ABSTRACT
OBJECTIVE: Misinformation regarding Covid vaccination has contributed to vaccine hesitancy. Initially, there were claims that immune cross reactivity between the SARS CoV-2 spike protein and syncytin-1 would prevent embryo implantation. We previously demonstrated no difference in implantation and sustained implantation rates between previously vaccinated or infected women compared to other women.1 More recently, misinterpretation of vaccine biodistribution data has led to a second claim that mRNA containing lipid nanoparticles are concentrated in the ovaries and spike protein produced there would also cause infertility. The purpose of this study is to determine whether prior in vivo ovarian exposure to lipid nanoparticle-mRNA vaccination against SARS-CoV2 spike protein reduces subsequent fertility in women. MATERIALS AND METHODS: This is an ongoing observational study of women undergoing frozen embryo transfer with a single expanded blastocyst. This is an interim report (n =128) encompassing transfers between Jan 1 and Jul 02. All patients had serum analyzed prior to starting stimulation for egg retrieval to quantitatively determine the level of AntiSARS-CoV-2 Spike IgG. Reactive (antibody positive) patients were questioned to determine a history of vaccination or infection. Patients were divided into three groups based on their status. Women who were vaccinated (n = 26);women who had previous infection with SARS-CoV-2 (n=11) and women without a history of either vaccination or infection (n=91). Only patients receiving the mRNA vaccines from BioNTech / Pfizer (BNT162b2) and Moderna (mRNA-1273) were analyzed. Outcome measure for the three groups were initial implantation rate (serum hCG level > 5 mIU/mL obtained 8 days after embryo transfer followed by a rising level two to three days later), sustained implantation rate (transvaginal ultrasound documented positive FHTs at two time points at least one week apart) and miscarriage rate (the difference between initial and sustained implantation rates). Baseline characteristics were analyzed using ANOVA. Chi square analysis was used to compare pregnancy rates. RESULTS: CONCLUSIONS: Embryos produced from oocytes exposed in vivo to lipid nanoparticles containing mRNA for the SARS CoV-2 spike protein are not less likely to produce pregnancy or more likely to miscarry. IMPACT STATEMENT: This data refutes the rumors that Covid-19 vaccinations are “toxic” to the ovaries & adds to the growing body of evidence that vaccinations do not cause infertility. (Table Presented).
ABSTRACT
AIM: To validate a reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) assay to detect SARS-CoV-2 in saliva in two independent Aotearoa New Zealand laboratories. METHODS: An RT-qPCR assay developed at University of Illinois Urbana-Champaign, USA, was validated in two New Zealand laboratories. Analytical measures, such as limit of detection (LOD) and cross-reactivity, were performed. One hundred and forty-seven saliva samples, each paired with a contemporaneously collected nasal swab, mainly of nasopharyngeal origin, were received. Positive (N=33) and negative (N=114) samples were tested blindly in each laboratory. Diagnostic sensitivity and specificity were then calculated. RESULTS: The LOD was <0.75 copy per mu L and no cross-reactivity with MERS-CoV was detected. There was complete concordance between laboratories for all saliva samples with the quantification cycle values for all three genes in close agreement. Saliva had 98.7% concordance with paired nasal samples: and a sensitivity, specificity and accuracy of 97.0%, 99.1% and 99.1%, respectively. CONCLUSION: This saliva RT-qPCR assay produces reproducible results with a low LOD. High sensitivity and specificity make it a reliable option for SARS-CoV-2 testing, including for asymptomatic people requiring regular screening.
ABSTRACT
BACKGROUND: The differences in clinical outcomes following emergency medical services between high and low-volume centers with respect to acute lower gastrointestinal bleeding (ALGIB) remain unknown. In this study, we aimed to compare clinical outcomes and management strategies between high and low-volume centers in emergency medical services. METHODS: In this retrospective study, propensity score matching was used to compare high and low-volume hospitals with respect to emergency medical services. We identified 10,550 cases of ALGIB from 43 hospitals including one prefectural group between May 2002 and August 2020. After excluding duplicated cases, 8,286 cases were included and divided into two groups (high and low-volume centers) according to the number of emergency medical services performed in 2019. Hospitals with more than 5,000 cases of emergency medical services in 2019 were categorized as high-volume centers. The remaining centers were considered to be low-volume centers. Age;sex;history of colectomy and colonic diverticular bleeding (CDB);and comorbidities, including Charlson Comorbidity Index, vital signs at admission, laboratory data, and use of antithrombotic agents were used to calculate propensity scores that were matched one-to-one using the nearest neighbor method and applied to the high and the low-volume centers. We compared the two groups in terms of the diagnostic and treatment strategies used, which included computed tomography (CT) and colonoscopy, as well as the clinical outcomes thereof. RESULTS: A total of 2,652 patients were matched in each group. Although CDB was the most common cause of ALGIB in both groups, the proportions of definitive and presumptive CDB were both significantly higher in the low-volume centers (22% vs. 16%, P < 0.0001;45% vs. 41%, P=0.001). Both CT and enhanced CT were performed with greater frequency in the high-volume centers (80% vs. 66%, P < 0.0001;77% vs. 67%, P < 0.0001), but colonoscopy was not (84% vs. 94%, P < 0.0001). The proportion of patients who underwent either early colonoscopy (performed within 24 hours after admission) or endoscopic therapy was significantly lower in the high-volume centers (56% vs. 72%, P <0.0001;24% vs. 30%, P < 0.0001). The incidence of early rebleeding was not significantly different between the groups (16% vs. 18%, P=0.097). The median values (interquartile range) of PRBCs transfused were highest in the high-volume centers (0 [4] vs. 0 [2], P < 0.0001). However, a significant difference was not observed in LOS (7 [7] vs. 7 [6], P=0.069). CONCLUSION: Although clinical strategies for the management of ALGIB varied between the hospitals with high or low volumes of emergency medical services, early rebleeding did not differ between the two groups.