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Changes in weather and climate are threatening food security and driving up food-, water- and vector-borne diseases, such best place to buy levitra as malaria, while climate impacts are also negatively affecting mental health. The WHO best place to buy levitra report states. €œThe burning of fossil fuels is killing us.

Climate change is best place to buy levitra the single biggest health threat facing humanity. While no one is safe from the health impacts of climate change, they are disproportionately felt by the most vulnerable and disadvantaged.”Meanwhile, air pollution, primarily the result of burning fossil fuels, which also drives climate change, causes 13 deaths per minute worldwide.The report concludes that protecting people’s health requires transformational action in every sector, including on energy, transport, nature, food systems and finance. And it states clearly that best place to buy levitra the public health benefits from implementing ambitious climate actions far outweigh the costs.“It has never been clearer that the climate crisis is one of the most urgent health emergencies we all face,” said Dr Maria Neira, WHO Director of Environment, Climate Change and Health.

€œBringing down air pollution to WHO guideline levels, for example, would reduce the total number of global deaths from air pollution by best place to buy levitra 80% while dramatically reducing the greenhouse gas emissions that fuel climate change. A shift to more nutritious, plant-based diets in line with WHO recommendations, as another example, could reduce global emissions significantly, ensure more resilient food systems, and avoid up to 5.1 million diet-related deaths a year by 2050.”Achieving the goals of the Paris Agreement would save millions of lives every year due to improvements in air quality, diet, and physical activity, among other benefits. However, most climate decision-making processes best place to buy levitra currently do not account for these health co-benefits and their economic valuation.

Notes to editors:WHO’s COP26 Special Report on Climate Change and Health, The Health Argument for Climate Action, provides 10 recommendations for governments on how to maximize the health benefits of tackling climate change in a variety of sectors, and avoid the worst health impacts of the climate crisis.The recommendations are the result of best place to buy levitra extensive consultations with health professionals, organizations and stakeholders worldwide, and represent a broad consensus statement from the global health community on the priority actions governments need to take to tackle the climate crisis, restore biodiversity, and protect health.Climate and Health RecommendationsThe COP26 report includes ten recommendations that highlight the urgent need and numerous opportunities for governments to prioritize health and equity in the international climate regime and sustainable development agenda.Commit to a healthy recovery. Commit to a healthy, green and just recovery from erectile dysfunction treatment.Our health is not negotiable. Place health best place to buy levitra and social justice at the heart of the UN climate talks.Harness the health benefits of climate action.

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And we call on them to build health into those plans;We call on all nations to deliver a rapid and just transition away from fossil fuels, starting with immediately cutting all related permits, subsidies and financing for fossil fuels, and to completely shift current financing into development of clean energy;We call on high income countries to make larger cuts to greenhouse gas emissions, in line with a 1.5°C temperature goal;We call on high income countries to also provide the promised transfer of funds to low-income countries to help achieve the necessary mitigation and adaptation measures;We call on governments to build climate resilient, low-carbon, sustainable health systems. AndWe call on governments to also ensure that levitra recovery investments support climate action and reduce social and health inequities.”The best place to buy levitra World Health Organization’s new Mental Health Atlas paints a disappointing picture of a worldwide failure to provide people with the mental health services they need, at a time when the erectile dysfunction treatment levitra is highlighting a growing need for mental health support.The latest edition of the Atlas, which includes data from 171 countries, provides a clear indication that the increased attention given to mental health in recent years has yet to result in a scale-up of quality mental services that is aligned with needs. Issued every three years, the Atlas is a compilation of data provided by countries around the world on mental health policies, legislation, financing, human resources, availability and utilization best place to buy levitra of services and data collection systems.

It is also the mechanism for monitoring progress towards meeting the targets in WHO’s Comprehensive Mental Health Action Plan.“It is extremely concerning that, despite the evident and increasing need for mental health services, which has become even more acute during the erectile dysfunction treatment levitra, good intentions are not being met with investment,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. €œWe must heed and act on this wake-up call and dramatically accelerate the scale-up of investment in mental health, because there is no health without mental health.”Lack of progress in leadership, governance and financingNone of the targets for effective leadership and governance for mental health, provision of mental health services in community-based settings, mental health promotion and prevention, and strengthening of information systems, were close to being achieved.In 2020, just 51% of WHO’s 194 Member States reported that their mental health policy or plan was in line with international and regional human rights instruments, way short best place to buy levitra of the 80% target. And only 52% of countries met the target relating to mental health promotion and prevention programmes, also well below the 80% target.

The only 2020 target met was a reduction in the rate of suicide by 10%, but even then, only 35 countries said they had a stand-alone prevention strategy, policy or plan.Steady progress was evident, however, in the adoption of best place to buy levitra mental health policies, plans and laws, as well as in improvements in capacity to report on a set of core mental health indicators. However, the percentage of government health budgets spent on mental health has scarcely best place to buy levitra changed during the last years, still hovering around 2%. Moreover, even when policies and plans included estimates of required human and financial resources, just 39% of responding countries indicated that the necessary human resources had been allocated and 34% that the required financial resources had been provided.Transfer of care to the community is slowWhile the systematic decentralization of mental health care to community settings has long been recommended by WHO, only 25% of responding countries met all the criteria for integration of mental health into primary care.

While progress has been made in training and supervision in most countries, the supply of medicines for mental health conditions and psychosocial care in primary health-care services remains limited.This is also best place to buy levitra reflected in the way that government funds to mental health are allocated, highlighting the urgent need for deinstitutionalization. More than 70% of total best place to buy levitra government expenditure on mental health was allocated to mental hospitals in middle-income countries, compared with 35% in high-income countries. This indicates that centralized mental hospitals and institutional inpatient care still receive more funds than services provided in general hospitals and primary health-care centres in many countries.

