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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.

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.

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

The first vaccines for prevention of coronavirus disease 2019 (COVID-19) in the United States were authorized for emergency use by the Food and Drug Administration (FDA) (1) and recommended by the Advisory Committee on Immunization Practices (ACIP) in December 2020.* However, demand for COVID-19 vaccines is expected to exceed supply during the first months of the national COVID-19 vaccination program. ACIP advises CDC on population groups and circumstances for vaccine use.† On December 1, ACIP recommended that 1) health care personnel§ and 2) residents of long-term care facilities¶ be offered COVID-19 vaccination first, in Phase 1a of the vaccination program (2). On December 20, 2020, ACIP recommended that in Phase 1b, vaccine should be offered to persons aged ≥75 years and frontline essential workers (non-health care workers), and that in Phase 1c, persons aged 65-74 years, persons aged 16-64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b should be offered vaccine.** These recommendations for phased allocation provide guidance for federal, state, and local jurisdictions while vaccine supply is limited. In its deliberations, ACIP considered scientific evidence regarding COVID-19 epidemiology, ethical principles, and vaccination program implementation considerations. ACIP's recommendations for COVID-19 vaccine allocation are interim and might be updated based on changes in conditions of FDA Emergency Use Authorization, FDA authorization for new COVID-19 vaccines, changes in vaccine supply, or changes in COVID-19 epidemiology.

To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.

To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.

The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has led to a global pandemic that has disrupted all sectors of society. Less than 1 year after the SARS-CoV-2 genome was first sequenced, an application* for Emergency Use Authorization for a candidate vaccine has been filed with the Food and Drug Administration (FDA). However, even if one or more vaccine candidates receive authorization for emergency use, demand for COVID-19 vaccine is expected to exceed supply during the first months of the national vaccination program. The Advisory Committee on Immunization Practices (ACIP) advises CDC on population groups and circumstances for vaccine use.† ACIP convened on December 1, 2020, in advance of the completion of FDA's review of the Emergency Use Authorization application, to provide interim guidance to federal, state, and local jurisdictions on allocation of initial doses of COVID-19 vaccine. ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both 1) health care personnel§ and 2) residents of long-term care facilities (LTCFs)¶ be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a**).†† In its deliberations, ACIP considered scientific evidence of SARS-CoV-2 epidemiology, vaccination program implementation, and ethical principles.§§ The interim recommendation might be updated over the coming weeks based on additional safety and efficacy data from phase III clinical trials and conditions of FDA Emergency Use Authorization.

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.

Summary This report summarizes the recommendations of the Advisory Committee on Immunization Practices (ACIP) for use of the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) in the United States. The vaccine contains rice-derived recombinant human serum albumin and live attenuated recombinant vesicular stomatitis virus (VSV) in which the gene encoding the glycoprotein of VSV was replaced with the gene encoding the glycoprotein of Ebola virus species Zaire ebolavirus. Persons with a history of severe allergic reaction (e.g., anaphylaxis) to rice protein should not receive Ervebo. This is the first and only vaccine currently licensed by the Food and Drug Administration for the prevention of Ebola virus disease (EVD). These guidelines will be updated based on availability of new data or as new vaccines are licensed to protect against EVD. ACIP recommends preexposure vaccination with Ervebo for adults aged ≥18 years in the U.S. population who are at highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus because they are responding to an outbreak of EVD, work as health care personnel at federally designated Ebola treatment centers in the United States, or work as laboratorians or other staff at biosafety level 4 facilities in the United States. Recommendations for use of Ervebo in additional populations at risk for exposure and other settings will be considered and discussed by ACIP in the future.

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.

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.

The introduction of Zika virus into the Region of the Americas (Americas) and the subsequent increase in cases of congenital microcephaly resulted in activation of CDC's Emergency Operations Center on January 22, 2016, to ensure a coordinated response and timely dissemination of information, and led the World Health Organization to declare a Public Health Emergency of International Concern on February 1, 2016. During the past year, public health agencies and researchers worldwide have collaborated to protect pregnant women, inform clinicians and the public, and advance knowledge about Zika virus (Figure 1). This report summarizes 10 important contributions toward addressing the threat posed by Zika virus in 2016. To protect pregnant women and their fetuses and infants from the effects of Zika virus infection during pregnancy, public health activities must focus on preventing mosquito-borne transmission through vector control and personal protective practices, preventing sexual transmission by advising abstention from sex or consistent and correct use of condoms, and preventing unintended pregnancies by reducing barriers to access to highly effective reversible contraception.

