IMPORTANCE: Seasonal influenza is associated with substantial disease burden. The relationship between census tract-based social vulnerability and clinical outcomes among patients with influenza remains unknown. OBJECTIVE: To characterize associations between social vulnerability and outcomes among patients hospitalized with influenza and to evaluate seasonal influenza vaccine and influenza antiviral utilization patterns across levels of social vulnerability. DESIGN, SETTING, AND PARTICIPANTS: This retrospective repeated cross-sectional study was conducted among adults with laboratory-confirmed influenza-associated hospitalizations from the 2014 to 2015 through the 2018 to 2019 influenza seasons. Data were from a population-based surveillance network of counties within 13 states. Data analysis was conducted in December 2023. EXPOSURE: Census tract-based social vulnerability. MAIN OUTCOMES AND MEASURES: Associations between census tract-based social vulnerability and influenza outcomes (intensive care unit admission, invasive mechanical ventilation and/or extracorporeal membrane oxygenation support, and 30-day mortality) were estimated using modified Poisson regression as adjusted prevalence ratios. Seasonal influenza vaccine and influenza antiviral utilization were also characterized across levels of social vulnerability. RESULTS: Among 57 964 sampled cases, the median (IQR) age was 71 (58-82) years; 55.5% (95% CI, 51.5%-56.0%) were female; 5.2% (5.0%-5.4%) were Asian or Pacific Islander, 18.3% (95% CI, 18.0%-18.6%) were Black or African American, and 64.6% (95% CI, 64.2%-65.0%) were White; and 6.6% (95% CI, 6.4%-68%) were Hispanic or Latino and 74.7% (95% CI, 74.3%-75.0%) were non-Hispanic or Latino. High social vulnerability was associated with higher prevalence of invasive mechanical ventilation and/or extracorporeal membrane oxygenation support (931 of 13 563 unweighted cases; adjusted prevalence ratio [aPR], 1.25 [95% CI, 1.13-1.39]), primarily due to socioeconomic status (790 of 11 255; aPR, 1.31 [95% CI, 1.17-1.47]) and household composition and disability (773 of 11 256; aPR, 1.20 [95% CI, 1.09-1.32]). Vaccination status, presence of underlying medical conditions, and respiratory symptoms partially mediated all significant associations. As social vulnerability increased, the proportion of patients receiving seasonal influenza vaccination declined (-19.4% relative change across quartiles; P < .001) as did the proportion vaccinated by October 31 (-6.8%; P < .001). No differences based on social vulnerability were found in in-hospital antiviral receipt, but early in-hospital antiviral initiation (-1.0%; P = .01) and prehospital antiviral receipt (-17.3%; P < .001) declined as social vulnerability increased. CONCLUSIONS AND RELEVANCE: In this cross-sectional study, social vulnerability was associated with a modestly increased prevalence of invasive mechanical ventilation and/or extracorporeal membrane oxygenation support among patients hospitalized with influenza. Contributing factors may have included worsened baseline respiratory health and reduced receipt of influenza prevention and prehospital or early in-hospital treatment interventions among persons residing in low socioeconomic areas.

Increasing opportunities for prevention of infectious diseases by new, effective vaccines and the expansion of global immunization programs across the life course highlight the importance and value of evidence-informed decision-making (EIDM) by National Immunization Technical Advisory Groups (NITAGs). The U.S. Centers for Disease Control and Prevention (CDC) and Task Force for Global Health (TFGH) have developed and made available new tools to support NITAGs in EIDM. These include a toolkit for conducting facilitated training of NITAGs, Secretariats, or work groups on the use of the Evidence to Recommendations (EtR) approach to advise Ministries of Health (MoH) on specific vaccine policies, and an eLearning module on the EtR approach for NITAG members, Secretariat and others. The CDC and TFGH have also supported final development and implementation of the NITAG Maturity Assessment Tool (NMAT) for assessing maturity of NITAG capabilities in seven functional domains. The EtR toolkit and eLearning have been widely promoted in collaboration with the World Health Organization (WHO) Headquarters and Regional Offices through workshops engaging over 30 countries to date, and the NMAT assessment tool used in most countries in 3 WHO regions (Americas, Eastern Mediterranean, African). Important lessons have been learned regarding planning and conducting trainings for multiple countries and additional ways to support countries in applying the EtR approach to complete vaccine recommendations. Priorities for future work include the need to evaluate the impact of EtR training and NMAT assessments, working with partners to expand and adapt these tools for wider use, synergizing with other approaches for NITAG strengthening, and developing the best approaches to empower NITAGs to use the EtR approach.