There was, however, an increase in the percentage of countries reporting that treatment of people with specific mental health conditions (psychosis, bipolar disorder and depression) is included in national health insurance or reimbursement schemes – from 73% in 2017 to 80% (or 55% of Member States) best place to buy levitra in 2020.Global estimates of people receiving care for specific mental health conditions (used as a proxy for mental health care as a whole) remained less than 50%, with a global median of 40% of people with depression and just 29% of people with psychosis receiving care.Increase in mental health promotion, but effectiveness questionableMore encouraging was the increase in countries reporting mental health promotion and prevention programmes, from 41% of Member States in 2014 to 52% in 2020. However, 31% of total reported programmes did not have dedicated human and financial resources, 27% did not have a defined plan, and 39% had no documented evidence of progress and/or impact.Slight increase in the mental health workforceThe global best place to buy levitra median number of mental health workers per 100 000 population has increased slightly from nine workers in 2014 to 13 workers per 100 000 population in 2020. However, there was a very high variation between countries of different income levels, with the number of mental health workers in high-income countries more than 40 times higher than in low-income countries.New targets for 2030The global targets reported on in the Mental Health Atlas are from WHO’s Comprehensive Mental Health Action Plan, which contained targets for 2020 endorsed by the World Health Assembly in 2013.

This Plan has now been extended to 2030 and includes new targets for the inclusion of mental health and psychosocial support in emergency preparedness plans, the integration of mental health into primary health care, and research on mental health.“The new data from the Mental Health Atlas shows us that we still best place to buy levitra have a very long way to go in making sure that everyone, everywhere, has access to quality mental health care,” said Dévora Kestel, Director of the Department of Mental Health and Substance Use at WHO. €œBut I am encouraged by the renewed vigour that we saw from governments as the new targets for 2030 were discussed and agreed and am confident that together we can do what is necessary to move from baby steps to giant leaps forward in the next 10 years.”Note for editors:The Atlas is being released in the lead-up to World Mental Health Day on 10 October, for which the focus this year is scaling up access to quality mental health care..

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With the emergence of high-profile climate activists and a wider appreciation of generic levitra best price the need for sustainable healthcare, training within radiology can no longer be excused from its responsibility to consider the environment in its actions. In this paper, we aim to evaluate the environmental impact of the travel undertaken by trainees within the Peninsula training programme, with the aim of developing practices and providing suggestions (evidence-based where possible) on how to improve the impact on the environment of trainee travel. We envisage that many of the lessons and suggestions may be transferrable to other training schemes in the UK and further afield. During the early months of 2020, in addition to the environmental crisis, erectile dysfunction treatment escalated to a levitra resulting generic levitra best price in the alteration of working practices across the UK (and the rest of the world).

This led to many environmentally beneficial working practices being adopted in Radiology in the South West Peninsula Deanery, and throughout this paper we have evaluated these changes and used our collective experience of these to inform our suggestions on how to improve the environmental sustainability of Medical and Radiological training.Radiology &. ImagingDiagnostic radiologyMedical education &. Training.

With the emergence of high-profile climate activists and a wider appreciation of the need for sustainable healthcare, training within radiology best place to buy levitra can no longer be excused from its responsibility to consider the environment in its actions. In this paper, we aim to evaluate the environmental impact of the travel undertaken by trainees within the Peninsula training programme, with the aim of developing practices and providing suggestions (evidence-based where possible) on how to improve the impact on the environment of trainee travel. We envisage that many of the lessons and suggestions may be transferrable to other training schemes in the UK and further afield. During the early months of 2020, in addition to the environmental crisis, erectile dysfunction treatment escalated to a levitra resulting in the alteration of working practices across the UK (and the best place to buy levitra rest of the world).

This led to many environmentally beneficial working practices being adopted in Radiology in the South West Peninsula Deanery, and throughout this paper we have evaluated these changes and used our collective experience of these to inform our suggestions on how to improve the environmental sustainability of Medical and Radiological training.Radiology &. ImagingDiagnostic radiologyMedical education &. Training.

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Study Design https://look-i.de/lowest-price-amoxil We used two approaches to estimate the effect of vaccination on the delta where to get levitra variant. First, we used a test-negative case–control design to estimate treatment effectiveness against where to get levitra symptomatic disease caused by the delta variant, as compared with the alpha variant, over the period that the delta variant has been circulating. This approach has been described in detail elsewhere.10 In brief, we compared vaccination status in persons with symptomatic erectile dysfunction treatment with vaccination status in persons who reported symptoms but had a negative test.

This approach helps to control for biases where to get levitra related to health-seeking behavior, access to testing, and case ascertainment. For the secondary analysis, the proportion of persons with cases caused by the delta variant relative to the main circulating levitra (the alpha variant) was estimated according to vaccination status. The underlying assumption was where to get levitra that if the treatment had some efficacy and was equally effective against each variant, a similar proportion of cases with either variant would be expected in unvaccinated persons and in vaccinated persons.

Conversely, if the treatment was less effective against the delta variant than against the alpha variant, then the delta variant would be expected to make up a higher proportion of cases occurring more than 3 weeks after vaccination than among unvaccinated persons. Details of this analysis are described in Section S1 in the Supplementary Appendix, available with the full text of this article where to get levitra at NEJM.org. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

Data Sources Vaccination Status Data on where to get levitra all persons in England who have been vaccinated with erectile dysfunction treatments are available in a national vaccination register (the National Immunisation Management System). Data regarding vaccinations that had occurred up to May 16, 2021, including the date of receipt of each dose of treatment and the treatment type, were extracted on May 17, 2021. Vaccination status was categorized as receipt of one dose of treatment among persons who had symptom onset occurring 21 days or more after receipt of the first dose up to where to get levitra the day before the second dose was received, as receipt of the second dose among persons who had symptom onset occurring 14 days or more after receipt of the second dose, and as receipt of the first or second dose among persons with symptom onset occurring 21 days or more after the receipt of the first dose (including any period after the receipt of the second dose).

erectile dysfunction Testing Polymerase-chain-reaction (PCR) testing for erectile dysfunction in the United Kingdom is undertaken by hospital and public health laboratories, as well as by community testing with the use of drive-through or at-home testing, which is available to anyone with symptoms where to get levitra consistent with erectile dysfunction treatment (high temperature, new continuous cough, or loss or change in sense of smell or taste). Data on all positive PCR tests between October 26, 2020, and May 16, 2021, were extracted. Data on all recorded negative community tests among persons who reported symptoms were also extracted for where to get levitra the test-negative case–control analysis.

