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About Insight Insight provides an in-depth look at health care issues viagra for sale in and affecting California.Have a story suggestion?. Let us viagra for sale know. Use Our Content This story can be republished for free (details). SACRAMENTO — After years of failed attempts and vociferous opposition, California lawmakers on Monday adopted a measure to grant nurse practitioners the ability to practice without doctor supervision — but only after making big concessions to the powerful doctors’ lobby, which nonetheless remains opposed.The bill now heads to Gov. Gavin Newsom for consideration, fenced in by amendments that would stringently limit how much independence nurse practitioners — viagra for sale nurses with advanced training and degrees — can have to practice medicine.Lawmakers credit these compromises, like them or not, for finally allowing them to push the issue over the finish line, capping years of political scrapping and perhaps one day altering the delivery of health care in California.“This is not an intrusion on a hallowed profession, it’s a relief,” said state Sen.

John Moorlach (R-Costa Mesa), one viagra for sale of four Republican senators who voted for the bill. Moorlach said the measure would get more practitioners into underserved areas that don’t have enough doctors.“It’s like the cavalry coming up over the hill to provide reinforcements to a tired army of wonderful and overworked doctors,” he said.California is behind most other states in empowering nurse practitioners. If the bill becomes viagra for sale law, the state would join nearly 40 others to grant some level of independence to nurse practitioners. 22 grant full independence, according to the American Association viagra for sale of Nurse Practitioners.

California would have among the most restrictive policies on nurse practitioner independence in the country. Email viagra for sale Sign-Up Subscribe to California Healthline’s free Daily Edition. “I’m not going to say I regret any of these changes,” said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee and authored the bill, AB-890.Wood opposed previous attempts to remove supervision requirements.“I wish it could be a little less strict, quite frankly,” he said, adding that this was a reasonable compromise informed by his experiences as a dentist and what he learned from other providers.Today, nurse practitioners viagra for sale must enter into a written agreement with a physician to oversee their work with patients. In exchange, physicians bill them between $5,000 and $15,000 per year, according to a report by the California Health Care Foundation and the University of California-San Francisco.

(California Healthline is an editorially independent service of the California Health Care Foundation.)“Where we are with the viagra and the craziness of the world today, it highlights why there’s a need for this,” said Andrew Acosta, a spokesperson viagra for sale for the California Association for Nurse Practitioners. €œThe doctor shortage isn’t going away anytime soon.”Under Wood’s measure, nurse practitioners would be able to see patients in their own practice, but only after working under viagra for sale physician supervision for at least three years. The bill also contains many other restrictions.Nurse practitioners argue that the measure, even with its limitations, would ease primary care shortages, especially in rural areas — a problem the viagra has made more stark.Opponents, primarily the powerful California Medical Association, which is the doctors’ lobbying group, counter that stripping nurse practitioners of physician oversight would lead to a lower standard of care, and that nurse practitioners wouldn’t necessarily flock to rural areas once they’re free of physician supervision.These arguments aren’t new in Sacramento, but lawmakers and lobbyists say this version of the bill succeeded because there are new leaders at the helm of influential legislative committees who were willing to make changes, and because the viagra has changed health care.“I think the legislature is starting to realize decades of evidence that nurse practitioners are safe, productive providers,” said Ed Hernandez, a former legislator who was termed out in 2018 and authored the last two failed bills. €œI think the policy is finally overshadowing the politics” of the California Medical Association.Still, the biggest difference this year viagra for sale is the bill itself.

Hernandez’s bills, introduced in 2013 and 2015, were “clean” bills that granted independence to nurse practitioners without many requirements.There’s nothing clean about Wood’s bill, which viagra for sale was heavily amended in the state Senate. Instead of simply lifting the supervision requirements on nurse practitioners, the measure imposes several hoops for nurse practitioners to jump through. Before they could viagra for sale practice independently, nurse practitioners would have to be certified by preapproved national nursing boards, and possibly complete additional California-specific testing if accredited out of state.Once certified, they would have to practice under physician supervision for at least three years — up to six in some cases — before they could strike out on their own. And they would have to disclose to patients that viagra for sale they aren’t doctors.The bill even prescribes a Spanish phrase for “nurse practitioner”.

Enfermera especializada. (Technically, this refers viagra for sale to a female nurse. The bill doesn’t provide the equivalent phrase for a male nurse.)That’s not even all the amendments — and the measure wouldn’t take effect until 2023.The requirements were inserted in response to criticism from the California Medical Association that nurse practitioners are not qualified to provide patient care without physician oversight, and that patients wouldn’t understand that they’re seeing someone with less training than a doctor, lawmakers said.Despite the numerous amendments, the association remains opposed, saying the changes don’t address their fundamental concerns.“We’ve increased the training required for physicians over the last couple years and now all of viagra for sale a sudden we’re allowing unsupervised providers to treat patients who have even less training,” said association spokesperson Anthony York.Rounds of negotiations, major concessions and hourslong Zoom calls still could not get the doctors’ group on board, Wood said.He said it was like chasing “goalposts that continue to move.”“It’s very disappointing when you work with opposition and nothing is ever good enough,” Wood said. €œCMA will never support this bill.

They’ll never viagra for sale go neutral on it.”York said that characterization is not accurate. He pointed to a different bill — SB-1237 — that would allow certified nurse viagra for sale midwives to attend to low-risk pregnancies without physician supervision. The association was initially opposed, but after negotiations and amendments to the bill, it changed its position to neutral. That bill is also headed to Newsom.“You don’t have to look too far to viagra for sale find a case where we were willing to engage on a scope-of-practice issue,” York said.David McCuan, a political science professor at Sonoma State University, called the association’s inability to kill Wood’s bill a political “watershed moment” for the group.“Their M.O.

For 70 viagra for sale years has been about blocking, stunting and preventing change,” McCuan said. €œThe deference toward the medical profession has changed. In that sense, it would be a momentous event if this is signed.”Though the California Association for Nurse Practitioners is celebrating legislative passage of the viagra for sale measure, even in its amended form, it’s a different story at the national level. Sophia Thomas, president of the American Association of Nurse Practitioners, said in a statement that the bill is choked by too much red tape to provide any meaningful change.“California’s so-called ‘solution,’ viagra for sale the flawed AB-890, would establish a cascading set of new restrictions on NP practice that would maintain California’s position among the most heavily regulated and restrictive in the nation,” Thomas said.State Sen.

Richard Pan (D-Sacramento), a pediatrician who chairs the Senate Health Committee, said he also opposed the bill, but not simply because he is a doctor or a member of the California Medical Association.Yet many of his objections reflect those of the association, such as concerns about training and access to care in rural areas.He also believes independence for nurse practitioners could exacerbate inequalities in the health care system, as people with less means see providers with less training.“People with more resources are going to go with the person they think is more qualified. That’s just the way it tends to happen,” Pan said.California viagra for sale Healthline’s Angela Hart contributed to this report. Rachel Bluth. rbluth@kff.org, @RachelHBluth Related Topics California California Healthline Health Industry Insight States California Legislature Doctors Legislation Nurses Rural Medicine.

