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This story also ran cheap kamagra jelly on Fortune. This story can be republished for free (details). Michelina Moen lost her job and health insurance in April. Only weeks earlier she had begun to feel ill and not her usual energetic self — in what she describes as a textbook case of “really bad timing.”The Orlando, Florida, resident sought treatment in May. After a series of tests, doctors told Moen she had a rare kidney condition that would require months of treatment.“Losing the coverage ended up cheap kamagra jelly being worse than losing the job,” said Moen, 36, a dancer who had worked for both Walt Disney World and Universal Studios. €œIt was very stressful.”Moen rushed to find replacement coverage. With help from a social service agency, she enrolled in a plan through healthcare.gov, the cheap kamagra jelly federal Affordable Care Act insurance marketplace.

Because she and her husband, Brett, were not working — he had been laid off by Disney, too — they qualified for federal subsidies, so the coverage cost her just $35 a month. Most of her medical expenses, cheap kamagra jelly which involve traveling frequently to Jacksonville for specialty treatment, are covered. Email Sign-Up Subscribe to KHN’s free Morning Briefing. Moen’s husband recently found a job, however, and the increase in the couple’s income likely means her subsidy will fall and she’ll have to pay cheap kamagra jelly more for health insurance. Moen said she’ll evaluate her options and may switch plans during this year’s ACA open enrollment period, which began Nov.

1 and ends Dec. 15 for cheap kamagra jelly coverage starting Jan. 1.“A priority is to continue seeing my medical team in Jacksonville,” Moen said.Moen is one of millions of Americans who have been dropped from their jobs and their employer-provided health insurance since March, when the erectile dysfunction first ravaged the economy. Although no official tally exists, studies indicate that at least 10 million workers lost their insurance but that about two-thirds of them found alternative coverage — through a new job, Medicaid, a spouse’s or parent’s plan, or the ACA marketplaces.That leaves at least 3 million people without coverage, the most added in cheap kamagra jelly a single year since accurate record-keeping began in 1968. And experts are worried that, as the kamagra continues to play havoc with the economy, new rounds of business closings and layoffs could add to that number.Navigators Want More ResourcesThe unprecedented situation has health insurance counselors (called navigators), ACA marketplace staff members and insurers scrambling to assist a possible surge of people looking for health insurance during open enrollment.For the 36 states that rely on the federal ACA enrollment platform — healthcare.gov — the Trump administration awarded grants totaling $10 million for marketing and outreach this year, the same level as in 2019.

In 2016, the last year of the Obama administration, navigator grants totaled $63 million.Many navigator organizations say they don’t have the resources from the federal cheap kamagra jelly government to do the job as they would like.“I’m trying not to panic,” said Jodi Ray, executive director of Florida Covering Kids &. Families. €œWe’ve seen substantially more people needing coverage and help in recent months compared cheap kamagra jelly to last year, and more are new to being uninsured.”Ray said her team is booked with appointments well into November. But she bemoans the fact that she has a third of the counselors she had a few years ago — 50, compared with 150 — and only a tiny ad budget.Like Ray, Jeremy Smith, program director at First Choice Services in Charleston, West Virginia, said his team is expecting “tens of thousands more people” needing help compared with last year — but no bigger budget to serve them. First Choice provides telephone-based enrollment assistance in West Virginia, New Hampshire, Iowa and Montana with a federal grant of $100,000 per state.“We are talking to a lot more people who have had job-based coverage for years,” Smith said.

€œThis is the first time cheap kamagra jelly they are having to find insurance elsewhere. They don’t know what to do or who to trust.”In Wisconsin, the governor shifted $1 million into health insurance outreach, in part to make up for a lack of federal funds, said Allison Espeseth, managing director at Covering Wisconsin, the state’s navigator agency. She said the money will go to radio and TV spots, billboards, bus ads and small grants to community organizations.“A lot of people who lost jobs and insurance didn’t know they could enroll before open enrollment, so we are hoping to see them cheap kamagra jelly now,” Espeseth said.Toula Barber, 60, is happy to be among those who got clear and useful help. €œI’m not that savvy with computers and figuring all this stuff out,” said Barber, who lives in Manchester, New Hampshire. After she lost her job as a waitress in August, Barber’s health insurance lapsed at the cheap kamagra jelly end of September.

A First Choice Services navigator helped her find a plan with coverage that started Oct. 1. She pays $200 a month after subsidies.Because that plan has a $6,000 deductible, however, Barber said she would look for something better during open enrollment, in consultation with the same navigator.An analysis published last summer found evidence of a shortage of enrollment assistance. It also pointed out that people who turned to insurance brokers rather than independent navigators for help sometimes were presented with the option of plans (such as short-term policies or cancer-only policies) that don’t meet ACA standards.“The bottom line was that nearly 5 million people who sought help during the last open enrollment could not find it,” said Karen Pollitz, a senior fellow at KFF and one of the authors of the study. €œI’m concerned that people will face barriers to finding help this year, too.”Some States Are Pushing HarderIn contrast to the states that use the federal website, healthcare.gov, many of the 15 states that run their own ACA marketplaces are committing more resources to outreach and marketing this year to meet the higher demand.“We market aggressively,” said Peter Lee, executive director of Covered California, that state’s marketplace.

€œWe want everyone who needs coverage to get it.” Of Covered California’s $440 million budget this year, Lee said $140 million will go for marketing and outreach. In addition, California is inserting information about the marketplace and subsidized coverage in all unemployment checks.Just short of 300,000 Californians have enrolled since the kamagra began, and about half did so because they lost employment-based coverage, said Lee.At the same time, however, about 1 in 4 Covered California enrollees dropped out this year, higher than the normal turnover as some newly qualified for Medicaid and an unknown number could no longer afford the premiums. Still, enrollment was at an all-time high of 1.5 million as of June.In New York, state officials and private groups have been helping people enroll in Medicaid, marketplace plans or other state-supported programs.“We’ve been super busy since April,” said Elizabeth Benjamin, vice president of health initiatives at the Community Service Society of New York, an independent advocacy group for low-income residents. €œOur governor prioritized this, so it’s going well.”One challenge Benjamin noted are the fears that a case currently before the Supreme Court might overturn the law. €œOur clients keep asking whether the ACA will still be around next year,” she said.

€œWe reassure them it will.”Madeline McGrath, 27, sought insurance help from the service society in May after her coverage through the Peace Corps expired. The corps laid off all its overseas staff in March. Madeline was in Moldova. She returned home to Chazy, New York. She qualified for Medicaid, and just in the nick of time.

A few weeks earlier, she had been diagnosed with Crohn’s disease, a chronic digestive disorder.“I’ll stick with Medicaid since my copayments are very low,” said McGrath, who is pursuing a graduate degree. Related Topics Cost and Quality Insurance States The Health Law erectile dysfunction treatment Florida Obamacare Plans Open EnrollmentNursing homes are still taking days to get back erectile dysfunction treatment test results as many shun the Trump administration’s central strategy to limit the spread of the kamagra among old and sick Americans. In late summer, federal officials began distributing to nursing homes millions of point-of-care antigen tests, which can be given on-site and report the presence or absence of the kamagra within minutes. By January, the Department of Health and Human Services is slated to send roughly 23 million rapid tests. But as of Oct.

