RSVpreF

To describe the post-marketing safety profile of respiratory syncytial virus prefusion F (RSVpreF) vaccine among pregnant individuals.

This study analysed adverse event (AE) reports submitted to the U.S. Food and Drug Administration’s Vaccine Adverse Event Reporting System (VAERS) database following RSVpreF immunisation from 1 September 2023 to 23 February 2024.

VAERS, as a national spontaneous vaccine safety surveillance system, provides insights into the safety profile of the RSVpreF vaccine in a real-world setting.

Surveillance data included all AE reports submitted to VAERS in pregnant individuals following vaccination.

Receipt of RSVpreF vaccine among pregnant individuals in the USA.

Descriptive statistics were used to assess all AE reports with RSVpreF, including frequency, gestational age at vaccination, time to AE onset, reported outcomes and proportion of serious reports. Data mining techniques were employed to identify disproportionate reporting of RSVpreF-event pairs. Reports of preterm births were clinically reviewed.

VAERS received 77 reports pertaining to RSVpreF vaccination in pregnant individuals, with 42 (54.55%) classified as serious. The most frequently reported non-pregnancy-specific AEs were headache, injection site erythema and injection site pain. For pregnancy-specific AEs, preterm birth was the most frequently reported (12.8%), followed by AE terms such as preterm premature rupture of membranes and caesarean section (each at 3.3%), and cervical dilatation, haemorrhage during pregnancy and uterine contractions during pregnancy (each at 1.4%). Our disproportionality analysis indicated signals for various AEs, particularly preterm birth, indicating that reports of preterm birth in conjunction with RSVpreF vaccination were observed more frequently than statistically expected. Most of the reported preterm births were moderate to late, occurring between 32 and less than 37 weeks of gestation. The median time from immunisation to the onset of preterm birth was 3 days, with two-thirds of cases reported within a week of vaccination.

The AEs reported to VAERS among pregnant individuals vaccinated with RSVpreF largely aligned with the safety profile observed in prelicensure studies; however, this analysis also highlights the previously observed safety signal for preterm birth. Active surveillance studies focusing on maternal and perinatal outcomes are needed to further evaluate this signal and guide future clinical recommendations.

The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide Best Practice Advice statements for gastroenterologists and other healthcare providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings and vaccinations, as well as advice for mental health and general well-being.

This expert review was commissioned and approved by the AGA CPU Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. The Best Practice Advice statements were drawn from reviewing existing literature combined with expert opinion to provide practical advice on the screening for noncolorectal cancers and vaccinations in patients with IBD. Because this was not a systematic review, formal rating of the quality of evidence or strength of the presented considerations was not performed. Best Practice Advice Statements BEST PRACTICE ADVICE 1: All adult patients with IBD should receive age-appropriate cancer screening. BEST PRACTICE ADVICE 2: Adult women with IBD should follow age-appropriate screening for cervical dysplasia. Data are insufficient to determine whether patients receiving combined immunosuppression or thiopurines require more frequent screening. Shared decision making and individual risk stratification are encouraged. BEST PRACTICE ADVICE 3: All adult patients with IBD should follow skin cancer primary prevention practices by avoiding excessive exposure to the sun's ultraviolet radiation. Patients on immunomodulators, anti-tumor necrosis factor biologic agents, or small molecules should undergo yearly total body skin exam. Patients with any history of thiopurine use should continue with yearly total body skin exam even after thiopurine cessation. BEST PRACTICE ADVICE 4: At every colonoscopy, a thorough perianal and anal examination should be performed. Special attention should be made to inspection of the anal canal of patients with perianal Crohn's disease, with anal stricture, with human papillomavirus, with human immunodeficiency virus, and who engage in anoreceptive intercourse. BEST PRACTICE ADVICE 5: Gastroenterology clinicians should discuss age-appropriate vaccines with adult patients who have IBD and share responsibility with primary care providers for administering these vaccines. Patients with IBD should follow the adult immunization schedule advised by the Centers for Disease Control and Prevention (CDC) for all vaccines with the exception of live vaccines; Patients receiving immune-modifying agents should be counseled against receiving live vaccines; Immunization history to the 2 live pediatric vaccines, varicella and measles, mumps, and rubella vaccine series, is presumptive evidence of immunity. All adults 18 to 26 years of age should receive human papillomavirus vaccine series, and those between 27 and 45 of age years should be vaccinated if they are likely to have a new sexual partner. BEST PRACTICE ADVICE 6: Inactivated vaccines are safe in patients with IBD, and their administration is not associated with exacerbation of IBD activity. We suggest that patients receive vaccines at the earliest opportunity and preferably be off corticosteroids or at the lowest tolerable corticosteroid dose. BEST PRACTICE ADVICE 7: All adult patients with IBD should be evaluated for latent hepatitis B infection. Patients who have previously completed a full hepatitis B vaccine series but are not seroprotected (hepatitis B surface antibody [anti-HBs] <10 mIU/mL) should receive a single challenge dose of hepatitis B vaccine; Four to 8 weeks after this challenge dose, their anti-HBs levels should be measured to evaluate for an amnestic response. An amnestic response, indicated by an anti-HBs level ≥10 mIU/mL (seroprotection), suggests immunologic memory, and no further doses are needed. If no amnestic response is observed, the patient should complete a second full 2- or 3-dose series of hepatitis B vaccination. BEST PRACTICE ADVICE 8: All adult patients with IBD should receive an annual inactivated influenza vaccine. Patients receiving anti-tumor necrosis factor monotherapy or who have undergone a solid organ transplant recipients can benefit from a high-dose influenza vaccine. Adults 65 years of age and older should receive a high-dose, recombinant, or adjuvanted influenza vaccine. Live attenuated intranasal vaccines should be avoided. BEST PRACTICE ADVICE 9: All adult patients with IBD 19 to 64 years of age should receive an initial pneumococcal vaccine, with an subsequent second pneumococcal vaccine administered at 65 years of age and older. BEST PRACTICE ADVICE 10: All adult patients with IBD who are 60 years of age and older should receive a respiratory syncytial virus vaccine. There is no preference for any of the available respiratory syncytial virus vaccines. BEST PRACTICE ADVICE 11: All adult patients 19 years of age and older receiving immune-modifying therapies, or with plans to initiate immune-modifying therapies, should receive a recombinant herpes zoster vaccine series, regardless of their prior varicella vaccination status. BEST PRACTICE ADVICE 12: Bone densitometry should be considered in patients with IBD, regardless of age, when risk factors for osteopenia and osteoporosis are present. These risk factors include low body mass index (<20 kg/m²), >3 months of cumulative corticosteroid exposure, current smoking, postmenopausal status, or hypogonadism. In the absence of other factors, bone densitometry should be considered for postmenopausal women and men 65 years or older. BEST PRACTICE ADVICE 13: All adult patients with IBD should be screened for depression and anxiety annually. Patients who screen positive for depression or anxiety should be referred to the appropriate specialist, be it their primary care physician or a mental health specialist.