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A New York Where to get zithromax man has been charged with an elaborate murder-for-hire scheme taken straight out of a movie script where he killed and dismantled the body of a 26-year-old woman for life insurance benefits, federal officials announced.Queens resident Cory Martin, age 34, was charged in Brooklyn federal court with murder-for-hire and conspiracy to commit murder-for-hire for his role in the death of 26-year-old viagra at cvs Brandy Odom.Previously, Martin was charged with conspiracy to commit wire fraud, aggravated identity theft, and fraudulent use of identification relating to an alleged scheme to fraudulently obtain life insurance policies in Odom’s name, murder her, then claim the cash.US Attorney Breon Peace said that the indictment claims that in March 2017, a year prior to Odom’s murder, Martin and a co-conspirator - reportedly Adelle Anderson, age 32 - fraudulently obtained two life insurance policies in her name. They allegedly viagra at cvs arranged for premium payments to the life insurance companies to be made by Western Union money order and by using a debit card in Odom’s name.More than a year later, in April 2018, Martin allegedly strangled Odom, and began the process of dismembering her corpse after searching Home Depot’s website for an online listing for a “Dewalt 12-Amp Corded Reciprocating Saw,” described as featuring a “powerful 12 Amp motor designed for heavy-duty applications.”Later that same night, Martin allegedly searched YouTube using the search term “how to insert blade for reciprocating saw” and “using reciprocating saw,” which he subsequently deleted from his cell phone. On April 8 and April 9, 2018, Martin disposed of Odom’s body parts in Canarsie Park in Brooklyn with an assist from his co-conspirator.Peace said that on April 10, 2018, Martin conducted dozens of Internet searches for news articles about Odom, including “Search area expands after dismembered body found in Canarsie Park in Brooklyn.” Martin also accessed a Twitter post titled “Person walking dog discovers remains of woman in Brooklyn park.” The following day, Peace said that Martin searched YouTube using the search term “exclusive interview of mother of girl found in park, and after Odom’s murder, at Martin’s direction, several unsuccessful attempts to claim benefits under Odom’s life insurance policies were made by his co-conspirator."It's unthinkable that a person could view another human being as a get rich quick scheme," FBI Assistant Director-in-Charge Michael Driscoll said. "We allege Mr viagra at cvs. Martin murdered, viagra at cvs then dismembered a young woman so he could cash in on fraudulent life insurance policies.

"Ms. Odom didn't deserve the sheer indignity of dying that way, no one does viagra at cvs. Mr. Martin facing justice won't viagra at cvs bring Ms. Odom back, but it will keep him from plotting another despicable viagra at cvs attempt at profiting off someone's life." Odom.

Was arrested in Trenton, New Jersey, in November 2020."With dogged tenacity and meticulous investigative work, our NYPD detectives and law enforcement partners never wavered in their mission to seek justice for this crime victim," NYPD Commissioner Dermot Shea stated. "Now, more than three years after the malicious fraud and brutal killing alleged in today's indictment, New Yorkers can find our collective answer in these court papers from the United States Attorney's Office." If convicted, Martin faces life in prison or viagra at cvs the death penalty."The defendant allegedly brutally murdered a young woman, dismembered her body, and scattered her body parts in a Brooklyn park in order to profit from life insurance policies that he fraudulently obtained in her name,” Peace said. €œHe will now be held to account for his alleged heinous acts. We hope that today’s charges bring some measure of solace to the victim’s family.” Click here to sign up for Daily Voice's free daily emails and news alerts.The United States Postal Service is gearing up viagra at cvs for the holidays, unveiling its brand-new holiday stamps and announcing shipping deadlines to deliver mail by Christmas.The USPS shared in an announcement on Thursday, Oct. 7, that the postal service is releasing a number of holiday viagra at cvs and winter-themed stamps, including the brand new Santa Claus stamps.“The A Visit From St.

Nick stamps bring joy to the kid in all of us,” said Scott Bombaugh, the Postal Service’s vice president and chief technology officer. €œHoliday cards and letters mailed with these viagra at cvs stamps will delight people of all ages. They are good to give as gifts or stocking stuffers, too.”The Postal Service also released its recommendations for sending mail in time for Christmas.USPS recommends the following mailing and shipping deadlines for expected delivery by viagra at cvs Dec. 25 to domestic addresses:Nov. 6 — viagra at cvs APO/FPO/DPO (all ZIP Codes) USPS Retail Ground serviceDec.

9 — APO/FPO/DPO (all ZIP Codes) Priority Mail and First-Class MailDec. 15 — USPS Retail viagra at cvs Ground serviceDec. 16 — APO/FPO/DPO (except ZIP Code 093) USPS viagra at cvs Priority Mail Express Military serviceDec. 17 — First-Class Mail service (including greeting cards)Dec. 17 — viagra at cvs First-class packages (up to 15.99 ounces)Dec.

18 — Priority Mail serviceDec. 23 — viagra at cvs Priority Mail Express* serviceAlaskaDec. 18 — viagra at cvs Alaska to/from Continental U.S.– First-Class MailDec. 18 — Alaska to/from Continental U.S.– Priority MailDec. 21 — viagra at cvs Alaska to/from Continental U.S.– Priority Mail ExpressHawaiiDec.

17 — Hawaii to/from mainland--Priority Mail viagra at cvs and First-Class MailDec. 21 — Hawaii to/from mainland--Priority Mail Express Click here to sign up for Daily Voice's free daily emails and news alerts.An area child who was out celebrating Halloween was struck and injured by a hit-and-run driver.The incident took place around 6:30 p.m., Sunday, Oct. 31, when the 4-year-old child was crossing a busy roadway near the Plaza Diner in the Town of Greenport with his mother.According to viagra at cvs the Columbia County Sheriff's Office, as two crossed Fairview Avenue, the child was struck by a northbound vehicle. The vehicle did not stop and continued northbound, police said. The vehicle is described as a dark-colored SUV viagra at cvs.

The Sheriff's Office is seeking the public's assistance in trying viagra at cvs to locate the vehicle (pictured). If anyone has any information about this vehicle and/or operator, please contact the Sheriff's Office at 518-828-3344 and refer to incident number 289713.The child did suffer a fractured ankle, and cuts and bruises. He was released from the hospital viagra at cvs and is at home recovering. Click here to sign up for Daily Voice's free daily emails and news alerts..

