Project description:Background: Patients on hemodialysis (HD) are at higher risk for COVID-19, overall are poor responders to vaccines, and were prioritized in the Portuguese vaccination campaign. Objective: This work aimed at evaluating in HD patients the immunogenicity of BTN162b2 after the two doses induction phase, the persistence of specific antibodies along time, and factors predicting these outcomes. Methods: We performed a prospective, 6-month long longitudinal cohort analysis of 156 HD patients scheduled to receive BTN162b2. ELISA quantified anti-spike IgG, IgM, and IgA levels in sera were collected every 3 weeks during the induction phase (t0 before vaccine; t1, d21 post first dose; and t2 d21 post second dose), and every 3-4 months during the waning phase (t3, d140, and t4, d180 post first dose). The age-matched control cohort was similarly analyzed from t0 to t2. Results: Upon exclusion of participants identified as previously exposed to SARS-CoV-2, seroconversion at t1 was lower in patients than controls (29 and 50%, respectively, p = 0.0014), while the second vaccine dose served as a boost in both cohorts (91 and 95% positivity, respectively, at t2, p = 0.2463). Lower response in patients than controls at t1 was a singularity of the participants ≤ 70 years (p = 2.01 × 10-05), associated with immunosuppressive therapies (p = 0.013), but not with lack of responsiveness to hepatitis B. Anti-spike IgG, IgM, and IgA levels decreased at t3, with IgG levels further waning at t4 and resulting in >30% seronegativity. Anti-spike IgG levels at t1 and t4 were correlated (ρ = 0.65, p < 2.2 × 10-16). Conclusions: While most HD patients seroconvert upon 2 doses of BNT162b2 vaccination, anti-spike antibodies levels wane over the following 4 months, leading to early seroreversion in a sizeable fraction of the patients. These findings warrant close monitoring of COVID-19 infection in vaccinated HD patients, and advocate for further studies following reinforced vaccination schedules.
Project description:BACKGROUND:Financial concerns are often cited by physicians as a barrier to administering routinely recommended vaccines to adults. The purpose of this study was to assess perceived payments and profit from administering recommended adult vaccines and vaccine purchasing practices among general internal medicine (GIM) and family medicine (FM) practices in the United States. METHODS:We conducted an interviewer-administered survey from January-June 2014 of practices stratified by specialty (FM or GIM), affiliation (standalone or???2 practice sites), and level of financial decision-making (independent or larger system level) in FM and GIM practices that responded to a previous survey on adult vaccine financing and provided contact information for follow-up. Practice personnel identified as knowledgeable about vaccine financing and billing responded to questions about payments relative to vaccine purchase price and payment for vaccine administration, perceived profit on vaccination, claim denial, and utilization of various purchasing strategies for private vaccine stocks. Survey items on payment and perceived profit were assessed for various public and private payer types. Descriptive statistics were calculated and responses compared by physician specialty, practice affiliation, and level of financial decision-making. RESULTS:Of 242 practices approached, 43% (n?=?104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination. CONCLUSIONS:Practices vaccinating adults may benefit from education and technical assistance related to vaccine financing and billing and greater use of purchasing strategies to decrease upfront vaccine cost.
Project description:As the first authorized COVID-19 vaccine in Japan, the BNT162b2 mRNA COVID-19 vaccine is utilized for mass vaccination. Although efficacy has been proved, real-world evidence on reactogenicity in Japanese personnel is needed to prepare the public. Healthcare workers in a large academic hospital in Japan received two doses of the Pfizer-BioNTech vaccine from March 17 to May 19, 2021. Online questionnaires were distributed to registered recipients following each dose, from day 0 through day 8. Primary outcomes are the frequency of reactogenicity including local and systemic reactions. Length of absence from work was also analyzed. Most recipients self-reported reactogenicity after the first dose (97.3%; n = 3254; mean age [36.4]) and after the second dose (97.2%; n = 3165; mean age [36.5]). Systemic reactions following the second dose were substantially higher than the first dose, especially for fever (OR, 27.38; 95% CI, [22.00-34.06]; p < 0.001), chills (OR, 16.49; 95% CI, [13.53-20.11]; p < 0.001), joint pain (OR, 8.49; 95% CI, [7.21-9.99]; p < 0.001), fatigue (OR, 7.18; 95% CI, [6.43-8.02]; p < 0.001) and headache (OR, 5.43; 95% CI, [4.80-6.14]; p < 0.001). Reactogenicity was more commonly seen in young, female groups. 19.3% of participants took days off from work after the second dose (2.2% after the first dose), with 4.7% absent for more than two days. Although most participants reported reactogenicity, severe cases were limited. This study provides real-world evidence for the general population and organizations to prepare for BNT162b2 mRNA COVID-19 vaccination in Japan and other countries in the region.