During 2014-2016, CDC, working with U.S. and international partners, mounted a concerted response to end the unprecedented epidemic of Ebola virus disease (Ebola) in West Africa. CDC's response, which was the largest in the agency's history, was directed simultaneously at controlling the epidemic in West Africa and strengthening preparedness for Ebola in the United States. Although experience in responding to approximately 20 Ebola outbreaks since 1976 had provided CDC and other international responders an understanding of the disease and how to stop its spread, the epidemic in West Africa presented new and formidable challenges. The initial response was slow and complicated for several reasons, including wide geographic spread of cases, poor public health and societal infrastructure, sociodemographic factors, local unfamiliarity with Ebola, and distrust of government and health care workers. In the United States, widespread public alarm erupted after Ebola cases were diagnosed in Dallas, Texas, and New York City, New York. CDC, in collaboration with its U.S. and international counterparts, applied proven public health strategies as well as innovative new approaches to help control the Ebola epidemic in West Africa and strengthen public health readiness in the United States. Lessons learned include the recognition that West African and other countries need effective systems to detect and stop infectious disease threats, the need for stronger international surge capacity for times when countries are overwhelmed by an outbreak, and the importance of improving infection prevention and control in health care settings. The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

Stopping the Ebola outbreak at its source will take many months. But three core interventions have stopped every previous outbreak and can stop this one: exhaustive case and contact finding, effective response to patients and the community, and preventive interventions.

In response to the 2014-2016 Ebola virus disease (Ebola) epidemic in West Africa, CDC prepared for the potential introduction of Ebola into the United States. The immediate goals were to rapidly identify and isolate any cases of Ebola, prevent transmission, and promote timely treatment of affected patients. CDC's technical expertise and the collaboration of multiple partners in state, local, and municipal public health departments; health care facilities; emergency medical services; and U.S. government agencies were essential to the domestic preparedness and response to the Ebola epidemic and relied on longstanding partnerships. CDC established a comprehensive response that included two new strategies: 1) active monitoring of travelers arriving from countries affected by Ebola and other persons at risk for Ebola and 2) a tiered system of hospital facility preparedness that enabled prioritization of training. CDC rapidly deployed a diagnostic assay for Ebola virus (EBOV) to public health laboratories. Guidance was developed to assist in evaluation of patients possibly infected with EBOV, for appropriate infection control, to support emergency responders, and for handling of infectious waste. CDC rapid response teams were formed to provide assistance within 24 hours to a health care facility managing a patient with Ebola. As a result of the collaborations to rapidly identify, isolate, and manage Ebola patients and the extensive preparations to prevent spread of EBOV, the United States is now better prepared to address the next global infectious disease threat.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

Background In April 2009, a novel influenza A virus emerged in the United States. By the end of July, influenza A (H1N1) 2009 monovalent (2009 H1N1) vaccine had been developed, licensed, and recommended by the Advisory Committee on Immunization Practices. Initial target groups for vaccination were identified and the first vaccine was publicly available in early October 2009. Objective This study examines socio-demographic differences in opinions about 2009 pandemic influenza A (H1N1) (pH1N1) and seasonal influenza disease and vaccines and the association with receipt of influenza vaccinations during the 2009–2010 influenza season. Changes in opinions over the course of the pH1N1 pandemic were also examined. Methods Data from the 2009 National H1N1 Flu Survey (NHFS) were analyzed. The NHFS was a CDC-sponsored telephone survey initiated in response to the 2009 pH1N1 pandemic to obtain weekly within-season estimates of vaccination coverage, opinions, and other information. Results Opinions about influenza vaccine and disease varied significantly by race/ethnicity, income, and education level. In multivariable logistic regression analysis, adjusted 2009 H1N1 vaccination coverage was most strongly associated with opinions about the effectiveness of the vaccine and personal risk of disease, varying from 7 to 11% among adults who believed the vaccine to have low effectiveness and themselves at low risk of influenza, to 50–53% among those who thought vaccine effectiveness to be high and themselves at high risk of influenza. Conclusion Improving communication about personal risk and the effectiveness of influenza vaccines may improve vaccination coverage. The findings of difference in opinions could be used to target communication.

A strong evidence base provides the foundation for planning and response strategies. Investments in pandemic preparedness included support for research that aided early detection, response, and control of the 2009 influenza A (H1N1) (pH1N1) pandemic. Scientific investigations conducted during the pandemic guided understanding of the virus, disease severity, and epidemiologic risk factors. Field investigations also produced information that strengthened guidance for the use of antivirals, identification of target populations for monovalent pH1N1 vaccine, and refinement of recommendations for social distancing measures. Communication of this evolving evidence base was important to sustaining credibility of public health. Areas where substantial controversy emerged, such as the optimal approach to respiratory protection of healthcare workers, often suffered from gaps in the evidence base. Many aspects of the 2009-2010 pandemic influenza experience provide ongoing opportunities for additional study, which will strengthen plans for future pandemic response as well as control of seasonal influenza.

