The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021.

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.

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public.

Canadian Association of Gastroenterology Clinical Practice Guideline for Immunizations in Patients With Inflammatory Bowel Disease (IBD)-Part 2: Inactivated Vaccines.

BACKGROUND AND AIMS: The effectiveness and safety of vaccinations can be altered by immunosuppressive therapies, and perhaps by inflammatory bowel disease (IBD) itself. These recommendations developed by the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association, aim to provide guidance on immunizations in adult and pediatric patients with IBD. This publication focused on inactivated vaccines. METHODS: Systematic reviews evaluating the efficacy, effectiveness, and safety of vaccines in patients with IBD, other immune-mediated inflammatory diseases, and the general population were performed. Critical outcomes included mortality, vaccine-preventable diseases, and serious adverse events. Immunogenicity was considered a surrogate outcome for vaccine efficacy. Certainty of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. Key questions were developed through an iterative online platform, and voted on by a multidisciplinary group. Recommendations were formulated using the Evidence-to-Decision framework. Strong recommendation means that most patients should receive the recommended course of action, whereas a conditional recommendation means that different choices will be appropriate for different patients. RESULTS: Consensus was reached on 15 of 20 questions. Recommendations address the following vaccines: Haemophilus influenzae type b, recombinant zoster, hepatitis B, influenza, pneumococcus, meningococcus, tetanus-diphtheria-pertussis, and human papillomavirus. Most of the recommendations for patients with IBD are congruent with the current Centers for Disease Control and Prevention and Canada's National Advisory Committee on Immunization recommendations for the general population, with the following exceptions. In patients with IBD, the panel suggested Haemophilus influenzae type b vaccine for patients older than 5 years of age, recombinant zoster vaccine for adults younger than 50 year of age, and hepatitis B vaccine for adults without a risk factor. Consensus was not reached, and recommendations were not made for 5 statements, due largely to lack of evidence, including double-dose hepatitis B vaccine, timing of influenza immunization in patients on biologics, pneumococcal and meningococcal vaccines in adult patients without risk factors, and human papillomavirus vaccine in patients aged 27-45 years. CONCLUSIONS: Patients with IBD may be at increased risk of some vaccine-preventable diseases. Therefore, maintaining appropriate vaccination status in these patients is critical to optimize patient outcomes. In general, IBD is not a contraindication to the use of inactivated vaccines, but immunosuppressive therapy may reduce vaccine responses.

Optimizing Immunization Strategies in Patients with IBD.

Recent advances in the treatment of inflammatory bowel disease (IBD) include the use of immune modifiers and monoclonal antibodies, such as tumor necrosis factor (TNF) alpha inhibitors, anti-integrin agents, janus kinase inhibitors, and interleukin-12/23 inhibitors. These agents achieve higher rates of clinical remission and mucosal healing than conventional therapy. However, these therapies increase the risk of infections, including some vaccine-preventable diseases. Infections are one of the most common adverse event of immunosuppressive therapy. Thus, providers should optimize immunization strategies to reduce the risk of vaccine-preventable infections in patients with IBD. There are several newly licensed vaccines recommended for adults by the US Advisory Committee on Immunization Practices. This review will focus on how gastroenterology providers can implement the adult immunization schedule approved by ACIP for patients with IBD.

Immunisation status screening in the emergency department: Why are we forgetting the elderly?

BACKGROUND: Pneumonia is one of the most common reasons patients over the age of 65 years present to the Emergency Department (ED). There is a 23-valent pneumococcal vaccine (23vPPV) available under the National Immunisation Program (NIP) with demonstrated 61-71% effectiveness against Invasive Pneumococcal Disease (IPD), but only 51% of adults aged over 65 years are vaccinated in Australia. METHODS: Short semi-structured interviews were conducted with emergency nurses working across a Local Health District in Sydney New South Wales (n=9) in order to determine their knowledge, behaviour and attitudes towards immunisation status screening in the elderly who present to the ED with pneumonia. Questions were structured to the COM-B Model (capability, opportunity and motivation to change behaviour), and a thematic analysis was conducted. RESULTS: There were three major themes identified: (1) The importance of routinisation, (2) Low knowledge levels and, (3) The 'vaccination is for children' heuristic, as well as suggestions for future interventions to improve screening. CONCLUSIONS: These findings clarify how to improve vaccine uptake amongst this vulnerable cohort. They suggest that emergency departments should provide education to nurses. In addition, checklists/tick boxes can prompt nurses whilst conducting routine work, which may lead to increased vaccination uptake.

Emerging Topics in Vaccine Therapeutics for Adolescents and Adults: An Update for Immunizing Pharmacists.

