for protecting children aged 6 months-5 years against COVID-19. |
Demographic Characteristics of Persons Vaccinated During the First Month of the COVID-19 Vaccination Program - United States, December 14, 2020-January 14, 2021.
Painter EM , Ussery EN , Patel A , Hughes MM , Zell ER , Moulia DL , Scharf LG , Lynch M , Ritchey MD , Toblin RL , Murthy BP , Harris LQ , Wasley A , Rose DA , Cohn A , Messonnier NE . MMWR Morb Mortal Wkly Rep 2021 70 (5) 174-177 In December 2020, two COVID-19 vaccines (Pfizer-BioNTech and Moderna) were authorized for emergency use in the United States for the prevention of coronavirus disease 2019 (COVID-19).* Because of limited initial vaccine supply, the Advisory Committee on Immunization Practices (ACIP) prioritized vaccination of health care personnel(†) and residents and staff members of long-term care facilities (LTCF) during the first phase of the U.S. COVID-19 vaccination program (1). Both vaccines require 2 doses to complete the series. Data on vaccines administered during December 14, 2020-January 14, 2021, and reported to CDC by January 26, 2021, were analyzed to describe demographic characteristics, including sex, age, and race/ethnicity, of persons who received ≥1 dose of COVID-19 vaccine (i.e., initiated vaccination). During this period, 12,928,749 persons in the United States in 64 jurisdictions and five federal entities(§) initiated COVID-19 vaccination. Data on sex were reported for 97.0%, age for 99.9%, and race/ethnicity for 51.9% of vaccine recipients. Among persons who received the first vaccine dose and had reported demographic data, 63.0% were women, 55.0% were aged ≥50 years, and 60.4% were non-Hispanic White (White). More complete reporting of race and ethnicity data at the provider and jurisdictional levels is critical to ensure rapid detection of and response to potential disparities in COVID-19 vaccination. As the U.S. COVID-19 vaccination program expands, public health officials should ensure that vaccine is administered efficiently and equitably within each successive vaccination priority category, especially among those at highest risk for infection and severe adverse health outcomes, many of whom are non-Hispanic Black (Black), non-Hispanic American Indian/Alaska Native (AI/AN), and Hispanic persons (2,3). |
Cost-effectiveness of increased influenza vaccination uptake against readmissions of major adverse cardiac events in the US.
Peasah SK , Meltzer MI , Vu M , Moulia DL , Bridges CB . PLoS One 2019 14 (4) e0213499 BACKGROUND: Although influenza vaccination has been shown to reduce the incidence of major adverse cardiac events (MACE) among those with existing cardiovascular disease (CVD), in the 2015-16 season, coverage for persons with heart disease was only 48% in the US. METHODS: We built a Monte Carlo (probabilistic) spreadsheet-based decision tree in 2018 to estimate the cost-effectiveness of increased influenza vaccination to prevent MACE readmissions. We based our model on current US influenza vaccination coverage of the estimated 493,750 US acute coronary syndrome (ACS) patients from the healthcare payer perspective. We excluded outpatient costs and time lost from work and included only hospitalization and vaccination costs. We also estimated the incremental cost/MACE case averted and incremental cost/QALY gained (ICER) if 75% hospitalized ACS patients were vaccinated by discharge and estimated the impact of increasing vaccination coverage incrementally by 5% up to 95% in a sensitivity analysis, among hospitalized adults aged >/= 65 years and 18-64 years, and varying vaccine effectiveness from 30-40%. RESULT: At 75% vaccination coverage by discharge, vaccination was cost-saving from the healthcare payer perspective in adults >/= 65 years and the ICER was $12,680/QALY (95% CI: 6,273-20,264) in adults 18-64 years and $2,400 (95% CI: -1,992-7,398) in all adults 18 + years. These resulted in ~ 500 (95% CI: 439-625) additional averted MACEs/year for all adult patients aged >/=18 years and added ~700 (95% CI: 578-825) QALYs. In the sensitivity analysis, vaccination becomes cost-saving in adults 18+years after about 80% vaccination rate. To achieve 75% vaccination rate in all adults aged >/= 18 years will require an additional cost of $3 million. The effectiveness of the vaccine, cost of vaccination, and vaccination coverage rate had the most impact on the results. CONCLUSION: Increasing vaccination rate among hospitalized ACS patients has a favorable cost-effectiveness profile and becomes cost-saving when at least 80% are vaccinated. |