25, 38% of the nation’s roughly 15,000 nursing homes have yet to use a point-of-care test, a KHN analysis of nursing home records shows. The numbers suggest a basic disagreement among the Trump administration, state health officials and nursing home administrators over the best way to test this population and how to strike the right balance between speed and accuracy. Many nursing homes still primarily send samples out to laboratories, using a type of test that’s considered more reliable but can take days to deliver results. As a result, in 29% of the approximately 13,000 facilities that provided their testing speed to the government, results for residents took an average of three days or more, the analysis found. Just 17% of nursing homes reported their average turnaround time was less than a day, and the remainder tended to get results in one or two days.

Wait times for test results of staff members were similar. Those lags could have devastating consequences, because even one undetected can quietly but rapidly trigger a broad outbreak. It’s especially concerning as winter sets in and the kamagra notches daily records of s. In the meantime, the erectile dysfunction continues its march through institutions. Nursing homes have reported more than 262,000 s and 59,000 deaths since the government began collecting the information in May.

Even without estimating how many residents died from erectile dysfunction treatment before then, reported nursing home deaths amount to more than a quarter of all erectile dysfunction treatment fatalities in the U.S. So far. During the week ending Oct. 25, the most recent period for which data is available, a third of skilled nursing facilities reported a new suspected or confirmed erectile dysfunction of a resident or staff member. Many state public health authorities and nursing homes have ongoing reservations about the rapid tests.

They are considered less accurate than the more expensive ones sent out to laboratories, which are known as polymerase chain reaction, or PCR, tests and identify the kamagra’s genetic material but often take days to complete. And their manufacturers say the rapid tests are designed for people with symptoms — not for screening a general population. In early November, the Food and Drug Administration warned of false-positive results — in which someone is told incorrectly they are infected — associated with one type of rapid erectile dysfunction treatment test, and urged providers to follow Centers for Disease Control and Prevention recommendations for using them in nursing homes. False negatives are also a concern because people who don’t know they are infected can unwittingly spread the kamagra. HHS bought millions of rapid tests to distribute to nursing homes as the federal government imposed new mandates for the facilities to test staffers at least once a month.

Routine staff testing increases to as often as twice a week for homes in areas with the highest rates. The Centers for Medicare &. Medicaid Services, which is part of HHS, does not recommend testing asymptomatic residents unless a new outbreak occurs or a resident routinely goes outside the facility. Leaders in multiple states, including Nevada, Vermont and Illinois, have moved to ban antigen tests in nursing homes or limit their use. €œI thought the hard part was getting the testing to the different facilities,” said David Grabowski, a health care policy professor at Harvard Medical School.

Instead, he said, “the major barriers to the use of rapid testing seem to be a lack of guidance on when and how to use the tests, coupled with concerns about their accuracy.” Dr. Michael Wasserman, immediate past president of the California Association of Long Term Care Medicine, said the national effort has been chaotic and inadequate. The federal government “just hands stuff off to nursing homes and then says, ‘Hey, it’s yours. Go use it,’” he said. €œAnd then when things fall apart, ‘We’re not to blame.’” Nursing homes that don’t trust the rapid tests are having to shoulder the higher cost of lab tests.

It costs Stuart Almer, president and CEO of Gurwin Jewish Nursing &. Rehabilitation Center on New York’s Long Island, $125,000 a week to conduct lab tests on up to 1,500 residents and staff members. €œWe embrace the testing,” Almer said. €œBut how are we supposed to continue operating and paying for this?. € Goodwin House in Virginia, which includes skilled nursing and assisted living facilities, had performed more than 9,500 tests for erectile dysfunction treatment as of late October, said Joshua Bagley, an administrator.

Only 100 of them were antigen tests. €œThe majority of our focus is still toward the PCR testing,” Bagley said. The concerns of state health officials were perhaps most evident in Nevada, where in early October the state banned antigen testing in nursing homes. HHS said the order was illegal, and it was revoked within days. €œThere is no such thing as a perfect test,” Adm.

Brett Giroir, a senior HHS official who leads the Trump administration’s erectile dysfunction treatment testing efforts, said on a call with reporters Nov. 9. For example, Giroir said, a risk of PCR tests is that they could provide a positive diagnosis when a person is no longer “actually infectious.” Although there have been widespread accuracy concerns over antigen tests, certain tests the administration is distributing nationwide have comparable accuracy to lab-based tests, he said. Other state responses have not been as aggressive as Nevada’s but nonetheless demonstrated unease over how best to use the devices, if at all. Vermont recommends the use of antigen tests after a known erectile dysfunction treatment exposure but says they should not be used to diagnose asymptomatic people.

Ohio was initially reluctant to deploy them after Republican Gov. Mike DeWine’s false-positive result from an antigen device, although the tests have since been adopted, said Peter Van Runkle, executive director of the Ohio Health Care Association, which represents some skilled nursing facilities in the state. Some nursing homes say relying on antigen tests has made a monumental difference. In Hutchinson, Kansas, Wesley Towers Retirement Community has used both types of tests, but it was Abbott’s BinaxNOW antigen test that detected its first two asymptomatic people with erectile dysfunction treatment, said Gretchen Sapp, Wesley Towers’ vice president of health services. €œWe have more confidence that our staff are indeed erectile dysfunction treatment-free or that they are out and not exposing residents.

And that is incredibly helpful,” Sapp said. €œThe biggest challenge is I need more tests.” A total of 1,150 homes told the federal government they did not have enough supplies for point-of-care tests for all workers, the KHN analysis found. Nursing homes can go through millions of tests quickly when testing monthly or more often, depending on the level of erectile dysfunction treatment in the area. White House spokesperson Michael Bars said the administration is working “hand-in-hand with our state and local partners” and “doing more than ever to protect the health and safety of high-risk age groups most susceptible to the kamagra.” Janet Snipes, executive director of Holly Heights Care Center in Denver, said antigen tests have been useful to screen staff members despite a few false-positive results. One test was used on a clergy member a resident had summoned.

€œWe wouldn’t have been able to allow him in, but we were able to do the antigen testing,” she said. €œWith the vulnerable residents we serve, we’re hoping for more antigen testing, more testing period, more testing of any type.” Jordan Rau. jrau@kff.org, @JordanRau Lauren Weber. LaurenW@kff.org, @LaurenWeberHP Rachana Pradhan. rpradhan@kff.org, @rachanadixit Related Topics Contact Us Submit a Story Tip.

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The 2019/20 Annual liquid kamagra Report summarises the Ministry’s major work programmes and http://alohafromoahu.com/kukui-nut-oil-benefit/ achievements, and demonstrates our progress towards our strategic intentions 2017-2021, Ta Tatou Rautaki | Our Strategy and Pae Ora | Healthy Futures.During the year, the Ministry led New Zealand’s health response to the erectile dysfunction treatment global kamagra, stewarded the health and disability system through other emergencies, and continued to deliver on an ambitious core work programme. The Annual Report summarises our financial performance for the year, presents the results results of our non-financial performance measures, and meets our reporting requirements under the Public Finance Act. The Annual Report is buy cheap kamagra next day delivery complemented by the Vote Health. Report in relation to selected non-departmental appropriations for the year ended 30 June 2020, which is the Minister’s report on the financial and non-financial performance of the non-departmental appropriations that the Ministry administers on behalf of the Crown..