A New York man has been charged with an elaborate murder-for-hire scheme taken straight out of a movie script where he killed and dismantled the body of a 26-year-old woman for life insurance benefits, federal officials announced.Queens resident Cory Martin, age 34, was charged in Brooklyn federal court with murder-for-hire and conspiracy to commit murder-for-hire for his role in the death of 26-year-old Brandy Odom.Previously, Martin was charged with conspiracy to commit wire fraud, aggravated identity theft, and fraudulent viagra for sale use of identification relating to an alleged scheme to fraudulently obtain life insurance policies in Odom’s name, murder her, then claim the cash.US Attorney Breon Peace said that the indictment claims that in March 2017, a year prior to Odom’s murder, http://imayotv.com/where-to-get-zithromax/ Martin and a co-conspirator - reportedly Adelle Anderson, age 32 - fraudulently obtained two life insurance policies in her name. They allegedly arranged for premium payments to the life insurance companies to be made by Western Union money order and by using a debit card in Odom’s name.More than a year later, in viagra for sale April 2018, Martin allegedly strangled Odom, and began the process of dismembering her corpse after searching Home Depot’s website for an online listing for a “Dewalt 12-Amp Corded Reciprocating Saw,” described as featuring a “powerful 12 Amp motor designed for heavy-duty applications.”Later that same night, Martin allegedly searched YouTube using the search term “how to insert blade for reciprocating saw” and “using reciprocating saw,” which he subsequently deleted from his cell phone. On April 8 and April 9, 2018, Martin disposed of Odom’s body parts in Canarsie Park in Brooklyn with an assist from his co-conspirator.Peace said that on April 10, 2018, Martin conducted dozens of Internet searches for news articles about Odom, including “Search area expands after dismembered body found in Canarsie Park in Brooklyn.” Martin also accessed a Twitter post titled “Person walking dog discovers remains of woman in Brooklyn park.” The following day, Peace said that Martin searched YouTube using the search term “exclusive interview of mother of girl found in park, and after Odom’s murder, at Martin’s direction, several unsuccessful attempts to claim benefits under Odom’s life insurance policies were made by his co-conspirator."It's unthinkable that a person could view another human being as a get rich quick scheme," FBI Assistant Director-in-Charge Michael Driscoll said. "We allege viagra for sale Mr.

Martin murdered, then dismembered a young woman viagra for sale so he could cash in on fraudulent life insurance policies. "Ms. Odom didn't deserve the sheer indignity of viagra for sale dying that way, no one does. Mr.

Martin facing justice won't viagra for sale bring Ms. Odom back, but it will keep him from viagra for sale plotting another despicable attempt at profiting off someone's life." Odom. Was arrested in Trenton, New Jersey, in November 2020."With dogged tenacity and meticulous investigative work, our NYPD detectives and law enforcement partners never wavered in their mission to seek justice for this crime victim," NYPD Commissioner Dermot Shea stated. "Now, more than three years after the viagra for sale malicious fraud and brutal killing alleged in today's indictment, New Yorkers can find our collective answer in these court papers from the United States Attorney's Office." If convicted, Martin faces life in prison or the death penalty."The defendant allegedly brutally murdered a young woman, dismembered her body, and scattered her body parts in a Brooklyn park in order to profit from life insurance policies that he fraudulently obtained in her name,” Peace said.

€œHe will now be held to account for his alleged heinous acts. We hope that today’s charges bring some measure of solace to the victim’s family.” Click here to sign up for Daily Voice's free daily emails and news alerts.The United States Postal Service is gearing up for the holidays, unveiling its brand-new holiday stamps and announcing shipping deadlines to deliver mail by Christmas.The USPS shared in an announcement on viagra for sale Thursday, Oct. 7, that the postal service is releasing a number of viagra for sale holiday and winter-themed stamps, including the brand new Santa Claus stamps.“The A Visit From St. Nick stamps bring joy to the kid in all of us,” said Scott Bombaugh, the Postal Service’s vice president and chief technology officer.

€œHoliday cards and letters mailed viagra for sale with these stamps will delight people of all ages. They are good viagra for sale to give as gifts or stocking stuffers, too.”The Postal Service also released its recommendations for sending mail in time for Christmas.USPS recommends the following mailing and shipping deadlines for expected delivery by Dec. 25 to domestic addresses:Nov. 6 — APO/FPO/DPO viagra for sale (all ZIP Codes) USPS Retail Ground serviceDec.

9 — APO/FPO/DPO (all ZIP Codes) Priority Mail and First-Class MailDec. 15 — viagra for sale USPS Retail Ground serviceDec. 16 — APO/FPO/DPO (except ZIP Code 093) USPS Priority Mail Express Military viagra for sale serviceDec. 17 — First-Class Mail service (including greeting cards)Dec.

17 — First-class packages viagra for sale (up to 15.99 ounces)Dec. 18 — Priority Mail serviceDec. 23 — viagra for sale Priority Mail Express* serviceAlaskaDec. 18 — Alaska to/from Continental U.S.– First-Class viagra for sale MailDec.

18 — Alaska to/from Continental U.S.– Priority MailDec. 21 — viagra for sale Alaska to/from Continental U.S.– Priority Mail ExpressHawaiiDec. 17 — Hawaii to/from mainland--Priority viagra for sale Mail and First-Class MailDec. 21 — Hawaii to/from mainland--Priority Mail Express Click here to sign up for Daily Voice's free daily emails and news alerts.An area child who was out celebrating Halloween was struck and injured by a hit-and-run driver.The incident took place around 6:30 p.m., Sunday, Oct.

31, when the 4-year-old child was crossing a busy roadway near the Plaza Diner in the Town viagra for sale of Greenport with his mother.According to the Columbia County Sheriff's Office, as two crossed Fairview Avenue, the child was struck by a northbound vehicle. The vehicle did not stop and continued northbound, police said. The vehicle is described as viagra for sale a dark-colored SUV. The Sheriff's Office is seeking the public's assistance in trying to locate viagra for sale the vehicle (pictured).

If anyone has any information about this vehicle and/or operator, please contact the Sheriff's Office at 518-828-3344 and refer to incident number 289713.The child did suffer a fractured ankle, and cuts and bruises. He was released from the hospital and is at viagra for sale home recovering. Click here to sign up for Daily Voice's free daily emails and news alerts..

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The agency welcomed the start of how long does it take for viagra to start working the vaccination drive, in line with national authorities’ broader public health efforts, which began on Tuesday. €¯ “The first step in fully protecting communities…is through the rollout of vaccination[s]”, said Johannes Van Der Klaauw, UNHCR’s Representative in Bangladesh. Fair distribution UNHCR stressed that when allocating the how long does it take for viagra to start working treatments, the equitable inclusion of Rohingya refugees is critical to curbing the spread of the deadly disease. The drive is being led by the Bangladesh authorities with technical support from UNHCR, the World Health Organization (WHO) and other humanitarian partners.  “We are grateful to the Government of Bangladesh for having included Rohingya refugees in the vaccination campaign”, said Mr.

Van Der Klaauw. The complex Rohingya refugee crisis erupted in August 2017, following attacks on remote police outposts in western Myanmar by armed groups alleged to be from how long does it take for viagra to start working within the community. These were followed by systematic counter attacks against the minority, mainly Muslim Rohingya, which human rights groups, including senior UN officials, have said amounted to ethnic cleansing. Frontline efforts Thousands of refugee and host community volunteers have taken the lead, working to fight the on-going viagra since it began, by informing refugees about health and hygiene, monitoring signs of illness, and connecting how long does it take for viagra to start working the refugee community with critical health services, according to UNHCR.

