This article summarizes what is currently known about the 2019 novel coronavirus and offers interim guidance.

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.

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).

On February 27, 2020, the Santa Clara County Public Health Department (SCCPHD) identified its first case of coronavirus disease 2019 (COVID-19) associated with probable community transmission (i.e., infection among persons without a known exposure by travel or close contact with a patient with confirmed COVID-19). At the time the investigation began, testing guidance recommended focusing on persons with clinical findings of lower respiratory illness and travel to an affected area or an epidemiologic link to a laboratory-confirmed COVID-19 case, or on persons hospitalized for severe respiratory disease and no alternative diagnosis (1). To rapidly understand the extent of COVID-19 in the community, SCCPHD, the California Department of Public Health (CDPH), and CDC began sentinel surveillance in Santa Clara County. During March 5-14, 2020, four urgent care centers in Santa Clara County participated as sentinel sites. For this investigation, county residents evaluated for respiratory symptoms (e.g., fever, cough, or shortness of breath) who had no known risk for COVID-19 were identified at participating urgent care centers. A convenience sample of specimens that tested negative for influenza virus was tested for SARS-CoV-2 RNA. Among 226 patients who met the inclusion criteria, 23% had positive test results for influenza. Among patients who had negative test results for influenza, 79 specimens were tested for SARS-CoV-2, and 11% had evidence of infection. This sentinel surveillance system helped confirm community transmission of SARS-CoV-2 in Santa Clara County. As a result of these data and an increasing number of cases with no known source of transmission, the county initiated a series of community mitigation strategies. Detection of community transmission is critical for informing response activities, including testing criteria, quarantine guidance, investigation protocols, and community mitigation measures (2). Sentinel surveillance in outpatient settings and emergency departments, implemented together with hospital-based surveillance, mortality surveillance, and serologic surveys, can provide a robust approach to monitor the epidemiology of COVID-19.

During a severe pandemic, especially one causing respiratory illness, many people may require mechanical ventilation. Depending on the extent of the outbreak, there may be insufficient capacity to provide ventilator support to all of those in need. As part of a larger conceptual framework for determining need for and allocation of ventilators during a public health emergency, this article focuses on the strategies to assist state and local planners to allocate stockpiled ventilators to healthcare facilities during a pandemic, accounting for critical factors in facilities' ability to make use of additional ventilators. These strategies include actions both in the pre-pandemic and intra-pandemic stages. As a part of pandemic preparedness, public health officials should identify and query healthcare facilities in their jurisdiction that currently care for critically ill patients on mechanical ventilation to determine existing inventory of these devices and facilities' ability to absorb additional ventilators. Facilities must have sufficient staff, space, equipment, and supplies to utilize allocated ventilators adequately. At the time of an event, jurisdictions will need to verify and update information on facilities' capacity prior to making allocation decisions. Allocation of scarce life-saving resources during a pandemic should consider ethical principles to inform state and local plans for allocation of ventilators. In addition to ethical principles, decisions should be informed by assessment of need, determination of facilities' ability to use additional ventilators, and facilities' capacity to ensure access to ventilators for vulnerable populations (eg, rural, inner city, and uninsured and underinsured individuals) or high-risk populations that may be more susceptible to illness.

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.