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      Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021

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          The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020

          On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine (Pfizer, Inc; Philadelphia, Pennsylvania), a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) ( 1 ). Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 doses (30 μg, 0.3 mL each) administered intramuscularly, 3 weeks apart. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, † using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. § The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP’s interim recommendation for allocating initial supplies of COVID-19 vaccines ( 2 ). The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available. Since June 2020, ACIP has convened nine public meetings to review data on the epidemiology of COVID-19 and the potential use of COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 vaccine ( 3 ). Within the EtR Framework, ACIP considered the importance of the public health problem of COVID-19, as well as issues of resource use, benefits and harms, patients’ values and preferences, acceptability, feasibility, and equity for the Pfizer-BioNTech COVID-19 vaccine. To inform the EtR Framework, the COVID-19 Vaccines Work Group, comprising experts in infectious disease, vaccinology, vaccine safety, public health, and ethics, held 27 meetings to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccines, including the Pfizer-BioNTech COVID-19 vaccine. After a systematic review of the literature, the Work Group used the GRADE approach to assess the certainty of evidence for outcomes related to the vaccine, rated on a scale of 1 (high certainty) to 4 (very low certainty) ( 4 ). Work Group conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at public meetings. The body of evidence for the Pfizer-BioNTech COVID-19 vaccine was primarily informed by one large, randomized, double-blind, placebo-controlled Phase II/III clinical trial that enrolled >43,000 participants (median age = 52 years, range = 16–91 years) ( 5 , 6 ). Interim findings from this clinical trial, using data from participants with a median of 2 months of follow-up, indicate that the Pfizer-BioNTech COVID-19 vaccine was 95.0% effective (95% confidence interval = 90.3%–97.6%) in preventing symptomatic laboratory-confirmed COVID-19 in persons without evidence of previous SARS-CoV-2 infection. Consistent high efficacy (≥92%) was observed across age, sex, race, and ethnicity categories and among persons with underlying medical conditions as well as among participants with evidence of previous SARS-CoV-2 infection. Although numbers of observed hospitalizations and deaths were low, the available data were consistent with reduced risk for these severe outcomes among vaccinated persons compared with that among placebo recipients. Among vaccine recipients, reactogenicity symptoms, defined as solicited local injection site or systemic reactions during the 7 days after vaccination, were frequent and mostly mild to moderate. Systemic adverse reactions were more commonly reported after the second dose than after the first dose and were generally more frequent and severe in persons aged 18–55 years than in those aged >55 years. Systemic adverse reactions had a median onset of 1–2 days after vaccine receipt and resolved in a median of 1 day. Severe local and systemic adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly in vaccine recipients than in placebo recipients. Among vaccine recipients, 8.8% reported any grade ≥3 reaction; the most common symptoms were fatigue (4.2%), headache (2.4%), muscle pain (1.8%), chills (1.7%), and injection site pain (1.4%). Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose and were less prevalent in older than in younger participants. Serious adverse events ¶ were observed in a similar proportion of vaccine (0.6%) and placebo (0.5%) recipients and encompassed medical events occurring at a frequency similar to that within the general population ( 6 ). No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection. A detailed summary of safety data, including information on reactogenicity, is available at https://www.cdc.gov/vaccines/covid-19/info-by-manufacturer/pfizer/reactogenicity.html. From the GRADE evidence assessment, the level of certainty for the benefits of the Pfizer-BioNTech COVID-19 vaccine was type 1 (high certainty) for the prevention of symptomatic COVID-19. Evidence was type 3 (low certainty) for the estimate of prevention of COVID-19–associated hospitalization and type 4 (very low certainty) for the estimate of prevention of death. Data on hospitalizations and deaths are limited at this time, but a vaccine that effectively prevents symptomatic infection is expected to also prevent hospitalizations and deaths. Regarding potential harms after vaccination, evidence was type 2 (moderate certainty) for serious adverse events and type 1 (high certainty) for reactogenicity. No data were available to assess the efficacy for prevention of asymptomatic SARS-CoV-2 infection. Data reviewed within the EtR Framework supported the use of the Pfizer-BioNTech COVID-19 vaccine. ACIP determined that COVID-19 is a major public health problem and that use of the Pfizer-BioNTech COVID-19 vaccine is a reasonable and efficient allocation of resources. Whereas there might be uncertainty in how all populations value the vaccine, it was determined that for most populations, the desirable effects outweigh the undesirable effects. The vaccine is probably acceptable to implementation stakeholders and feasible to implement in spite of difficult ultracold-chain storage and