Children younger than 16 years of age as of March 21, 2021, were excluded. Data were restricted to persons who had reported symptoms, and only persons who had undergone testing within 10 days after symptom onset were included, in order to where to get levitra account for reduced sensitivity of PCR testing beyond this period.25 Identification of Variant Whole-genome sequencing was used to identify the delta and alpha variants. The proportion of all positive samples that were sequenced increased from approximately 10% in February 2021 to approximately 60% in May 2021.4 Sequencing is undertaken at a network of laboratories, including the Wellcome Sanger Institute, where a high proportion of samples has been tested, and whole-genome sequences are assigned to Public Health England definitions of variants on the basis of mutations.26 Spike gene target status on PCR was used as a second approach for identifying each variant.

Laboratories used the TaqPath assay (Thermo Fisher Scientific) to test for where to get levitra three gene targets. Spike (S), nucleocapsid (N), and open reading frame 1ab (ORF1ab). In December 2020, the alpha variant was noted to be associated with negative testing on the S target, so S target–negative status was subsequently where to get levitra used as a proxy for identification of the variant.

The alpha variant accounts for between 98% and 100% of S target–negative results in England. Among sequenced samples that tested positive for the S target, the delta variant was in 72.2% of the samples in April 2021 and in 93.0% in May (as of May 12, 2021).4 For the test-negative case–control analysis, only samples where to get levitra that had been tested at laboratories with the use of the TaqPath assay were included. Data Linkage The three data sources described above were linked where to get levitra with the use of the National Health Service number (a unique identifier for each person receiving medical care in the United Kingdom).

These data sources were also linked with data on the patient’s date of birth, surname, first name, postal code, and specimen identifiers and sample dates. Covariates Multiple covariates that may be associated with the likelihood of being offered or accepting a treatment and the risk of exposure to erectile dysfunction treatment or specifically to where to get levitra either of the variants analyzed were also extracted from the National Immunisation Management System and the testing data. These data included age (in 10-year age groups), sex, index of multiple deprivation (a national indication of level of deprivation that is based on small geographic areas of residence,27 assessed in quintiles), race or ethnic group, care home residence status, history of foreign travel (i.e., outside the United Kingdom or Ireland), geographic region, period (calendar week), health and social care worker status, and status of being in a clinically extremely vulnerable group.28 In addition, for the test-negative case–control analysis, history of erectile dysfunction before the start of the vaccination program was included.

Persons were considered to have traveled if, at the point of requesting a test, they reported having where to get levitra traveled outside the United Kingdom and Ireland within the preceding 14 days or if they had been tested in a quarantine hotel or while quarantining at home. Postal codes were used to determine the index of multiple deprivation, and unique property-reference numbers were used to identify care homes.29 Statistical Analysis For the test-negative case–control analysis, logistic regression was used to estimate the odds of having a symptomatic, PCR-confirmed case of erectile dysfunction treatment among vaccinated persons as compared with unvaccinated persons (control). Cases were identified as having the delta variant by means of sequencing or if they were S target–positive on the TaqPath PCR where to get levitra assay.

Cases were identified as having the alpha variant by means of sequencing or if they were S target–negative on the TaqPath PCR assay. If a person had tested positive on multiple occasions within a 90-day period (which may where to get levitra represent a single illness episode), only the first positive test was included. A maximum of three randomly chosen negative test results were included for each person.

Negative tests in which the sample had been obtained within 3 weeks before a positive result or after a positive result could have been where to get levitra false negatives. Therefore, these where to get levitra were excluded. Tests that had been administered within 7 days after a previous negative result were also excluded.

Persons who had previously tested positive before the analysis period were also excluded in order to estimate treatment effectiveness in fully where to get levitra susceptible persons. All the covariates were included in the model as had been done with previous test-negative case–control analyses, with calendar week included as a factor and without an interaction with region. With regard to S target–positive or –negative status, only persons who had tested positive on the other two where to get levitra PCR gene targets were included.

Assignment to the delta variant on the basis of S target status was restricted to the week commencing April 12, 2021, and onward in order to aim for high specificity of S target–positive testing for the delta variant.4 treatment effectiveness for the first dose was estimated among persons with a symptom-onset date that was 21 days or more after receipt of the first dose of treatment, and treatment effects for the second dose were estimated among persons with a symptom-onset date that was 14 days or more after receipt of the second dose. Comparison was made with unvaccinated persons and with persons who where to get levitra had symptom onset in the period of 4 to 13 days after vaccination in order to help account for differences in underlying risk of . The period from the day of treatment administration (day 0) to day 3 was excluded because reactogenicity to the treatment can cause an increase in testing that biases results, as previously described.10Trial Population Between December 9, 2020, and February 28, 2021, a total of 3732 adolescents were randomly assigned in a 2:1 ratio to receive mRNA-1273 (2489 participants) or placebo (1243 participants) at 26 sites in the United States (Figure 1 and Fig.

S1). More than 98% of the participants received a second injection. The most common reasons for not receiving a second injection were withdrawal of consent (10 participants) and loss to follow-up (8 participants).

