Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults.

INTRODUCTION: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial benefits, including streamlining vaccine delivery. METHODS: In this phase 3 study, healthy 18- to 64-year-olds who had received three previous doses of BNT162b2 were randomized (1:1) to the coadministration group (month 0, BNT162b2 + SIIV; month 1, placebo) or the separate-administration group (month 0, placebo + SIIV; month 1, BNT162b2). The primary immunogenicity objective was to demonstrate that the immune responses elicited by BNT162b2 and SIIV [measured by full-length S-binding immunoglobulin G (IgG) levels and strain-specific hemagglutination inhibition assay (HAI) titers against four influenza strains 1 month post-vaccination, respectively] when coadministered were noninferior to those elicited by either vaccine administered alone, based on a prespecified 1.5-fold noninferiority margin [lower bound 95% CI for geometric mean ratio (GMR) > 0.67]. Reactogenicity and adverse event (AE) rates were evaluated. RESULTS: Randomized participants who received study vaccination (N = 1128; coadministration group, n = 564; separate-administration group, n = 564) had a median age of 39 years. Model-adjusted GMRs for coadministration to separate administration were 0.83 (95% CI 0.77, 0.89) for full-length S-binding IgG levels and 0.89-1.00 (lower bound of all 95% CIs > 0.67) for the four influenza strain-specific HAI titers, with all endpoints achieving the prespecified noninferiority criterion. Reactogenicity events were mostly mild or moderate when BNT162b2 was coadministered with SIIV. Serious AEs were reported in < 1% of participants within 1 month after any vaccination; none were considered vaccine-related. CONCLUSIONS: BNT162b2 coadministered with SIIV elicited immune responses that were noninferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT05310084.

An extra pair of eyes: do patients want a chaperone when having an anogenital examination?

BACKGROUND: Anogenital examinations can be embarrassing for patients and can leave clinicians open to accusations of professional misconduct. Little is known about the attitudes of patients in Australia towards the use of chaperones. METHODS: In 2006, we surveyed 480 patients attending two sexual health clinics in northern Sydney. Our aim was to determine their attitudes towards the use of chaperones for anogenital examinations. RESULTS: Of the 480, 58% were male and 42% female. Most women (64%) preferred a female examining clinician, whereas most men (68%) had no preference for gender of the examining clinician (P < 0.0001). While 32% of women wanted a chaperone if being examined by a male, 29% did not. Only 4% of women wanted a chaperone when being examined by a female. Only 1% of men wanted a chaperone irrespective of the sex of the examining clinician. Independent predictors of women wanting a chaperone with a male clinician were preference for a female clinician (OR 6.59, 2.48-17.5; P < 0.001) and preference for a female chaperone (OR 4.02, 1.44-11.2; P = 0.008). The majority of participants felt that they should be involved in the decision to have a chaperone. CONCLUSIONS: Although a substantial minority of women want a chaperone when being examined by a male, a similar proportion do not want a chaperone. If a woman requests a female clinician, she should be offered a chaperone if there is only a male examiner available. Further study is required to determine why some women want a chaperone and how to distinguish them from other women.