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NCHS Data how much does generic diflucan cost Brief No. 286, September 2017PDF Versionpdf icon (374 KB)Anjel Vahratian, Ph.D.Key findingsData from the National Health Interview Survey, 2015Among those aged 40–59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less than 7 hours, on average, in a 24-hour period.Postmenopausal women aged 40–59 were more likely than premenopausal women aged 40–59 to have trouble falling asleep (27.1% compared with 16.8%, respectively), and staying asleep (35.9% compared with 23.7%), four times or more in the past week.Postmenopausal women aged 40–59 (55.1%) were more likely than premenopausal women aged 40–59 (47.0%) to not wake up feeling well rested 4 days or more in the past week.Sleep duration and quality are important contributors to health and wellness. Insufficient sleep how much does generic diflucan cost is associated with an increased risk for chronic conditions such as cardiovascular disease (1) and diabetes (2).

Women may be particularly vulnerable to sleep problems during times of reproductive hormonal change, such as after the menopausal transition. Menopause is “the permanent cessation of menstruation that occurs how much does generic diflucan cost after the loss of ovarian activity” (3). This data brief describes sleep duration and sleep quality among nonpregnant women aged 40–59 by menopausal status.

The age range selected for this analysis reflects the focus on midlife sleep health. In this analysis, 74.2% of women are premenopausal, 3.7% are perimenopausal, and 22.1% how much does generic diflucan cost are postmenopausal. Keywords.

Insufficient sleep, menopause, National Health Interview Survey Perimenopausal women were more likely than premenopausal and postmenopausal women to sleep less than 7 hours, on average, in a 24-hour period.More than how much does generic diflucan cost one in three nonpregnant women aged 40–59 slept less than 7 hours, on average, in a 24-hour period (35.1%) (Figure 1). Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period (56.0%), compared with 32.5% of premenopausal and 40.5% of postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to sleep less than 7 hours, on average, in a 24-hour period.

Figure 1 how much does generic diflucan cost. Percentage of nonpregnant women aged 40–59 who slept less than 7 hours, on average, in a 24-hour period, by menopausal status. United States, 2015image icon1Significant quadratic trend how much does generic diflucan cost by menopausal status (p <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual how much does generic diflucan cost cycle was 1 year ago or less.

Women were premenopausal if they still had a menstrual cycle. Access data how much does generic diflucan cost table for Figure 1pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015.

The percentage of women aged 40–59 who had trouble falling asleep four times or more in the past week varied by menopausal status.Nearly one in five nonpregnant women aged 40–59 how much does generic diflucan cost had trouble falling asleep four times or more in the past week (19.4%) (Figure 2). The percentage of women in this age group who had trouble falling asleep four times or more in the past week increased from 16.8% among premenopausal women to 24.7% among perimenopausal and 27.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble falling asleep four times or more in the past week.

Figure 2 how much does generic diflucan cost. Percentage of nonpregnant women aged 40–59 who had trouble falling asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p how much does generic diflucan cost <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year how much does generic diflucan cost ago or less.

Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 2pdf icon.SOURCE how much does generic diflucan cost. NCHS, National Health Interview Survey, 2015.

The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week varied by menopausal status.More how much does generic diflucan cost than one in four nonpregnant women aged 40–59 had trouble staying asleep four times or more in the past week (26.7%) (Figure 3). The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week increased from 23.7% among premenopausal, to 30.8% among perimenopausal, and to 35.9% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble staying asleep four times or more in the past week.

Figure 3 how much does generic diflucan cost. Percentage of nonpregnant women aged 40–59 who had trouble staying asleep four times or more in the past week, by menopausal status. United States, how much does generic diflucan cost 2015image icon1Significant linear trend by menopausal status (p <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year how much does generic diflucan cost ago or less.

Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 3pdf icon.SOURCE how much does generic diflucan cost. NCHS, National Health Interview Survey, 2015.

The percentage of women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week varied by menopausal status.Nearly one in two nonpregnant women aged 40–59 did not wake up feeling well rested 4 days or more in the past week (48.9%) (Figure 4). The percentage of women in this age group who did not wake up feeling well rested 4 days or how much does generic diflucan cost more in the past week increased from 47.0% among premenopausal women to 49.9% among perimenopausal and 55.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to not wake up feeling well rested 4 days or more in the past week.

Figure 4 how much does generic diflucan cost. Percentage of nonpregnant women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status (p <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less.

Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 4pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015.

SummaryThis report describes sleep duration and sleep quality among U.S. Nonpregnant women aged 40–59 by menopausal status. Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period compared with premenopausal and postmenopausal women.

In contrast, postmenopausal women were most likely to have poor-quality sleep. A greater percentage of postmenopausal women had frequent trouble falling asleep, staying asleep, and not waking well rested compared with premenopausal women. The percentage of perimenopausal women with poor-quality sleep was between the percentages for the other two groups in all three categories.

Sleep duration changes with advancing age (4), but sleep duration and quality are also influenced by concurrent changes in women’s reproductive hormone levels (5). Because sleep is critical for optimal health and well-being (6), the findings in this report highlight areas for further research and targeted health promotion. DefinitionsMenopausal status.

A three-level categorical variable was created from a series of questions that asked women. 1) “How old were you when your periods or menstrual cycles started?. €.

2) “Do you still have periods or menstrual cycles?. €. 3) “When did you have your last period or menstrual cycle?.

€. And 4) “Have you ever had both ovaries removed, either as part of a hysterectomy or as one or more separate surgeries?. € Women were postmenopausal if they a) had gone without a menstrual cycle for more than 1 year or b) were in surgical menopause after the removal of their ovaries.

Women were perimenopausal if they a) no longer had a menstrual cycle and b) their last menstrual cycle was 1 year ago or less. Premenopausal women still had a menstrual cycle.Not waking feeling well rested. Determined by respondents who answered 3 days or less on the questionnaire item asking, “In the past week, on how many days did you wake up feeling well rested?.

€Short sleep duration. Determined by respondents who answered 6 hours or less on the questionnaire item asking, “On average, how many hours of sleep do you get in a 24-hour period?. €Trouble falling asleep.

Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble falling asleep?. €Trouble staying asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble staying asleep?.

€ Data source and methodsData from the 2015 National Health Interview Survey (NHIS) were used for this analysis. NHIS is a multipurpose health survey conducted continuously throughout the year by the National Center for Health Statistics. Interviews are conducted in person in respondents’ homes, but follow-ups to complete interviews may be conducted over the telephone.

Data for this analysis came from the Sample Adult core and cancer supplement sections of the 2015 NHIS. For more information about NHIS, including the questionnaire, visit the NHIS website.All analyses used weights to produce national estimates. Estimates on sleep duration and quality in this report are nationally representative of the civilian, noninstitutionalized nonpregnant female population aged 40–59 living in households across the United States.

The sample design is described in more detail elsewhere (7). Point estimates and their estimated variances were calculated using SUDAAN software (8) to account for the complex sample design of NHIS. Linear and quadratic trend tests of the estimated proportions across menopausal status were tested in SUDAAN via PROC DESCRIPT using the POLY option.

Differences between percentages were evaluated using two-sided significance tests at the 0.05 level. About the authorAnjel Vahratian is with the National Center for Health Statistics, Division of Health Interview Statistics. The author gratefully acknowledges the assistance of Lindsey Black in the preparation of this report.

ReferencesFord ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc 3(6):e001454.