Palivizumab was licensed in June 1998 by the US Food and Drug Administration for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients who are at increased risk of severe disease. Safety and efficacy have been established for infants born at or before 35 weeks' gestation with or without chronic lung disease of prematurity and for infants and children with hemodynamically significant heart disease. The American Academy of Pediatrics (AAP) published a policy statement on the use of palivizumab in November 1998 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 1998;102[5]:1211–1216) and revised it in December 2003 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1442–1446), and an AAP technical report on palivizumab was published in 2003 (Meissner HC, Long SS; American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1447–1452). On the basis of the availability of additional data regarding seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children who are at increased risk of serious RSV lower respiratory tract disease, AAP recommendations for immunoprophylaxis have been updated in an effort to ensure optimal balance of benefit and cost from this expensive intervention. This statement updates and replaces the 2003 AAP statement and the 2006 Red Book and is consistent with the 2009 Red Book recommendations.

Background. The duration of protection in children and adults (including health care workers) resulting from the hepatitis B vaccine primary series is unknown. Methods. To determine the protection afforded by hepatitis B vaccine, Alaska Native persons who had received plasma-derived hepatitis B vaccine when they were 16 months of age were tested for antibody to hepatitis B surface antigen (anti-HBs) 22 years later. Those with levels !10 mIU/mL received 1 dose of recombinant hepatitis B vaccine and were evaluated on the basis of anti-HBs measurements at 10–14 days, 30–60 days, and 1 year. Results. Of 493 participants, 60% (298) had an anti-HBs level 10 mIU/mL. A booster dose was administered to 164 persons, and 77% responded with an anti-HBs level 10 mIU/mL at 10–14 days, reaching 81% by 60 days. Response to a booster dose was positively correlated with younger age, peak anti-HBs response after primary vaccination, and the presence of detectable anti-HBs before boosting. Considering persons with an anti-HBs level 10 mIU/mL at 22 years and those who responded to the booster dose, protection was demonstrated in 87% of the participants. No new acute or chronic hepatitis B virus infections were identified. Conclusions. The protection afforded by primary immunization with plasma-derived hepatitis B vaccine during childhood and adulthood lasts at least 22 years. Booster doses are not needed. Hepatitis B vaccine (both plasma derived and recombinant) has been shown to be highly efficacious in preventing infection with hepatitis B virus (HBV). Immunization with this vaccine starting at birth has

We demonstrate that after implementation of recommendations for universal infant hepatitis B vaccination, HBV infection prevalence among children of foreign-born Asian parents in Georgia declined dramatically; horizontal transmission of infection within households has occurred infrequently; and the vast majority of infants and children have received the recommended hepatitis B vaccinations. These results provide evidence of the success of the hepatitis B infant vaccination program and highlight its potential impact on reducing chronic HBV infection morbidity and mortality among U.S. populations at high risk.

Obesity appears to be a risk factor for hepatic steatosis, which has been implicated in the development of hepatic fibrosis in patients with hepatitis C virus infection. We conducted the current study to examine whether obesity is associated with hepatic steatosis among patients with chronic hepatitis C identified from a population-based cohort. Study participants were persons with chronic hepatitis C who had had a liver biopsy, identified from a population-based study of persons with newly identified chronic liver disease conducted in gastroenterology practices. Data were collected through patient interviews, medical record abstraction, and review of previously performed liver biopsies. The outcome variable of interest was significant steatosis, defined as steatosis grade > or =2 determined from liver biopsy samples. Univariate and multivariate analyses were performed using logistic regression techniques. The analysis included 450 patients with chronic hepatitis C with available liver biopsy slides. Overall, only 15.8% of subjects had significant hepatic steatosis (grade > or =2), while 35.9% of obese subjects had significant steatosis. In multivariate analysis, significant fibrosis (defined as > or = grade 2) (odds ratio [OR], 3.43; 95% confidence interval [CI], 1.59-7.37), obesity (OR, 3.32; 95% CI, 1.84-5.98), genotype 3 (OR, 2.5; 95% CI, 1.09-5.75), and the presence of multiple metabolic comorbidities (OR, 1.91; 95% CI, 0.88-4.11) were independently associated with steatosis. In this unique United States cohort of patients with newly diagnosed chronic liver disease due to hepatitis C, obesity was independently associated with hepatic steatosis. The results of this study provide additional evidence that obesity worsens liver damage in patients with chronic hepatitis C, and suggest a role for weight loss as a treatment modality in these patients.