Vaccine therapeutics and the practice of immunization provision are ever-changing. As pharmacy-based immunization services continue to flourish in the United States, more and more patients are requesting both routine and travel vaccines in community pharmacies. However, vaccine recommendations from the Centers for Disease Control and Prevention/Advisory Committee on Immunization Practices (CDC/ACIP) can sometimes differ from product-specific US Food and Drug Administration (FDA)-indicated uses. In addition, changes in vaccine schedules, product availability, and disease outbreaks can present immunizing pharmacists with scenarios requiring a high level of clinical judgment. Thus, it is of paramount importance that all immunizing pharmacists maintain competency in the most recent evidence in vaccine therapeutics, as well as practice standards for vaccine provision and administration. This review provides an update of the most recent literature surrounding emerging topics in adolescent and adult immunizations-highlighting influential studies and recent developments in the prevention of herpes zoster, human papillomavirus (HPV), measles, mumps, rubella (MMR), meningococcal disease, tetanus, diphtheria, and pertussis. Key concepts discussed include the emergence of the new recombinant zoster vaccine (RZV), meningococcal vaccine product selection, MMR revaccination during disease outbreaks, tetanus vaccine product selection, and duration of pertussis immunity with vaccination.

Update From the Advisory Committee on Immunization Practices.

The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. The group usually has 15 voting members, each of whom is appointed to a 4-year term. ACIP members and Centers for Disease Control and Prevention staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met February 27 to 28, 2019, to discuss hepatitis A (HepA) vaccination of human immunodeficiency virus-infected persons, pneumococcal vaccination among adults aged 65 years or older, influenza vaccine effectiveness and safety, anthrax vaccination in the setting of a mass exposure, human papillomavirus vaccine, zoster vaccines, and Japanese encephalitis vaccine.

Going beyond the individual: how state-level characteristics relate to HPV vaccine rates in the United States.

BACKGROUND: The human papillomavirus (HPV) vaccine is an underutilized cancer control practice in the United States. Although individual contextual factors are known to impact HPV vaccine coverage rates, the impact of macro-level elements are still unclear. The aim of this analysis was to use HPV vaccination rates to explore the underuse of an evidence-based cancer control intervention and explore broader-level correlates influencing completion rates. METHODS: A comprehensive database was developed using individual-level date from the National Immunization Survey (NIS)-Teen (2016) and state-level data collected from publically available sources to analyze HPV vaccine completion. Multi-level logistic models were fit to identify significant correlates. Level-1 (individual) and level-2 (state) correlates were fitted to a random intercept model. Deviance and AIC assessed model fit and sampling weights were applied. RESULTS: The analysis included 20,495 adolescents from 50 U.S. states and the District of Columbia. Teen age, gender, race/ethnicity, and maternal education were significant individual predictors of HPV completion rates. Significant state-level predictors included sex education policy, religiosity, and HPV vaccine mandate. States with the lowest HPV coverage rates were found to be conservative and highly religious. Little variation in vaccine exemptions and enacted sex and abstinence education polices were observed between states with high and low HPV vaccine coverage suggesting various contextual and situational factors impact HPV vaccine completion rates. CONCLUSIONS: Given that gender, religiosity, political ideology, and education policies are predictors of HPV vaccine completion, the interaction and underlying mechanism of these factors can be used to address the underutilization of the HPV vaccine.

Developing standardized competencies to strengthen immunization systems and workforce

Despite global support for immunization as a core component of the human right to health and the maturity of immunization programs in low- and middle-income countries throughout the world, there is no comprehensive description of the standardized competencies needed for immunization programs at the national, multiple sub-national, and community levels. The lack of defined and standardized competencies means countries have few guidelines to help them address immunization workforce planning, program management, and performance monitoring. Potential consequences resulting from the lack of defined competencies include inadequate or inefficient distribution of resources to support the required functions and difficulties in adequately managing the health workforce. In 2015, an international multi-agency working group convened to define standardized competencies that national immunization programs could adapt for their own workforce planning needs. The working group used a stepwise approach to ensure that the competencies would align with immunization programs' objectives. The first step defined the attributes of a successful immunization program. The group then defined the work functions needed to achieve those attributes. Based on the work functions, the working group defined specific competencies. This process resulted in three products: (1) Attributes of an immunization program described within eight technical domains at four levels within a health system: National, Provincial, District/Local, and Community; (2) 229 distinct functions within those eight domains at each of the four levels; and (3) 242 competencies, representing eight technical domains and two foundational domains (Management and Leadership and Vaccine Preventable Diseases and Program). Currently available as a working draft and being tested with immunization projects in several countries, the final document will be published by WHO as normative guidelines. Vertical immunization programs as well as integrated systems can customize the framework to suit their needs. Standardized competencies can support immunization program improvements and help strengthen effective health systems.

Propranolol efficacy as a novel adjuvant for immunization against Toxoplasma gondii tachyzoites.