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.

BACKGROUND: Influenza is a persistent public health problem associated with severe morbidity and mortality. Drug use is related to myriad health complications, but the relationship between drug use and severe influenza outcomes is not well understood. The study objective was to evaluate the relationship between drug use and severe influenza-associated outcomes. METHODS: Data were collected by the Influenza Hospitalization Surveillance Network (FluSurv-NET) from the 2016-2017 through 2018-2019 influenza seasons. Among persons hospitalized with influenza, descriptive statistics and logistic regression models were used to analyze differences in demographic characteristics, risk and behavioral factors, and severe outcomes (intensive care unit [ICU] admission, mechanical ventilation, or death) between people who use drugs (PWUD), defined as having documented drug use within the past year, and non-PWUD. RESULTS: Among 48,430 eligible hospitalized influenza cases, 2019 were PWUD and 46,411 were non-PWUD. PWUD were younger than non-PWUD and more likely to be male, non-Hispanic Black or Hispanic/Latino, smoke tobacco, abuse alcohol, and have chronic conditions including asthma, chronic liver disease, chronic lung disease, or immunosuppressive conditions. PWUD had greater odds of ICU admission and mechanical ventilation, but not death compared with non-PWUD; however, these findings were not statistically significant after adjustment. Opioid use specifically was associated with increased risk of ICU admission and mechanical ventilation. CONCLUSION: These results support targeted initiatives to prevent influenza in this population, including influenza vaccination, which remains one of the most important tools to prevent influenza infection and associated severe outcomes.

BACKGROUND: During August-September 2021, a Connecticut college experienced a large SARS-CoV-2 Delta outbreak despite high (99%) vaccination coverage, indoor masking policies, and twice weekly reverse transcription-polymerase chain reaction (RT-PCR) testing. The Connecticut Department of Public Health investigated characteristics associated with infection and phylogenetic relationships among cases. METHODS: A case was a SARS-CoV-2 infection diagnosed by RT-PCR or antigen test during August-September 2021 in a student. College staff provided enrollment data, case information, and class rosters. An anonymous online student survey collected demographics, SARS-CoV-2 case and vaccination history, and activities the weekend before the outbreak. Multivariate logistic regression identified characteristics associated with infection. Phylogenetic analyses compared 115 student viral genome sequences with contemporaneous community genomes. RESULTS: Overall, 199/1788 students (11%) had lab-confirmed SARS-CoV-2 infection; most were fully vaccinated (194/199, 97%). Attack rates were highest among sophomores (72/414, 17%) and unvaccinated students (5/18, 28%). Attending in-person classes with an infectious student was not associated with infection (adjusted odds ratio [aOR] 1.0; 95%CI 0.5-2.2). Compared with uninfected students, students reporting an infection were more likely sophomores (aOR 3.3; 95%CI 1.1-10.7), attended parties/gatherings before the outbreak (aOR 2.8; 95%CI 1.3-6.4), and completed a vaccine series ≥180 days prior (aOR 5.5; 95%CI 1.8-16.2). Phylogenetic analyses suggested most cases derived from a common viral source. CONCLUSIONS: This college SARS-CoV-2 outbreak occurred in a highly vaccinated population with prevention strategies in place. Infection was associated with unmasked off-campus parties/gatherings, not in-person classes. Students should stay up-to-date on vaccination to reduce infection.

The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged 18 years (1), which was adopted by CDC. During December 19, 2020-January 30, 2022, approximately 204 million doses of Moderna COVID-19 vaccine were administered in the United States (2) as a primary series of 2 intramuscular doses (100 g [0.5 mL] each) 4 weeks apart. On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, ModernaTX, Inc.) in persons aged 18 years (3). On February 4, 2022, the ACIP COVID-19 Vaccines Work Group conclusions regarding recommendations for the use of the Moderna COVID-19 vaccine were presented to ACIP at a public meeting. The Work Group's deliberations were based on the Evidence to Recommendation (EtR) Framework,* which incorporates the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach() to rank evidence quality. In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine). Based on this evidence, CDC has provided guidance that an 8-week interval might be optimal for some adolescents and adults. The additional information gathered since the issuance of the interim recommendations increased certainty that the benefits of preventing symptomatic and asymptomatic SARS-CoV-2 infection, hospitalization, and death outweigh vaccine-associated risks of the Moderna COVID-19 vaccine. On February 4, 2022, ACIP modified its interim recommendation to a standard recommendation() for use of the fully licensed Moderna COVID-19 vaccine in persons aged 18 years.