This statement updates and replaces the 2007 American Academy of Pediatrics statement for prevention of rotavirus gastroenteritis. In February 2006, a live oral human-bovine reassortant rotavirus vaccine (RV5 [RotaTeq]) was licensed as a 3-dose series for use in infants in the United States. The American Academy of Pediatrics recommended routine use of RV5 in infants in the United States. In April 2008, a live, oral, human attenuated rotavirus vaccine (RV1 [Rotarix]) was licensed as a 2-dose series for use in infants in the United States. The American Academy of Pediatrics recommends routine immunization of infants in the United States with rotavirus vaccine. The American Academy of Pediatrics does not express a preference for either RV5 or RV1. RV5 is to be administered orally in a 3-dose series with doses administered at 2, 4, and 6 months of age; RV1 is to be administered orally in a 2-dose series with doses administered at 2 and 4 months of age. The first dose of rotavirus vaccine should be administered from 6 weeks through 14 weeks, 6 days of age. The minimum interval between doses of rotavirus vaccine is 4 weeks. All doses should be administered by 8 months, 0 days of age. Recommendations in this statement also address the maximum ages for doses, contraindications, precautions, and special situations for administration of rotavirus vaccine.

Background & Aims Assessment of liver histology has an important role in the management of chronic liver disease. It is not clear whether there are interobserver variabilities between hepatopathologists and general community pathologists. We evaluated the effect of type of pathologist and biopsy specimen size on interobserver agreement for hepatic fibrosis. Methods Subjects were identified from a population-based sample of adults from a chronic liver disease surveillance network. Biopsy slides from 391 hepatitis C patients who had undergone liver biopsy were obtained and read by 2 study hepatopathologists blinded to the patients' diagnoses (the gold standard). The interobserver agreement of the fibrosis stage between the hepatopathologists and the general pathologists' report were evaluated by kappa index. Results There was complete agreement between the study pathologist and community pathologist in 49.9% of biopsy specimens. The overall kappa index across all stages of fibrosis was 0.409, with the best agreement occurring at higher stages of fibrosis (kappa: 0.482 for stage 3, 0.776 for stage 4). Overall agreement was good (kappa, 0.465) when biopsy samples were greater than 1.5 cm in size. The community pathologist understaged fibrosis in 73% of biopsy specimens with disagreement. A total of 26% of patients with stages 2 to 4 fibrosis were understaged by the community pathologist. Conclusions Results from this population-based study show good overall interobserver agreement between hepatopathologists and general pathologists when determining fibrosis stage in liver biopsy specimens from hepatitis C patients when liver biopsy sizes are adequate. However, community pathologists tended to understage fibrosis, which could keep patients from receiving proper treatment.

Background Hepatitis A vaccination is effective in preventing disease. However, the duration of protection after vaccination is unknown. Methods We enrolled persons who responded to a 3-dose primary series of hepatitis A vaccine. For adults, the first dose was 720 ELISA units (EU) of hepatitis A vaccine, readministered at 1 and 12 months after the first vaccination (hereafter, "0-1-12 months"); for children aged 3-6 years, the first dose was 360 EU, readministered according to 1 of 3 vaccination schedules: 1 and 2 months after the first vaccination ("0-1-2 months"), 1 and 6 months after the first vaccination ("0-1-6 months"), or 1 and 12 months after vaccination ("0-1-12 months"). Specimens collected 1 month and 1-10 years after vaccination were tested for antibody to hepatitis A virus (anti-HAV) by ELISA. Long-term antibody persistence was estimated by using the observed rate of decline in geometric mean concentration (GMC). Results A total of 144 children and 128 adults were enrolled. Children vaccinated at 0-1-2 months had a significantly lower GMC of antibody than children vaccinated at 0-1-12 months, but this difference was statistically significant only through 4 years of follow-up. All 67 children tested at 10 years and 25 (96%) of 26 adults tested at 8-9 years had detectable anti-HAV. The estimated duration of antibody persistence was 21-27 years, depending on the vaccination schedule. Conclusions Anti-HAV persists in adults and children for more than 10 years after the primary vaccination series. Additional studies are needed to evaluate the duration of antibody persistence beyond 10 years and to assess the long-term immunogenicity of the currently recommended 2-dose schedule.