2014.Ford ES, Wheaton AG, Chapman DP, Li C, Perry GS, Croft JB. Associations between self-reported sleep duration and sleeping disorder with concentrations of fasting and 2-h glucose, insulin, and glycosylated hemoglobin among adults without diagnosed diabetes. J Diabetes 6(4):338–50.

2014.American College of Obstetrics and Gynecology. ACOG Practice Bulletin No. 141.

Management of menopausal symptoms. Obstet Gynecol 123(1):202–16. 2014.Black LI, Nugent CN, Adams PF.

Tables of adult health behaviors, sleep. National Health Interview Survey, 2011–2014pdf icon. 2016.Santoro N.

Perimenopause. From research to practice. J Women’s Health (Larchmt) 25(4):332–9.

2016.Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al. Recommended amount of sleep for a healthy adult. A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society.

J Clin Sleep Med 11(6):591–2. 2015.Parsons VL, Moriarity C, Jonas K, et al. Design and estimation for the National Health Interview Survey, 2006–2015.

National Center for Health Statistics. Vital Health Stat 2(165). 2014.RTI International.

SUDAAN (Release 11.0.0) [computer software]. 2012. Suggested citationVahratian A.

Sleep duration and quality among women aged 40–59, by menopausal status. NCHS data brief, no 286. Hyattsville, MD.

National Center for Health Statistics. 2017.Copyright informationAll material appearing in this report is in the public domain and may be reproduced or copied without permission. Citation as to source, however, is appreciated.National Center for Health StatisticsCharles J.

Rothwell, M.S., M.B.A., DirectorJennifer H. Madans, Ph.D., Associate Director for ScienceDivision of Health Interview StatisticsMarcie L. Cynamon, DirectorStephen J.

Blumberg, Ph.D., Associate Director for Science.

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It is vital people continue to come forward for testing to help how does diflucan kill yeast us find any antifungal medication cases in the community. Restrictions in regional NSW remain unchanged. Read the latest antifungal medication information.​​Given the growing number of infectious cases in the community and unlinked cases of community transmission, antifungal medication restrictions will be tightened across Greater Sydney including the Central Coast, Blue Mountains, Wollongong how does diflucan kill yeast and Shellharbour.From 5pm today (Friday, 9 July) the following additional restrictions will be in placeOutdoor public gatherings limited to two people (excluding members of the same household)People must stay in their Local Government Area or within 10kms of home for exercise and outdoor recreation, with no carpooling between non-household membersBrowsing in shops is prohibited, plus only one person per household, per day may leave the home for shoppingFunerals limited to ten people in total (this will take effect from Sunday, 11 July).The four reasons to leave your home remain in placeShopping for food or other essential goods and services (one person only)Medical care or compassionate needs (only one visitor can enter another residence to fulfil carers' responsibilities or provide care or assistance, or for compassionate reasons)Exercise with no more than 2 (unless members of the same household)Essential work, or education, where you cannot work or study from home.Restrictions in regional NSW will remain unchanged.These tightened restrictions are based on health advice from the Chief Health Officer Dr Kerry Chant.They are necessary due to the increasing number of unlinked cases in the community.

We understand this is a difficult time for how does diflucan kill yeast the community and businesses. We thank them for their understanding and patience. High testing numbers are key to finding unrecognised chains of transmission in the community, so please continue to come forward for a antifungal medication test, even how does diflucan kill yeast if you have the mildest of symptoms.

Given the ongoing number of infectious cases in the community, the current lockdown will be extended how much does generic diflucan cost for at least another navigate to this web-site two weeks until 11:59pm on Friday, 30 July. We are constantly reviewing the health advice and will continue to update the community how much does generic diflucan cost if any changes are required. This means the restrictions currently in place across Greater Sydney including the Central Coast, Blue Mountains, Wollongong and Shellharbour will remain in place until this time.In these areas, online learning for students will also continue for an additional two weeks.We understand this is a difficult time for the community and appreciate their ongoing patience. It is vital people how much does generic diflucan cost continue to come forward for testing to help us find any antifungal medication cases in the community.

Restrictions in regional NSW remain unchanged. Read the latest antifungal medication information.​​Given the growing number of infectious cases in the community and unlinked cases of community transmission, antifungal medication restrictions will be tightened across Greater how much does generic diflucan cost Sydney including the Central Coast, Blue Mountains, Wollongong and Shellharbour.From 5pm today (Friday, 9 July) the following additional restrictions will be in placeOutdoor public gatherings limited to two people (excluding members of the same household)People must stay in their Local Government Area or within 10kms of home for exercise and outdoor recreation, with no carpooling between non-household membersBrowsing in shops is prohibited, plus only one person per household, per day may leave the home for shoppingFunerals limited to ten people in total (this will take effect from Sunday, 11 July).The four reasons to leave your home remain in placeShopping for food or other essential goods and services (one person only)Medical care or compassionate needs (only one visitor can enter another residence to fulfil carers' responsibilities or provide care or assistance, or for compassionate reasons)Exercise with no more than 2 (unless members of the same household)Essential work, or education, where you cannot work or study from home.Restrictions in regional NSW will remain unchanged.These tightened restrictions are based on health advice from the Chief Health Officer Dr Kerry Chant.They are necessary due to the increasing number of unlinked cases in the community. We understand this is a how much does generic diflucan cost difficult time for the community and businesses. We thank them for their understanding and patience.

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Study Population http://www.em-sarah-banzet-oberhausbergen.ac-strasbourg.fr/lecole/lequipe-pedagogique/ Figure 1 diflucan fluconazole side effects. Figure 1. Study Population diflucan fluconazole side effects. The participants in the study included persons who were 60 years of age or older and who had been fully vaccinated before March 1, 2021, had available data regarding sex, had no documented positive result on polymerase-chain-reaction assay for antifungals before July 30, 2021, and had not returned from travel abroad in August 2021.

The number of confirmed s in each population is shown diflucan fluconazole side effects in parentheses.Our analysis was based on medical data from the Ministry of Health database that were extracted on September 2, 2021. At that time, a total of 1,186,779 Israeli residents who were 60 years of age or older had been fully vaccinated (i.e., received two doses of BNT162b2) at least 5 months earlier (i.e., before March 1, 2021) and were alive on July 30, 2021. We excluded from the analysis participants diflucan fluconazole side effects who had missing data regarding sex. Were abroad in August 2021.

Had received a diagnosis of PCR-positive antifungal medication diflucan fluconazole side effects before July 30, 2021. Had received a booster dose before July 30, 2021. Or had been fully vaccinated before January 16, 2021 diflucan fluconazole side effects. A total of 1,137,804 participants met the inclusion criteria for the analysis (Figure 1).

The data included diflucan fluconazole side effects vaccination dates (first, second, and third doses). Information regarding PCR testing (sampling dates and results). The date of any antifungal medication hospitalization (if relevant) diflucan fluconazole side effects. Demographic variables, such as age, sex, and demographic group (general Jewish, Arab, or ua-Orthodox Jewish population), as determined by the participant’s statistical area of residence (similar to a census block)8.

And clinical status (mild or severe diflucan fluconazole side effects disease). Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, an oxygen saturation of less than 94% while breathing ambient air, or a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 300.9 Study Design Our study period started at the beginning of the booster vaccination campaign on July 30, 2021. The end diflucan fluconazole side effects dates were chosen as August 31, 2021, for confirmed and August 26, 2021, for severe illness. The selection of dates was designed to minimize the effects of missing outcome data owing to delays in the reporting of test results and to the development of severe illness.