Table 1. Table 1. Demographic and Clinical Characteristics in the Safety Population at Baseline.

The baseline characteristics were generally balanced in the mRNA-1273 and placebo groups. The mean age of the participants was 14.3 years (74% were 12 to 15 years of age), half of the participants were male (51%), most were White (84%) and most were not Hispanic or Latinx (88%), and 93% had a body-mass index (the weight in kilograms divided by the square of the height in meters) of less than 30 (Table 1). The median duration of follow-up from randomization to the data snapshot was 83 days, and the median duration from the second injection to the database lock was 53 days.

The demographic characteristics of the adolescents were generally similar to those of the young adults in the phase 3 trial (Table S12). A total of 2% of the adults in the phase 3 trial had a positive erectile dysfunction status at baseline as compared with 6% of the adolescents. The demographic characteristics of the per-protocol immunogenicity subpopulations are shown in Table S10.

The percentages of adolescents as compared with the young adults years were 8% and 27% for Hispanic or Latinx, 1% and 11% for Black, and 79% and 48% for White non-Hispanic participants, respectively (Table S10). Safety Figure 2. Figure 2.

Solicited Local and Systemic Adverse Reactions. Shown is the percentage of participants who had a solicited local or systemic adverse reaction within 7 days after the first or second injection (dose 1 or dose 2) of either mRNA-1273 treatment or placebo.Solicited local reactions occurred more frequently in the mRNA-1273 group after the first injection (94.2%) and after the second injection (93.4%) than in the placebo group (36.8% and 32.6%, respectively). In the mRNA-1273 group, the most common solicited local reaction was injection-site pain after the first injection (93.1%.

Grade 3, 5.4%) and second injection (92.4%. Grade 3, 5.1%). In the placebo group, injection-site pain was reported in 34.8% of the participants after the first injection and in 30.3% after the second injection.

Grade 3 local adverse reactions in the mRNA-1273 group occurred in 6.8% of the participants after the first injection and in 8.9% after the second injection (Figure 2 and Table S2). In the mRNA-1273 group, systemic adverse reactions were reported in 68.5% of the participants after the first injection and in 86.1% after the second injection. Grade 3 events were reported in 4.4% and 13.7%, respectively.

The most common systemic reactions were fatigue, headache, myalgia, and chills. Headache was reported in 44.6% of the participants in the mRNA-1273 group after the first injection and in 70.2% after the second injection, as compared with 38.5% and 30.2%, respectively, in the placebo group. Fatigue was reported in 47.9% of the participants in the mRNA-1273 group after the first injection and in 67.8% after the second injection, as compared with 36.6% and 28.9%, respectively, in the placebo group.

After the second injection, among the mRNA-1273 recipients with available data, grade 3 fever occurred in 46 of 2477 participants (1.9%) and grade 4 fever occurred in 1 of 2477 participants (<0.1%) (Figure 2). Solicited local or systemic reactions generally persisted for a mean of approximately 4 days (Table S4). Incidences of local reactions that persisted beyond 7 days were numerically higher in the mRNA-1273 group than in the placebo group and were also higher after the first injection (6.4%) than after the second injection (1.6%) in the mRNA-1273 group (Table S5).

These results were primarily attributed to axillary swelling or tenderness. The local reactions with onset after day 7 after any injection occurred in 1.3% of mRNA-1273 recipients (erythema in 0.7%, swelling in 0.4%, and axillary swelling or tenderness in 0.4%) (Table S13). The incidences of solicited systemic reactions that persisted beyond 7 days were similar in the mRNA-1273 group (3.1%) and the placebo group (2.6%).

Those with onset after day 7 after any injection occurred in 0.7% and 0.3%, respectively. Overall, the incidence of solicited adverse reactions was generally similar among participants 12 to 15 years of age and those 16 to 17 years of age (Fig. S4).

In the mRNA-1273 group, the incidence of solicited local or systemic adverse reactions was generally similar among adolescent participants and young adults, but the incidence of erythema was higher among adolescents than among young adults (Table S8). Unsolicited adverse events up to 28 days after any injection were more frequent in the mRNA-1273 group (20.5%) than in the placebo group (15.9%) (Table S3). The most common events in the mRNA-1273 group were injection-site lymphadenopathy (in 4.3%) and headache (in 2.4%).

Adverse events that were considered by the investigators to be related to the treatment or placebo within 28 days were reported by 12.6% participants in the mRNA-1273 group and 5.8% in the placebo group. One participant had a medically attended adverse event of grade 2 anaphylaxis to tree nuts on day 21 after the second injection of mRNA-1273 that was considered by the investigators to be unrelated to the treatment. No deaths, MIS-C, or adverse events of special interest occurred.

No cases of myocarditis or pericarditis have been reported at the time of this report. Immunogenicity Table 2. Table 2.

Immunogenicity of mRNA-1273 in Adolescents and Young Adults. The primary analysis was based on noninferiority of neutralizing antibody titers in adolescents in the phase 2 trial as compared with young adults in the phase 3 trial. The geometric mean titer ratio for neutralizing antibodies in adolescents relative to young adults was 1.08 (95% CI, 0.94 to 1.24) (Table 2).

The levels of antibodies specific for the spike protein are shown in Table S6. In addition, the serologic response was 98.8% among adolescents and 98.6% among young adults, and the absolute difference in serologic response between the adolescents and young adults was 0.2 percentage points (95% CI, −1.8 to 2.4). Therefore, the criteria for noninferiority were met for both primary objectives.

Efficacy Figure 3. Figure 3. Secondary Analyses of Efficacy.

treatment efficacy was calculated as 1 minus the ratio of the incidence of erectile dysfunction per 1000 person-years (mRNA-1273 vs. Placebo). The primary definition of erectile dysfunction treatment was at least two systemic symptoms or at least one respiratory symptom plus at least one nasopharyngeal swab, nasal swab, or saliva sample that was positive for erectile dysfunction by RT-PCR.