The 2019/20 Annual Report summarises the Ministry’s major cheap kamagra jelly work programmes and achievements, and demonstrates our progress towards our strategic intentions 2017-2021, Ta Tatou Rautaki | Our go to my blog Strategy and Pae Ora | Healthy Futures.During the year, the Ministry led New Zealand’s health response to the erectile dysfunction treatment global kamagra, stewarded the health and disability system through other emergencies, and continued to deliver on an ambitious core work programme. The Annual Report summarises our financial performance for the year, presents the results results of our non-financial performance measures, and meets our reporting requirements under the Public Finance Act. The Annual Report is complemented by the Vote http://alohafromoahu.com/kukui-nut-oil-benefit/ Health.

Report in relation to selected non-departmental appropriations for the year ended 30 June 2020, which is the Minister’s report on the financial and non-financial performance of the non-departmental appropriations that the Ministry administers on behalf of the Crown..

What should I watch for while taking Kamagra?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Kamagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Kamagra does not protect you or your partner against HIV (the kamagra that causes AIDS) or other sexually transmitted diseases.

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Latest Healthy Kids kamagra 100 side effects News WEDNESDAY, Nov. 11, 2020 (HealthDay News)Overall, babies have a low risk of severe erectile dysfunction treatment , and transmission from mother to newborn is unlikely, new research suggests.For the study, researchers analyzed data from all babies under 29 days old who had erectile dysfunction treatment and had to be admitted to hospitals across the United Kingdom between the beginning of March and the end of April, at the peak of the first kamagra wave in the United Kingdom.Only 66 babies required hospital treatment for erectile dysfunction treatment in this period, which is the equivalent of one in 1,785 births, or 0.06% of births.Nearly half (45%) of the babies who developed severe erectile dysfunction treatment were from Black, Asian or minority ethnic groups, kamagra 100 side effects and 24% were born prematurely. These rates are higher than in the typical U.K. Birth population.Of the 66 babies, 17 were suspected to have caught erectile dysfunction treatment kamagra 100 side effects from their mother in the first seven days after birth.

Seven of the 17 babies developed erectile dysfunction treatment despite being separated from their mother immediately after birth, the investigators found.That finding supports guidance to keep mother and baby together even when the mother is suspected or known to have erectile dysfunction treatment, according to the authors of the study published online Nov. 9 in The Lancet Child kamagra 100 side effects &. Adolescent Health.Six babies are believed to have contracted erectile dysfunction treatment while in the hospital, the study kamagra 100 side effects authors reported. None of the 66 babies died from erectile dysfunction treatment, but one did die from another cause.At the time of data analysis, nearly 90% of the babies had fully recovered from the and had been discharged from the hospital, according to the report.The study also found that newborns with severe erectile dysfunction treatment are more likely to require intensive care or breathing support (36%) than older children (13%)."Parents, and expectant parents, are understandably worried about their babies becoming ill with erectile dysfunction treatment," said study co-lead author Chris Gale, from the School of Public Health, Imperial College London."This study will hopefully provide some reassurance, as it suggests severe erectile dysfunction treatment in newborns is very rare.

Most babies only develop mild symptoms when infected with the kamagra and make a full kamagra 100 side effects recovery. This research also supports U.K. And international guidance to keep mother and baby together even when the mother is known or suspected to have erectile dysfunction treatment," Gale said in a kamagra 100 side effects college news release."Although this study did show that six babies may have contracted hospital-acquired erectile dysfunction treatment, this data was from the beginning of the kamagra, and control measures on neonatal and pediatric units have improved dramatically over the past six months," Gale explained.More informationThe U.S. Centers for Disease Control and Prevention kamagra 100 side effects has more on newborns and erectile dysfunction treatment.SOURCE.

Imperial College London, news release, Nov. 9, 2020Robert kamagra 100 side effects PreidtCopyright © 2020 HealthDay. All rights reserved. QUESTION Newborn babies don't kamagra 100 side effects sleep very much.

Latest Healthy cheap kamagra jelly Kids News WEDNESDAY, Purchase cipro Nov. 11, 2020 (HealthDay News)Overall, babies have a low risk of severe erectile dysfunction treatment , and transmission from mother to newborn is unlikely, new research suggests.For the study, researchers analyzed data from all babies under 29 days old who had erectile dysfunction treatment and had to be admitted to hospitals across the United Kingdom between the beginning of March and the end of April, at the peak of the first kamagra wave in the United Kingdom.Only 66 babies required hospital treatment for erectile dysfunction treatment in this period, which cheap kamagra jelly is the equivalent of one in 1,785 births, or 0.06% of births.Nearly half (45%) of the babies who developed severe erectile dysfunction treatment were from Black, Asian or minority ethnic groups, and 24% were born prematurely. These rates are higher than in the typical U.K. Birth population.Of the 66 babies, 17 were suspected to have caught erectile dysfunction treatment from their cheap kamagra jelly mother in the first seven days after birth.

Seven of the 17 babies developed erectile dysfunction treatment despite being separated from their mother immediately after birth, the investigators found.That finding supports guidance to keep mother and baby together even when the mother is suspected or known to have erectile dysfunction treatment, according to the authors of the study published online Nov. 9 in cheap kamagra jelly The Lancet Child &. Adolescent Health.Six babies are believed to have contracted erectile dysfunction treatment while in cheap kamagra jelly the hospital, the study authors reported. None of the 66 babies died from erectile dysfunction treatment, but one did die from another cause.At the time of data analysis, nearly 90% of the babies had fully recovered from the and had been discharged from the hospital, according to the report.The study also found that newborns with severe erectile dysfunction treatment are more likely to require intensive care or breathing support (36%) than older children (13%)."Parents, and expectant parents, are understandably worried about their babies becoming ill with erectile dysfunction treatment," said study co-lead author Chris Gale, from the School of Public Health, Imperial College London."This study will hopefully provide some reassurance, as it suggests severe erectile dysfunction treatment in newborns is very rare.

Most babies only cheap kamagra jelly develop mild symptoms when infected with the kamagra and make a full recovery. This research also supports U.K. And international guidance to keep mother and baby together even when the mother is known or suspected to have erectile dysfunction treatment," Gale said in a college news release."Although this study did show that six babies may have contracted hospital-acquired erectile dysfunction treatment, this data was from the beginning of the kamagra, and control measures on neonatal and pediatric units have improved dramatically over the past six cheap kamagra jelly months," Gale explained.More informationThe U.S. Centers for Disease Control and Prevention has more on newborns and cheap kamagra jelly erectile dysfunction treatment.SOURCE.