The protection gained by the booster shot was not expected to reach its maximal capacity immediately after vaccination but rather to build up during the subsequent week.10,11 At the same time, during the first days after vaccination, substantial behavioral changes in the diflucan fluconazole side effects booster-vaccinated population are possible (Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). One such potential change is increased avoidance of exposure to excess diflucan fluconazole side effects risk until the booster dose becomes effective. Another potential change is a reduced incidence of testing for antifungal medication around the time of receipt of the booster (Fig.

S2). Thus, it is preferable to assess the effect of the booster only after a sufficient period has passed since its administration. We considered 12 days as the interval between the administration of a booster dose and its likely effect on the observed number of confirmed s. The choice of the interval of at least 12 days after booster vaccination as the cutoff was scientifically justified from an immunologic perspective, since studies have shown that after the booster dose, neutralization levels increase only after several days.6 In addition, when confirmed (i.e., positivity on PCR assay) is used as an outcome, a delay occurs between the date of and the date of PCR testing.

For symptomatic cases, it is likely that occurs on average 5 to 6 days before testing, similar to the incubation period for antifungal medication.12,13 Thus, our chosen interval of 12 days included 7 days until an effective buildup of antibodies after vaccination plus 5 days of delay in the detection of . To estimate the reduction in the rates of confirmed and severe disease among booster recipients, we analyzed data on the rate of confirmed and on the rate of severe illness among fully vaccinated participants who had received the booster dose (booster group) and those who had received only two treatment doses (nonbooster group). The membership in these groups was dynamic, since participants who were initially included in the nonbooster group left it after receipt of the booster dose and subsequently were included in the booster group 12 days later, provided that they did not have confirmed during the interim period (Fig. S3).

In each group, we calculated the rate of both confirmed and severe illness per person-days at risk. In the booster group, we considered that days at risk started 12 days after receipt of the third dose and ended either at the time of the occurrence of a study outcome or at the end of the study period. In the nonbooster group, days at risk started 12 days after the beginning of the study period (August 10, 2021) and ended at time of the occurrence of a study outcome, at the end of the study period, or at the time of receipt of a booster dose. The time of onset of severe antifungal medication was considered to be the date of the confirmed .

In order to minimize the problem of censoring, the rate of severe illness was calculated on the basis of cases that had been confirmed on or before August 26, 2021. This schedule was adopted to allow for a week of follow-up (until the date when we extracted the data) for determining whether severe illness had developed. The study protocol is available at NEJM.org. Oversight The study was approved by the institutional review board of the Sheba Medical Center.

All the authors contributed to the writing and critical review of the manuscript, approved the final version, and made the decision to submit the manuscript for publication. The Israeli Ministry of Health and Pfizer have a data-sharing agreement, but only the final results of this study were shared. Statistical Analysis We performed Poisson regression to estimate the rate of a specific outcome, using the function for fitting generalized linear models (glm) in R statistical software.14 These analyses were adjusted for the following covariates. Age (60 to 69 years, 70 to 79 years, and ≥80 years), sex, demographic group (general Jewish, Arab, or ua-Orthodox Jewish population),8 and the date of the second treatment dose (in half-month intervals).

We included the date of the second dose as a covariate to account for the waning effect of the earlier vaccination and for the likely early administration of treatment in high-risk groups.2 Since the overall rate of both confirmed and severe illness increased exponentially during the study period, days at the beginning of the study period had lower exposure risk than days at the end. To account for growing exposure risk, we included the calendar date as an additional covariate. After accounting for these covariates, we used the study group (booster or nonbooster) as a factor in the regression model and estimated its effect on rate. We estimated the rate ratio comparing the nonbooster group with the booster group, a measure that is similar to relative risk.

For reporting uncertainty around our estimate, we took the exponent of the 95% confidence interval for the regression coefficient without adjustment for multiplicity. We also used the results of the model to calculate the average between-group difference in the rates of confirmed and severe illness.15 In a secondary analysis, we compared rates before and after the booster dose became effective. Specifically, we repeated the Poisson regression analysis described above but compared the rate of confirmed between 4 and 6 days after the booster dose with the rate at least 12 days after the booster dose. Our hypothesis was that the booster dose was not yet effective during the former period.10 This analysis compares different periods after booster vaccination among persons who received the booster dose and may reduce selection bias.

However, booster recipients might have undergone less frequent PCR testing and behaved more cautiously with regard to diflucan exposure soon after receiving the booster dose (Fig. S2). Thus, we hypothesize that the rate ratio could be underestimated in this analysis. To further examine the reduction in the rate of confirmed as a function of the interval since receipt of the booster, we fitted a Poisson regression that includes days 1 to 32 after the booster dose as separate factors in the model.

The period before receipt of the booster dose was used as the reference category. This analysis was similar to the Poisson modeling described above and produced rates for different days after the booster vaccination. To test for different possible biases, we performed several sensitivity analyses. First, we analyzed the data using alternative statistical methods relying on matching and weighting.

These analyses are described in detail in the Methods section in the Supplementary Appendix. Second, we tested the effect of a specific study period by splitting the data into different study periods and performing the same analysis on each. Third, we performed the same analyses using data only from the general Jewish population, since the participants in that cohort dominated the booster-vaccinated population.Participants Figure 1. Figure 1.

Screening, Randomization, and Follow-up. The diagram represents all enrolled participants 16 years of age or older through the data cutoff date (March 13, 2021). The diagram includes two deaths that occurred after the second dose in human immunodeficiency diflucan (HIV)–infected participants (one in the BNT162b2 group and one in the placebo group. These deaths were not reported in the Results section of this article because the analysis of HIV-infected participants is being conducted separately).

Information on the screening, randomization, and follow-up of the participants 12 to 15 years of age has been reported previously.11Table 1. Table 1. Demographic Characteristics of the Participants at Baseline. Between July 27, 2020, and October 29, 2020, a total of 45,441 participants 16 years of age or older underwent screening, and 44,165 underwent randomization at 152 sites (130 sites in the United States, 1 site in Argentina, 2 sites in Brazil, 4 sites in South Africa, 6 sites in Germany, and 9 sites in Turkey) in the phase 2–3 portion of the trial.

Of these participants, 44,060 received at least one dose of BNT162b2 (22,030 participants) or placebo (22,030), and 98% (21,759 in the BNT162b2 group and 21,650 in the placebo group) received the second dose (Figure 1). During the blinded period of the trial, 51% of the participants in each group had 4 to less than 6 months of follow-up after the second dose. 8% of the participants in the BNT162b2 group and 6% of those in the placebo group had 6 months of follow-up or more after the second dose. During the combined blinded and open-label periods, 55% of the participants in the BNT162b2 group had 6 months of follow-up or more after the second dose.

A total of 49% of the participants were female, 82% were White, 10% were Black, and 26% were Hispanic or Latinx. The median age was 51 years. A total of 34% of the participants had a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30.0 or more, 21% had at least one underlying medical condition, and 3% had baseline evidence of a previous or current antifungals (Table 1 and Table S2). Between October 15, 2020, and January 12, 2021, a total of 2306 participants 12 to 15 years of age underwent screening, and 2264 underwent randomization at 29 U.S.