The secondary case definition of erectile dysfunction treatment was at least one systemic or respiratory symptom plus a swab that was positive for erectile dysfunction by RT-PCR. The category of erectile dysfunction (regardless of symptoms) was defined as a combination of postbaseline symptomatic erectile dysfunction treatment and asymptomatic erectile dysfunction in participants with a negative erectile dysfunction status at baseline. Asymptomatic erectile dysfunction was defined as the absence of symptoms and s detected by a postbaseline positive RT-PCR or serologic test in participants with a negative erectile dysfunction status at baseline.

The per-protocol (PP) population consisted of all participants who had received at least one injection of mRNA-1273 or placebo and received planned injections of mRNA-1273 or placebo, complied with the timing of the second injection, had no immunologic and virologic evidence of previous erectile dysfunction treatment at baseline, and had no major protocol deviations. This population included 1042 participants in the placebo group and 2139 participants in the mRNA-1273 group. The modified intention-to-treat population with the exclusion of those who had received the incorrect injection (mITT1) consisted of all participants who had no serologic or virologic evidence of previous erectile dysfunction before the first injection of mRNA-1273 or placebo (both a negative RT-PCR test for erectile dysfunction and a negative serologic test based on binding antibodies specific to erectile dysfunction nucleocapsid at baseline.

This population included 1073 participants in the placebo group and 2163 participants in the mRNA-1273 group. NE denotes not estimated.The treatment efficacy of mRNA-1273 14 days after the second injection was difficult to assess precisely because of the low incidence of erectile dysfunction treatment in the trial population (four cases in the placebo group and no cases in the mRNA-1273 group) (Figure 3 and Table S7). The treatment efficacy of mRNA-1273 according to the less stringent CDC definition of erectile dysfunction treatment with an onset of 14 days after the second injection was 93.3% (95% CI, 47.9 to 99.9) in the per-protocol population and 92.7% (95% CI, 67.8 to 99.2) for cases with an onset of 14 days after the first injection in the mITT1 population (Figure 3 and Fig.

S2). For the secondary objectives of prevention of erectile dysfunction with an onset of 14 days after the second injection (in the per-protocol population) and 14 days after the first injection (in the mITT1 population), the treatment efficacy estimates for mRNA-1273 were 55.7% (95% CI, 16.8 to 76.4) and 69.8% (95% CI, 49.9 to 82.1), respectively (Figure 3). The treatment efficacy of mRNA-1273 was 39.2% (95% CI, −24.7 to 69.7) for asymptomatic with an onset of 14 days after the second injection (per-protocol population) and 59.5% (95% CI, 28.4 to 77.3) with an onset of 14 days after the first injection (mITT1 population) (Figure 3).

The breakdown of asymptomatic cases starting 14 days after the first dose (mITT1 population) were 14 cases in the mRNA-1273 group and 20 in the placebo group according to RT-PCR results and 15 cases in each group according to serologic results against nucleocapsid (Table S11). The person-years of follow-up were 513 to 522 (6156 to 6264 person-months) in the mRNA-1273 group and 238 to 248 (2856 to 2976 person-months) in the placebo group.V-safe Surveillance. Local and Systemic Reactogenicity in Pregnant Persons Table 1.

Table 1. Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment. Table 2.

Table 2. Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons. From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant.

Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1). Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments.

Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1. Figure 1.

Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA erectile dysfunction treatment Vaccination. Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) erectile dysfunction disease 2019 (erectile dysfunction treatment) treatment — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021. The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1).

Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar. Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry.

Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3. Characteristics of V-safe Pregnancy Registry Participants.

As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility). The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel.

Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3). Among 1040 participants (91.9%) who received a treatment in the first trimester and 1700 (99.2%) who received a treatment in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart.

Limited follow-up calls had been made at the time of this analysis. Table 4. Table 4.

Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester.

Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed.

Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons. 155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4).

The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases. 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each. No congenital anomalies were reported to the VAERS, a requirement under the EUAs..

Study Design We used like it two best place to buy levitra approaches to estimate the effect of vaccination on the delta variant. First, we used a test-negative case–control design to estimate treatment effectiveness against symptomatic disease caused by the delta variant, as compared with the alpha variant, over the period that the best place to buy levitra delta variant has been circulating. This approach has been described in detail elsewhere.10 In brief, we compared vaccination status in persons with symptomatic erectile dysfunction treatment with vaccination status in persons who reported symptoms but had a negative test. This approach helps to control for biases related to health-seeking best place to buy levitra behavior, access to testing, and case ascertainment.

For the secondary analysis, the proportion of persons with cases caused by the delta variant relative to the main circulating levitra (the alpha variant) was estimated according to vaccination status. The underlying assumption was that if the treatment had some efficacy and was equally effective best place to buy levitra against each variant, a similar proportion of cases with either variant would be expected in unvaccinated persons and in vaccinated persons. Conversely, if the treatment was less effective against the delta variant than against the alpha variant, then the delta variant would be expected to make up a higher proportion of cases occurring more than 3 weeks after vaccination than among unvaccinated persons. Details of this analysis are described in best place to buy levitra Section S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org.