Imperial College London, news release, Nov. 9, 2020Robert cheap kamagra jelly PreidtCopyright © 2020 HealthDay. All rights reserved. QUESTION Newborn cheap kamagra jelly babies don't sleep very much.

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Zero-waste bra kamagra oral jelly side effects company founder, Stephanie Devine, of http://www.ec-schluthfeld-strasbourg.ac-strasbourg.fr/wp/?p=2230 The Very Good Bra, shares her story from breast cancer to award-winning product.Forget the bra burning days of yester-year. When you’re done with this one you can literally bury it in your garden.The Very Good Bra has just won a Circle Award in the fashion category and is taking the world by storm. This is because it’s the world's FIRST zero-waste, circular economy kamagra oral jelly side effects bra.

If you’re wondering, ‘circular economy’ refers to the reduction/eradication of product waste through smart design and conscious materials.The bra in question was designed by Sydneysider Stephanie Devine, whose mission began when she was diagnosed with breast cancer back in 2006.“Initially it was being diagnosed with breast cancer and being unable to find a non-wired bra in a natural fibre to see me through treatment. The only kamagra oral jelly side effects bras in my size were maternity bras,” she tells Body+Soul.Like what you see?. Sign up to our bodyandsoul.com.au newsletter for more stories like this.“Five years post treatment I started making wire free, organic cotton bras, however the more I learned about the industry, the more I realised there was more to worry about than the wire!.

A chance meeting with a visiting circular economy guru in 2016 changed my course, and I became determined to make the world’s first circular economy bra.”There’s good reason for this too. Bras are amongst the kamagra oral jelly side effects least sustainable garments. A traditional bra is made from nine different materials, in small pieces, all worn against the body which makes recycling difficult.

99.9% of bras have ended up in landfill in for the last 200 years.“There simply haven’t been the kamagra oral jelly side effects materials available until fairly recently, nor the consumer demand,” explains Devine when asked why zero-waste bras hadn’t been created yet.“In addition, these materials, and particularly the elastic and sewing thread, are phenomenally expensive meaning narrower margins than big brands are prepared to tolerate. In Australia, we’ve been slower on sustainability because of the luxury (and size) of our natural environment.”She says countries that experience more obvious environmental impacts have been at the forefront of demanding change and innovating for it.“30% of the Netherlands is below sea level for example, so environmental issues have been an urgent consideration for them for years. I also think the industry (and most industries) have been slow to fully comprehend that this is a real market not a fad, that demand for sustainability has reached a tipping point, and that conscious consumers are prepared to pay a little more, wait a little longer, and consider a different type of performance to conventional ‘plastic’ bras if it has a positive planetary impact.”Couldn’t have said it better ourselves! kamagra oral jelly side effects.

There was a few snags when trying to create The Very Good Bra, given the many elements that go into making bras.“We only have one global supplier of tree rubber and organic cotton elastic, which results in some design constraints. Making a bra free from spandex means we have to be clever around internal stabilising and also the cut of the fabric to capitalise on mechanical stretch for support,” she explains.“Hook and eye pieces are a constant challenge for me!. We have to custom make them and factories dislike not using a poly stabiliser or polyester sewing thread which runs faster in their machines, so I have kamagra oral jelly side effects had many run-ins over the years,” she adds.Devine persisted with determination, and was able to bring all the elements together.

The body of her bras are made from Tencel (eucalyptus trees) or organic cotton, which is dyed in accordance with the GOTs (Global Organic Textile Standard).“All contain tree rubber and organic cotton elastic, cellulose sewing thread, and organic cotton stabiliser.”The reason Devine had to source such specific fabrics, was due to the issue of how ‘end of life’ would work for the bra, because they’re basically impossible to recycle.“Given that bras are intimates that sit on the skin, and consist of small pieces of different materials, it quickly became clear that recycling wasn't an option. When Trump was elected president late 2016 and women in the US started burning their bras, whilst at the same time the poor in kamagra oral jelly side effects Delhi were dying in their dozens ingesting toxic smoke from rubbish they were burning to keep warm, I realised I needed to make a bra that left no trace at the end of its life and therefore botanical circularity was the only option.”“The bra is mostly eaten in a worm farm in 8 weeks (elastic can take a little longer or be thrown into the compost) and can compost in 3 months. In regular soil it can take longer depending on temperature and moisture.

Sadly our experiments at UNE in Armidale were stalled 3 times, by kamagra oral jelly side effects drought, bushfires, then erectile dysfunction treatment!. So we don’t have the final answer yet on regular soil,” she explains.Of course, while all this effort is commendable, sourcing all of these elements doesn’t necessarily come cheap. As a result, The Very Good Bra in black retails for $95.00.When you understand how much work has gone into it, and the benefit to the environment, it makes sense, but it is more than the average Aussie would allocate for bra expenditure.“I know this frustrates many women,” Devine explains in regards to the price.

€œIt is my absolute aim to try kamagra oral jelly side effects and make this bra as accessible to as many women as possible. In order to do this we have to create volume, which in turn means materials manufacturers realise there is a market they need to address.”Greater consumer investment in sustainable products has a cyclical effect, and as a result, helps to bring down prices for conscious materials.“Competition amongst them [materials manufacturers] will bring down the cost of raw materials. Until we can get there, those who can afford to pay a little more keep driving us towards this goal,” she says.“High profile public awards significantly kamagra oral jelly side effects contribute to public awareness and demand.

We were lucky enough to win last year’s Good Design Award for Fashion Impact, and winning the inaugural Circle Awards this year was a great honour.”And finally, one of the most important questions – does The Very Good Bra cater to both smaller and larger breast sizes?. €œAbsolutely!. I’m a small band with a large cup who was frustrated that wire-free bras only come in kamagra oral jelly side effects S/M/L - who are those women?.

!. € says Devine.“We go up to an E cup with the use of partial liner in the cup, and our new styles with front V wires really kamagra oral jelly side effects help separate and support. A longer band also anchors and supports.

Contrary to what people think, kamagra oral jelly side effects underwires don’t actually support, they separate. The support comes from the straps and the band. We are developing some wider strap elastic for larger sizes in future productions.”For more info on The Very Good Bra, visit their website or Instagram.Kristy Lee Peters talks about the importance of a daily debrief with your S.O, her Rationale skin journey and becoming a mother of two.In our editorial series My Healthy Habits, we chat to inspiring individuals about their health and wellness routines, where they share everything from their fitness routines to their beauty go-to's and midweek meals.

KAAIAA founder Leah Simmons shares her morning and evening rituals, Sjarna Elise Earp looks to meditation and medicinal mushrooms, Nagnata co-founder Laura May Gibbs turns to baths to deal with burnout and Jessica Sepel has some relatable wellness rituals you can actually follow.Kristy Lee Peters AKA KLP Music is a musician and mother of two (having just given birth to her second child), the 'Energy' creator and DJ shares with Body+Soul how she stays well.Outline your kamagra oral jelly side effects morning ritual for us….To kick things off nicely I smash a cheeky coffee straight off the bat and then I take it in turns with my partner Nick to do drop off at daycare for our eldest daughter Siena. I will do exercise of some sort (Pilates, walk/run), shower and get ready (which includes picking out a good outfit – I swear it helps set the tone for my day). Then I head to work – which is generally walking upstairs to the studio in my house.Outline your night ritual for us…A lot kamagra oral jelly side effects revolves around the rituals for the kids.