Chronic liver disease (CLD) is an important cause of morbidity and mortality, but the epidemiology is not well described. We conducted prospective population-based surveillance to estimate newly diagnosed CLD incidence, characterize etiology distribution, and determine disease stage.We identified cases of CLD newly diagnosed during 1999-2001 among adult county residents seen in any gastroenterology practice in New Haven County, Connecticut; Multnomah County, Oregon; and Northern California Kaiser Permanente Medical Care Program (KPMCP, Oakland, California [total population 1.48 million]). We defined CLD as abnormal liver tests of at least 6 months' duration or pathologic, clinical, or radiologic evidence of CLD. Consenting patients were interviewed, a blood specimen obtained, and the medical record reviewed.We identified 2,353 patients with newly diagnosed CLD (63.9 cases/100,000 population), including 1,225 hepatitis C patients (33.2 cases/100,000). Men aged 45-54 yr had the highest hepatitis C incidence rate (111.3/100,000). Among 1,040 enrolled patients, the median age was 48 yr (range 19-86 yr). Hepatitis C, either alone (442 [42%]) or in combination with alcohol-related liver disease (ALD) (228 [22%]), accounted for two-thirds of the cases. Other etiologies included nonalcoholic fatty liver disease (NAFLD, 95 [9%]), ALD (82 [8%]), and hepatitis B (36 [3%]). Other identified etiologies each accounted for3% of the cases. A total of 184 patients (18%) presented with cirrhosis, including 44% of patients with ALD.Extrapolating from this population-based surveillance network to the adult U.S. population, approximately 150,000 patients with CLD were diagnosed in gastroenterology practices each year during 1999-2001. Most patients had hepatitis C; heavy alcohol consumption among these patients was common. Almost 20% of patients, an estimated 30,000 per year, had cirrhosis at presentation. These results provide population-level baseline data to evaluate trends in identification of patients with CLD in gastroenterology practices.

Long-term follow-up studies of populations that received recombinant hepatitis B (HB) vaccination beginning at birth are limited.Micronesian adolescents who had received 3 doses of recombinant HB vaccine (Recombivax 5 microg at birth, 2.5 microg at 2 months, 2.5 microg ug at 6 months) and tested negative for antibody to HB core antigen (anti-HBc) 2 years after primary vaccination (baseline testing) were followed up 15 years after primary vaccination. After testing for anti-HBc, HB surface antigen (HBsAg), and antibody to HBsAg (anti-HBs), participants received a booster dose of HB vaccine. An anamnestic response was defined as an increase in anti-HBs concentrations to a levelor = 10 mIU/mL 14 days postbooster.Of the 105 participants, 42 (40.0%) had anti-HBs concentrationsor = 10 mIU/mL on baseline testing. At 15 years, 8 (7.6%) were anti-HBc positive; none were HBsAg positive. Of the remaining 97, 7 (7.3%) had anti-HBs concentrationsor = 10 mIU/mL. Of the 96 who received a booster dose, 46 (47.9%) had an anamnestic response; final antibody concentrations were 10-99 mIU/mL for 17 (17.7%) and100 mIU/mL for 29 (30.2%). Participants with anti-HBs concentrationsor = 10 mIU/mL on baseline testing were more likely to have an anamnestic response at 15 years [26/39 (66.7%) versus 20/57 (35.1%); P = 0.003].Fifteen years after primary vaccination starting at birth, 8% of participants had evidence of past HB virus infection, but none had chronic infection. Absence of an anamnestic response to an additional vaccine dose, seen in half of participants, might indicate waning immunity.

BACKGROUND Since the mid-1990s, hepatitis A vaccine has been recommended for US children living in historically high-incidence states and for persons with other risk factors or chronic liver disease (CLD). The incidence of hepatitis A has declined dramatically during the era of vaccination, but trends in mortality are largely unknown. METHODS US death certificates from 1990 to 2004 for which hepatitis A was listed as the underlying cause of death were analyzed. Average annual age-adjusted mortality rates during the prevaccine (1990-1995) and post-vaccination recommendation (2000-2004) periods were compared using a Mantel-Haenszel test of association. The number of deaths for which CLD was listed as a contributing cause was determined. RESULTS Overall, 1436 deaths due to hepatitis A occurred, averaging 96 annually (range, 142 in 1995 to 54 in 2003). CLD contributed to nearly half of these deaths. Mortality rates paralleled incidence rates, beginning to decline in the mid-1990s and achieving low points in 2003 and 2004. Average rates were 32% lower in the post-vaccination recommendation period than in the prevaccine period (P < .01). The decline was more dramatic for states with (45%; P < .001) than without (23%; P = .002) recommendations. CONCLUSIONS Hepatitis A mortality rates have declined over the past decade. CLD remains an important and preventable contributing cause of death due to hepatitis A.