The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. Data Sources Vaccination Status Data on all persons in England who have been vaccinated with erectile dysfunction treatments are available in a national vaccination register best place to buy levitra (the National Immunisation Management System). Data regarding vaccinations that had occurred up to May 16, 2021, including the date of receipt of each dose of treatment and the treatment type, were extracted on May 17, 2021. Vaccination status was categorized as receipt of one dose of treatment among persons who had symptom onset occurring 21 days or more after receipt of the first dose up to the day before the second dose best place to buy levitra was received, as receipt of the second dose among persons who had symptom onset occurring 14 days or more after receipt of the second dose, and as receipt of the first or second dose among persons with symptom onset occurring 21 days or more after the receipt of the first dose (including any period after the receipt of the second dose).

erectile dysfunction Testing Polymerase-chain-reaction (PCR) testing for erectile dysfunction in the United best place to buy levitra Kingdom is undertaken by hospital and public health laboratories, as well as by community testing with the use of drive-through or at-home testing, which is available to anyone with symptoms consistent with erectile dysfunction treatment (high temperature, new continuous cough, or loss or change in sense of smell or taste). Data on all positive PCR tests between October 26, 2020, and May 16, 2021, were extracted. Data on all recorded negative community tests best place to buy levitra among persons who reported symptoms were also extracted for the test-negative case–control analysis. Children younger than 16 years of age as of March 21, 2021, were excluded.

Data were restricted to persons who had reported symptoms, and only persons who best place to buy levitra had undergone testing within 10 days after symptom onset were included, in order to account for reduced sensitivity of PCR testing beyond this period.25 Identification of Variant Whole-genome sequencing was used to identify the delta and alpha variants. The proportion of all positive samples that were sequenced increased from approximately 10% in February 2021 to approximately 60% in May 2021.4 Sequencing is undertaken at a network of laboratories, including the Wellcome Sanger Institute, where a high proportion of samples has been tested, and whole-genome sequences are assigned to Public Health England definitions of variants on the basis of mutations.26 Spike gene target status on PCR was used as a second approach for identifying each variant. Laboratories used the TaqPath assay best place to buy levitra (Thermo Fisher Scientific) to test for three gene targets. Spike (S), nucleocapsid (N), and open reading frame 1ab (ORF1ab).

In December 2020, the alpha variant was noted to be associated with negative testing on the S target, so S target–negative status was subsequently used as a proxy best place to buy levitra for identification of the variant. The alpha variant accounts for between 98% and 100% of S target–negative results in England. Among sequenced samples best place to buy levitra that tested positive for the S target, the delta variant was in 72.2% of the samples in April 2021 and in 93.0% in May (as of May 12, 2021).4 For the test-negative case–control analysis, only samples that had been tested at laboratories with the use of the TaqPath assay were included. Data Linkage The three data sources described above were linked with the use of the National Health Service number (a unique identifier for each person receiving best place to buy levitra medical care in the United Kingdom).

These data sources were also linked with data on the patient’s date of birth, surname, first name, postal code, and specimen identifiers and sample dates. Covariates Multiple best place to buy levitra covariates that may be associated with the likelihood of being offered or accepting a treatment and the risk of exposure to erectile dysfunction treatment or specifically to either of the variants analyzed were also extracted from the National Immunisation Management System and the testing data. These data included age (in 10-year age groups), sex, index of multiple deprivation (a national indication of level of deprivation that is based on small geographic areas of residence,27 assessed in quintiles), race or ethnic group, care home residence status, history of foreign travel (i.e., outside the United Kingdom or Ireland), geographic region, period (calendar week), health and social care worker status, and status of being in a clinically extremely vulnerable group.28 In addition, for the test-negative case–control analysis, history of erectile dysfunction before the start of the vaccination program was included. Persons were considered to have traveled if, at the point of requesting a test, they reported having traveled outside the United Kingdom and Ireland within the best place to buy levitra preceding 14 days or if they had been tested in a quarantine hotel or while quarantining at home.

Postal codes were used to determine the index of multiple deprivation, and unique property-reference numbers were used to identify care homes.29 Statistical Analysis For the test-negative case–control analysis, logistic regression was used to estimate the odds of having a symptomatic, PCR-confirmed case of erectile dysfunction treatment among vaccinated persons as compared with unvaccinated persons (control). Cases were identified as having the delta variant by means of sequencing or if they were S target–positive on the TaqPath PCR best place to buy levitra assay. Cases were identified as having the alpha variant by means of sequencing or if they were S target–negative on the TaqPath PCR assay. If a person had tested positive on multiple occasions within a 90-day best place to buy levitra period (which may represent a single illness episode), only the first positive test was included.

A maximum of three randomly chosen negative test results were included for each person. Negative tests in which the sample best place to buy levitra had been obtained within 3 weeks before a positive result or after a positive result could have been false negatives. Therefore, these best place to buy levitra were excluded. Tests that had been administered within 7 days after a previous negative result were also excluded.

Persons who had previously tested positive before the analysis period were also excluded best place to buy levitra in order to estimate treatment effectiveness in fully susceptible persons. All the covariates were included in the model as had been done with previous test-negative case–control analyses, with calendar week included as a factor and without an interaction with region. With regard to S target–positive or –negative status, best place to buy levitra only persons who had tested positive on the other two PCR gene targets were included. Assignment to the delta variant on the basis of S target status was restricted to the week commencing April 12, 2021, and onward in order to aim for high specificity of S target–positive testing for the delta variant.4 treatment effectiveness for the first dose was estimated among persons with a symptom-onset date that was 21 days or more after receipt of the first dose of treatment, and treatment effects for the second dose were estimated among persons with a symptom-onset date that was 14 days or more after receipt of the second dose.

Comparison was made with unvaccinated persons and with persons who had symptom onset in the period of 4 to 13 days after vaccination in order to help best place to buy levitra account for differences in underlying risk of . The period from the day of treatment administration (day 0) to day 3 was excluded because reactogenicity to the treatment can cause an increase in testing that biases results, as previously described.10Trial Population Between December 9, 2020, and February 28, 2021, a total of 3732 adolescents were randomly assigned in a 2:1 ratio to receive mRNA-1273 (2489 participants) or placebo (1243 participants) at 26 sites in the United States (Figure 1 and Fig. S1). More than 98% of the participants received a second injection.