So, dinner, bath, story time, singing, bed. They’re both generally down around 7pm so then Nick and I have kamagra oral jelly side effects time to hang out together, chat about our days or watch something on tv. We have been re-watching 30 Rock and it’s so nice to have an easy viewing, speedy episode or two before bed.First thing you do when you wake up?.

I really want to say something epic like ‘meditate’ or ‘stretch my body to some zen music’, but to be completely honest it is checking one of two devices – my phone or the baby monitor!. I really look forward to the day when I am no longer madly watching a baby monitor and kamagra oral jelly side effects I can instead do that morning meditation. I do have a little morning ritual I do with Nick - we probably remember to do it 5 out of 7 days.

It consists of three things we ask or say kamagra oral jelly side effects to each other. What are you looking forward to today?. Whose life are you going to improve/make better/do something nice for?.

And lastly, a compliment for the other person.Last thing kamagra oral jelly side effects you do before you go to sleep?. Nick and I will do the night version of our daily debrief and we ask each other. What were you grateful kamagra oral jelly side effects for today?.

What could you have done?. And then, one thing we kamagra oral jelly side effects are appreciative that the other person did. These can be big things or simple things like, you made me a coffee, or you sent me a new song to check out.Talk us through your supplement intake...I’ve recently had my second daughter, so I’m slowly trying to build my body back up and reintroduce things I couldn’t have over the past 10 months.

I take probiotics daily, and magnesium at night. The rest – collagen and other key vitamins - I am trying kamagra oral jelly side effects to hold out on and see how my body feels post ‘new baby zone’. Over time, I know my body will begin to tell me what it needs.What is your weeknight dinner philosophy - what's a normal meal look like?.

Nick is the chef in our house – he takes it very seriously kamagra oral jelly side effects and he is really good at it!. I can cook, but it just doesn’t give me the satisfaction it does for him. He cooks and I clean - it’s a kamagra oral jelly side effects perfect little team combo.

He will make some regulars – he does incredible Italian pastas, which are my favourite - but then go through one of the many, many cook books he has and try new things out all the time. His favourite is Mexican, salads (hot and cold) Buddha bowls, soups in winter and for me, lots of pasta!. What health or kamagra oral jelly side effects body treatment is a regular for you and why?.

Facials and massage!. I broke out kamagra oral jelly side effects with very bad acne throughout my first pregnancy and so in between babies I started using Rationale skincare products. They are not cheap, but I made a decision that I wanted to invest in my ageing process and so it is totally worth it.

I have regular facials in the Rationale Balmain store and then use their products daily. Other than that, great massages, reflexology and acupuncture are all part of my general body treatment kamagra oral jelly side effects routines. In the early stages of my second pregnancy, I had very bad morning sickness, so acupuncture was my go-to and really helped reduce the nausea.Do you practice mindfulness or meditation?.

I do, however, definitely not as much as I want kamagra oral jelly side effects to right now. Right now, I am in survival mode with our newborn baby. However, once I get out the other kamagra oral jelly side effects side of these first few months, I will reintroduce my daily breathing techniques and mindfulness activity.

A huge part of that, for me, is just switching off and having some quiet time. Right now, my mindfulness activity is getting a few solid hours of sleep!. What's your approach to more alternative forms of beauty and wellness kamagra oral jelly side effects practises?.

I am very open to giving most things a go, as long as it doesn’t involve injecting anything into my body. That’s something I’m kamagra oral jelly side effects not at the phase of wanting or trying. However, incorporating wellness activities, particularly things like guided reiki and meditations, I am very receptive to.

I enjoy burning sage at home, just kamagra oral jelly side effects to clear the energy and give our space a bit of a reset.What do you do to help your body recover after a workout/hectic week?. Post workout, and if I am feeling really indulgent, I will go for a massage or some acupuncture. Post a hectic week, the only things I need are some sleep, 20 second hugs and a good glass of natural wine.Talk us through your fitness approach...I do reformer Pilates twice a week at Scout Pilates in Sydney, then a mat/barre Pilates class, a dance class and then on my days off from pilates, I will go for an hour long walk – but I keep it fast paced, so it is close to running.What's your trick to making it through 3pm slump?.

Music, music, Playing a good song and having a little dance around my studio.An average Sunday night looks like…Delicious home cooked meal, followed by kids in bed (no kamagra oral jelly side effects tears!. ), a bottle of natural red, cuddles on the couch with Nick and then, hopefully, it starts raining just as we go to bed – that’s the best!. Who do you look up to in kamagra oral jelly side effects the wellness world and why?.

I don’t have any big role models in the public space, but more so look to the people around me that take on the everyday aspects of life with a smile and some serious fearlessness. I like to look at what they need and what they do to achieve balanced health and wellness – that really inspires me..

Zero-waste bra company founder, Stephanie Devine, of The Very Good Bra, shares her story from breast cancer to award-winning product.Forget http://www.em-louis-pasteur-strasbourg.ac-strasbourg.fr/wp/?p=572 the cheap kamagra jelly bra burning days of yester-year. When you’re done with this one you can literally bury it in your garden.The Very Good Bra has just won a Circle Award in the fashion category and is taking the world by storm. This is cheap kamagra jelly because it’s the world's FIRST zero-waste, circular economy bra. If you’re wondering, ‘circular economy’ refers to the reduction/eradication of product waste through smart design and conscious materials.The bra in question was designed by Sydneysider Stephanie Devine, whose mission began when she was diagnosed with breast cancer back in 2006.“Initially it was being diagnosed with breast cancer and being unable to find a non-wired bra in a natural fibre to see me through treatment. The only bras in my size were maternity bras,” she tells Body+Soul.Like what cheap kamagra jelly you see?.

Sign up to our bodyandsoul.com.au newsletter for more stories like this.“Five years post treatment I started making wire free, organic cotton bras, however the more I learned about the industry, the more I realised there was more to worry about than the wire!. A chance meeting with a visiting circular economy guru in 2016 changed my course, and I became determined to make the world’s first circular economy bra.”There’s good reason for this too. Bras are amongst the cheap kamagra jelly least sustainable garments. A traditional bra is made from nine different materials, in small pieces, all worn against the body which makes recycling difficult. 99.9% of bras have ended up in landfill in for the last 200 years.“There simply haven’t been the materials available until fairly recently, nor the consumer demand,” explains Devine when asked why zero-waste bras hadn’t been created yet.“In addition, these materials, and particularly the elastic and sewing cheap kamagra jelly thread, are phenomenally expensive meaning narrower margins than big brands are prepared to tolerate.