€œThe Rohingya refugee and host community volunteers have an essential frontline role in containing the spread of erectile dysfunction treatment in the camps”, the UNHCR official underscored. While the threat of erectile dysfunction treatment remains critical, their efforts have helped to prevent and curb outbreaks and have saved lives.  Disasters pile up The vaccinations follow weeks of devastating monsoon rains that have pummelled the Cox’s Bazar District, killing eight refugees and 15 of their Bangladeshi hosts. And landslides, flooding, wind and storms have displaced almost 25,000 refugees how long does it take for viagra to start working while ravaging thousands of facilities, including primary health clinics, distribution points and latrines. At the same time, damaged roads, pathways and bridges have hindered humanitarian access.

Stepping up response UNHCR’s Emergency Response Teams, and partners, refugee and host community volunteers were deployed to assess the damage. They aim to support how long does it take for viagra to start working families forced to relocate, repair shelters and other sites, and ensure access to essential services for everyone.  While the weather has improved over the last few days, the agency warned that monsoon season will continue for several more months, followed by the cyclone season.Marburg, a highly infectious disease that causes haemorrhagic fever, is transmitted to humans by fruit bats. The viagra is in the same family as Ebola. .@WHO & how long does it take for viagra to start working.

Partners are supporting #Guinea’s Ministry of Health to investigate the source of the #Marburg outbreak, trace contacts, &. Inform the local community about how to protect themselves. About 150 contacts have been identified and are being followed up so far.— Tedros Adhanom Ghebreyesus (@DrTedros) August 11, 2021 It was detected in Gueckedou prefecture in southwestern Guinea, and less than two months after the country declared an end to an Ebola outbreak this year which killed 12 how long does it take for viagra to start working people. The patient was a man who died on 2 August, eight days after the onset of symptoms.

The village where he lived is near the borders with both Sierra Leone and Liberia. Tedros Adhanom Ghebreyesus, the WHO Director-General, said Guinea’s Ministry of Health reported the how long does it take for viagra to start working case to the UN agency on Friday. 150 contacts identified WHO is supporting the authorities in investigating the source of the outbreak, tracing contacts and informing the local community about protection measures. €œAbout 150 contacts have been identified and are being followed up, including how long does it take for viagra to start working three family members and a health worker, who have been identified as high-risk close contacts,” Tedros told journalists in Geneva.

Gueckedou prefecture is the same region where cases of the Ebola outbreak in Guinea this year, as well as the 2014–2016 West Africa outbreak, were initially detected. Marburg disease has a nearly 90 cent fatality rate, according to WHO. Currently there is no treatment against it, although treatments are under development, but rehydration with oral or intravenous fluids how long does it take for viagra to start working and treatment of specific symptoms, improves survival. Previous outbreaks and sporadic cases on the African continent have been reported in Angola, the Democratic Republic of the Congo, Kenya, South Africa and Uganda.

The disease was first recognized in 1967, following two large simultaneous outbreaks in laboratories in the German cities of Marburg, and in Belgrade, capital of the then Yugoslavia..

The agency welcomed the start of the vaccination drive, in line with national authorities’ broader viagra for sale public health why not try these out efforts, which began on Tuesday. €¯ “The first step in fully protecting communities…is through the rollout of vaccination[s]”, said Johannes Van Der Klaauw, UNHCR’s Representative in Bangladesh. Fair distribution UNHCR stressed that when allocating the treatments, the equitable inclusion viagra for sale of Rohingya refugees is critical to curbing the spread of the deadly disease.

The drive is being led by the Bangladesh authorities with technical support from UNHCR, the World Health Organization (WHO) and other humanitarian partners.  “We are grateful to the Government of Bangladesh for having included Rohingya refugees in the vaccination campaign”, said Mr. Van Der Klaauw. The complex viagra for sale Rohingya refugee crisis erupted in August 2017, following attacks on remote police outposts in western Myanmar by armed groups alleged to be from within the community.

These were followed by systematic counter attacks against the minority, mainly Muslim Rohingya, which human rights groups, including senior UN officials, have said amounted to ethnic cleansing. Frontline efforts Thousands of refugee and host community volunteers have taken the lead, working to fight the on-going viagra since it began, by informing refugees about health and hygiene, monitoring signs of illness, and connecting the viagra for sale refugee community with critical health services, according to UNHCR. €œThe Rohingya refugee and host community volunteers have an essential frontline role in containing the spread of erectile dysfunction treatment in the camps”, the UNHCR official underscored.

While the threat of erectile dysfunction treatment remains critical, their efforts have helped to prevent and curb outbreaks and have saved lives.  Disasters pile up The vaccinations follow weeks of devastating monsoon rains that have pummelled the Cox’s Bazar District, killing eight refugees and 15 of their Bangladeshi hosts. And landslides, flooding, wind and storms have displaced almost 25,000 refugees while ravaging thousands of facilities, including primary health clinics, distribution points and latrines viagra for sale. At the same time, damaged roads, pathways and bridges have hindered humanitarian access.

Stepping up response UNHCR’s Emergency Response Teams, and partners, refugee and host community volunteers were deployed to assess the damage. They aim to support families forced to relocate, repair shelters and other sites, and ensure access to essential services for everyone.  viagra for sale While the weather has improved over the last few days, the agency warned that monsoon season will continue for several more months, followed by the cyclone season.Marburg, a highly infectious disease that causes haemorrhagic fever, is transmitted to humans by fruit bats. The viagra is in the same family as Ebola.

.@WHO & viagra for sale. Partners are supporting #Guinea’s Ministry of Health to investigate the source of the #Marburg outbreak, trace contacts, &. Inform the local community about how to protect themselves.

About 150 contacts have been identified and are being followed up so far.— Tedros Adhanom Ghebreyesus (@DrTedros) August 11, 2021 It was viagra for sale detected in Gueckedou prefecture in southwestern Guinea, and less than two months after the country declared an end to an Ebola outbreak this year which killed 12 people. The patient was a man who died on 2 August, eight days after the onset of symptoms. The village where he lived is near the borders with both Sierra Leone and Liberia.

Tedros Adhanom Ghebreyesus, the WHO viagra for sale Director-General, said Guinea’s Ministry of Health reported the case to the UN agency on Friday. 150 contacts identified WHO is supporting the authorities in investigating the source of the outbreak, tracing contacts and informing the local community about protection measures. €œAbout 150 contacts have been identified viagra for sale and are being followed up, including three family members and a health worker, who have been identified as high-risk close contacts,” Tedros told journalists in Geneva.

Gueckedou prefecture is the same region where cases of the Ebola outbreak in Guinea this year, as well as the 2014–2016 West Africa outbreak, were initially detected. Marburg disease has a nearly 90 cent fatality rate, according to WHO. Currently there is no treatment against it, although treatments are under development, but rehydration with oral or intravenous fluids viagra for sale and treatment of specific symptoms, improves survival.