Sites. Of these participants, 2260 received at least one dose of BNT162b2 (1131 participants) or placebo (1129), and 99% (1124 in the BNT162b2 group and 1117 in the placebo group) received the second dose.11 Among participants who received at least one dose of BNT162b2 or placebo, 58% had at least 2 months of follow-up after the second dose, 49% were female, 86% were White, 5% were Black, and 12% were Hispanic or Latinx. Full details of the demographic characteristics of the participants have been reported previously.11 Safety Reactogenicity The subgroup that was evaluated for reactogenicity in the current report, in which reactions were reported in an electronic diary, included 9839 participants 16 years of age or older. In this subgroup, 8183 participants had been included in the previous analysis, and 1656 were enrolled after the data cutoff for that analysis.9 The reactogenicity profile of BNT162b2 in this expanded subgroup did not differ substantially from that described previously.9 This subgroup included 364 participants who had evidence of previous antifungals , 9426 who did not have evidence, and 49 who lacked the data needed to determine previous status.

More participants in the BNT162b2 group than in the placebo group reported local reactions, the most common of which was mild-to-moderate pain at the injection site (Fig. S1A). Local reactions were reported with similar frequency among the participants with or without evidence of previous antifungals , and the reactions were of similar severity. No local reactions of grade 4 (according to the guidelines of the Center for Biologics Evaluation and Research12) were reported.

More participants in the BNT162b2 group than in the placebo group reported systemic events, the most common of which was fatigue (Fig. S1B). Systemic events were mostly mild to moderate in severity, but there were occasional severe events. Systemic reactogenicity was similar among those with or without evidence of previous antifungals , although BNT162b2 recipients with evidence of previous reported systemic events more often after receipt of the first dose, and those without evidence reported systemic events more often after receipt of the second dose.

For example, 12% of recipients with evidence of previous antifungals and 3% of those without evidence reported fever after receipt of the first dose. 8% of those with evidence of previous and 15% of those without evidence reported fever after the second dose. The highest temperature reported was a transient fever of higher than 40.0°C on day 2 after the second dose in a BNT162b2 recipient without evidence of previous . Adverse Events Analyses of adverse events during the blinded period included 43,847 participants 16 years of age or older (Table S3).

Reactogenicity events among the participants who were not in the reactogenicity subgroup were reported as adverse events, which resulted in imbalances between the BNT162b2 group and the placebo group with respect to adverse events (30% vs. 14%), related adverse events (24% vs who can buy diflucan online. 6%), and severe adverse events (1.2% vs. 0.7%).

New adverse events attributable to BNT162b2 that were not previously identified in earlier reports included decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis. Few participants had serious adverse events or adverse events that led to trial withdrawal. No new serious adverse events were considered by the investigators to be related to BNT162b2 after the data cutoff date of the previous report.9 During the combined blinded and open-label periods, cumulative safety data during follow-up were available through 6 months after the second dose for 12,006 participants who were originally randomly assigned to the BNT162b2 group. No new safety signals relative to the previous report were observed during the longer follow-up period in the current report, which included open-label observation of the original BNT162b2 recipients and placebo recipients who received BNT162b2 after unblinding.9 During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died.

During the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died. None of these deaths were considered to be related to BNT162b2 by the investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4). Safety monitoring will continue according to the protocol for 2 years after the second dose for participants who originally received BNT162b2 and for 18 months after the second BNT162b2 dose for placebo recipients who received BNT162b2 after unblinding.

Efficacy Table 2. Table 2. treatment Efficacy against antifungal medication from 7 Days after Receipt of the Second Dose during the Blinded, Placebo-Controlled Follow-up Period. Among 42,094 participants 12 years of age or older who could be evaluated and had no evidence of previous antifungals , antifungal medication with an onset of 7 days or more after the second dose was observed in 77 treatment recipients and in 850 placebo recipients up to the data cutoff date (March 13, 2021), corresponding to a treatment efficacy of 91.3% (95% confidence interval [CI], 89.0 to 93.2) (Table 2).

Among 44,486 participants with or without evidence of previous who could be evaluated, cases of antifungal medication were observed in 81 treatment recipients and in 873 placebo recipients, corresponding to a treatment efficacy of 91.1% (95% CI, 88.8 to 93.0). Among the participants with evidence of previous antifungals based on a positive baseline N-binding antibody test, antifungal medication was observed in 2 treatment recipients after the first dose and in 7 placebo recipients. Among the participants with evidence of previous antifungals based on a positive nucleic acid amplification test at baseline, cases of antifungal medication were observed in 10 treatment recipients and in 9 placebo recipients (Table S5). antifungal medication was less common among the placebo recipients with positive N-binding antibodies at trial entry (7 of 542 participants, for an incidence of 1.3%) than among those without evidence of at trial entry (1015 of 21,521, for an incidence of 4.7%).

These findings indicate that previous conferred approximately 72.6% protection. Figure 2. Figure 2. Efficacy of BNT162b2 against antifungal medication after Receipt of the First Dose (Blinded Follow-up Period).

The top of the figure shows the cumulative incidence curves for the first occurrence of antifungals disease 2019 (antifungal medication) after receipt of the first dose (efficacy analysis population of participants ≥12 years of age who could be evaluated). Each symbol represents antifungal medication cases starting on a given day, and filled symbols represent severe antifungal medication cases. Because of overlapping dates, some symbols represent more than one case. The inset shows the same data on an enlarged y axis through 21 days.

The bottom of the figure shows the time intervals for the first occurrence of antifungal medication in the efficacy analysis population, as well as the surveillance time, which is given as the total time (in 1000 person-years) at risk for the given end point across all participants within each group. The time period for the accrual of antifungal medication cases was from after receipt of the first dose to the end of the surveillance period for the overall row and from the start to the end of the range stated for each time interval. treatment efficacy was calculated as 100×(1–IRR), where IRR (incidence rate ratio) is the ratio of the rate (number per 1000 person-years of follow-up) of confirmed cases of antifungal medication in the BNT162b2 group to the corresponding rate in the placebo group. The 95% confidence interval for treatment efficacy was derived with the use of the Clopper–Pearson method, with adjustment for surveillance time.Among the participants with or without evidence of previous , cases of antifungal medication were observed in 46 treatment recipients and in 110 placebo recipients from receipt of the first dose up to receipt of the second dose, corresponding to a treatment efficacy of 58.4% (95% CI, 40.8 to 71.2) (Figure 2).

During the interval from the approximate start of observed protection at 11 days after receipt of the first dose up to receipt of the second dose, treatment efficacy increased to 91.7% (95% CI, 79.6 to 97.4). From its peak after the second dose, observed treatment efficacy declined. From 7 days to less than 2 months after the second dose, treatment efficacy was 96.2% (95% CI, 93.3 to 98.1). From 2 months to less than 4 months after the second dose, treatment efficacy was 90.1% (95% CI, 86.6 to 92.9).

And from 4 months after the second dose to the data cutoff date, treatment efficacy was 83.7% (95% CI, 74.7 to 89.9). Table 3. Table 3. treatment Efficacy against antifungal medication up to 7 Days after Receipt of the Second Dose among Participants without Evidence of .

