Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines - United States, October 2022.

Four COVID-19 vaccines are currently approved for primary series vaccination in the United States under a Biologics License Application or authorized under an emergency use authorization (EUA) by the Food and Drug Administration (FDA), and recommended for primary series vaccination by the Advisory Committee on Immunization Practices (ACIP): 1) the 2- or 3-dose monovalent mRNA BNT162b2 (Pfizer-BioNTech, Comirnaty) COVID-19 vaccine; 2) the 2- or 3-dose monovalent mRNA mRNA-1273 (Moderna, Spikevax) COVID-19 vaccine; 3) the single-dose adenovirus vector-based Ad26.COV.S (Janssen [Johnson & Johnson]) COVID-19 vaccine; and 4) the 2-dose adjuvanted, protein subunit-based NVX-CoV2373 (Novavax) COVID-19 vaccine. The number of doses recommended is based on recipient age and immunocompromise status (1). For additional protection, FDA has amended EUAs to allow for COVID-19 booster doses in eligible persons (1). Because COVID-19 vaccines have demonstrated decreased effectiveness during the period when the Omicron variant (B.1.1.529) of SARS-CoV-2 predominated, bivalent booster doses (i.e., vaccine with equal components from the ancestral and Omicron strains) were considered for the express purpose of improving protection conferred by COVID-19 vaccine booster doses (2). During September-October 2022, FDA authorized bivalent mRNA vaccines for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series and removed EUAs for monovalent COVID-19 booster doses (1). Pfizer-BioNTech and Moderna bivalent booster vaccines each contain equal amounts of spike mRNA from the ancestral and Omicron BA.4/BA.5 strains. After the EUA amendments, ACIP and CDC recommended that all persons aged ≥5 years receive 1 bivalent mRNA booster dose ≥2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or monovalent booster doses.

Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines.

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.

Genital Mycoplasma, Shigellosis, Zika, Pubic Lice, and Other Sexually Transmitted Infections: Neither Gone Nor Forgotten.

ABSTRACT: Most estimates of the combined burden and cost of sexually transmitted infections (STIs) in the United States have focused on 8 common STIs with established national surveillance strategies (chlamydia, gonorrhea, syphilis, trichomoniasis, genital herpes, human papillomavirus, and sexually transmitted human immunodeficiency virus and hepatitis B). However, over 30 STIs are primarily sexually transmitted or sexually transmissible. In this article, we review what is known about the burden of "other STIs" in the United States, including those where sexual transmission is not the primary transmission route of infection. Although the combined burden of these other STIs may be substantial, accurately estimating their burden due to sexual transmission is difficult due to diagnostic and surveillance challenges. Developing better estimates will require innovative strategies, such as leveraging existing surveillance systems, partnering with public health and academic researchers outside of the STI field, and developing methodology to estimate the frequency of sexual transmission, particularly for new and emerging STIs.

Persons Evaluated for 2019 Novel Coronavirus - United States, January 2020.

In December 2019, a cluster of cases of pneumonia emerged in Wuhan City in central China's Hubei Province. Genetic sequencing of isolates obtained from patients with pneumonia identified a novel coronavirus (2019-nCoV) as the etiology (1). As of February 4, 2020, approximately 20,000 confirmed cases had been identified in China and an additional 159 confirmed cases in 23 other countries, including 11 in the United States (2,3). On January 17, CDC and the U.S. Department of Homeland Security's Customs and Border Protection began health screenings at U.S. airports to identify ill travelers returning from Wuhan City (4). CDC activated its Emergency Operations Center on January 21 and formalized a process for inquiries regarding persons suspected of having 2019-nCoV infection (2). As of January 31, 2020, CDC had responded to clinical inquiries from public health officials and health care providers to assist in evaluating approximately 650 persons thought to be at risk for 2019-nCoV infection. Guided by CDC criteria for the evaluation of persons under investigation (PUIs) (5), 210 symptomatic persons were tested for 2019-nCoV; among these persons, 148 (70%) had travel-related risk only, 42 (20%) had close contact with an ill laboratory-confirmed 2019-nCoV patient or PUI, and 18 (9%) had both travel- and contact-related risks. Eleven of these persons had laboratory-confirmed 2019-nCoV infection. Recognizing persons at risk for 2019-nCoV is critical to identifying cases and preventing further transmission. Health care providers should remain vigilant and adhere to recommended infection prevention and control practices when evaluating patients for possible 2019-nCoV infection (6). Providers should consult with their local and state health departments when assessing not only ill travelers from 2019-nCoV-affected countries but also ill persons who have been in close contact with patients with laboratory-confirmed 2019-nCoV infection in the United States.