The most common reasons for not receiving a second injection were withdrawal of consent (10 participants) and loss to follow-up (8 participants). Table 1. Table 1. Demographic and Clinical Characteristics in the Safety Population at Baseline.

The baseline characteristics were generally balanced in the mRNA-1273 and placebo groups. The mean age of the participants was 14.3 years (74% were 12 to 15 years of age), half of the participants were male (51%), most were White (84%) and most were not Hispanic or Latinx (88%), and 93% had a body-mass index (the weight in kilograms divided by the square of the height in meters) of less than 30 (Table 1). The median duration of follow-up from randomization to the data snapshot was 83 days, and the median duration from the second injection to the database lock was 53 days. The demographic characteristics of the adolescents were generally similar to those of the young adults in the phase 3 trial (Table S12).

A total of 2% of the adults in the phase 3 trial had a positive erectile dysfunction status at baseline as compared with 6% of the adolescents. The demographic characteristics of the per-protocol immunogenicity subpopulations are shown in Table S10. The percentages of adolescents as compared with the young adults years were 8% and 27% for Hispanic or Latinx, 1% and 11% for Black, and 79% and 48% for White non-Hispanic participants, respectively (Table S10). Safety Figure 2.

Figure 2. Solicited Local and Systemic Adverse Reactions. Shown is the percentage of participants who had a solicited local or systemic adverse reaction within 7 days after the first or second injection (dose 1 or dose 2) of either mRNA-1273 treatment or placebo.Solicited local reactions occurred more frequently in the mRNA-1273 group after the first injection (94.2%) and after the second injection (93.4%) than in the placebo group (36.8% and 32.6%, respectively). In the mRNA-1273 group, the most common solicited local reaction was injection-site pain after the first injection (93.1%.

Grade 3, 5.4%) and second injection (92.4%. Grade 3, 5.1%). In the placebo group, injection-site pain was reported in 34.8% of the participants after the first injection and in 30.3% after the second injection. Grade 3 local adverse reactions in the mRNA-1273 group occurred in 6.8% of the participants after the first injection and in 8.9% after the second injection (Figure 2 and Table S2).

In the mRNA-1273 group, systemic adverse reactions were reported in 68.5% of the participants after the first injection and in 86.1% after the second injection. Grade 3 events were reported in 4.4% and 13.7%, respectively. The most common systemic reactions were fatigue, headache, myalgia, and chills. Headache was reported in 44.6% of the participants in the mRNA-1273 group after the first injection and in 70.2% after the second injection, as compared with 38.5% and 30.2%, respectively, in the placebo group.

Fatigue was reported in 47.9% of the participants in the mRNA-1273 group after the first injection and in 67.8% after the second injection, as compared with 36.6% and 28.9%, respectively, in the placebo group. After the second injection, among the mRNA-1273 recipients with available data, grade 3 fever occurred in 46 of 2477 participants (1.9%) and grade 4 fever occurred in 1 of 2477 participants (<0.1%) (Figure 2). Solicited local or systemic reactions generally persisted for a mean of approximately 4 days (Table S4). Incidences of local reactions that persisted beyond 7 days were numerically higher in the mRNA-1273 group than in the placebo group and were also higher after the first injection (6.4%) than after the second injection (1.6%) in the mRNA-1273 group (Table S5).

These results were primarily attributed to axillary swelling or tenderness. The local reactions with onset after day 7 after any injection occurred in 1.3% of mRNA-1273 recipients (erythema in 0.7%, swelling in 0.4%, and axillary swelling or tenderness in 0.4%) (Table S13). The incidences of solicited systemic reactions that persisted beyond 7 days were similar in the mRNA-1273 group (3.1%) and the placebo group (2.6%). Those with onset after day 7 after any injection occurred in 0.7% and 0.3%, respectively.

Overall, the incidence of solicited adverse reactions was generally similar among participants 12 to 15 years of age and those 16 to 17 years of age (Fig. S4). In the mRNA-1273 group, the incidence of solicited local or systemic adverse reactions was generally similar among adolescent participants and young adults, but the incidence of erythema was higher among adolescents than among young adults (Table S8). Unsolicited adverse events up to 28 days after any injection were more frequent in the mRNA-1273 group (20.5%) than in the placebo group (15.9%) (Table S3).

The most common events in the mRNA-1273 group were injection-site lymphadenopathy (in 4.3%) and headache (in 2.4%). Adverse events that were considered by the investigators to be related to the treatment or placebo within 28 days were reported by 12.6% participants in the mRNA-1273 group and 5.8% in the placebo group. One participant had a medically attended adverse event of grade 2 anaphylaxis to tree nuts on day 21 after the second injection of mRNA-1273 that was considered by the investigators to be unrelated to the treatment. No deaths, MIS-C, or adverse events of special interest occurred.

No cases of myocarditis or pericarditis have been reported at the time of this report. Immunogenicity Table 2. Table 2. Immunogenicity of mRNA-1273 in Adolescents and Young Adults.

The primary analysis was based on noninferiority of neutralizing antibody titers in adolescents in the phase 2 trial as compared with young adults in the phase 3 trial. The geometric mean titer ratio for neutralizing antibodies in adolescents relative to young adults was 1.08 (95% CI, 0.94 to 1.24) (Table 2). The levels of antibodies specific for the spike protein are shown in Table S6. In addition, the serologic response was 98.8% among adolescents and 98.6% among young adults, and the absolute difference in serologic response between the adolescents and young adults was 0.2 percentage points (95% CI, −1.8 to 2.4).