OBJECTIVES: Most U.S. studies of acute liver failure (ALF) patients have been conducted at tertiary care liver transplantation centers. The aim of this study was to conduct population-based surveillance for ALF. METHODS: We conducted population-based surveillance for ALF within the 8 counties comprising Metropolitan Atlanta between November 2000 and October 2004. ALF cases were defined as the presence of coagulopathy, any grade of hepatic encephalopathy within 26 wk of illness onset, and no history of underlying liver disease. A questionnaire was administered and medical records were reviewed to determine clinical features, etiologies, and outcomes. RESULTS: A total of 65 cases were enrolled, yielding an annualized incidence for all causes of ALF of 5.5 (95% Cl 4.3-7.0) per million. Acetaminophen (APAP)-related ALF was the most common (41%) etiology in adults while ALF of undetermined etiology was most common (38%) in children, followed by APAP-related ALF (25%). Unintentional APAP overdose was the most common type (61%) of APAP-related cause. Blacks were more likely than other races to have ALF of undetermined etiology (32% vs 11%). Overall mortality was 40%, with 27 (42%) surviving with supportive care alone and 8 (12%) requiring orthotopic liver transplantation. CONCLUSIONS: Our population-based study suggests approximately 1,600 ALF cases occur in the United States each year. Consistent with findings from studies conducted exclusively at liver transplantation centers, APAP-related ALF was the most common etiology. Increased awareness of APAP-related ALF in the medical community may limit future cases. More research is warranted into ALF of undetermined etiology, especially in children.

Identify deaths related to chronic liver disease (CLD) in 2000 among Multnomah County, Oregon residents and estimate the proportion of these deaths attributable to hepatitis B or hepatitis C.Although CLD is among the most common causes of mortality in the United States, little information is available regarding the proportion of CLD mortality attributable to viral hepatitis.We developed a comprehensive list of 117 International Classification of Disease-10 codes potentially related to CLD. We identified deaths among residents of Multnomah County, Oregon whose death certificates included any one of these 117 codes. We verified the history of CLD and viral hepatitis using a combination of hospital charts, medical examiner reports, and a clinical questionnaire mailed to the certifying physician.We verified that 118 patients had died of CLD in Multnomah County, Oregon in 2000; 38 (32%) of the death certificates listed hepatitis B or hepatitis C as the underlying or a contributing cause of death. By medical record review, an additional 16 patients were found to have hepatitis B or hepatitis C not indicated on the death certificate [total 54 (46%) patients with viral hepatitis]. The majority of the 38 patients with viral hepatitis listed on the death certificate had an International Classification of Disease-10 code indicating acute infection with hepatitis B or hepatitis C.Chronic viral hepatitis is often unreported on death certificates of patients with CLD and, when reported, may be incorrectly coded as acute instead of chronic infection.

Background Hepatitis A vaccine coverage estimates needed for surveillance and vaccine policy decisions are not readily available for children older than 35 months or for adolescents. This article reports methodology developed for obtaining such estimates by telephone survey with and without provider record verification. Methods A random-digit-dial telephone survey with provider verification was conducted in Arizona and Oregon in 2004–2005 to obtain coverage estimates for children aged 2.5 to 15 years based on parental reports from telephone survey data alone, and from multiple logistic regressions using both telephone survey and provider data. Analysis was performed during 2006. Results Vaccination information was collected from parents of 1266 children, and provider verification from 488. Telephone survey and provider record–based hepatitis A vaccine coverage (one or more doses) was 60% and 65%, respectively, in Arizona, and 39% and 26%, respectively, in Oregon. Children who were younger, lived in metropolitan areas, or were Hispanic or nonwhite had significantly higher coverage; parents with immunization records provided more-accurate information. While a logistic model–based estimator developed using both parent and provider data performed slightly better than the estimator based on parent data alone, they differed mostly in the subgroups that had small sample sizes. Conclusions These are the first statewide provider-verified hepatitis A vaccine coverage estimates for children older than 35 months and indicate that telephone survey estimates as developed using this methodology could prove useful for immunization surveillance activities if interpreted cautiously.

OBJECTIVES. Because of the herd-immunity phenomenon, the benefits of immunization against hepatitis A extend beyond those received by those who are vaccinated. This analysis estimates the impact of herd immunity on the cost-effectiveness of routine hepatitis A immunization among US children. PATITENS AND METHODS. In an economic model, the costs and benefits of hepatitis A immunization were estimated for immunizing all US children at age 1 year over a 10-year period starting in 2005. The future burden of disease from hepatitis A was also estimated with this model, and the fraction that would be prevented by herd immunity was modeled by using a previously published analysis of the relationship between hepatitis A vaccination coverage and declines in hepatitis A incidence. RESULTS. Without accounting for herd-immunity effects, the costs of routine immunization would average $32000 per quality-adjusted life-year gained for the first 10 cohorts immunized starting with the 2005 birth cohort. Herd-immunity effects would be expected to produce substantial additional benefits, lowering the cost of the immunization program to $1000 per quality-adjusted life-year gained for the first 10 cohorts. Herd-immunity benefits would be greatest for the first few cohorts, more than doubling the benefits of immunization, and would decline over time. In a univariate sensitivity analysis, estimates were most sensitive to vaccination costs but remained below $20000 per quality-adjusted life-year under all of the assumptions. CONCLUSIONS. Herd-immunity effects more than double the savings from hepatitis A immunization during the first 10 years of the program. After accounting for these effects, immunization is close to cost-neutral on a cost-per-quality-adjusted-life-year basis.