Risk Factors for Oral Human Papillomavirus Infection Among Young Men Who Have Sex With Men-2 Cities, United States, 2012-2014.

BACKGROUND: Men who have sex with men (MSM) are at risk for cancers attributable to human papillomavirus (HPV), including oropharyngeal cancer. Human papillomavirus vaccination is recommended for US MSM through age 26 years. Oral HPV infection is associated with oropharyngeal cancer. We determined oral HPV prevalence and risk factors among young MSM. METHODS: The Young Men's HPV study enrolled MSM aged 18 through 26 years from clinics in Chicago and Los Angeles during 2012 to 2014. Participants self-reported demographics, sexual behaviors, vaccination and human immunodeficiency virus (HIV) status. Self-collected oral rinse specimens were tested for HPV DNA (37 types) by L1-consensus PCR. We calculated adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for risk factors associated with oral HPV among participants not previously vaccinated. RESULTS: Oral HPV was detected in 87 (9.4%) of 922; 9-valent vaccine types were detected in 37 (4.0%) of 922. Among HIV-positive participants, 17 (19.3%) of 88 had oral HPV detected. Oral HPV was more prevalent among those reporting first sex at 18 years of age or younger (aPR, 2.44; 95% CI, 1.16-5.12); HIV infection (aPR, 1.99; 95% CI, 1.14-3.48); greater than 5 sex partners within the past month (aPR, 1.93; 95% CI, 1.13-3.31); performing oral sex on greater than 5 partners within the last 3 months (aPR, 1.87; 95% CI, 1.12-3.13); and having greater than 5 male sex partners within the last 3 months (aPR, 1.76; 95% CI, 1.08-2.87). Only 454 (49.2%) of 922 were aware that HPV can cause oropharyngeal cancers. CONCLUSIONS: Many oral HPV infections were with types targeted by vaccination. Oral HPV infections were significantly associated with HIV and sexual behaviors. Fewer than half of participants were aware that HPV could cause oropharyngeal cancer.

Prevalence of Human Papillomavirus Among Females After Vaccine Introduction-National Health and Nutrition Examination Survey, United States, 2003-2014.

Background: Human papillomavirus (HPV) vaccine was recommended in 2006 for routine vaccination of US females aged 11-12 years. Most vaccine used through 2014 was quadrivalent vaccine (4vHPV), which prevents HPV-6, -11, -16, and -18 infection. To evaluate vaccine impact, we measured HPV prevalence in the National Health and Nutrition Examination Survey (NHANES). Methods: We analyzed HPV DNA types detected in self-collected cervicovaginal specimens and demographic, sexual behavior, and self-reported vaccination data from females 14-34 years old. We estimated HPV prevalence in the prevaccine (2003-2006) and vaccine eras (2007-2010 and 2011-2014). Results: Among 14- to 19-year-olds, 4vHPV-type prevalence decreased from 11.5% (95% confidence interval [CI], 9.1%-14.4%) in 2003-2006 to 3.3% (95% CI, 1.9%-5.8%) in 2011-2014, when ≥1-dose coverage was 55%. Among 20- to 24-year-olds, prevalence decreased from 18.5% (95% CI, 14.9%-22.8%) in 2003-2006 to 7.2% (95% CI, 4.7%-11.1%) in 2011-2014, when ≥1-dose coverage was 43%. Compared to 2003-2006, 4vHPV prevalence in sexually active 14- to 24-year-olds in 2011-2014 decreased 89% among those vaccinated and 34% among those unvaccinated. Vaccine effectiveness was 83%. Conclusions: Within 8 years of vaccine introduction, 4vHPV-type prevalence decreased 71% among 14- to 19-year-olds and 61% among 20- to 24-year-olds. Estimated vaccine effectiveness was high. The decrease in 4vHPV-type prevalence among unvaccinated females suggests herd protection.