Severe antifungal medication, as defined by the Food and Drug Administration,13 with an onset after receipt of the first dose occurred in 31 participants, of whom 30 were placebo recipients. This finding corresponds with a treatment efficacy of 96.7% (95% CI, 80.3 to 99.9) against severe antifungal medication (Figure 2 and Table S6). Although the trial was not powered to definitively assess efficacy according to subgroup, supplemental analyses indicated that treatment efficacy after the second dose in subgroups defined according to age, sex, race, ethnic group, presence or absence of coexisting medical conditions, and country was generally consistent with that observed in the overall population (Table 3 and Table S7). Given the concern about the antifungals B.1.351 (or beta) variant, which appears to be neutralized less efficiently by BNT162b2-immune sera than many other lineages,14 whole-viral-genome sequencing was performed on midturbinate samples from antifungal medication cases observed in South Africa, where this lineage was prevalent.

Nine cases of antifungal medication were observed in South African participants without evidence of previous antifungals , all of whom were placebo recipients. This finding corresponds with a treatment efficacy of 100% (95% CI, 53.5 to 100) (Table 3). Midturbinate specimens from 8 of 9 cases contained sufficient viral RNA for whole-genome sequencing. All viral genomes were the beta variant (Global Initiative on Sharing All Influenza Data accession codes are provided in the Supplementary Appendix).To the Editor.

Whether vaccination of individual persons for severe acute respiratory syndrome antifungals 2 (antifungals) protects members of their households is unclear. We investigated the effect of vaccination of health care workers in Scotland (who were among the earliest groups to be vaccinated worldwide) on the risk of antifungals disease 2019 (antifungal medication) among members of their households. We evaluated data from 194,362 household members (which represented 92,470 households of 2 to 14 persons per household) of 144,525 health care workers who had been employed during the period from March 2020 through November 2020. The mean ages of the household members and the health care workers were 31 and 44 years, respectively.

A majority (>96%) were White. A total of 113,253 health care workers (78.4%) had received at least one dose of either the BNT162b2 (Pfizer–BioNTech) mRNA treatment or the ChAdOx1 nCoV-19 (Oxford–AstraZeneca) treatment, and 36,227 (25.1%) had received a second dose. The primary outcome was any confirmed case of antifungal medication that occurred between December 8, 2020, and March 3, 2021. We also report results for antifungal medication–associated hospitalization.

The primary time periods we compared were the unvaccinated period before the first dose and the period beginning 14 days after the health care worker received the first dose. No adjustment was made for multiplicity. Events that occurred after any household member was vaccinated were censored. Detailed methods and results, strengths and limitations, and the protocol are provided in the Supplementary Appendix, which is available with the full text of this letter at NEJM.org.

This study was approved by the Public Benefit and Privacy Panel (2021-0013), and the scientific officer of the West of Scotland Research Ethics Committee provided written confirmation that formal ethics review was not required. Table 1. Table 1. Effect of Vaccination of Health Care Workers on Documented antifungal medication Cases and Hospitalizations in Health Care Workers and Their Households.

Cases of antifungal medication were less common among household members of vaccinated health care workers during the period beginning 14 days after the first dose than during the unvaccinated period before the first dose (event rate per 100 person-years, 9.40 before the first dose and 5.93 beginning 14 days after the first dose). After the health care worker’s second dose, the rate in household members was lower still (2.98 cases per 100 person-years). These differences persisted after fitting extended Cox models that were adjusted for calendar time, geographic region, age, sex, occupational and socioeconomic factors, and underlying conditions. Relative to the period before each health care worker was vaccinated, the hazard ratio for a household member to become infected was 0.70 (95% confidence interval [CI], 0.63 to 0.78) for the period beginning 14 days after the first dose and 0.46 (95% CI, 0.30 to 0.70) for the period beginning 14 days after the second dose (Table 1 and the Supplementary Appendix).

Not all the cases of antifungal medication in the household members were transmitted from the health care worker. Therefore, the effect of vaccination may be larger.1 For example, if half the cases in the household members were transmitted from the health care worker, a 60% decrease in cases transmitted from health care workers would need to occur to elicit the association we observed (see the Supplementary Appendix). Vaccination was associated with a reduction in both the number of cases and the number of antifungal medication–related hospitalizations in health care workers between the unvaccinated period and the period beginning 14 days after the first dose. Given that vaccination reduces asymptomatic with antifungals,2,3 it is plausible that vaccination reduces transmission.

However, data from clinical trials and observational studies are lacking.4,5 We provide empirical evidence suggesting that vaccination may reduce transmission by showing that vaccination of health care workers is associated with a decrease in documented cases of antifungal medication among members of their households. This finding is reassuring for health care workers and their families. Anoop S.V. Shah, M.D.London School of Hygiene and Tropical Medicine, London, United KingdomCiara Gribben, M.Sc.Jennifer Bishop, M.Sc.Public Health Scotland, Edinburgh, United KingdomPeter Hanlon, M.D.University of Glasgow, Glasgow, United KingdomDavid Caldwell, M.Sc.Public Health Scotland, Edinburgh, United KingdomRachael Wood, Ph.D.University of Edinburgh, Edinburgh, United KingdomMartin Reid, B.Sc.Jim McMenamin, M.D.David Goldberg, M.D.Diane Stockton, M.Sc.Public Health Scotland, Edinburgh, United KingdomSharon Hutchinson, Ph.D.Glasgow Caledonian University, Glasgow, United KingdomChris Robertson, Ph.D.University of Strathclyde, Glasgow, United KingdomPaul M.

McKeigue, Ph.D.Helen M. Colhoun, Ph.D.University of Edinburgh, Edinburgh, United KingdomDavid A. McAllister, M.D.University of Glasgow, Glasgow, United Kingdom [email protected] Supported by the British Heart Foundation and Wellcome. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on September 8, 2021, at NEJM.org.5 References1. Shah ASV, Wood R, Gribben C, et al. Risk of hospital admission with antifungals disease 2019 in healthcare workers and their households. Nationwide linkage cohort study.

BMJ 2020;371:m3582-m3582.2. Voysey M, Costa Clemens SA, Madhi SA, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) treatment. A pooled analysis of four randomised trials.

Lancet 2021;397:881-891.3. Hall VJ, Foulkes S, Saei A, et al. antifungal medication treatment coverage in health-care workers in England and effectiveness of BNT162b2 mRNA treatment against (SIREN). A prospective, multicentre, cohort study.

Lancet 2021;397:1725-1735.4. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA antifungal medication treatment in a nationwide mass vaccination setting. N Engl J Med 2021;384:1412-1423.5.

Chodick G, Tene L, Patalon T, et al. Assessment of effectiveness of 1 dose of BNT162b2 treatment for antifungals 13 to 24 days after immunization. JAMA Netw Open 2021;4(6):e2115985-e2115985..

Study Population how much does generic diflucan cost Figure 1 http://donhughesdevelopment.com/?p=1. Figure 1. Study Population how much does generic diflucan cost. The participants in the study included persons who were 60 years of age or older and who had been fully vaccinated before March 1, 2021, had available data regarding sex, had no documented positive result on polymerase-chain-reaction assay for antifungals before July 30, 2021, and had not returned from travel abroad in August 2021.

The number of confirmed s in each population is shown in parentheses.Our analysis was based on medical data from the Ministry of Health database that how much does generic diflucan cost were extracted on September 2, 2021. At that time, a total of 1,186,779 Israeli residents who were 60 years of age or older had been fully vaccinated (i.e., received two doses of BNT162b2) at least 5 months earlier (i.e., before March 1, 2021) and were alive on July 30, 2021. We excluded from how much does generic diflucan cost the analysis participants who had missing data regarding sex. Were abroad in August 2021.