Hepatitis E virus (HEV) is an enterically transmitted RNA virus that causes both epidemic and sporadic cases of acute hepatitis. Despite sero-surveys showing antibody to HEV in up to 36% of the US population, acute hepatitis E has been reported among individuals with no history of international travel only three times in the United States. We report a case of apparently locally-acquired hepatitis E that occurred in El Paso, Texas that was 98% similar to a previously isolated HEV found in swine in the United States. Like the three previous cases, a thorough investigation found no conclusive sources of infection. Active case surveillance found no additional cases.

Background Limited data are available regarding global hepatitis B virus (HBV)-related morbidity and mortality and potential reduction in disease burden from hepatitis B vaccination. Methods A model was developed to calculate the age-specific risk of acquiring HBV infection, acute hepatitis B (illness and death), and progression to chronic HBV infection. HBV-related deaths among chronically infected persons were determined from HBV-related cirrhosis and hepatocellular carcinoma (HCC) mortality curves, adjusted for background mortality. The effect of hepatitis B vaccination was calculated from vaccine efficacy and vaccination series coverage, with and without administration of the first dose of vaccine within 24 h of birth (i.e. birth dose) to prevent perinatal HBV infection. Results For the year 2000, the model estimated 620,000 persons died worldwide from HBV-related causes: 580,000 (94%) from chronic infection-related cirrhosis and HCC and 40,000 (6%) from acute hepatitis B. In the surviving birth cohort for the year 2000, the model estimated that without vaccination, 64.8 million would become HBV-infected and 1.4 million would die from HBV-related disease. Infections acquired during the perinatal period, in early childhood ( or = 5 years of age accounted for 21, 48, and 31% of deaths, respectively. Routine infant hepatitis B vaccination, with 90% coverage and the first dose administered at birth would prevent 84% of global HBV-related deaths. Conclusion Globally, most HBV-related deaths result from the chronic sequelae of infection acquired in the perinatal and early childhood periods. Inclusion of hepatitis B vaccine into national infant immunization programs could prevent >80% of HBV-related deaths.

Objectives. We sought to determine hepatitis B virus (HBV) infection prevalence, associated exposures, and incidence among male inmates at a state correctional facility. Methods. A cross-sectional serological survey was conducted in June 2000, and susceptible inmates were retested in June 2001. Results. At baseline, 230 inmates (20.5%; 95% confidence interval [CI]=18.2%, 22.9%) exhibited evidence of HBV infection, including 11 acute and 11 chronic infections. Inmates with HBV infection were more likely than susceptible inmates to have injected drugs (38.8% vs 18.0%; adjusted prevalence odds ratio [OR]=3.0; 95% CI=1.9, 4.9), to have had more than 25 female sex partners (27.7% vs 17.5%; adjusted prevalence OR=2.0; 95% CI=1.4, 3.0), and to have been incarcerated for more than 14 years (38.4% vs 17.6%; adjusted prevalence OR=1.7; 95% CI=1.1, 2.6). One year later, 18 (3.6%) showed evidence of new HBV infection. Among 19 individuals with infections, molecular analysis identified 2 clusters involving 10 inmates, each with a unique HBV sequence. Conclusions. We documented ongoing HBV transmission at a state correctional facility. Similar transmission may occur at other US correctional facilities and could be prevented by vaccination of inmates.