Therefore, the criteria for noninferiority were met for both primary objectives. Efficacy Figure 3. Figure 3. Secondary Analyses of Efficacy.

treatment efficacy was calculated as 1 minus the ratio of the incidence of erectile dysfunction per 1000 person-years (mRNA-1273 vs. Placebo). The primary definition of erectile dysfunction treatment was at least two systemic symptoms or at least one respiratory symptom plus at least one nasopharyngeal swab, nasal swab, or saliva sample that was positive for erectile dysfunction by RT-PCR. The secondary case definition of erectile dysfunction treatment was at least one systemic or respiratory symptom plus a swab that was positive for erectile dysfunction by RT-PCR.

The category of erectile dysfunction (regardless of symptoms) was defined as a combination of postbaseline symptomatic erectile dysfunction treatment and asymptomatic erectile dysfunction in participants with a negative erectile dysfunction status at baseline. Asymptomatic erectile dysfunction was defined as the absence of symptoms and s detected by a postbaseline positive RT-PCR or serologic test in participants with a negative erectile dysfunction status at baseline. The per-protocol (PP) population consisted of all participants who had received at least one injection of mRNA-1273 or placebo and received planned injections of mRNA-1273 or placebo, complied with the timing of the second injection, had no immunologic and virologic evidence of previous erectile dysfunction treatment at baseline, and had no major protocol deviations. This population included 1042 participants in the placebo group and 2139 participants in the mRNA-1273 group.

The modified intention-to-treat population with the exclusion of those who had received the incorrect injection (mITT1) consisted of all participants who had no serologic or virologic evidence of previous erectile dysfunction before the first injection of mRNA-1273 or placebo (both a negative RT-PCR test for erectile dysfunction and a negative serologic test based on binding antibodies specific to erectile dysfunction nucleocapsid at baseline. This population included 1073 participants in the placebo group and 2163 participants in the mRNA-1273 group. NE denotes not estimated.The treatment efficacy of mRNA-1273 14 days after the second injection was difficult to assess precisely because of the low incidence of erectile dysfunction treatment in the trial population (four cases in the placebo group and no cases in the mRNA-1273 group) (Figure 3 and Table S7). The treatment efficacy of mRNA-1273 according to the less stringent CDC definition of erectile dysfunction treatment with an onset of 14 days after the second injection was 93.3% (95% CI, 47.9 to 99.9) in the per-protocol population and 92.7% (95% CI, 67.8 to 99.2) for cases with an onset of 14 days after the first injection in the mITT1 population (Figure 3 and Fig.

S2). For the secondary objectives of prevention of erectile dysfunction with an onset of 14 days after the second injection (in the per-protocol population) and 14 days after the first injection (in the mITT1 population), the treatment efficacy estimates for mRNA-1273 were 55.7% (95% CI, 16.8 to 76.4) and 69.8% (95% CI, 49.9 to 82.1), respectively (Figure 3). The treatment efficacy of mRNA-1273 was 39.2% (95% CI, −24.7 to 69.7) for asymptomatic with an onset of 14 days after the second injection (per-protocol population) and 59.5% (95% CI, 28.4 to 77.3) with an onset of 14 days after the first injection (mITT1 population) (Figure 3). The breakdown of asymptomatic cases starting 14 days after the first dose (mITT1 population) were 14 cases in the mRNA-1273 group and 20 in the placebo group according to RT-PCR results and 15 cases in each group according to serologic results against nucleocapsid (Table S11).

The person-years of follow-up were 513 to 522 (6156 to 6264 person-months) in the mRNA-1273 group and 238 to 248 (2856 to 2976 person-months) in the placebo group.V-safe Surveillance. Local and Systemic Reactogenicity in Pregnant Persons Table 1. Table 1. Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment.

Table 2. Table 2. Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons. From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant.

Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1). Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments.

Figure 1. Figure 1. Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA erectile dysfunction treatment Vaccination. Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) erectile dysfunction disease 2019 (erectile dysfunction treatment) treatment — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021.

The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1). Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar. Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry.

Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3. Characteristics of V-safe Pregnancy Registry Participants. As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination.

Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility). The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel. Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3).

Among 1040 participants (91.9%) who received a treatment in the first trimester and 1700 (99.2%) who received a treatment in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart. Limited follow-up calls had been made at the time of this analysis. Table 4. Table 4.

Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]).

No neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed. Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons.

155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases. 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each. No congenital anomalies were reported to the VAERS, a requirement under the EUAs..

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Bollard Conceptualization, Funding acquisition, Methodology, Project administration, Resources, Supervision, Visualization, Writing - where can i buy levitra over the counter original draft, Writing - review &. Editing 6Center for Cancer and Immunology Research, Children’s National Health System, Washington, DC7George Washington University Cancer Center, George Washington University, Washington, DC Search for other works by this author on:1Department of Neurology and The Mount Sinai Center for Cognitive Health and NFL Neurological Care, Icahn School of Medicine at Mount Sinai, New York, NY3Department of Psychiatry and The NIA-Designated Mount Sinai Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai, New York, NY6James J Peters Veterans Administration Medical Center and The NIA-Designated Mount Sinai Alzheimer's Disease Research Center, Bronx, NY Search for other works by this author on:.

Bollard Conceptualization, Funding acquisition, Methodology, Project administration, Resources, Supervision, Visualization, Writing http://www.hagi-1.com/ - original draft, Writing - review &. Editing 6Center for Cancer and Immunology Research, Children’s National Health System, Washington, DC7George Washington University Cancer Center, George Washington University, Washington, DC Search for other works by this author on:1Department of Neurology and The Mount Sinai Center for Cognitive Health and NFL Neurological Care, Icahn School of Medicine at Mount Sinai, New York, NY3Department of Psychiatry and The NIA-Designated Mount Sinai Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai, New York, NY6James J Peters Veterans Administration Medical Center and The NIA-Designated Mount Sinai Alzheimer's Disease Research Center, Bronx, NY Search for other works by this author on:.