Severe or lethal damages, caused by Toxoplasma gondii infection in congenital cases and immunocompromised patients implies the necessity for development of a vaccine and an appropriate adjuvant would be needed to elicit a protective Th1 biased-immune response. The adjuvant activity of propranolol was surveyed and compared with alum by immunization of BALB/c mice with protein components of T. gondii tachyzoites. Five groups of BALB/c mice were immunized with phosphate buffered saline (negative control), Toxoplasma lysate antigen (TLA), alum plus TLA, Propranolol plus TLA, and alum, propranolol and TLA. Immunization efficacy was evaluated by lymphocyte proliferation and DTH tests, challenge with live tachyzoites, IFN-γ production by spleen cells, serum TNF-α concentration and anti- Toxoplasma total IgG, IgG1 and IgG2a measurements. Mice of the PRP-TLA group induced significantly more IFN-γ and TNF-α production and lymphocyte proliferation than other groups. This group of mice also showed more anti-T. gondii IgG2a and DTH responses and showed a significantly increased survival time after challenge. These findings indicate that propranolol as an adjuvant in combination with TLA, may enhance cellular immunity against T. gondii.

Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices.

HEPATITIS B VIRUS (HBV) IS TRANSMITTED VIA BLOOD OR SEXUAL CONTACT. PERSONS WITH CHRONIC HBV INFECTION ARE AT INCREASED RISK FOR CIRRHOSIS AND LIVER CANCER AND REQUIRE MEDICAL CARE. THIS REPORT UPDATES AND SUMMARIZES PREVIOUSLY PUBLISHED RECOMMENDATIONS FROM THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) AND CDC REGARDING THE PREVENTION OF HBV INFECTION IN THE UNITED STATES. ACIP RECOMMENDS TESTING ALL PREGNANT WOMEN FOR HEPATITIS B SURFACE ANTIGEN (HBSAG), AND TESTING HBSAG-POSITIVE PREGNANT WOMEN FOR HEPATITIS B VIRUS DEOXYRIBONUCLEIC ACID (HBV DNA); ADMINISTRATION OF HEPB VACCINE AND HEPATITIS B IMMUNE GLOBULIN (HBIG) FOR INFANTS BORN TO HBV-INFECTED WOMEN WITHIN 12 HOURS OF BIRTH, FOLLOWED BY COMPLETION OF THE VACCINE SERIES AND POSTVACCINATION SEROLOGIC TESTING; UNIVERSAL HEPATITIS B VACCINATION WITHIN 24 HOURS OF BIRTH, FOLLOWED BY COMPLETION OF THE VACCINE SERIES; AND VACCINATION OF CHILDREN AND ADOLESCENTS AGED <19 YEARS WHO HAVE NOT BEEN VACCINATED PREVIOUSLY. ACIP RECOMMENDS VACCINATION OF ADULTS AT RISK FOR HBV INFECTION, INCLUDING UNIVERSAL VACCINATION OF ADULTS IN SETTINGS IN WHICH A HIGH PROPORTION HAVE RISK FACTORS FOR HBV INFECTION AND VACCINATION OF ADULTS REQUESTING PROTECTION FROM HBV WITHOUT ACKNOWLEDGMENT OF A SPECIFIC RISK FACTOR. THESE RECOMMENDATIONS ALSO PROVIDE CDC GUIDANCE FOR POSTEXPOSURE PROPHYLAXIS FOLLOWING OCCUPATIONAL AND OTHER EXPOSURES. THIS REPORT ALSO BRIEFLY SUMMARIZES PREVIOUSLY PUBLISHED AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASEST GUIDELINES FOR MATERNAL ANTIVIRAL THERAPY TO REDUCE PERINATAL HBV TRANSMISSION.

Vaccination for Human Papillomavirus: Immunization Practices in the U.S. Military

Human papillomavirus (HPV) is the most common sexually transmitted infection and is a leading etiology for cancer. The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of males and females aged 11-26 years. Studies suggest that U.S. military service members have higher HPV incidence rates and lower vaccination rates compared to the national average. Although the U.S. military enforces many recommended vaccines, the HPV vaccine fails to make the list.

Immunizations for adult women.

Immunizations protect individual persons and contribute to public health by reducing morbidity and mortality associated with common infectious diseases. In this Practice Pearl, we review guidelines for adult immunizations and recent and potential changes in vaccines.

Non-specific immunological effects of selected routine childhood immunisations: systematic review.