Had received a how much does generic diflucan cost diagnosis of PCR-positive antifungal medication before July 30, 2021. Had received a booster dose before July 30, 2021. Or had how much does generic diflucan cost been fully vaccinated before January 16, 2021. A total of 1,137,804 participants met the inclusion criteria for the analysis (Figure 1).

The data included vaccination dates (first, second, and third doses) how much does generic diflucan cost. Information regarding PCR testing (sampling dates and results). The date of how much does generic diflucan cost any antifungal medication hospitalization (if relevant). Demographic variables, such as age, sex, and demographic group (general Jewish, Arab, or ua-Orthodox Jewish population), as determined by the participant’s statistical area of residence (similar to a census block)8.

And clinical how much does generic diflucan cost status (mild or severe disease). Severe disease was defined as a resting respiratory rate of more than 30 breaths per minute, an oxygen saturation of less than 94% while breathing ambient air, or a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 300.9 Study Design Our study period started at the beginning of the booster vaccination campaign on July 30, 2021. The end dates were chosen as August 31, 2021, for confirmed how much does generic diflucan cost and August 26, 2021, for severe illness. The selection of dates was designed to minimize the effects of missing outcome data owing to delays in the reporting of test results and to the development of severe illness.

The protection gained by the booster shot was not expected to reach its maximal capacity immediately after vaccination but rather to build up during the subsequent week.10,11 At the same time, during the first days after vaccination, substantial behavioral changes in the booster-vaccinated population are how much does generic diflucan cost possible (Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). One such potential change is increased avoidance of exposure to excess risk until the booster dose how much does generic diflucan cost becomes effective. Another potential change is a reduced incidence of testing for antifungal medication around the time of receipt of the booster (Fig.

S2). Thus, it is preferable to assess the effect of the booster only after a sufficient period has passed since its administration. We considered 12 days as the interval between the administration of a booster dose and its likely effect on the observed number of confirmed s. The choice of the interval of at least 12 days after booster vaccination as the cutoff was scientifically justified from an immunologic perspective, since studies have shown that after the booster dose, neutralization levels increase only after several days.6 In addition, when confirmed (i.e., positivity on PCR assay) is used as an outcome, a delay occurs between the date of and the date of PCR testing.

For symptomatic cases, it is likely that occurs on average 5 to 6 days before testing, similar to the incubation period for antifungal medication.12,13 Thus, our chosen interval of 12 days included 7 days until an effective buildup of antibodies after vaccination plus 5 days of delay in the detection of . To estimate the reduction in the rates of confirmed and severe disease among booster recipients, we analyzed data on the rate of confirmed and on the rate of severe illness among fully vaccinated participants who had received the booster dose (booster group) and those who had received only two treatment doses (nonbooster group). The membership in these groups was dynamic, since participants who were initially included in the nonbooster group left it after receipt of the booster dose and subsequently were included in the booster group 12 days later, provided that they did not have confirmed during the interim period (Fig. S3).

In each group, we calculated the rate of both confirmed and severe illness per person-days at risk. In the booster group, we considered that days at risk started 12 days after receipt of the third dose and ended either at the time of the occurrence of a study outcome or at the end of the study period. In the nonbooster group, days at risk started 12 days after the beginning of the study period (August 10, 2021) and ended at time of the occurrence of a study outcome, at the end of the study period, or at the time of receipt of a booster dose. The time of onset of severe antifungal medication was considered to be the date of the confirmed .

In order to minimize the problem of censoring, the rate of severe illness was calculated on the basis of cases that had been confirmed on or before August 26, 2021. This schedule was adopted to allow for a week of follow-up (until the date when we extracted the data) for determining whether severe illness had developed. The study protocol is available at NEJM.org. Oversight The study was approved by the institutional review board of the Sheba Medical Center.

All the authors contributed to the writing and critical review of the manuscript, approved the final version, and made the decision to submit the manuscript for publication. The Israeli Ministry of Health and Pfizer have a data-sharing agreement, but only the final results of this study were shared. Statistical Analysis We performed Poisson regression to estimate the rate of a specific outcome, using the function for fitting generalized linear models (glm) in R statistical software.14 These analyses were adjusted for the following covariates. Age (60 to 69 years, 70 to 79 years, and ≥80 years), sex, demographic group (general Jewish, Arab, or ua-Orthodox Jewish population),8 and the date of the second treatment dose (in half-month intervals).

We included the date of the second dose as a covariate to account for the waning effect of the earlier vaccination and for the likely early administration of treatment in high-risk groups.2 Since the overall rate of both confirmed and severe illness increased exponentially during the study period, days at the beginning of the study period had lower exposure risk than days at the end. To account for growing exposure risk, we included the calendar date as an additional covariate. After accounting for these covariates, we used the study group (booster or nonbooster) as a factor in the regression model and estimated its effect on rate. We estimated the rate ratio comparing the nonbooster group with the booster group, a measure that is similar to relative risk.

For reporting uncertainty around our estimate, we took the exponent of the 95% confidence interval for the regression coefficient without adjustment for multiplicity. We also used the results of the model to calculate the average between-group difference in the rates of confirmed and severe illness.15 In a secondary analysis, we compared rates before and after the booster dose became effective. Specifically, we repeated the Poisson regression analysis described above but compared the rate of confirmed between 4 and 6 days after the booster dose with the rate at least 12 days after the booster dose. Our hypothesis was that the booster dose was not yet effective during the former period.10 This analysis compares different periods after booster vaccination among persons who received the booster dose and may reduce selection bias.

However, booster recipients might have undergone less frequent PCR testing and behaved more cautiously with regard to diflucan exposure soon after receiving the booster dose (Fig. S2). Thus, we hypothesize that the rate ratio could be underestimated in this analysis. To further examine the reduction in the rate of confirmed as a function of the interval since receipt of the booster, we fitted a Poisson regression that includes days 1 to 32 after the booster dose as separate factors in the model.

The period before receipt of the booster dose was used as the reference category. This analysis was similar to the Poisson modeling described above and produced rates for different days after the booster vaccination. To test for different possible biases, we performed several sensitivity analyses. First, we analyzed the data using alternative statistical methods relying on matching and weighting.

These analyses are described in detail in the Methods section in the Supplementary Appendix. Second, we tested the effect of a specific study period by splitting the data into different study periods and performing the same analysis on each. Third, we performed the same analyses using data only from the general Jewish population, since the participants in that cohort dominated the booster-vaccinated population.Participants Figure 1. Figure 1.

Screening, Randomization, and Follow-up. The diagram represents all enrolled participants 16 years of age or older through the data cutoff date (March 13, 2021). The diagram includes two deaths that occurred after the second dose in human immunodeficiency diflucan (HIV)–infected participants (one in the BNT162b2 group and one in the placebo group. These deaths were not reported in the Results section of this article because the analysis of HIV-infected participants is being conducted separately).

Information on the screening, randomization, and follow-up of the participants 12 to 15 years of age has been reported previously.11Table 1. Table 1. Demographic Characteristics of the Participants at Baseline. Between July 27, 2020, and October 29, 2020, a total of 45,441 participants 16 years of age or older underwent screening, and 44,165 underwent randomization at 152 sites (130 sites in the United States, 1 site in Argentina, 2 sites in Brazil, 4 sites in South Africa, 6 sites in Germany, and 9 sites in Turkey) in the phase 2–3 portion of the trial.