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.

Three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP) in the United States: the 2-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine (1,2) (Box 1). In August 2021, FDA amended the EUAs for the two mRNA COVID-19 vaccines to allow for an additional primary dose in certain immunocompromised recipients of an initial mRNA COVID-19 vaccination series (1). During September-October 2021, FDA amended the EUAs to allow for a COVID-19 vaccine booster dose following a primary mRNA COVID-19 vaccination series in certain recipients aged ≥18 years who are at increased risk for serious complications of COVID-19 or exposure to SARS-CoV-2 (the virus that causes COVID-19), as well as in recipients aged ≥18 years of Janssen COVID-19 vaccine (1) (Table). For the purposes of these recommendations, an additional primary (hereafter additional) dose refers to a dose of vaccine administered to persons who likely did not mount a protective immune response after initial vaccination. A booster dose refers to a dose of vaccine administered to enhance or restore protection by the primary vaccination, which might have waned over time. Health care professionals play a critical role in COVID-19 vaccination efforts, including for primary, additional, and booster vaccination, particularly to protect patients who are at increased risk for severe illness and death.

The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 μg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation(†) for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework(§) and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.(¶) The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.

OBJECTIVES: Some studies suggested more COVID-19-associated hospitalizations among racial and ethnic minorities. To inform public health practice, the COVID-19-associated Hospitalization Surveillance Network (COVID-NET) quantified associations between race/ethnicity, census tract socioeconomic indicators, and COVID-19-associated hospitalization rates. METHODS: Using data from COVID-NET population-based surveillance reported during March 1-April 30, 2020 along with socioeconomic and denominator data from the US Census Bureau, we calculated COVID-19-associated hospitalization rates by racial/ethnic and census tract-level socioeconomic strata. RESULTS: Among 16,000 COVID-19-associated hospitalizations, 34.8% occurred among non-Hispanic White (White) persons, 36.3% among non-Hispanic Black (Black) persons, and 18.2% among Hispanic or Latino (Hispanic) persons. Age-adjusted COVID-19-associated hospitalization rate were 151.6 (95% Confidence Interval (CI): 147.1-156.1) in census tracts with >15.2%-83.2% of persons living below the federal poverty level (high-poverty census tracts) and 75.5 (95% CI: 72.9-78.1) in census tracts with 0%-4.9% of persons living below the federal poverty level (low-poverty census tracts). Among White, Black, and Hispanic persons living in high-poverty census tracts, age-adjusted hospitalization rates were 120.3 (95% CI: 112.3-128.2), 252.2 (95% CI: 241.4-263.0), and 341.1 (95% CI: 317.3-365.0), respectively, compared with 58.2 (95% CI: 55.4-61.1), 304.0 (95%: 282.4-325.6), and 540.3 (95% CI: 477.0-603.6), respectively, in low-poverty census tracts. CONCLUSIONS: Overall, COVID-19-associated hospitalization rates were highest in high-poverty census tracts, but rates among Black and Hispanic persons were high regardless of poverty level. Public health practitioners must ensure mitigation measures and vaccination campaigns address needs of racial/ethnic minority groups and people living in high-poverty census tracts.

In fall 2020, a coronavirus disease cluster comprising 16 cases occurred in Connecticut, USA. Epidemiologic and genomic evidence supported transmission among persons at a school and fitness center but not a workplace. The multiple transmission chains identified within this cluster highlight the necessity of a combined investigatory approach.

The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. In December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as well as an interim recommendation for use among persons aged ≥16 years by the Advisory Committee on Immunization Practices (ACIP) (1). In May 2021, the EUA and interim ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine were extended to adolescents aged 12-15 years (2). During December 14, 2020-September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States.* On August 23, 2021, FDA approved a Biologics License Application for use of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (3). The ACIP COVID-19 Vaccines Work Group's conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at a public meeting on August 30, 2021. To guide its deliberations regarding the Pfizer-BioNTech COVID-19 vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,(†) and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.(§) In addition to initial clinical trial data, ACIP considered new information gathered in the 8 months since issuance of the interim recommendation for Pfizer-BioNTech COVID-19 vaccine, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. The additional information increased certainty that benefits from prevention of asymptomatic infection, COVID-19, and associated hospitalization and death outweighs vaccine-associated risks. On August 30, 2021, ACIP issued a recommendation(¶) for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.