In Australia, we’ve been slower on sustainability because of the luxury (and size) of our natural environment.”She says countries that experience more obvious environmental impacts have been at the forefront of demanding change and innovating for it.“30% of the Netherlands is below sea level for example, so environmental issues have been an urgent consideration for them for years. I also think the industry (and most industries) have cheap kamagra jelly been slow to fully comprehend that this is a real market not a fad, that demand for sustainability has reached a tipping point, and that conscious consumers are prepared to pay a little more, wait a little longer, and consider a different type of performance to conventional ‘plastic’ bras if it has a positive planetary impact.”Couldn’t have said it better ourselves!. There was a few snags when trying to create The Very Good Bra, given the many elements that go into making bras.“We only have one global supplier of tree rubber and organic cotton elastic, which results in some design constraints. Making a bra free from spandex means we have to be clever around internal stabilising and also the cut of the fabric to capitalise on mechanical stretch for support,” she explains.“Hook and eye pieces are a constant challenge for me!. We have to custom make them and factories dislike not using a poly stabiliser or polyester sewing thread which runs faster in their machines, so I have had many cheap kamagra jelly run-ins over the years,” she adds.Devine persisted with determination, and was able to bring all the elements together.

The body of her bras are made from Tencel (eucalyptus trees) or organic cotton, which is dyed in accordance with the GOTs (Global Organic Textile Standard).“All contain tree rubber and organic cotton elastic, cellulose sewing thread, and organic cotton stabiliser.”The reason Devine had to source such specific fabrics, was due to the issue of how ‘end of life’ would work for the bra, because they’re basically impossible to recycle.“Given that bras are intimates that sit on the skin, and consist of small pieces of different materials, it quickly became clear that recycling wasn't an option. When Trump was elected president late 2016 and women in the US started burning their bras, whilst at the same time the poor in Delhi were dying in cheap kamagra jelly their dozens ingesting toxic smoke from rubbish they were burning to keep warm, I realised I needed to make a bra that left no trace at the end of its life and therefore botanical circularity was the only option.”“The bra is mostly eaten in a worm farm in 8 weeks (elastic can take a little longer or be thrown into the compost) and can compost in 3 months. In regular soil it can take longer depending on temperature and moisture. Sadly our experiments at UNE in Armidale were stalled 3 times, cheap kamagra jelly by drought, bushfires, then erectile dysfunction treatment!. So we don’t have the final answer yet on regular soil,” she explains.Of course, while all this effort is commendable, sourcing all of these elements doesn’t necessarily come cheap.

As a result, The Very Good Bra in black retails for $95.00.When you understand how much work has gone into it, and the benefit to the environment, it makes sense, but it is more than the average Aussie would allocate for bra expenditure.“I know this frustrates many women,” Devine explains in regards to the price. €œIt is my absolute aim to cheap kamagra jelly try and make this bra as accessible to as many women as possible. In order to do this we have to create volume, which in turn means materials manufacturers realise there is a market they need to address.”Greater consumer investment in sustainable products has a cyclical effect, and as a result, helps to bring down prices for conscious materials.“Competition amongst them [materials manufacturers] will bring down the cost of raw materials. Until we can get there, those who can afford to pay a little more keep driving us towards this goal,” she says.“High profile cheap kamagra jelly public awards significantly contribute to public awareness and demand. We were lucky enough to win last year’s Good Design Award for Fashion Impact, and winning the inaugural Circle Awards this year was a great honour.”And finally, one of the most important questions – does The Very Good Bra cater to both smaller and larger breast sizes?.

€œAbsolutely!. I’m cheap kamagra jelly a small band with a large cup who was frustrated that wire-free bras only come in S/M/L - who are those women?. !. € says Devine.“We go up to an E cup with the use of partial liner in the cup, and our new styles with cheap kamagra jelly front V wires really help separate and support. A longer band also anchors and supports.

Contrary to what people think, cheap kamagra jelly underwires don’t actually support, they separate. The support comes from the straps and the band. We are developing some wider strap elastic for larger sizes in future productions.”For more info on The Very Good Bra, visit their website or Instagram.Kristy Lee Peters talks about the importance of a daily debrief with your S.O, her Rationale skin journey and becoming a mother of two.In our editorial series My Healthy Habits, we chat to inspiring individuals about their health and wellness routines, where they share everything from their fitness routines to their beauty go-to's and midweek meals. KAAIAA founder Leah Simmons shares her morning and evening rituals, Sjarna Elise Earp looks to meditation and medicinal mushrooms, Nagnata co-founder Laura May Gibbs turns to baths to deal with burnout and Jessica Sepel has some relatable wellness rituals you can actually follow.Kristy Lee Peters AKA KLP Music is a musician and mother of two (having just given birth to her second child), the 'Energy' creator and DJ shares with Body+Soul how she stays well.Outline your morning ritual for us….To kick things off nicely I smash a cheeky coffee straight off the bat cheap kamagra jelly and then I take it in turns with my partner Nick to do drop off at daycare for our eldest daughter Siena. I will do exercise of some sort (Pilates, walk/run), shower and get ready (which includes picking out a good outfit – I swear it helps set the tone for my day).

Then I head to work – which is generally walking upstairs to the cheap kamagra jelly studio in my house.Outline your night ritual for us…A lot revolves around the rituals for the kids. So, dinner, bath, story time, singing, bed. They’re both generally down around 7pm so then Nick and I have time to hang out together, cheap kamagra jelly chat about our days or watch something on tv. We have been re-watching 30 Rock and it’s so nice to have an easy viewing, speedy episode or two before bed.First thing you do when you wake up?. I really want to say something epic like ‘meditate’ or ‘stretch my body to some zen music’, but to be completely honest it is checking one of two devices – my phone or the baby monitor!.

I really look forward to the day when I am no cheap kamagra jelly longer madly watching a baby monitor and I can instead do that morning meditation. I do have a little morning ritual I do with Nick - we probably remember to do it 5 out of 7 days. It consists cheap kamagra jelly of three things we ask or say to each other. What are you looking forward to today?. Whose life are you going to improve/make better/do something nice for?.

And lastly, a compliment for the other person.Last thing you do before cheap kamagra jelly you go to sleep?. Nick and I will do the night version of our daily debrief and we ask each other. What were cheap kamagra jelly you grateful for today?. What could you have done?. And then, one thing we are appreciative that the cheap kamagra jelly other person did.

These can be big things or simple things like, you made me a coffee, or you sent me a new song to check out.Talk us through your supplement intake...I’ve recently had my second daughter, so I’m slowly trying to build my body back up and reintroduce things I couldn’t have over the past 10 months. I take probiotics daily, and magnesium at night. The rest – collagen and other key vitamins - I am trying to hold out on and see how my body cheap kamagra jelly feels post ‘new baby zone’. Over time, I know my body will begin to tell me what it needs.What is your weeknight dinner philosophy - what's a normal meal look like?. Nick is the chef in our house – he takes it very seriously and he is really good at cheap kamagra jelly it!.

I can cook, but it just doesn’t give me the satisfaction it does for him. He cooks and I clean - it’s a cheap kamagra jelly perfect little team combo. He will make some regulars – he does incredible Italian pastas, which are my favourite - but then go through one of the many, many cook books he has and try new things out all the time. His favourite is Mexican, salads (hot and cold) Buddha bowls, soups in winter and for me, lots of pasta!. What health or body treatment is a cheap kamagra jelly regular for you and why?.