Of these participants, 44,060 received at least one dose of BNT162b2 (22,030 participants) or placebo (22,030), and 98% (21,759 in the BNT162b2 group and 21,650 in the placebo group) received the second dose (Figure 1). During the blinded period of the trial, 51% of the participants in each group had 4 to less than 6 months of follow-up after the second dose. 8% of the participants in the BNT162b2 group and 6% of those in the placebo group had 6 months of follow-up or more after the second dose. During the combined blinded and open-label periods, 55% of the participants in the BNT162b2 group had 6 months of follow-up or more after the second dose.

A total of 49% of the participants were female, 82% were White, 10% were Black, and 26% were Hispanic or Latinx. The median age was 51 years. A total of 34% of the participants had a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30.0 or more, 21% had at least one underlying medical condition, and 3% had baseline evidence of a previous or current antifungals (Table 1 and Table S2). Between October 15, 2020, and January 12, 2021, a total of 2306 participants 12 to 15 years of age underwent screening, and 2264 underwent randomization at 29 U.S.

Sites. Of these participants, 2260 received at least one dose of BNT162b2 (1131 participants) or placebo (1129), and 99% (1124 in the BNT162b2 group and 1117 in the placebo group) received the second dose.11 Among participants who received at least one dose of BNT162b2 or placebo, 58% had at least 2 months of follow-up after the second dose, 49% were female, 86% were White, 5% were Black, and 12% were Hispanic or Latinx. Full details of the demographic characteristics of the participants have been reported previously.11 Safety Reactogenicity The subgroup that was evaluated for reactogenicity in the current report, in which reactions were reported in an electronic diary, included 9839 participants 16 years of age or older. In this subgroup, 8183 participants had been included in the previous analysis, and 1656 were enrolled after the data cutoff for that analysis.9 The reactogenicity profile of BNT162b2 in this expanded subgroup did not differ substantially from that described previously.9 This subgroup included 364 participants who had evidence of previous antifungals , 9426 who did not have evidence, and 49 who lacked the data needed to determine previous status.

More participants in the BNT162b2 group than in the placebo group reported local reactions, the most common of which was mild-to-moderate pain at the injection site (Fig. S1A). Local reactions were reported with similar frequency among the participants with or without evidence of previous antifungals , and the reactions were of similar severity. No local reactions of grade 4 (according to the guidelines of the Center for Biologics Evaluation and Research12) were reported.

More participants in the BNT162b2 group than in the placebo group reported systemic events, the most common of which was fatigue (Fig. S1B). Systemic events were mostly mild to moderate in severity, but there were occasional severe events. Systemic reactogenicity was similar among those with or without evidence of previous antifungals , although BNT162b2 recipients with evidence of previous reported systemic events more often after receipt of the first dose, and those without evidence reported systemic events more often after receipt of the second dose.

For example, 12% of recipients with evidence of previous antifungals and 3% of those without evidence reported fever after receipt of the first dose. 8% of those with evidence of previous and 15% of those without evidence reported fever after the second dose. The highest temperature reported was a transient fever of higher than 40.0°C on day 2 after the second dose in a BNT162b2 recipient without evidence of previous . Adverse Events Analyses of adverse events during the blinded period included 43,847 participants 16 years of age or older (Table S3).

Reactogenicity events among the participants who were not in the reactogenicity subgroup were reported as adverse events, which resulted in imbalances between the BNT162b2 group and the placebo group with respect to adverse events (30% vs. 14%), related adverse events (24% vs. 6%), and severe adverse events (1.2% vs. 0.7%).

New adverse events attributable to BNT162b2 that were not previously identified in earlier reports included decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis. Few participants had serious adverse events or adverse events that led to trial withdrawal. No new serious adverse events were considered by the investigators to be related to BNT162b2 after the data cutoff date of the previous report.9 During the combined blinded and open-label periods, cumulative safety data during follow-up were available through 6 months after the second dose for 12,006 participants who were originally randomly assigned to the BNT162b2 group. No new safety signals relative to the previous report were observed during the longer follow-up period in the current report, which included open-label observation of the original BNT162b2 recipients and placebo recipients who received BNT162b2 after unblinding.9 During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died.

During the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died. None of these deaths were considered to be related to BNT162b2 by the investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4). Safety monitoring will continue according to the protocol for 2 years after the second dose for participants who originally received BNT162b2 and for 18 months after the second BNT162b2 dose for placebo recipients who received BNT162b2 after unblinding.

Efficacy Table 2. Table 2. treatment Efficacy against antifungal medication from 7 Days after Receipt of the Second Dose during the Blinded, Placebo-Controlled Follow-up Period. Among 42,094 participants 12 years of age or older who could be evaluated and had no evidence of previous antifungals , antifungal medication with an onset of 7 days or more after the second dose was observed in 77 treatment recipients and in 850 placebo recipients up to the data cutoff date (March 13, 2021), corresponding to a treatment efficacy of 91.3% (95% confidence interval [CI], 89.0 to 93.2) (Table 2).

Among 44,486 participants with or without evidence of previous who could be evaluated, cases of antifungal medication were observed in 81 treatment recipients and in 873 placebo recipients, corresponding to a treatment efficacy of 91.1% (95% CI, 88.8 to 93.0). Among the participants with evidence of previous antifungals based on a positive baseline N-binding antibody test, antifungal medication was observed in 2 treatment recipients after the first dose and in 7 placebo recipients. Among the participants with evidence of previous antifungals based on a positive nucleic acid amplification test at baseline, cases of antifungal medication were observed in 10 treatment recipients and in 9 placebo recipients (Table S5). antifungal medication was less common among the placebo recipients with positive N-binding antibodies at trial entry (7 of 542 participants, for an incidence of 1.3%) than among those without evidence of at trial entry (1015 of 21,521, for an incidence of 4.7%).

These findings indicate that previous conferred approximately 72.6% protection. Figure 2. Figure 2. Efficacy of BNT162b2 against antifungal medication after Receipt of the First Dose (Blinded Follow-up Period).

The top of the figure shows the cumulative incidence curves for the first occurrence of antifungals disease 2019 (antifungal medication) after receipt of the first dose (efficacy analysis population of participants ≥12 years of age who could be evaluated). Each symbol represents antifungal medication cases starting on a given day, and filled symbols represent severe antifungal medication cases. Because of overlapping dates, some symbols represent more than one case. The inset shows the same data on an enlarged y axis through 21 days.

The bottom of the figure shows the time intervals for the first occurrence of antifungal medication in the efficacy analysis population, as well as the surveillance time, which is given as the total time (in 1000 person-years) at risk for the given end point across all participants within each group. The time period for the accrual of antifungal medication cases was from after receipt of the first dose to the end of the surveillance period for the overall row and from the start to the end of the range stated for each time interval. treatment efficacy was calculated as 100×(1–IRR), where IRR (incidence rate ratio) is the ratio of the rate (number per 1000 person-years of follow-up) of confirmed cases of antifungal medication in the BNT162b2 group to the corresponding rate in the placebo group. The 95% confidence interval for treatment efficacy was derived with the use of the Clopper–Pearson method, with adjustment for surveillance time.Among the participants with or without evidence of previous , cases of antifungal medication were observed in 46 treatment recipients and in 110 placebo recipients from receipt of the first dose up to receipt of the second dose, corresponding to a treatment efficacy of 58.4% (95% CI, 40.8 to 71.2) (Figure 2).