Key elements for conducting vaccination exercises for pandemic influenza preparedness
Lehnert JD , Moulia DL , Murthy NC , Fiebelkorn AP , Vagi SJ , Dopson SA , Graitcer SB . Am J Public Health 2018 108 S194-s195 The Centers for Disease Control and Prevention (CDC) coordinates the Public Health Emergency Preparedness (PHEP) program through cooperative agreements with 62 jurisdictions, including all 50 states, eight US territories and freely associated states, and four local jurisdictions.1 Jurisdictions are required to maintain plans to ensure that large volumes of medical countermeasures, both pharmaceutical and nonpharmaceutical, can be distributed and dispensed in a timely manner. Plans must consider both the characteristics of the emergency and the medical countermeasures being dispensed. For example, differences in skills, infrastructure, and equipment should be expected when dispensing antibiotics or antiviral medications compared with administering vaccines in mass vaccination settings. Jurisdictions that receive PHEP funding are required to conduct at least one full-scale exercise or functional exercise every five years to test the operational status of their distribution or dispensing plans.1 |
2015 pandemic influenza readiness assessment among US Public Health Emergency Preparedness awardees
Fitzgerald TJ , Moulia DL , Graitcer SB , Vagi SJ , Dopson SA . Am J Public Health 2017 107 S177-s179 OBJECTIVES: To assess how US Public Health Emergency Preparedness (PHEP) awardees plan to respond to an influenza pandemic with vaccination. METHODS: The Centers for Disease Control and Prevention developed the Pandemic Influenza Readiness Assessment, an online survey sent to PHEP directors, to analyze, in part, the readiness of PHEP awardees to vaccinate 80% of the populations of their jurisdictions with 2 doses of pandemic influenza vaccine, separated by 21 days, within 16 weeks of vaccine availability. RESULTS: Thirty-eight of 60 (63.3%) awardees reported being able to vaccinate their populations within 16 weeks; 38 (63.3%) planned to allocate more than 20% of their pandemic vaccine supply to points of dispensing (PODs). Thirty-four of 58 (58.6%) reported staffing as a challenge to vaccinating 80% of their populations; 28 of 60 (46.7%) reported preparedness workforce decreases, and 22 (36.7%) reported immunization workforce decreases between January 2012 and July 2015. CONCLUSIONS: Awardees relied on PODs to vaccinate segments of their jurisdictions despite workforce decreases. Planners must ensure readiness for POD sites to vaccinate, but should also leverage complementary sites and providers to augment public health response. |
Readiness to vaccinate critical personnel during an influenza pandemic, United States, 2015
Moulia DL , Dopson SA , Vagi SJ , Fitzgerald TJ , Fiebelkorn AP , Graitcer SB . Am J Public Health 2017 107 (10) e1-e3 OBJECTIVES: To assess the readiness to vaccinate critical infrastructure personnel (CIP) involved in managing public works, emergency services, transportation, or any other system or asset that would have an immediate debilitating impact on the community if not maintained. METHODS: We analyzed self-reported planning to vaccinate CIP during an influenza pandemic with data from 2 surveys: (1) the Program Annual Progress Assessment of immunization programs and (2) the Pandemic Influenza Readiness Assessment of public health emergency preparedness programs. Both surveys were conducted in 2015. RESULTS: Twenty-six (43.3%) of 60 responding public health emergency preparedness programs reported having an operational plan to identify and vaccinate CIP, and 16 (26.2%) of 61 responding immunization programs reported knowing the number of CIP in their program's jurisdictions. CONCLUSIONS: Many programs may not be ready to identify and vaccinate CIP during an influenza pandemic. Additional efforts are needed to ensure operational readiness to vaccinate CIP during the next influenza pandemic. |
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