Facials and massage!. I broke out with very bad acne throughout my first pregnancy cheap kamagra jelly and so in between babies I started using Rationale skincare products. They are not cheap, but I made a decision that I wanted to invest in my ageing process and so it is totally worth it. I have regular facials in the Rationale Balmain store and then use their products daily. Other than that, great massages, reflexology and acupuncture are all part of my general cheap kamagra jelly body treatment routines.

In the early stages of my second pregnancy, I had very bad morning sickness, so acupuncture was my go-to and really helped reduce the nausea.Do you practice mindfulness or meditation?. I do, however, definitely not as much as I want to right cheap kamagra jelly now. Right now, I am in survival mode with our newborn baby. However, once I get out the other side of these first few months, I cheap kamagra jelly will reintroduce my daily breathing techniques and mindfulness activity. A huge part of that, for me, is just switching off and having some quiet time.

Right now, my mindfulness activity is getting a few solid hours of sleep!. What's your approach to more alternative forms of cheap kamagra jelly beauty and wellness practises?. I am very open to giving most things a go, as long as it doesn’t involve injecting anything into my body. That’s something I’m not cheap kamagra jelly at the phase of wanting or trying. However, incorporating wellness activities, particularly things like guided reiki and meditations, I am very receptive to.

I enjoy burning sage at home, just to clear the energy and cheap kamagra jelly give our space a bit of a reset.What do you do to help your body recover after a workout/hectic week?. Post workout, and if I am feeling really indulgent, I will go for a massage or some acupuncture. Post a hectic week, the only things I need are some sleep, 20 second hugs and a good glass of natural wine.Talk us through your fitness approach...I do reformer Pilates twice a week at Scout Pilates in Sydney, then a mat/barre Pilates class, a dance class and then on my days off from pilates, I will go for an hour long walk – but I keep it fast paced, so it is close to running.What's your trick to making it through 3pm slump?. Music, music, Playing a good song and having a little dance around my studio.An cheap kamagra jelly average Sunday night looks like…Delicious home cooked meal, followed by kids in bed (no tears!. ), a bottle of natural red, cuddles on the couch with Nick and then, hopefully, it starts raining just as we go to bed – that’s the best!.

Who do you look up to in the wellness world and why?. I don’t have any big role models in the public space, but more so look to the people around me that take on the everyday aspects of life with a smile and some serious fearlessness. I like to look at what they need and what they do to achieve balanced health and wellness – that really inspires me..

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No Supplementary Data.No generic kamagra online Article MediaNo MetricsDocument Type. EditorialAffiliations:1. Saw Swee Hock School of Public Health, National University of Singapore, Singapore 2. Infectious Diseases Translational Research Programme, Department of Medicine, Yong generic kamagra online Loo Lin School of Medicine, National University of Singapore, Singapore, Institute for Health Innovation &. Technology, National University of Singapore, Singapore 3.

Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Infectious Diseases Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, SingaporePublication date:01 June 2021More about this publication?. The International Journal of Tuberculosis and Lung generic kamagra online Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as erectile dysfunction treatment, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health.

EditorialAffiliations:1 kamagra oral jelly for sale cheap kamagra jelly. Saw Swee Hock School of Public Health, National University of Singapore, Singapore 2. Infectious Diseases Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Institute for Health Innovation &.

Technology, National University of Singapore, Singapore 3. Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Infectious Diseases Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, SingaporePublication date:01 June 2021More about this publication?. The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as erectile dysfunction treatment, asthma, COPD, child lung health and the hazards of tobacco and air pollution.

Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details. The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication.

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V-safe Surveillance kamagra store https://alistkandb.co.uk/seroquel-online-in-canada/. Local and Systemic Reactogenicity in Pregnant Persons Table 1. Table 1 kamagra store.

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

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% kamagra store 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 kamagra store 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 kamagra store. 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 kamagra store 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 kamagra store more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3.

Table 3 kamagra store. 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 kamagra store 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 kamagra store 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 kamagra store this analysis.

Table 4. Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry kamagra store 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 kamagra store 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 kamagra store 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 kamagra store 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 kamagra store VAERS, a requirement under the EUAs.Participants Figure 1. Figure 1.

Enrollment and Randomization kamagra store. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures kamagra store that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older kamagra store underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1. Brazil, 2 kamagra store.

South Africa, 4. Germany, 6. And Turkey, kamagra store 9) in the phase 2/3 portion of the trial.

A total of 43,448 participants received injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at kamagra store least 2 months of safety data available after the second dose and contributed to the main safety data set.

Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of kamagra store age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According kamagra store to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination.

Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection kamagra store site was assessed according to the following scale. Mild, does not interfere with activity.

Moderate, interferes with activity. Severe, prevents daily activity kamagra store. And grade 4, emergency department visit or hospitalization.

Redness and kamagra store swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter.

Severe, >10.0 cm in kamagra store diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B.

Fever categories are designated kamagra store in the key. Medication use was not graded. Additional scales were kamagra store as follows.

Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity. Moderate.

Some interference with activity. Or severe. Prevents daily activity), vomiting (mild.

1 to 2 times in 24 hours. Moderate. >2 times in 24 hours.

Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants.

Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose.

66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling.

The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients).

The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients.

Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1.

45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy.

Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction).

No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period.

Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2.

treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3.

Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day.

Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days.

Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients.

This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9.

Case split. BNT162b2, 2 cases. Placebo, 44 cases).

Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Objectives, Participants, and Oversight We conducted a randomized, placebo-controlled, observer-blinded, phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 to 25 years of age and an evaluation of the noninferiority of immunogenicity in the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort.

Data were collected through the cutoff date of March 13, 2021. Eligible participants were healthy or had stable preexisting disease (including hepatitis B, hepatitis C, or human immunodeficiency kamagra ). Persons with a previous clinical or virologic erectile dysfunction treatment diagnosis or erectile dysfunction , previous erectile dysfunction vaccination, diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded.

The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the full text of this article at NEJM.org. Additional details of the trial are provided in the protocol, available at NEJM.org. Pfizer was responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the manuscript that was submitted.

Both Pfizer and BioNTech manufactured the treatment and placebo. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and writing of the manuscript. All data were available to the authors, who vouch for their accuracy and completeness and for the adherence of the trial to the protocol.

Procedures Randomization was conducted with the use of an interactive Web-based response system. Participants were assigned in a 1:1 ratio to receive two intramuscular injections of 30 μg of BNT162b2 or placebo (saline) 21 days apart. For evaluation of immediate treatment-associated reactions, participants were observed in the clinic for 30 minutes after vaccination.

Safety Safety objectives included the assessment of local or systemic reactogenicity events, which were recorded by the participants in an electronic diary (e-diary) for 7 days after each dose. Unsolicited adverse events (i.e., those reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose 2, respectively. Immunogenicity Immunogenicity assessments (erectile dysfunction serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants.