Previous outbreaks and sporadic cases on the African continent have been reported in Angola, the Democratic Republic of the Congo, Kenya, South Africa and Uganda. The disease was first recognized in 1967, following two large simultaneous outbreaks in laboratories in the German cities of Marburg, and in Belgrade, capital of the then Yugoslavia..

Grapefruit juice and viagra

To The grapefruit juice and viagra Editor. The grapefruit juice and viagra messenger RNA treatment BNT162b2 (Pfizer–BioNTech) has 95% efficacy against erectile dysfunction disease 2019 (erectile dysfunction treatment).1 Qatar launched a mass immunization campaign with this treatment on December 21, 2020. As of March 31, 2021, a total of 385,853 persons had received at least one treatment dose and 265,410 had completed the two doses.

Vaccination scale-up occurred as Qatar was undergoing its second and third waves of severe acute respiratory syndrome erectile dysfunction 2 (erectile dysfunction) , which were triggered by expansion of the B.1.1.7 variant (starting in mid-January 2021) grapefruit juice and viagra and the B.1.351 variant (starting in mid-February 2021). The B.1.1.7 wave peaked during the first week of March, and the rapid expansion of B.1.351 started in mid-March and continues to the present day. Viral genome sequencing conducted from February 23 through March 18 indicated that 50.0% of cases of erectile dysfunction treatment in Qatar were caused by B.1.351 and 44.5% grapefruit juice and viagra were caused by B.1.1.7.

Nearly all cases in which viagra was sequenced after March 7 were caused by either B.1.351 or B.1.1.7. Data on vaccinations, polymerase-chain-reaction testing, and clinical characteristics were extracted from the national, federated erectile dysfunction treatment databases that have captured all erectile dysfunction–related data since the start of the epidemic (Section S1 of the Supplementary Appendix, available with the full text of this grapefruit juice and viagra letter at NEJM.org). treatment effectiveness was estimated with a test-negative case–control study design, a preferred design for assessing treatment effectiveness against influenza (see the Supplementary Appendix).2 A key strength of this design is the ability to control for bias that may result from differences in health care–seeking behavior between vaccinated and unvaccinated persons.2 Table 1.

Table 1 grapefruit juice and viagra. treatment Effectiveness against and against Disease in Qatar. The estimated effectiveness of the treatment against grapefruit juice and viagra any documented with the B.1.1.7 variant was 89.5% (95% confidence interval [CI], 85.9 to 92.3) at 14 or more days after the second dose (Table 1 and Table S2).

The effectiveness against any documented with the B.1.351 variant was 75.0% (95% CI, 70.5 to 78.9). treatment effectiveness against severe, critical, or fatal disease due to with any erectile dysfunction (with the B.1.1.7 and B.1.351 variants being predominant grapefruit juice and viagra within Qatar) was very high, at 97.4% (95% CI, 92.2 to 99.5). Sensitivity analyses confirmed these results (Table S3).

treatment effectiveness was also assessed with the use of a cohort study design by comparing the incidence of among vaccinated persons with the incidence in the national cohort of persons grapefruit juice and viagra who were antibody-negative (Section S2). Effectiveness was estimated to be 87.0% (95% CI, 81.8 to 90.7) against the B.1.1.7 variant and 72.1% (95% CI, 66.4 to 76.8) against the B.1.351 variant, findings that confirm the results reported above. The BNT162b2 treatment was effective against and disease in the population of Qatar, despite the B.1.1.7 grapefruit juice and viagra and B.1.351 variants being predominant within the country.

However, treatment effectiveness against the B.1.351 variant was approximately 20 percentage points lower than the effectiveness (>90%) reported in the clinical trial1 and in real-world conditions in Israel4 and the United States.5 In Qatar, as of March 31, breakthrough s have been recorded in 6689 persons who had received one dose of the treatment and in 1616 persons who had received two doses. Seven deaths from erectile dysfunction treatment have been also recorded among grapefruit juice and viagra vaccinated persons. Five after the first dose and two after the second dose.

Nevertheless, the reduced protection against with the B.1.351 variant did not seem to translate into poor protection against the most severe forms of (i.e., those resulting in hospitalization or grapefruit juice and viagra death), which was robust, at greater than 90%. Laith J. Abu-Raddad, Ph.D.Hiam Chemaitelly, grapefruit juice and viagra M.Sc.Weill Cornell Medicine–Qatar, Doha, Qatar [email protected]Adeel A.

Butt, M.D.Hamad Medical Corporation, Doha, Qatarfor the National Study Group for erectile dysfunction treatment Vaccination Supported by the Biomedical Research Program and the Biostatistics, Epidemiology, and Biomathematics Research Core at Weill Cornell Medicine–Qatar. The Ministry of Public grapefruit juice and viagra Health. And Hamad Medical Corporation.

The Qatar Genome Program supported the viral genome grapefruit juice and viagra sequencing. Disclosure forms provided by the authors are available with the grapefruit juice and viagra full text of this letter at NEJM.org. This letter was published on May 5, 2021, at NEJM.org.

Members of the National Study Group for erectile dysfunction treatment Vaccination are listed grapefruit juice and viagra in the Supplementary Appendix, available with the full text of this letter at NEJM.org. 5 References1. Polack FP, Thomas SJ, Kitchin N, grapefruit juice and viagra et al.

Safety and efficacy of the BNT162b2 mRNA erectile dysfunction treatment. N Engl grapefruit juice and viagra J Med 2020;383:2603-2615.2. Jackson ML, Nelson JC.

The test-negative design for estimating grapefruit juice and viagra influenza treatment effectiveness. treatment 2013;31:2165-2168.3. erectile dysfunction treatment clinical grapefruit juice and viagra management.

Living guidance. Geneva. World Health Organization, January 25, 2021 (https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1).Google Scholar4.

Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA erectile dysfunction treatment in a nationwide mass vaccination setting. N Engl J Med 2021;384:1412-1423.5.

Thompson MG, Burgess JL, Naleway AL, et al. Interim estimates of treatment effectiveness of BNT162b2 and mRNA-1273 erectile dysfunction treatments in preventing erectile dysfunction among health care personnel, first responders, and other essential and frontline workers — eight U.S. Locations, December 2020–March 2021.

MMWR Morb Mortal Wkly Rep 2021;70:495-500.10.1056/NEJMc2104974-t1Table 1. treatment Effectiveness against and against Disease in Qatar. Type of or DiseasePCR-Positive PersonsPCR-Negative PersonsEffectiveness (95% CI)*VaccinatedUnvaccinatedVaccinatedUnvaccinatednumber of personspercentPCR-confirmed with the B.1.1.7 variant†After one dose89218,075124117,72629.5 (22.9–35.5)≥14 days after second dose5016,35446515,93989.5 (85.9–92.3)PCR-confirmed with the B.1.351 variant‡After one dose132920,177158019,92616.9 (10.4–23.0)≥14 days after second dose17919,39669818,87775.0 (70.5–78.9)Disease§Severe, critical, or fatal disease caused by the B.1.1.7 variantAfter one dose304686143754.1 (26.1–71.9)≥14 days after second dose040120381100.0 (81.7–100.0)Severe, critical, or fatal disease caused by the B.1.351 variantAfter one dose45348353580.0 (0.0–19.0)≥14 days after second dose030014286100.0 (73.7–100.0)Severe, critical, or fatal disease caused by any erectile dysfunctionAfter one dose1391,9662201,88539.4 (24.0–51.8)≥14 days after second dose31,6921091,58697.4 (92.2–99.5)V-safe Surveillance.