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.

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.

The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation(†) for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,(§) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.(¶) The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available.

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.

While seasonal influenza vaccines (SIV) remain the best method to prevent influenza-associated illnesses, implementing SIV programs may benefit countries beyond disease reduction, strengthening health systems and national immunization programs, or conversely, introduce new challenges. Few studies have examined perceived impacts of SIV introduction beyond disease reduction on health systems; understanding such impacts will be particularly salient in the context of COVID-19 vaccine introduction. We collected qualitative data from key informants-Partnership for Influenza Vaccine Introduction (PIVI) contacts in six middle-income PIVI vaccine recipient countries-to understand perceptions of ancillary benefits and challenges from SIV implementation. Respondents reported benefits associated with SIV introduction, including improved attitudes to SIV among risk groups (characterized by increased demand) and perceptions that SIV introduction improved relationships with other ministries and collaboration with mass media. Challenges included sustaining investment in SIV programs, as vaccine supply did not always meet coverage goals, and managing SIV campaigns.

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). The Janssen COVID-19 vaccine is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector vaccine, encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19 (1). Vaccination with the Janssen COVID-19 vaccine consists of a single dose (5 × 1010 virus particles per 0.5-mL dose) administered intramuscularly. On February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Janssen COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. This vaccine is the third COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendations (EtR) framework,† following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ The ACIP recommendation for the use of the Janssen COVID-19 vaccine under an EUA is interim and will be updated as additional information becomes available.

Respiratory illness caused by Corynebacterium diphtheriae and C. ulcerans, and use of diphtheria anti-toxin in the United States, 1996-2018. BACKGROUND: Respiratory diphtheria is a toxin-mediated disease caused by Corynebacterium diphtheriae. Diphtheria-like illness, clinically indistinguishable from diphtheria, is caused by C. ulcerans, a zoonotic bacterium that can also produce diphtheria toxin. In the United States, respiratory diphtheria is nationally notifiable: specimens from suspected cases are submitted to the Centers for Disease Control (CDC) for species and toxin confirmation, and diphtheria antitoxin (DAT) is obtained from CDC for treatment. We summarize the epidemiology of respiratory diphtheria and diphtheria-like illness and describe DAT use during 1996-2018 in the United States. METHODS: We described respiratory diphtheria cases reported to the National Notifiable Diseases Surveillance System (NNDSS) and C. ulcerans-related diphtheria-like illness identified through specimen submissions to CDC during 1996-2018. We reviewed DAT requests from 1997-2018. RESULTS: From 1996-2018, 14 respiratory diphtheria cases were reported to NNDSS. Among these 14 cases, 1 was toxigenic and 3 were non-toxigenic C. diphtheriae by culture and Elek, 6 were culture-negative but PCR-positive for diphtheria toxin gene, 1 was culture-positive without further testing, and the remaining 3 were either not tested or tested negative. Five cases of respiratory diphtheria-like illness caused by toxigenic C. ulcerans were identified. DAT was requested by healthcare providers for 151 suspected diphtheria cases between 1997-2018, with an average of 11 requests per year from 1997-2007, and 3 per year from 2008-2018. CONCLUSIONS: Respiratory diphtheria remains rare in the United States, and requests for DAT have declined. Incidental identification of C. ulcerans-related diphtheria-like illness suggests surveillance of this condition might be warranted.