requirements for handling and administration. These requirements could limit the availability of the Pfizer-BioNTech COVID-19 vaccine to some populations thereby negatively impacting health equity. Therefore, efforts should be made to overcome these challenges and advance health equity. The GRADE evidence profile and EtR supporting evidence are available at https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizer-biontech-vaccine.html and https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizer-biontech-etr.html. Before vaccination, the EUA Fact Sheet should be provided to recipients and caregivers. Providers should counsel Pfizer-BioNTech COVID-19 vaccine recipients about expected systemic and local reactogenicity. Additional clinical considerations, including details of administration and use in special populations (e.g., persons who are pregnant or immunocompromised or who have severe allergies) are available at https://www.cdc.gov/vaccines/covid-19/info-by-manufacturer/pfizer/clinical-considerations.html Additional studies of safety and effectiveness are planned after authorization and will be important to inform future ACIP recommendations as well as increase public confidence in the COVID-19 vaccination program. The interim recommendation and clinical considerations are based on use of the Pfizer-BioNTech COVID-19 vaccine under an EUA and might change as more evidence becomes available. ACIP will continue to review additional data as they become available; updates to recommendations or clinical considerations will be posted on the ACIP website (https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html). Reporting of Vaccine Adverse Events Adverse events that occur in a recipient after receipt of COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS). FDA requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under EUA. Reporting is encouraged for any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html or 1-800-822-7967. In addition, CDC has developed a new, voluntary smartphone-based tool, v-safe, that uses text messaging and web surveys to provide near real-time health check-ins after patients receive COVID-19 vaccination. The CDC/v-safe call center follows up on reports to v-safe that indicate a medically significant health impact to collect additional information for completion of a VAERS report. Information on v-safe is available at https://www.cdc.gov/vsafe. Summary What is already known about this topic? On December 11, 2020, the Food and Drug Administration issued an Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine. What is added by this report? On December 12, 2020, after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. What are the implications for public health practice? The recommendation for the Pfizer-BioNTech COVID-19 vaccine should be implemented in conjunction with ACIP’s interim recommendation for allocating initial supplies of COVID-19 vaccines.
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            Excess Deaths Associated with COVID-19, by Age and Race and Ethnicity — United States, January 26–October 3, 2020

            As of October 15, 216,025 deaths from coronavirus disease 2019 (COVID-19) have been reported in the United States*; however, this number might underestimate the total impact of the pandemic on mortality. Measures of excess deaths have been used to estimate the impact of public health pandemics or disasters, particularly when there are questions about underascertainment of deaths directly attributable to a given event or cause ( 1 – 6 ). † Excess deaths are defined as the number of persons who have died from all causes, in excess of the expected number of deaths for a given place and time. This report describes trends and demographic patterns in excess deaths during January 26–October 3, 2020. Expected numbers of deaths were estimated using overdispersed Poisson regression models with spline terms to account for seasonal patterns, using provisional mortality data from CDC’s National Vital Statistics System (NVSS) ( 7 ). Weekly numbers of deaths by age group and race/ethnicity were assessed to examine the difference between the weekly number of deaths occurring in 2020 and the average number occurring in the same week during 2015–2019 and the percentage change in 2020. Overall, an estimated 299,028 excess deaths have occurred in the United States from late January through October 3, 2020, with two thirds of these attributed to COVID-19. The largest percentage increases were seen among adults aged 25–44 years and among Hispanic or Latino (Hispanic) persons. These results provide information about the degree to which COVID-19 deaths might be underascertained and inform efforts to prevent mortality directly or indirectly associated with the COVID-19 pandemic, such as efforts to minimize disruptions to health care. Estimates of excess deaths can provide a comprehensive account of mortality related to the COVID-19 pandemic, including deaths that are directly or indirectly attributable to COVID-19. Estimates of the numbers of deaths directly attributable to COVID-19 might be limited by factors such as the availability and use of diagnostic testing (including postmortem testing) and the accurate and complete reporting of cause of death information on the death certificate. Excess death analyses are not subject to these limitations because they examine historical trends in all-cause mortality to determine the degree to which observed numbers of deaths differ from historical norms. In April 2020, CDC’s National Center for Health Statistics (NCHS) began publishing data on excess deaths associated with the COVID-19 pandemic ( 7 , 8 ). This report describes trends and demographic patterns in the number of excess deaths occurring in