Project description:BackgroundGlobally, few published studies have tracked the temporal trend of dioxin levels in the human body since 2000. This study describes the annual trend of dioxin levels in human breast milk in Japanese mothers from 1998 through 2015.MethodsAn observational study was conducted from 1998 through 2015. Participants were 1,194 healthy mothers following their first delivery who were recruited annually in Japan. Breast milk samples obtained from participants were analyzed using gas chromatography and mass spectrometry for dioxins, including polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), and coplanar polychlorinated biphenyls (PCBs).ResultsMean age was 29.5 years, and 53% of participants were 20-25 years old. A declining trend in total dioxin levels was found, from a peak of 20.8 pg toxic equivalence (TEQ)/g fat in 1998 to 7.2 pg TEQ/g fat in 2014. Data from the last 5 years of the study indicated a plateau at minimal levels. In contrast, an increasing trend was found in the mean age of participants during the last 5 years. Although significantly higher dioxin levels were observed in samples from older participants, an upward trend in dioxin levels was not observed, indicating that dietary and environmental exposure to dioxins had greatly diminished in recent years.ConclusionsDioxin levels in human breast milk may be approaching a minimum in recent years in Japan. The findings may contribute to global reference levels for environmental pollution of dioxins, which remains a problem for many developing countries.
Project description:BackgroundDetermining the humoral immunogenicity of tozinameran (BNT162b2) in patients requiring chronic renal replacement therapy, and its impact on COVID-19 morbidity several months after vaccination, may guide risk assessment and changes in vaccination policy.MethodsIn a prospective post-vaccination cohort study with up to 5 months follow-up we studied outpatient dialysis and kidney transplant patients and respective healthcare teams. Outcomes were anti S1/S2 antibody responses to vaccine or infection, and infection rate during follow-up.ResultsOne hundred seventy-five dialysis patients (40% women, 65 ± 15 years), 252 kidney transplant patients (33% women, 54 ± 14 years) and 71 controls (65% women, 44 ± 14 years) were followed. Three months or longer after vaccination we detected anti S1/S2 IgG antibodies in 79% of dialysis patients, 42% of transplant recipients and 100% of controls, whereas respective rates after infection were 94%, 69% and 100%. Predictors of non-response were older age, diabetes, history of cancer, lower lymphocyte count and lower vitamin-D levels. Factors associated with lower antibody levels in dialysis patients were modality (hemodialysis vs peritoneal) and high serum ferritin levels. In transplant patients, hypertension and higher calcineurin or mTOR inhibitor drug levels were linked with lower antibody response. Vaccination was associated with fewer subsequent infections (HR 0.23, p < 0.05). Moreover, higher antibody levels (particularly above 59 AU/ml) were associated with fewer events, with a HR 0.41 for each unit increased in log10titer (p < 0.05).ConclusionsDialysis patients, and more strikingly kidney transplant recipients, mounted reduced antibody response to COVID-19 mRNA vaccination. Lesser humoral response was associated with more infections. Measures to identify and protect non-responsive patients are required.
Project description:IntroductionWe surveyed a cohort of patients who recovered from severe SARS-CoV-2 infection to determine the COVID-19 vaccination rate. We also compared the willingness to accept COVID-19 vaccine before and after its availability to assess changes in perception and attitude towards vaccination.Materials and methodsRecovered patients with severe hypoxemic respiratory failure from SARS-CoV-2 infection treated in the ICU at Grady Memorial Hospital, Atlanta, Georgia between April 1, 2020, and June 30, 2020 were followed up over a 1-year period to assess vaccine acceptability and acceptance rates, and changes in perception towards COVID-19 vaccination before and after vaccine availability.ResultsA total of 98 and 93 patients completed the initial and follow up surveys respectively. During the initial survey, 41% of the patients intended to receive vaccination, 46% responded they would not accept a vaccine against COVID-19 even if it were proven to be 'safe and effective 'and 13% undecided. During the follow up survey, 44% of the study cohort had received at least one dose of a COVID-19 vaccine. Major reasons provided by respondents for not accepting COVID-19 vaccine were lack of trust in the effectiveness of the vaccine, pharmaceutical companies, government, vaccine technology, fear of side effects and perceived immunity against COVID-19. Respondents were more likely to be vaccinated if recommended by their physicians (OR 6.4, 95% CI 2.8-8.3), employers (OR 2.5, 95% CI 1.9-5.8), and family and friends (OR 1.6, 95% CI 1.1-4.5).ConclusionWe found a suboptimal COVID-19 vaccination rate in a cohort of patients who recovered from severe infection. COVID-19 vaccine information and recommendation by healthcare providers, employers, and family and friends may improve vaccination uptake.