Increasing Human Papillomavirus Vaccine Coverage Among Men Who Have Sex With Men-National HIV Behavioral Surveillance, United States, 2014.

BACKGROUND: Human papillomavirus (HPV) can cause oropharyngeal and anogenital cancers among men who have sex with men (MSM). In 2011, the Advisory Committee on Immunization Practices (ACIP) extended HPV vaccine recommendations to males through age 21 and MSM through age 26. Because of this distinction, vaccination for some MSM might rely on sexual behavior disclosure to health care providers. Receipt of ≥1 HPV vaccination among MSM aged 18-26 in National HIV Behavioral Surveillance (NHBS) was 4.9% in 2011. We evaluated HPV vaccine coverage and associated factors among MSM in 2014. SETTING: Twenty US metropolitan statistical areas in 2014. METHODS: Coverage was calculated as percentage of MSM self-reporting ≥1 HPV vaccination. Adjusted prevalence ratios were calculated from Poisson regression models to estimate associations of demographic and behavioral characteristics with HPV vaccination. RESULTS: Among 2892 MSM aged 18-26 years, HPV vaccine coverage was 17.2%. Overall, 2326 (80.4%) reported a health care visit within 12 months, and 2095 (72.4%) disclosed MSM attraction or behavior to a health care provider. Factors associated with vaccination included self-reported HIV infection; having a health care visit within 12 months, health insurance, or a usual place of care; and disclosing MSM attraction or behavior to a health care provider. CONCLUSIONS: Since the 2011 recommendation for vaccination of males, HPV vaccine coverage among MSM increased, but remains low. Most MSM reported a recent health care visit and disclosed sexual behavior, indicating opportunities for vaccination. Potential strategies for increasing MSM coverage include improving access to recommended care, and offering education for providers and patients.

Chromobacterium Violaceum Sepsis: Rethinking Conventional Therapy to Improve Outcome.

BACKGROUND: Chromobacterium violaceum (C. violaceum) is a facultative anaerobic gram-negative bacterium found in soil and water, especially in tropical and subtropical areas. Although infection in humans is rare, it is associated with significant morbidity. The bacterium is known for its resistance to multiple antimicrobials, and the possibility of relapse and reinfection. Presence of bacteremia, disseminated infection, and ineffective antimicrobial agents are predictors of mortality. CASE REPORT: We report the case of a previously healthy 11-year-old male with C. violaceum sepsis who was exposed to stagnant water. He presented with severe septic shock and developed multi-organ system failure. Initial presumptive diagnosis was staphylococcal infection secondary to presence of skin abscesses resulting in antibiotic coverage with vancomycin, clindamycin, nafcillin and ceftriaxone. He also had multiple lung and liver abscesses. Once C. violaceum was identified, he received meropenem and ciprofloxacin, and was later discharged on ertapenem and trimethoprim-sulfamethoxazole (TMP-SMX) to complete a total of six months of antibiotics. He was diagnosed with chronic granulomatous disease (CGD) and is currently on prophylactic TMP-SMX and itraconazole. He has not had any relapses since his initial presentation. CONCLUSIONS: This case highlights the importance of considering C. violaceum as a relevant human pathogen, and considering it early in temperate regions, particularly in cases of fulminant sepsis associated with multi-organ abscesses. Once C. violaceum is identified, appropriate antimicrobial therapy should be started promptly, and sufficient duration of treatment is necessary for successful therapy.