Objectives:To determine whether hepatitis B virus (HBV) transmission occurred among patients visiting a physician's office and to evaluate potential transmission mechanisms.Design:Serologic survey, retrospective cohort study, and observation of infection control practices.Setting:Private medical office.Patients:Those visiting the office between March 1 and December 26, 2001.Results:We identified 38 patients with acute HBV infection occurring between February 2000 and February 2002. The cohort study, limited to the 10 months before outbreak detection, included 91 patients with serologic test results and available charts representing 18 case-patients and 73 susceptible patients. Overall, 67 patients (74%) received at least one injection during the observation period. Case-patients received a median of 14 injections (range, 2-25) versus 2 injections (range, 0-17) for susceptible patients (P < .001). Acute infections occurred among 18 (27%) of 67 who received at least one injection versus none of 24 who received no injections (RR, 13.6; CI95, 2.4-undefined). Risk of infection increased 5.2-fold (CI95, 0.6-47.3) for those with 3 to 6 injections and 20.0-fold (CI95, 2.8-143.5) for those with more than 6 injections. Typically, injections consisted of doses of atropine, dexamethasone, vitamin B12, or a combination of these mixed in one syringe. HBV DNA genetic sequences of 24 patients with acute infection and 4 patients with chronic infection were identical in the 1,500-bp region examined. Medical staff were seronegative for HBV infection markers. The same surface was used for storing multidose vials, preparing injections, and dismantling used injection equipment.Conclusion:Administration of unnecessary injections combined with failure to separate clean from contaminated areas and follow safe injection practices likely resulted in patient-to-patient HBV transmission in a private physician's office.

Illicit drug use (IDU) is an important risk factor for hepatitis A, but implementing vaccination programs among drug users is difficult. During January 2001–July 2002, 403 hepatitis A cases were reported in Polk County, Florida; 48% were drug users and of these, 80% were recently in jail. To assess the county jail as a potential vaccination venue, we interviewed 280 inmates and conducted a serologic survey during July–August 2002. Of these, 227 (81%) reported a past IDU history. Previous HAV infection was found in 33%. In communities with illicit drug users at risk for hepatitis A and who are frequently jailed, vaccination programs in jails could be an important component of a community-based strategy to control hepatitis A outbreaks among illicit drug users.

Hepatitis A rates have declined to historically low rates in the United States. To assess the degree to which this decline was attributable to immunization, we correlated changes in the incidence of hepatitis A with increases in immunization coverage in a Poisson regression model. In a model allowing for herd immunity, an estimated 97,800 hepatitis A cases were averted due to immunization between 1995-2001, including 39% of potential cases in 2001. Assuming no herd immunity; 32,300 cases of hepatitis A would have been prevented. Sensitivity analysis showed that the number of averted cases in this period could range from 45,500 to 172,900. Among children 2-18 years old, vaccination coverage averaged 10% in 2001 and is estimated to have prevented 51% of cases in this age group. These results suggest that much of the recent reduction of hepatitis A rates is attributable to immunization and that immunization has been associated with a strong herd immunity effect.

Background and Objective:In August 2002, the Oklahoma State Department of Health received a report of six patients with unexplained hepatitis C virus (HCV) infection treated in the same pain remediation clinic. We investigated the outbreak's extent and etiology.Design, Setting, and Participants:We conducted a retrospective cohort study of clinic patients, including a serologic survey, interviews of infected patients, and reviews of medical records and staff infection control practices. Patients received outpatient pain remediation treatments one afternoon a week in a clinic within a hospital. Cases were defined as HCV or hepatitis B virus (HBV) infections among patients who reported no prior diagnosis or risk factors for disease or reported previous risk factors but had evidence of acute infection.Results:Of 908 patients, 795 (87.6%) were tested, and 71 HCV-infected patients (8.9%) and 31 HBV-infected patients (3.9%) met the case definition. Multiple HCV genotypes were identified. Significantly higher HCV infection rates were found among individuals treated after an HCV-infected patient during the same visit (adjusted odds ratio [AOR], 6.2; 95% confidence interval [CI95], 2.4–15.8); a similar association was observed for HBV (AOR, 2.9; CI95, 1.3–6.5). Review of staff practices revealed the nurse anesthetist had been using the same syringe–needle to sequentially administer sedation medications to every treated patient each clinic day.Conclusions:Reuse of needles–syringes was the mechanism for patient-to-patient transmission of HCV and HBV in this large nosocomial outbreak. Further education and stricter oversight of infection control practices may prevent future outbreaks.

In the United States, transmission of viral hepatitis from health care-related exposures is uncommon and primarily recognized in the context of outbreaks. Transmission is typically associated with unsafe injection practices, as exemplified by several recent outbreaks that occurred in ambulatory health care settings. To prevent transmission of bloodborne pathogens, health care workers must adhere to standard precautions and follow fundamental infection-control principles, including safe injection practices and appropriate aseptic techniques. These principles and practices need to be made explicit in institutional policies and reinforced through in-service education for all personnel involved in direct patient care, including those in ambulatory care settings. The effectiveness of these measures should be monitored as part of the oversight process. In addition, prompt reporting of suspected health care-related cases coupled with appropriate investigation and improved monitoring of surveillance data are needed to accurately characterize and prevent health care-related transmission of viral hepatitis.