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

Table 2. Table 2. Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons.

From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1).

Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1.

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

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

V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3.

Characteristics of V-safe Pregnancy Registry Participants. As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility).

The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel. Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3).

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

Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%).

A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview.

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

155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases. 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each.

No congenital anomalies were reported to the VAERS, a requirement under the EUAs.Trial Design and Participants From August 17, 2020, through November 25, 2020, we enrolled participants at 16 sites in South Africa. The trial was designed to provide a preliminary evaluation of treatment safety and efficacy during ongoing viagra transmission of erectile dysfunction. Participants were healthy adults between the ages of 18 and 84 years without human immunodeficiency viagra (HIV) or a subgroup of adults between the ages of 18 and 64 years with HIV whose condition was medically stable.

Baseline IgG antibodies against the spike protein (anti-spike IgG antibodies) were measured at study entry to help determine baseline erectile dysfunction serostatus for the analysis of treatment efficacy. As a safety measure, enrollment was staggered into stage 1 (defined by the first third of targeted enrollment) and stage 2 (the remainder of enrollment) for both HIV-negative and HIV-positive participants. Progression from stage 1 to stage 2 in each group required a favorable review of safety data through day 7 from the previous stage against prespecified rules that would trigger a pause in treatment administration.

(Details regarding the participants in each stage are provided in Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org.) Key exclusion criteria were pregnancy, long-term receipt of immunosuppressive therapy, autoimmune or immunodeficiency disease except for medically stable HIV , a history of confirmed or suspected erectile dysfunction treatment, and erectile dysfunction as confirmed on a nucleic acid amplification test (NAAT) performed as part of screening within 5 days before anticipated initial administration of the treatment or placebo. All the participants provided written informed consent before enrollment. Additional details regarding the trial design, conduct, oversight, and analyses are provided in the Supplementary Appendix and the protocol (which includes the statistical analysis plan), available at NEJM.org.

Oversight The NVX-CoV2373 treatment was developed by Novavax, which sponsored the trial and was responsible for the overall design (with input from the lead investigator), site selection, monitoring, and analysis. Trial investigators were responsible for data collection. The protocol was approved by the South African Health Products Regulatory Authority and by the institutional review board at each trial center.

Oversight of safety, which included monitoring for specific vaccination-pause rules, was performed by an independent safety monitoring committee. The first author wrote the first draft of the manuscript with assistance from a medical writer who is an author and an employee of Novavax. All the authors made the decision to submit the manuscript for publication and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

Trial Procedures Participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections, 21 days apart, of either NVX-CoV2373 (5 μg of recombinant spike protein with 50 μg of Matrix-M1 adjuvant) or saline placebo (injection volume, 0.5 ml), administered by staff members who were aware of trial-group assignments but were not otherwise involved with other trial procedures or data collection. All other staff members and trial participants remained unaware of trial-group assignments. Participants were scheduled for in-person follow-up visits on days 7, 21, and 35 and at 3 months and 6 months to collect vital signs, review any adverse events, discuss changes in concomitant medications, and obtain blood samples for immunogenicity analyses.

A follow-up telephone visit was scheduled for 12 months after vaccination. Safety Assessments The primary safety end points were the occurrence of all unsolicited adverse events, including those that were medically attended, serious, or of special interest, through day 35 (Tables S2 and S3) and solicited local and systemic adverse events that were evaluated by means of a reactogenicity diary for 7 days after each vaccination (Tables S4 and S5). Safety follow-up was ongoing through month 12.

Efficacy Assessments The primary efficacy end point was confirmed symptomatic erectile dysfunction treatment that was categorized as mild, moderate, or severe (hereafter called symptomatic erectile dysfunction treatment) and that occurred within 7 days after receipt of the second injection (i.e., after day 28) (Table S6). Starting on day 8 and continuing through 12 months, we performed active surveillance (telephone calls every 2 weeks from trial sites to participants) and passive surveillance (telephone contact at any time from participants to trial sites) for symptoms of suspected erectile dysfunction treatment (Table S7 and Fig. S1).

A new onset of suspected symptoms of erectile dysfunction treatment triggered initial in-person and follow-up surveillance visits to perform clinical assessments (vital signs, including pulse oximetry, and a lung examination) and for collection of nasal swabs (Fig. S2). In addition, suspected erectile dysfunction treatment symptoms were also assessed and nasal swabs collected at all scheduled trial visits.

Nasal-swab samples were tested for the presence of erectile dysfunction by NAAT with the use of the BD MAX system (Becton Dickinson). We used the InFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire to comprehensively assess symptoms for the first 10 days of a suspected episode of erectile dysfunction treatment. Whole-Genome Sequencing In a blinded fashion, we performed post hoc whole-genome sequencing of nasal samples obtained from all the participants who had symptomatic erectile dysfunction treatment.

Details regarding the whole-genome sequencing methods and phylogenetic analysis are provided in Fig. S3. Statistical Analysis The safety analysis population included all the participants who had received at least one injection of NVX-CoV2373 or placebo.

Regardless of group assignment, participants were evaluated according to the intervention they had actually received. Safety analyses were presented as numbers and percentages of participants who had solicited local and systemic adverse events through day 7 after each vaccination and who had unsolicited adverse events through day 35. We performed a per-protocol efficacy analysis in the population of participants who had been seronegative for erectile dysfunction at baseline and who had received both injections of NVX-CoV2373 or placebo as assigned, had no evidence of erectile dysfunction (by NAAT or anti-spike IgG analysis) within 7 days after the second injection (i.e., before day 28), and had no major protocol deviations affecting the primary efficacy outcome.

A second per-protocol efficacy analysis population was defined in a similar fashion except that participants who were seropositive for erectile dysfunction at baseline could be included. treatment efficacy (calculated as a percentage) was defined as (1–RR)×100, where RR is the relative risk of erectile dysfunction treatment illness in the treatment group as compared with the placebo group. The official, event-driven efficacy analysis targeted a minimum number of 23 end points (range, 23 to 50) to provide approximately 90% power to detect treatment efficacy of 80% on the basis of an incidence of symptomatic erectile dysfunction treatment of 2 to 6% in the placebo group.

This analysis was performed at an overall one-sided type I error rate of 0.025 for the single primary efficacy end point. The relative risk and its confidence interval were estimated with the use of Poisson regression with robust error variance. Hypothesis testing of the primary efficacy end point was performed against the null hypothesis of treatment efficacy of 0%.

The success criterion required rejection of the null hypothesis to show a statistically significant treatment efficacy.Participants Figure 1. Figure 1. Enrollment and 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 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 underwent randomization at 152 sites worldwide (United States, 130 sites.