Noninferiority was assessed among participants who had no evidence of previous erectile dysfunction with the use of the two-sided 95% confidence interval for the geometric mean ratio of erectile dysfunction 50% neutralizing titers in 12-to-15-year-old participants as compared with 16-to-25-year-old participants 1 month after dose 2. BNT162b2 immunogenicity was evaluated in participants with and those without serologic or virologic evidence of previous erectile dysfunction . Corresponding end points were the geometric mean erectile dysfunction neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2.

Efficacy The efficacy of BNT162b2 against confirmed erectile dysfunction treatment with an onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous erectile dysfunction , as well as in all vaccinated participants. Surveillance for potential erectile dysfunction treatment cases was undertaken throughout the trial. If acute respiratory illness developed in a participant, the participant was tested for erectile dysfunction.

Methods for identifying erectile dysfunction s and erectile dysfunction treatment diagnoses are summarized in the Supplementary Appendix. Statistical Analysis The safety population included all participants who received at least one dose of BNT162b2 or placebo. The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events).

Safety end points are presented descriptively as counts, percentages, and associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described according to terms in the Medical Dictionary for Regulatory Activities, version 23.1, for each group. Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure. For immunogenicity assessments, all participants in both age cohorts were from U.S.

Sites. The dose 2 immunogenicity population that could be evaluated included participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of erectile dysfunction 50% neutralizing titers.

A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67). A testing laboratory supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix.

Although the formal evaluation of efficacy was to be based on the overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the stratification factor). The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population that could be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations.

The all-available efficacy population included all participants who received one or two doses. treatment efficacy was defined as 100×(1−IRR), where IRR is the ratio of the rate of a first confirmed erectile dysfunction treatment illness in the BNT162b2 group to the corresponding rate in the placebo group. Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons).

Because the number of participants who reported symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not imputed in the analysis..

V-safe Surveillance cheap kamagra jelly Seroquel online in canada. Local and Systemic Reactogenicity in Pregnant Persons Table 1. Table 1 cheap kamagra jelly. Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment.

Table 2. Table 2 cheap kamagra jelly. 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 cheap kamagra jelly 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, cheap kamagra jelly 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 cheap kamagra jelly. 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 cheap kamagra jelly 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 cheap kamagra jelly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry.

Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3 cheap kamagra jelly. 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 cheap kamagra jelly 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 cheap kamagra jelly 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 cheap kamagra jelly 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 cheap kamagra jelly 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 cheap kamagra jelly (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 cheap kamagra jelly 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 cheap kamagra jelly 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 cheap kamagra jelly requirement under the EUAs.Participants Figure 1.

Figure 1. Enrollment and cheap kamagra jelly Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table cheap kamagra jelly 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population. Between July cheap kamagra jelly 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites.

Argentina, 1. Brazil, 2 cheap kamagra jelly. South Africa, 4. Germany, 6.

And Turkey, cheap kamagra jelly 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a cheap kamagra jelly total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set.

Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of cheap kamagra jelly age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2. Figure 2.

Local and Systemic Reactions cheap kamagra jelly Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was cheap kamagra jelly assessed according to the following scale.

Mild, does not interfere with activity. Moderate, interferes with activity. Severe, prevents cheap kamagra jelly daily activity. And grade 4, emergency department visit or hospitalization.

Redness and cheap kamagra jelly swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 cm cheap kamagra jelly in diameter.

And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories cheap kamagra jelly are designated in the key. Medication use was not graded.

Additional scales were as cheap kamagra jelly follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity. Moderate.

Some interference with activity. Or severe. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild.

2 to 3 loose stools in 24 hours. Moderate. 4 to 5 loose stools in 24 hours. Or severe.

6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients.

Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose).

A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less.

Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C.

Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter.

Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%).

This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period.

Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose.

Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3.

Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day.

Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2).

Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9.

Case split. BNT162b2, 2 cases. Placebo, 44 cases). Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5).

Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Objectives, Participants, and Oversight We conducted a randomized, placebo-controlled, observer-blinded, phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 to 25 years of age and an evaluation of the noninferiority of immunogenicity in the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort. Data were collected through the cutoff date of March 13, 2021. Eligible participants were healthy or had stable preexisting disease (including hepatitis B, hepatitis C, or human immunodeficiency kamagra ).

Persons with a previous clinical or virologic erectile dysfunction treatment diagnosis or erectile dysfunction , previous erectile dysfunction vaccination, diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded. The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the full text of this article at NEJM.org. Additional details of the trial are provided in the protocol, available at NEJM.org. Pfizer was responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the manuscript that was submitted.

Both Pfizer and BioNTech manufactured the treatment and placebo. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and writing of the manuscript. All data were available to the authors, who vouch for their accuracy and completeness and for the adherence of the trial to the protocol. Procedures Randomization was conducted with the use of an interactive Web-based response system.

Participants were assigned in a 1:1 ratio to receive two intramuscular injections of 30 μg of BNT162b2 or placebo (saline) 21 days apart. For evaluation of immediate treatment-associated reactions, participants were observed in the clinic for 30 minutes after vaccination. Safety Safety objectives included the assessment of local or systemic reactogenicity events, which were recorded by the participants in an electronic diary (e-diary) for 7 days after each dose. Unsolicited adverse events (i.e., those reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose 2, respectively.

Immunogenicity Immunogenicity assessments (erectile dysfunction serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants. Noninferiority was assessed among participants who had no evidence of previous erectile dysfunction with the use of the two-sided 95% confidence interval for the geometric mean ratio of erectile dysfunction 50% neutralizing titers in 12-to-15-year-old participants as compared with 16-to-25-year-old participants 1 month after dose 2. BNT162b2 immunogenicity was evaluated in participants with and those without serologic or virologic evidence of previous erectile dysfunction . Corresponding end points were the geometric mean erectile dysfunction neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2.

Efficacy The efficacy of BNT162b2 against confirmed erectile dysfunction treatment with an onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous erectile dysfunction , as well as in all vaccinated participants. Surveillance for potential erectile dysfunction treatment cases was undertaken throughout the trial. If acute respiratory illness developed in a participant, the participant was tested for erectile dysfunction. Methods for identifying erectile dysfunction s and erectile dysfunction treatment diagnoses are summarized in the Supplementary Appendix.

Statistical Analysis The safety population included all participants who received at least one dose of BNT162b2 or placebo. The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events). Safety end points are presented descriptively as counts, percentages, and associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described according to terms in the Medical Dictionary for Regulatory Activities, version 23.1, for each group. Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure.

For immunogenicity assessments, all participants in both age cohorts were from U.S. Sites. The dose 2 immunogenicity population that could be evaluated included participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of erectile dysfunction 50% neutralizing titers.

A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67). A testing laboratory supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix. Although the formal evaluation of efficacy was to be based on the overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the stratification factor).

The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population that could be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations. The all-available efficacy population included all participants who received one or two doses. treatment efficacy was defined as 100×(1−IRR), where IRR is the ratio of the rate of a first confirmed erectile dysfunction treatment illness in the BNT162b2 group to the corresponding rate in the placebo group.

Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons). Because the number of participants who reported symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not imputed in the analysis..