During the interval from the approximate start of observed protection at 11 days after receipt of the first dose up to receipt of the second dose, treatment efficacy increased to 91.7% (95% CI, 79.6 to 97.4). From its peak after the second dose, observed treatment efficacy declined. From 7 days to less than 2 months after the second dose, treatment efficacy was 96.2% (95% CI, 93.3 to 98.1). From 2 months to less than 4 months after the second dose, treatment efficacy was 90.1% (95% CI, 86.6 to 92.9).

And from 4 months after the second dose to the data cutoff date, treatment efficacy was 83.7% (95% CI, 74.7 to 89.9). Table 3. Table 3. treatment Efficacy against antifungal medication up to 7 Days after Receipt of the Second Dose among Participants without Evidence of .

Severe antifungal medication, as defined by the Food and Drug Administration,13 with an onset after receipt of the first dose occurred in 31 participants, of whom 30 were placebo recipients. This finding corresponds with a treatment efficacy of 96.7% (95% CI, 80.3 to 99.9) against severe antifungal medication (Figure 2 and Table S6). Although the trial was not powered to definitively assess efficacy according to subgroup, supplemental analyses indicated that treatment efficacy after the second dose in subgroups defined according to age, sex, race, ethnic group, presence or absence of coexisting medical conditions, and country was generally consistent with that observed in the overall population (Table 3 and Table S7). Given the concern about the antifungals B.1.351 (or beta) variant, which appears to be neutralized less efficiently by BNT162b2-immune sera than many other lineages,14 whole-viral-genome sequencing was performed on midturbinate samples from antifungal medication cases observed in South Africa, where this lineage was prevalent.

Nine cases of antifungal medication were observed in South African participants without evidence of previous antifungals , all of whom were placebo recipients. This finding corresponds with a treatment efficacy of 100% (95% CI, 53.5 to 100) (Table 3). Midturbinate specimens from 8 of 9 cases contained sufficient viral RNA for whole-genome sequencing. All viral genomes were the beta variant (Global Initiative on Sharing All Influenza Data accession codes are provided in the Supplementary Appendix).To the Editor.

Whether vaccination of individual persons for severe acute respiratory syndrome antifungals 2 (antifungals) protects members of their households is unclear. We investigated the effect of vaccination of health care workers in Scotland (who were among the earliest groups to be vaccinated worldwide) on the risk of antifungals disease 2019 (antifungal medication) among members of their households. We evaluated data from 194,362 household members (which represented 92,470 households of 2 to 14 persons per household) of 144,525 health care workers who had been employed during the period from March 2020 through November 2020. The mean ages of the household members and the health care workers were 31 and 44 years, respectively.

A majority (>96%) were White. A total of 113,253 health care workers (78.4%) had received at least one dose of either the BNT162b2 (Pfizer–BioNTech) mRNA treatment or the ChAdOx1 nCoV-19 (Oxford–AstraZeneca) treatment, and 36,227 (25.1%) had received a second dose. The primary outcome was any confirmed case of antifungal medication that occurred between December 8, 2020, and March 3, 2021. We also report results for antifungal medication–associated hospitalization.

The primary time periods we compared were the unvaccinated period before the first dose and the period beginning 14 days after the health care worker received the first dose. No adjustment was made for multiplicity. Events that occurred after any household member was vaccinated were censored. Detailed methods and results, strengths and limitations, and the protocol are provided in the Supplementary Appendix, which is available with the full text of this letter at NEJM.org.

This study was approved by the Public Benefit and Privacy Panel (2021-0013), and the scientific officer of the West of Scotland Research Ethics Committee provided written confirmation that formal ethics review was not required. Table 1. Table 1. Effect of Vaccination of Health Care Workers on Documented antifungal medication Cases and Hospitalizations in Health Care Workers and Their Households.

Cases of antifungal medication were less common among household members of vaccinated health care workers during the period beginning 14 days after the first dose than during the unvaccinated period before the first dose (event rate per 100 person-years, 9.40 before the first dose and 5.93 beginning 14 days after the first dose). After the health care worker’s second dose, the rate in household members was lower still (2.98 cases per 100 person-years). These differences persisted after fitting extended Cox models that were adjusted for calendar time, geographic region, age, sex, occupational and socioeconomic factors, and underlying conditions. Relative to the period before each health care worker was vaccinated, the hazard ratio for a household member to become infected was 0.70 (95% confidence interval [CI], 0.63 to 0.78) for the period beginning 14 days after the first dose and 0.46 (95% CI, 0.30 to 0.70) for the period beginning 14 days after the second dose (Table 1 and the Supplementary Appendix).

Not all the cases of antifungal medication in the household members were transmitted from the health care worker. Therefore, the effect of vaccination may be larger.1 For example, if half the cases in the household members were transmitted from the health care worker, a 60% decrease in cases transmitted from health care workers would need to occur to elicit the association we observed (see the Supplementary Appendix). Vaccination was associated with a reduction in both the number of cases and the number of antifungal medication–related hospitalizations in health care workers between the unvaccinated period and the period beginning 14 days after the first dose. Given that vaccination reduces asymptomatic with antifungals,2,3 it is plausible that vaccination reduces transmission.

However, data from clinical trials and observational studies are lacking.4,5 We provide empirical evidence suggesting that vaccination may reduce transmission by showing that vaccination of health care workers is associated with a decrease in documented cases of antifungal medication among members of their households. This finding is reassuring for health care workers and their families. Anoop S.V. Shah, M.D.London School of Hygiene and Tropical Medicine, London, United KingdomCiara Gribben, M.Sc.Jennifer Bishop, M.Sc.Public Health Scotland, Edinburgh, United KingdomPeter Hanlon, M.D.University of Glasgow, Glasgow, United KingdomDavid Caldwell, M.Sc.Public Health Scotland, Edinburgh, United KingdomRachael Wood, Ph.D.University of Edinburgh, Edinburgh, United KingdomMartin Reid, B.Sc.Jim McMenamin, M.D.David Goldberg, M.D.Diane Stockton, M.Sc.Public Health Scotland, Edinburgh, United KingdomSharon Hutchinson, Ph.D.Glasgow Caledonian University, Glasgow, United KingdomChris Robertson, Ph.D.University of Strathclyde, Glasgow, United KingdomPaul M.

McKeigue, Ph.D.Helen M. Colhoun, Ph.D.University of Edinburgh, Edinburgh, United KingdomDavid A. McAllister, M.D.University of Glasgow, Glasgow, United Kingdom [email protected] Supported by the British Heart Foundation and Wellcome. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

This letter was published on September 8, 2021, at NEJM.org.5 References1. Shah ASV, Wood R, Gribben C, et al. Risk of hospital admission with antifungals disease 2019 in healthcare workers and their households. Nationwide linkage cohort study.

BMJ 2020;371:m3582-m3582.2. Voysey M, Costa Clemens SA, Madhi SA, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) treatment. A pooled analysis of four randomised trials.

Lancet 2021;397:881-891.3. Hall VJ, Foulkes S, Saei A, et al. antifungal medication treatment coverage in health-care workers in England and effectiveness of BNT162b2 mRNA treatment against (SIREN). A prospective, multicentre, cohort study.

Lancet 2021;397:1725-1735.4. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA antifungal medication treatment in a nationwide mass vaccination setting. N Engl J Med 2021;384:1412-1423.5.

Chodick G, Tene L, Patalon T, et al. Assessment of effectiveness of 1 dose of BNT162b2 treatment for antifungals 13 to 24 days after immunization. JAMA Netw Open 2021;4(6):e2115985-e2115985..

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