Germany, 6. And Turkey, 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 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 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 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 assessed according to the following scale. Mild, does not interfere with activity. Moderate, interferes with activity.

Severe, prevents daily activity. And grade 4, emergency department visit or hospitalization. Redness and 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 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 in the key.

Medication use was not graded. Additional scales were 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..

To The viagra for sale Editor Bonuses. The messenger RNA treatment BNT162b2 (Pfizer–BioNTech) has 95% efficacy against erectile dysfunction disease 2019 (erectile dysfunction treatment).1 Qatar launched a mass immunization viagra for sale campaign with this treatment on December 21, 2020. As of March 31, 2021, a total of 385,853 persons had received at least one treatment dose and 265,410 had completed the two doses. Vaccination scale-up occurred as Qatar was undergoing its second and third waves of severe acute respiratory syndrome erectile dysfunction 2 (erectile dysfunction) , which were triggered by expansion of the B.1.1.7 variant (starting in mid-January 2021) and the B.1.351 variant (starting in viagra for sale mid-February 2021).

The B.1.1.7 wave peaked during the first week of March, and the rapid expansion of B.1.351 started in mid-March and continues to the present day. Viral genome sequencing conducted from February 23 through March 18 indicated that 50.0% of cases of erectile dysfunction treatment in Qatar were caused by B.1.351 and 44.5% were caused by B.1.1.7 viagra for sale. Nearly all cases in which viagra was sequenced after March 7 were caused by either B.1.351 or B.1.1.7. Data on vaccinations, polymerase-chain-reaction testing, and clinical characteristics were extracted from the national, federated erectile dysfunction treatment databases that have captured all erectile dysfunction–related data since the start of the epidemic (Section S1 viagra for sale of the Supplementary Appendix, available with the full text of this letter at NEJM.org).

treatment effectiveness was estimated with a test-negative case–control study design, a preferred design for assessing treatment effectiveness against influenza (see the Supplementary Appendix).2 A key strength of this design is the ability to control for bias that may result from differences in health care–seeking behavior between vaccinated and unvaccinated persons.2 Table 1. Table 1 viagra for sale. treatment Effectiveness against and against Disease in Qatar. The estimated effectiveness of the treatment against any viagra for sale documented with the B.1.1.7 variant was 89.5% (95% confidence interval [CI], 85.9 to 92.3) at 14 or more days after the second dose (Table 1 and Table S2).

The effectiveness against any documented with the B.1.351 variant was 75.0% (95% CI, 70.5 to 78.9). treatment effectiveness against severe, critical, or fatal disease due to with any erectile dysfunction (with the B.1.1.7 and B.1.351 variants being predominant within Qatar) was very high, at 97.4% (95% CI, 92.2 viagra for sale to 99.5). Sensitivity analyses confirmed these results (Table S3). treatment effectiveness viagra for sale was also assessed with the use of a cohort study design by comparing the incidence of among vaccinated persons with the incidence in the national cohort of persons who were antibody-negative (Section S2).

Effectiveness was estimated to be 87.0% (95% CI, 81.8 to 90.7) against the B.1.1.7 variant and 72.1% (95% CI, 66.4 to 76.8) against the B.1.351 variant, findings that confirm the results reported above. The BNT162b2 treatment was effective against viagra for sale and disease in the population of Qatar, despite the B.1.1.7 and B.1.351 variants being predominant within the country. However, treatment effectiveness against the B.1.351 variant was approximately 20 percentage points lower than the effectiveness (>90%) reported in the clinical trial1 and in real-world conditions in Israel4 and the United States.5 In Qatar, as of March 31, breakthrough s have been recorded in 6689 persons who had received one dose of the treatment and in 1616 persons who had received two doses. Seven deaths from erectile dysfunction treatment have been also recorded among vaccinated viagra for sale persons.

Five after the first dose and two after the second dose. Nevertheless, the reduced protection against with the B.1.351 variant did not seem to translate into poor protection against the most severe forms of (i.e., those resulting in viagra for sale hospitalization or death), which was robust, at greater than 90%. Laith J. Abu-Raddad, Ph.D.Hiam Chemaitelly, M.Sc.Weill viagra for sale Cornell Medicine–Qatar, Doha, Qatar [email protected]Adeel A.

Butt, M.D.Hamad Medical Corporation, Doha, Qatarfor the National Study Group for erectile dysfunction treatment Vaccination Supported by the Biomedical Research Program and the Biostatistics, Epidemiology, and Biomathematics Research Core at Weill Cornell Medicine–Qatar. The Ministry of Public Health viagra for sale. And Hamad Medical Corporation. The Qatar Genome Program supported the viral genome sequencing viagra for sale.

Disclosure forms provided by the authors are available with the viagra for sale full text of this letter at NEJM.org. This letter was published on May 5, 2021, at NEJM.org. Members of viagra for sale the National Study Group for erectile dysfunction treatment Vaccination are listed in the Supplementary Appendix, available with the full text of this letter at NEJM.org. 5 References1.

Polack FP, viagra for sale Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA erectile dysfunction treatment. N Engl viagra for sale J Med 2020;383:2603-2615.2. Jackson ML, Nelson JC.

The test-negative design for viagra for sale estimating influenza treatment effectiveness. treatment 2013;31:2165-2168.3. erectile dysfunction treatment clinical viagra for sale management. Living guidance.

Geneva. World Health Organization, January 25, 2021 (https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1).Google Scholar4. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA erectile dysfunction treatment in a nationwide mass vaccination setting.

N Engl J Med 2021;384:1412-1423.5. Thompson MG, Burgess JL, Naleway AL, et al. Interim estimates of treatment effectiveness of BNT162b2 and mRNA-1273 erectile dysfunction treatments in preventing erectile dysfunction among health care personnel, first responders, and other essential and frontline workers — eight U.S. Locations, December 2020–March 2021.

MMWR Morb Mortal Wkly Rep 2021;70:495-500.10.1056/NEJMc2104974-t1Table 1. treatment Effectiveness against and against Disease in Qatar. Type of or DiseasePCR-Positive PersonsPCR-Negative PersonsEffectiveness (95% CI)*VaccinatedUnvaccinatedVaccinatedUnvaccinatednumber of personspercentPCR-confirmed with the B.1.1.7 variant†After one dose89218,075124117,72629.5 (22.9–35.5)≥14 days after second dose5016,35446515,93989.5 (85.9–92.3)PCR-confirmed with the B.1.351 variant‡After one dose132920,177158019,92616.9 (10.4–23.0)≥14 days after second dose17919,39669818,87775.0 (70.5–78.9)Disease§Severe, critical, or fatal disease caused by the B.1.1.7 variantAfter one dose304686143754.1 (26.1–71.9)≥14 days after second dose040120381100.0 (81.7–100.0)Severe, critical, or fatal disease caused by the B.1.351 variantAfter one dose45348353580.0 (0.0–19.0)≥14 days after second dose030014286100.0 (73.7–100.0)Severe, critical, or fatal disease caused by any erectile dysfunctionAfter one dose1391,9662201,88539.4 (24.0–51.8)≥14 days after second dose31,6921091,58697.4 (92.2–99.5)V-safe Surveillance. Local and Systemic Reactogenicity in Pregnant Persons Table 1.