the United States from January 26, 2020, through October 3, 2020, and differences by age and race/ethnicity using provisional mortality data from the NVSS. § Excess deaths are typically defined as the number of persons who have died from all causes, in excess of the expected number of deaths for a given place and time. A detailed description of the methodology for estimating excess deaths has been described previously ( 7 ). Briefly, expected numbers of deaths are estimated using overdispersed Poisson regression models with spline terms to account for seasonal patterns. The average expected number, as well as the upper bound of the 95% prediction interval (the range of values likely to contain the value of a single new observation), are used as thresholds to determine the number of excess deaths (i.e., observed numbers above each threshold) and percentage excess (excess deaths divided by average expected number of deaths). Estimates described here refer to the number or percentage above the average; estimates above the upper bound threshold have been published elsewhere ( 7 ). Observed numbers of deaths are weighted to account for incomplete reporting by jurisdictions (50 states and the District of Columbia [DC]) in the most recent weeks, where the weights were estimated based on completeness of provisional data in the past year ( 7 ). Weekly NVSS data on excess deaths occurring from January 26 (the week ending February 1), 2020, through October 3, 2020, were used to quantify the number of excess deaths and the percentage excess for deaths from all causes and deaths from all causes excluding COVID-19. ¶ Deaths attributed to COVID-19 have the International Classification of Diseases, Tenth Revision code U07.1 as an underlying or contributing cause of death. Weekly numbers of deaths by age group (0–24, 25–44, 45–64, 65–74, 75–84, and ≥85 years) and race/ethnicity (Hispanic or Latino [Hispanic], non-Hispanic White [White], non-Hispanic Black or African American [Black], non-Hispanic Asian [Asian], non-Hispanic American Indian or Alaska Native [AI/AN], and other/unknown race/ethnicity, which included non-Hispanic Native Hawaiian or other Pacific Islander, non-Hispanic multiracial, and unknown) were used to examine the difference between the weekly number of deaths occurring in 2020 and the average number occurring in the same week during 2015–2019. These values were used to calculate an average percentage change in 2020 (i.e., above or below average compared with past years), over the period of analysis, by age group and race and Hispanic ethnicity. NVSS data in this report include all deaths occurring in the 50 states and DC and are not limited to U.S. residents. Approximately 0.2% of decedents overall are foreign residents. R statistical software (version 3.5.0; The R Foundation) was used to conduct all analyses. From January 26, 2020, through October 3, 2020, an estimated 299,028 more persons than expected have died in the United States.** Excess deaths reached their highest points to date during the weeks ending April 11 (40.4% excess) and August 8, 2020 (23.5% excess) (Figure 1). Two thirds of excess deaths during the analysis period (66.2%; 198,081) were attributed to COVID-19 and the remaining third to other causes †† (Figure 1). FIGURE 1 Weekly numbers of deaths from all causes and from all causes excluding COVID-19 relative to the average expected number and the upper bound of the 95% prediction interval (A), and the weekly and total numbers of deaths from all causes and from all causes excluding COVID-19 above the average expected number and the upper bound of the 95% prediction interval (B) — National Vital Statistics System, United States, January–September 2020 Abbreviation: COVID-19 = coronavirus disease 2019. The figure is a histogram, an epidemiologic curve showing the weekly numbers of deaths from all causes and from all causes excluding COVID-19 relative to the average expected number and the upper bound of the 95% prediction interval (A), and the weekly and total numbers of deaths from all causes and from all causes excluding COVID-19 above the average expected number and the upper bound of the 95% prediction interval (B), using data from the National Vital Statistics System, in United States, during January–September 2020. The total number of excess deaths (deaths above average levels) from January 26 through October 3 ranged from a low of approximately 841 in the youngest age group (<25 years) to a high of 94,646 among adults aged 75–84 years. §§ However, the average percentage change in deaths over this period compared with previous years was largest for adults aged 25–44 years (26.5%) (Figure 2). Overall, numbers of deaths among persons aged <25 years were 2.0% below average, ¶¶ and among adults aged 45–64, 65–74 years, 75–84, and ≥85 years were 14.4%, 24.1%, 21.5%, and 14.7% above average, respectively. FIGURE 2 Percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by age group — United States, 2015–2019 and 2020 The figure is a histogram, an epidemiologic curve showing the percentage change in the weekly number of deaths in 2020 relative to average numbers during the same weeks in 2015–2019, by age group, in the United States, during 2015–2019 and 2020. When examined by race and ethnicity, the total numbers of excess deaths during the analysis period ranged from a low of approximately 3,412 among AI/AN persons to a high of 171,491 among White persons. For White persons, deaths were 11.9% higher when compared to average numbers during 2015–2019. However, some racial and ethnic subgroups experienced disproportionately higher percentage increases in deaths (Figure 3). Specifically, the average percentage increase over this period was largest for Hispanic persons (53.6%). Deaths were 