CONTEXT: Food-induced anaphylaxis is potentially fatal but preventable by allergen avoidance and manageable through immediate treatment. Considerable effort has been invested in preventing fatalities from nut exposure among school-aged children, but few population-based studies exist to guide additional prevention efforts. OBJECTIVES: To describe the epidemiology and trends of food-related anaphylaxis requiring emergency treatment during a 15-year span in New York City when public health initiatives to prevent deaths were implemented and to understand the situational circumstances of food-related deaths. DESIGN/SETTING/PARTICIPANTS: Retrospective death record review and analysis of inpatient hospital discharges and emergency department (ED) visits in New York City residents, 2000-2014. MAIN OUTCOME: Vital statistics data, medical examiner reports, ED, and hospital discharge data were used to examine risk for death and incidence trends in medically attended food-related anaphylaxis. Potentially preventable deaths were those among persons with a known allergy to the implicated food or occurring in public settings. RESULTS: There were 24 deaths, (1.6 deaths/year; range: 0-5), 3049 hospitalizations, and 4014 ED visits, including 7 deaths from crustacean, 4 from peanut, and 2 each from tree nut or seeds and fish exposures. Risk for death among those hospitalized or treated in the ED was highest for persons older than 65 years and for those treated for crustacean reactions (relative risk 6.5 compared with those treated for peanuts, 95% confidence interval = 1.9-22.1). Eleven of 16 deaths with medical examiner data were potentially preventable. Hospitalizations (2000-2014) and ED visit rates (2005-2014) were highest for children and those with peanut exposure and increased across periods. CONCLUSIONS: Deaths from food-related anaphylaxis were rare; however, rates of hospitalization and ED visits increased. Prevention efforts related to peanut allergies among children should continue, and additional attention is needed to prevent and treat anaphylaxis among adults, particularly those with known crustacean allergies where case fatality is highest.

BACKGROUND: The relationships between socioeconomic status (SES) and domestically-acquired salmonellosis and leading Salmonella serotypes are poorly understood. METHODS: We analyzed surveillance data from laboratory-confirmed cases of salmonellosis from 2010-2016 for all 10 Foodborne Disease Active Surveillance Network (FoodNet) sites, having a catchment population of 47.9 million. Case-residential data were geocoded, linked to census tract poverty (CTP) level, then categorized into four CTP-level groups. After excluding those reporting international travel before illness onset, age-specific and age-adjusted salmonellosis incidence rates were calculated for each CTP level, overall and for each of the 10 leading serotypes. RESULTS: Of 52,821 (>96%) geocodable Salmonella infections, 48,111 (91.1%) were domestically-acquired. Higher age-adjusted incidence occurred with higher CTP level (p<0.001, relative risk (RR) for highest (>20%) compared to lowest (<5%) CTP group = 1.37). Children <5 years had the highest RR (2.07). While this relationship was consistent by race/ethnicity and by serotype, it was not present in five FoodNet sites or among those 18-49 years. CONCLUSION: Children and older adults living in higher CTP have had a higher incidence of domestically-acquired salmonellosis. There is a need to understand SES differences for risk factors for domestically-acquired salmonellosis by age group and FoodNet site to help focus prevention efforts.

Epidemic meningitis has posed a recurrent threat for more than a century for the approximately 430 million people living in the 26 countries in the sub-Saharan region of Africa known as the “meningitis belt.” This population experiences high rates of endemic meningitis, annual seasonal outbreaks, and explosive epidemics occurring every 5–12 years. Hope to eliminate this devastating public health threat came in the form of a novel meningococcal serogroup A conjugate vaccine (MACV [MenAfriVac]) developed by the Meningitis Vaccine Project (MVP; available at: http://www.meningvax.org) specifically for use in the meningitis belt and priced at less than $1.00 per dose [1]. Licensed in 2009, MACV was subsequently prequalified by the World Health Organization (WHO) on the basis of its safety and immunogenicity data but without phase 3 efficacy studies. Starting in 2010, MACV was rolled out across the meningitis belt via mass campaigns to vaccinate all persons 1–29 years of age. By the end of 2018, >300 million people in 22 African countries had been immunized with MACV [2]. The vaccine has been a remarkable public health success, effectively eliminating serogroup A meningitis epidemics in sub-Saharan Africa [3].

In 2017, a total of 8,819 cases of diphtheria were reported worldwide, the most since 2004. However, recent diphtheria epidemiology has not been well described. We analyzed incidence data and data from the literature to describe diphtheria epidemiology. World Health Organization surveillance data were 81% complete; completeness varied by region, indicating underreporting. As national diphtheria-tetanus-pertussis (DTP) 3 coverage increased, the proportion of case-patients <15 years of age decreased, indicating increased protection of young children. In countries with higher case counts, 66% of case-patients were unvaccinated and 63% were <15 years of age. In countries with sporadic cases, 32% of case-patients were unvaccinated and 66% were >15 years of age, consistent with waning vaccine immunity. Global DTP3 coverage is suboptimal. Attaining high DTP3 coverage and implementing recommended booster doses are necessary to decrease diphtheria incidence. Collection and use of data on subnational and booster dose coverage, enhanced laboratory capacity, and case-based surveillance would improve data quality.