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

Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons. From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1).

Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1. Figure 1.

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

Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3.

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

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

Table 4. Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%).

A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed.

Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons. 155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases.

37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each. No congenital anomalies were reported to the VAERS, a requirement under the EUAs.Trial Design and Participants From August 17, 2020, through November 25, 2020, we enrolled participants at 16 sites in South Africa. The trial was designed to provide a preliminary evaluation of treatment safety and efficacy during ongoing viagra transmission of erectile dysfunction. Participants were healthy adults between the ages of 18 and 84 years without human immunodeficiency viagra (HIV) or a subgroup of adults between the ages of 18 and 64 years with HIV whose condition was medically stable.

Baseline IgG antibodies against the spike protein (anti-spike IgG antibodies) were measured at study entry to help determine baseline erectile dysfunction serostatus for the analysis of treatment efficacy. As a safety measure, enrollment was staggered into stage 1 (defined by the first third of targeted enrollment) and stage 2 (the remainder of enrollment) for both HIV-negative and HIV-positive participants. Progression from stage 1 to stage 2 in each group required a favorable review of safety data through day 7 from the previous stage against prespecified rules that would trigger a pause in treatment administration. (Details regarding the participants in each stage are provided in Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org.) Key exclusion criteria were pregnancy, long-term receipt of immunosuppressive therapy, autoimmune or immunodeficiency disease except for medically stable HIV , a history of confirmed or suspected erectile dysfunction treatment, and erectile dysfunction as confirmed on a nucleic acid amplification test (NAAT) performed as part of screening within 5 days before anticipated initial administration of the treatment or placebo.

All the participants provided written informed consent before enrollment. Additional details regarding the trial design, conduct, oversight, and analyses are provided in the Supplementary Appendix and the protocol (which includes the statistical analysis plan), available at NEJM.org. Oversight The NVX-CoV2373 treatment was developed by Novavax, which sponsored the trial and was responsible for the overall design (with input from the lead investigator), site selection, monitoring, and analysis. Trial investigators were responsible for data collection.

The protocol was approved by the South African Health Products Regulatory Authority and by the institutional review board at each trial center. Oversight of safety, which included monitoring for specific vaccination-pause rules, was performed by an independent safety monitoring committee. The first author wrote the first draft of the manuscript with assistance from a medical writer who is an author and an employee of Novavax. All the authors made the decision to submit the manuscript for publication and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

Trial Procedures Participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections, 21 days apart, of either NVX-CoV2373 (5 μg of recombinant spike protein with 50 μg of Matrix-M1 adjuvant) or saline placebo (injection volume, 0.5 ml), administered by staff members who were aware of trial-group assignments but were not otherwise involved with other trial procedures or data collection. All other staff members and trial participants remained unaware of trial-group assignments. Participants were scheduled for in-person follow-up visits on days 7, 21, and 35 and at 3 months and 6 months to collect vital signs, review any adverse events, discuss changes in concomitant medications, and obtain blood samples for immunogenicity analyses. A follow-up telephone visit was scheduled for 12 months after vaccination.

Safety Assessments The primary safety end points were the occurrence of all unsolicited adverse events, including those that were medically attended, serious, or of special interest, through day 35 (Tables S2 and S3) and solicited local and systemic adverse events that were evaluated by means of a reactogenicity diary for 7 days after each vaccination (Tables S4 and S5). Safety follow-up was ongoing through month 12. Efficacy Assessments The primary efficacy end point was confirmed symptomatic erectile dysfunction treatment that was categorized as mild, moderate, or severe (hereafter called symptomatic erectile dysfunction treatment) and that occurred within 7 days after receipt of the second injection (i.e., after day 28) (Table S6). Starting on day 8 and continuing through 12 months, we performed active surveillance (telephone calls every 2 weeks from trial sites to participants) and passive surveillance (telephone contact at any time from participants to trial sites) for symptoms of suspected erectile dysfunction treatment (Table S7 and Fig.

S1). A new onset of suspected symptoms of erectile dysfunction treatment triggered initial in-person and follow-up surveillance visits to perform clinical assessments (vital signs, including pulse oximetry, and a lung examination) and for collection of nasal swabs (Fig. S2). In addition, suspected erectile dysfunction treatment symptoms were also assessed and nasal swabs collected at all scheduled trial visits.

Nasal-swab samples were tested for the presence of erectile dysfunction by NAAT with the use of the BD MAX system (Becton Dickinson). We used the InFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire to comprehensively assess symptoms for the first 10 days of a suspected episode of erectile dysfunction treatment. Whole-Genome Sequencing In a blinded fashion, we performed post hoc whole-genome sequencing of nasal samples obtained from all the participants who had symptomatic erectile dysfunction treatment. Details regarding the whole-genome sequencing methods and phylogenetic analysis are provided in Fig.

S3. Statistical Analysis The safety analysis population included all the participants who had received at least one injection of NVX-CoV2373 or placebo. Regardless of http://onetracktrainers.com/member/blog/167/ group assignment, participants were evaluated according to the intervention they had actually received. Safety analyses were presented as numbers and percentages of participants who had solicited local and systemic adverse events through day 7 after each vaccination and who had unsolicited adverse events through day 35.

We performed a per-protocol efficacy analysis in the population of participants who had been seronegative for erectile dysfunction at baseline and who had received both injections of NVX-CoV2373 or placebo as assigned, had no evidence of erectile dysfunction (by NAAT or anti-spike IgG analysis) within 7 days after the second injection (i.e., before day 28), and had no major protocol deviations affecting the primary efficacy outcome. A second per-protocol efficacy analysis population was defined in a similar fashion except that participants who were seropositive for erectile dysfunction at baseline could be included. treatment efficacy (calculated as a percentage) was defined as (1–RR)×100, where RR is the relative risk of erectile dysfunction treatment illness in the treatment group as compared with the placebo group. The official, event-driven efficacy analysis targeted a minimum number of 23 end points (range, 23 to 50) to provide approximately 90% power to detect treatment efficacy of 80% on the basis of an incidence of symptomatic erectile dysfunction treatment of 2 to 6% in the placebo group.

This analysis was performed at an overall one-sided type I error rate of 0.025 for the single primary efficacy end point. The relative risk and its confidence interval were estimated with the use of Poisson regression with robust error variance. Hypothesis testing of the primary efficacy end point was performed against the null hypothesis of treatment efficacy of 0%. The success criterion required rejection of the null hypothesis to show a statistically significant treatment efficacy.Participants Figure 1.

Figure 1. Enrollment and 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 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 underwent randomization at 152 sites worldwide (United States, 130 sites.

Argentina, 1. Brazil, 2. South Africa, 4. Germany, 6.

And Turkey, 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 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 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 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 assessed according to the following scale.

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

Redness and 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 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 in the key. Medication use was not graded.

Additional scales were 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..