28.9% above average for AI/AN persons, 32.9% above average for Black persons, 34.6% above average for those of other or unknown race or ethnicity, and 36.6% above average for Asian persons. FIGURE 3 Percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by race and Hispanic ethnicity — United States, 2015–2019 and 2020 The figure is a histogram, an epidemiologic curve showing the percentage change in the weekly number of deaths in 2020 relative to average numbers in the same weeks during 2015–2019, by race and Hispanic ethnicity, in the United States, during 2015–2019 and 2020. Discussion Based on NVSS data, excess deaths have occurred every week in the United States since March 2020. An estimated 299,028 more persons than expected have died since January 26, 2020; approximately two thirds of these deaths were attributed to COVID-19. A recent analysis of excess deaths from March through July reported very similar findings, but that study did not include more recent data through September ( 5 ). Although more excess deaths have occurred among older age groups, relative to past years, adults aged 25–44 years have experienced the largest average percentage increase in the number of deaths from all causes from late January through October 3, 2020. The age distribution of COVID-19 deaths shifted toward younger age groups from May through August ( 9 ); however, these disproportionate increases might also be related to underlying trends in other causes of death. Future analyses might shed light on the extent to which increases among younger age groups are driven by COVID-19 or by other causes of death. Among racial and ethnic groups, the smallest average percentage increase in numbers of deaths compared with previous years occurred among White persons (11.9%) and the largest for Hispanic persons (53.6%), with intermediate increases (28.9%–36.6%) among AI/AN, Black, and Asian persons. These disproportionate increases among certain racial and ethnic groups are consistent with noted disparities in COVID-19 mortality.*** The findings in this report are subject to at least five limitations. First, the weighting of provisional NVSS mortality data might not fully account for reporting lags, particularly in recent weeks. Estimated numbers of deaths in the most recent weeks are likely underestimated and will increase as more data become available. Second, there is uncertainty associated with the models used to generate the expected numbers of deaths in a given week. A range of values for excess death estimates is provided elsewhere ( 7 ), but these ranges might not reflect all of the sources of uncertainty, such as the completeness of provisional data. Third, different methods or models for estimating the expected numbers of deaths might lead to different results. Estimates of the number or percentage of deaths above average levels by race/ethnicity and age reported here might not sum to the total numbers of excess deaths reported elsewhere, which might have been estimated using different methodologies. Fourth, using the average numbers of deaths from past years might underestimate the total expected numbers because of population growth or aging, or because of increasing trends in certain causes such as drug overdose mortality. Finally, estimates of excess deaths attributed to COVID-19 might underestimate the actual number directly attributable to COVID-19, because deaths from other causes might represent misclassified COVID-19–related deaths or deaths indirectly caused by the pandemic. Specifically, deaths from circulatory diseases, Alzheimer disease and dementia, and respiratory diseases have increased in 2020 relative to past years ( 7 ), and it is unclear to what extent these represent misclassified COVID-19 deaths or deaths indirectly related to the pandemic (e.g., because of disruptions in health care access or utilization). Despite these limitations, however, this report demonstrates important trends and demographic patterns in excess deaths that occurred during the COVID-19 pandemic. These results provide more information about deaths during the COVID-19 pandemic and inform public health messaging and mitigation efforts focused on the prevention of infection and mortality directly or indirectly associated with the COVID-19 pandemic and the elimination of health inequities. CDC continues to recommend the use of masks, frequent handwashing, and maintenance of social distancing to prevent COVID-19. ††† Summary What is already known about this topic? As of October 15, 216,025 deaths from COVID-19 have been reported in the United States; however, this might underestimate the total impact of the pandemic on mortality. What is added by this report? Overall, an estimated 299,028 excess deaths occurred from late January through October 3, 2020, with 198,081 (66%) excess deaths attributed to COVID-19. The largest percentage increases were seen among adults aged 25–44 years and among Hispanic or Latino persons. What are the implications for public health practice? These results inform efforts to prevent mortality directly or indirectly associated with the COVID-19 pandemic, such as efforts to minimize disruptions to health care.
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              The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020

              On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                February 12 2021
                Affiliations
                [1 ]Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
                [2 ]Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
                Article
                10.1001/jama.2021.1967
                42749319-ca10-4a90-b37f-63d53fd7ba6d
                © 2021

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