Background: Despite successful vaccination programs, pertussis remains endemic in the United States and increasing incidence has been reported. We used national surveillance data to describe pertussis epidemiology, including patient demographic characteristics, geographic distribution, and temporal trends. Methods: We included cases reported through the National Notifiable Diseases Surveillance System between January 1, 2000 and December 31, 2016. Differences in case characteristics were compared using Pearson's 2. Average annual incidence (cases per 100,000 population) was calculated overall, and by age (<1 year, 1-6 years, 7-10 years, 11-18 years, 19-39 years, 30-64 years, and >/=65 years) and geographic subgroup. Negative binomial regression was used to calculate annual percent change. Results: During 2000-2016, 339,420 pertussis cases were reported. The majority were in white (88.2%) and non-Hispanic (81.3%) persons, 9.9% resulted in hospitalization, and 0.1% were fatal; however, differences existed by age. Infants had the highest incidence (75.3/100,000 population), accounting for 88.8% of deaths. Incidence increased significantly over time (p=0.0019), with baseline rates rising 1.7-fold between 2000-2008 and 2009-2016; increases were observed for all groups except persons aged <1 year and 19-64 years. Elevated case counts among persons aged 7-10 and 11-18 years coincided with the aging of acellular-primed birth cohorts. Incidence varied by geographic region, with some similarities in disease cyclicity. Conclusions: Increasing baseline incidence and changing age distribution of pertussis suggest a central role of the transition to acellular vaccines in the U.S. disease resurgence. Continued monitoring of national surveillance data is important to evaluate and optimize pertussis prevention and control strategies.

Background. The relationship between socioeconomic status and Shiga toxin-producing Escherichia coli (STEC) is not well understood. However, recent studies in Connecticut and New York City found that as census tract poverty (CTP) decreased, rates of STEC increased. To explore this nationally, we analyzed surveillance data from laboratory-confirmed cases of STEC from 2010-2014 for all Foodborne Disease Active Surveillance Network (FoodNet) sites, population 47.9 million. Methods. Case residential data were geocoded and linked to CTP level (2010-2014 American Community Survey). Relative rates were calculated comparing incidence in census tracts with < 20% of residents below poverty with those with ≥20%. Relative rates of age-adjusted 5-year incidence per 100 000 population were determined for all STEC, hospitalized only and hemolytic-uremic syndrome (HUS) cases overall, by demographic features, FoodNet site, and surveillance year. Results. There were 5234 cases of STEC; 26.3% were hospitalized, and 5.9% had HUS. Five-year incidence was 10.9/100 000 population. Relative STEC rates for the < 20% compared with the ≥ 20% CTP group were > 1.0 for each age group, FoodNet site, surveillance year, and race/ethnic group except Asian. Relative hospitalization and HUS rates tended to be higher than their respective STEC relative rates. Conclusions. Persons living in lower CTP were at higher risk of STEC than those in the highest poverty census tracts. This is unlikely to be due to health care-seeking or diagnostic bias as it applies to analysis limited to hospitalized and HUS cases. Research is needed to better understand exposure differences between people living in the lower vs highest poverty-level census tracts to help direct prevention efforts.

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSVG-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at </=-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

Due to security, access, and programmatic challenges in areas of Pakistan and Afghanistan, both countries continue to sustain indigenous wild poliovirus (WPV) transmission and threaten the success of global polio eradication and oral poliovirus vaccine (OPV) cessation. We fitted an existing differential-equation-based poliovirus transmission and OPV evolution model to Pakistan and Afghanistan using four subpopulations to characterize the well-vaccinated and undervaccinated subpopulations in each country. We explored retrospective and prospective scenarios for using inactivated poliovirus vaccine (IPV) in routine immunization or supplemental immunization activities (SIAs). The undervaccinated subpopulations sustain the circulation of serotype 1 WPV and serotype 2 circulating vaccine-derived poliovirus. We find a moderate impact of past IPV use on polio incidence and population immunity to transmission mainly due to (1) the boosting effect of IPV for individuals with preexisting immunity from a live poliovirus infection and (2) the effect of IPV-only on oropharyngeal transmission for individuals without preexisting immunity from a live poliovirus infection. Future IPV use may similarly yield moderate benefits, particularly if access to undervaccinated subpopulations dramatically improves. However, OPV provides a much greater impact on transmission and the incremental benefit of IPV in addition to OPV remains limited. This study suggests that despite the moderate effect of using IPV in SIAs, using OPV in SIAs remains the most effective means to stop transmission, while limited IPV resources should prioritize IPV use in routine immunization.