OBJECTIVE:  To identify and characterise non-specific immunological effects after routine childhood vaccines against BCG, measles, diphtheria, pertussis, and tetanus. DESIGN:  Systematic review of randomised controlled trials, cohort studies, and case-control studies. DATA SOURCES:  Embase, PubMed, Cochrane library, and Trip searched between 1947 and January 2014. Publications submitted by a panel of experts in the specialty were also included. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:  All human studies reporting non-specific immunological effects after vaccination with standard childhood immunisations. Studies using recombinant vaccines, no vaccine at all, or reporting only vaccine specific outcomes were excluded. The primary aim was to systematically identify, assemble, and review all available studies and data on the possible non-specific or heterologous immunological effects of BCG; measles; mumps, measles, and rubella (MMR); diphtheria; tetanus; and pertussis vaccines. RESULTS:  The initial search yielded 11 168 references; 77 manuscripts met the inclusion criteria for data analysis. In most included studies (48%) BCG was the vaccine intervention. The final time point of outcome measurement was primarily performed (70%) between one and 12 months after vaccination. There was a high risk of bias in the included studies, with no single study rated low risk across all assessment criteria. A total of 143 different immunological variables were reported, which, in conjunction with differences in measurement units and summary statistics, created a high number of combinations thus precluding any meta-analysis. Studies that compared BCG vaccinated with unvaccinated groups showed a trend towards increased IFN-γ production in vitro in the vaccinated groups. Increases were also observed for IFN-γ measured after BCG vaccination in response to in vitro stimulation with microbial antigens from Candida albicans, tetanus toxoid, Staphylococcus aureas, lipopolysaccharide, and hepatitis B. Cohort studies of measles vaccination showed an increase in lymphoproliferation to microbial antigens from tetanus toxoid and C albicans Increases in immunogenicity to heterologous antigens were noted after diphtheria-tetanus (herpes simplex virus and polio antibody titres) and diphtheria-tetanus-pertussis (pneumococcus serotype 14 and polio neutralising responses) vaccination. CONCLUSIONS:  The papers reporting non-specific immunological effects had heterogeneous study designs and could not be conventionally meta-analysed, providing a low level of evidence quality. Some studies, such as BCG vaccine studies examining in vitro IFN-γ responses and measles vaccine studies examining lymphoproliferation to microbial antigen stimulation, showed a consistent direction of effect suggestive of non-specific immunological effects. The quality of the evidence, however, does not provide confidence in the nature, magnitude, or timing of non-specific immunological effects after vaccination with BCG, diphtheria, pertussis, tetanus, or measles containing vaccines nor the clinical importance of the findings.

Immunization update: This year's changes.

The 9-valent formulation of HPV vaccine is now on the schedule, but don't delay starting or continuing the vaccine series just because HPV9 is not on hand. Give the 2 pneumococcal vaccines a year apart.

Committee Opinion No. 661: Integrating Immunizations Into Practice.

Immunization against vaccine-preventable diseases is an essential component of women's primary and preventive health care. Despite the importance of vaccination and clear guidance from public health agencies, rates of vaccination lag behind national goals. Obstetrician-gynecologists can play a major role in reducing morbidity and mortality from a range of vaccine-preventable diseases, including pertussis, influenza, human papillomavirus, and hepatitis. Given demonstrated vaccine efficacy and safety, and the large potential for prevention of many infectious diseases that affect adults, pregnant women, and newborns, obstetrician-gynecologists should include immunizations as an integral part of their practice. To do so, they must embrace their role as important sources of information and advice on immunization for adults, adolescents, and pregnant women, and advance their patients' well-being with continued efforts to augment immunization services in their offices. Increasing awareness combined with the many suggestions in this document will work to enhance immunization uptake.

Use of Vaccinia Virus Smallpox Vaccine in Laboratory and Health Care Personnel at Risk for Occupational Exposure to Orthopoxviruses - Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2015.

On June 25, 2015, the Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination with live smallpox (vaccinia) vaccine (ACAM2000) for laboratory personnel who directly handle 1) cultures or 2) animals contaminated or infected with replication-competent vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains (i.e., those that are capable of causing clinical infection and producing infectious virus in humans), or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, and variola) (recommendation category: A, evidence type 2 [Box]). Health care personnel (e.g., physicians and nurses) who currently treat or anticipate treating patients with vaccinia virus infections and whose contact with replication-competent vaccinia viruses is limited to contaminated materials (e.g., dressings) and persons administering ACAM2000 smallpox vaccine who adhere to appropriate infection prevention measures can be offered vaccination with ACAM2000 (recommendation category: B, evidence type 2 [Box]). These revised recommendations update the previous ACIP recommendations for nonemergency use of vaccinia virus smallpox vaccine for laboratory and health care personnel at risk for occupational exposure to orthopoxviruses (1). Since 2001, when the previous ACIP recommendations were developed, ACAM2000 has replaced Dryvax as the only smallpox vaccine licensed by the U.S. Food and Drug Administration (FDA) and available for use in the United States (2). These recommendations contain information on ACAM2000 and its use in laboratory and health care personnel at risk for occupational exposure to orthopoxviruses.