Afghanistan, Pakistan, and Nigeria remain the only countries where the transmission of endemic wild poliovirus type 1 (WPV1) continues (1). This report describes polio eradication activities, progress, and challenges in Afghanistan during January 2016-June 2017 and updates previous reports (2,3). Thirteen WPV1 cases were confirmed in Afghanistan in 2016, a decrease of seven from the 20 cases reported in 2015. From January to June 2017, five WPV1 cases were reported, compared with six during the same period in 2016. The number of affected districts declined from 23 (including WPV1-positive acute flaccid paralysis [AFP] cases and positive environmental sewage samples) in 2015 to six in 2016. To achieve WPV1 eradication, it is important that Afghanistan's polio program continue to collaborate with that of neighboring Pakistan to track and vaccinate groups of high-risk mobile populations and strengthen efforts to reach children in security-compromised areas.

INTRODUCTION: Previous FluSurv-NET studies found that adult females had a higher incidence of influenza-associated hospitalizations than males. To identify groups of women at higher risk than men, we analyzed data from 14 FluSurv-NET sites that conducted population-based surveillance for laboratory-confirmed influenza-associated hospitalizations among residents of 78 US counties. METHODS: We analyzed 6292 laboratory-confirmed, geocodable (96%) adult cases collected by FluSurv-NET during the 2010-12 influenza seasons. We used 2010 US Census and 2008-2012 American Community Survey data to calculate overall age-adjusted and age group-specific female:male incidence rate ratios (IRR) by race/ethnicity and census tract-level poverty. We used national 2010 pregnancy rates to estimate denominators for pregnant women aged 18-49. We calculated male:female IRRs excluding them and IRRs for pregnant:non-pregnant women. RESULTS: Overall, 55% of laboratory-confirmed influenza cases were female. Female:male IRRs were highest for females aged 18-49 of high neighborhood poverty (IRR 1.50, 95% CI 1.30-1.74) and of Hispanic ethnicity (IRR 1.70, 95% CI 1.34-2.17). These differences disappeared after excluding pregnant women. Overall, 26% of 1083 hospitalized females aged 18-49 were pregnant. Pregnant adult females were more likely to have influenza-associated hospitalizations than their non-pregnant counterparts (relative risk [RR] 5.86, 95% CI 5.12-6.71), but vaccination levels were similar (25.5% vs 27.8%). CONCLUSIONS: Overall rates of influenza-associated hospitalization were not significantly different for men and women after excluding pregnant women. Among women aged 18-49, pregnancy increased the risk of influenza-associated hospitalization sixfold but did not increase the likelihood of vaccination. Improving vaccination rates in pregnant women should be an influenza vaccination priority.

Background. The Basic Package of Health Services (BPHS) program has increased access to immunization services for children living in rural Afghanistan. However, multiple surveys have indicated persistent immunization coverage gaps. Hence, to identify gaps in implementation, an assessment of the BPHS program was undertaken, with specific focus on the routine immunization (RI) component. Methods. A cross-sectional survey was conducted in 2014 on a representative sample drawn from a sampling frame of 1858 BPHS health facilities. Basic descriptive analysis was performed, capturing general characteristics of survey respondents and assessing specific RI components, and ++ 2 tests were used to evaluate possible differences in service delivery by type of health facility. Results. Of 447 survey respondents, 27% were health subcenters (HSCs), 30% were basic health centers, 32% were comprehensive health centers, and 12% were district hospitals. Eighty-seven percent of all respondents offered RI services, though only 61% of HSCs did so. Compared with other facility types, HSCs were less likely to have adequate stock of vaccines, essential cold-chain equipment, or proper documentation of vaccination activities. Conclusions. There is an urgent need to address manpower and infrastructural deficits in RI service delivery through the BPHS program, especially at the HSC level.