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  • What you should know about Tadalafil

    Tadalafil is a drug prescribed to treat erectile dysfunction (ED). This medication increases blood flow to the penis during sexual stimulation.

    It is estimated that 1 in 10 men experience sexual difficulties. This may include erectile dysfunction, premature ejaculation or loss of libido.

    This article discusses erectile dysfunction, tadalafil, alternative remedies and the need to seek medical attention.

    Sexual health and erectile dysfunction
    Erectile dysfunction refers to the difficulty a person has in achieving or maintaining an erection. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) states that approximately 30 million men in the United States may suffer from this health problem.

    The NIDDK adds that erectile dysfunction is more common in:

    the elderly
    people with specific psychological, emotional or physical conditions
    People who take specific medications
    smokers
    people with a high BMI.
    In addition, a recent study found that erectile dysfunction was common in a cohort of sexually active men aged 18 to 31 in the United States. The study found that relationship status and mental health were the most important factors.

    Brand name and generic drugs
    When a pharmaceutical company develops a new drug, it must obtain New Drug Approval (NDA) from the Food and Drug Administration (FDA). Once approval is granted, there is a period of exclusivity during which no other company can produce the same drug using the same active ingredients. Exclusivity periods can last from 180 days to 7 years.

    After this period, other manufacturers are free to produce generic versions of a drug under an Abbreviated New Drug Application (ANDA). The term “abbreviated” means that generic drug developers do not have to submit the preclinical and clinical trial data provided by the brand-name pharmaceutical company. This also explains the cost difference between branded and generic drugs.

    Tadalafil is the generic name for the branded drug Cialis. At the time of publication, the average price of 30 Cialis 10-milligram (mg) tablets is about $2,524.92, while tadalafil is about $1,603.20, making it much more cost-effective. Some online companies, such as Canadian Pharmacy, also offer discount coupons that bring the price down considerably. For example, the same dose and quantity of tadalafil tablets using a Promo-23 coupon at Canadian Pharmacy for tadalafil please check through the link https://salecanadianpharmacy.com/product/cialis-2/

    How does tadalafil work?
    Tadalafil is one of a class of phosphodiesterase (PDE5) inhibitors that treat people with high blood pressure in the lungs, also known as pulmonary hypertension, erectile dysfunction and benign prostatic hypertrophy.

    PDE5 inhibitors work by increasing blood flow to the penis. They block a specific enzyme in the blood vessels. This means that these blood vessels can relax, resulting in increased blood flow to a specific area.

    To learn more about PDE5 inhibitors, click here.

    The effects of tadalafil can last up to 36 hours. This is much longer than the similar drug, sildenafil (brand name Viagra), which lasts about 4 hours. A person may consider this an advantage or a disadvantage.

    Where to buy tadalafil
    Tadalafil is available at most pharmacies in the United States, subject to a prescription. FDATrusted Source recommends against purchasing erectile dysfunction treatments without a prescription, as these products may contain undisclosed ingredients.

    Romans and Hims offer free online consultations, but the person must pay for the prescription if the doctor feels tadalafil is right for them. Insurance generally does not cover the cost of these companies’ drugs.

    Lemonaid charges a fee for a consultation, but a person can submit a request for free. Insurance does not cover Lemonaid consultations but may cover some prescription drugs. The available benefits should be checked with the insurance company.

    Side Effects and Warnings
    Because of the possibility of side effects and allergic reactions, a person should always consult their doctor before taking tadalafil.

    Some people experience few or no side effects when taking tadalafil, but the most common side effects are

    headaches
    indigestion or heartburn
    nausea
    diarrhea
    pain in the stomach, legs, arms or back
    cough
    red or flushed face
    stuffy nose
    More rarely, a person may experience serious side effects, including

    chest pain
    prolonged or painful erections
    sudden loss of vision or hearing
    skin reactions such as rashes
    seizures
    In these cases, people should stop taking the medication and seek medical attention immediately.

    In extremely rare cases, a person may experience a severe allergic reaction, known as anaphylaxis. In this case, medical attention should be sought immediately and urgently.

    To learn more about anaphylaxis, click here.

    A doctor may not recommend tadalafil for everyone. For example, if a person has severe heart or liver problems, low or high blood pressure, or has recently had a stroke or heart attack, the doctor may consider other options.

    Frequently Asked Questions
    Below we look at the most common questions about tadalafil.

    Can I take tadalafil every day?
    In some cases, yes, but this is usually to treat medical problems other than erectile dysfunction. A person can take the medication daily or as needed, but they should discuss the dosage and frequency with their doctor first.

    How long does it take for Tadalafil to work?
    Tadalafil should be taken at least 30 minutes before sexual intercourse, if it is taken only as needed.

    How long do the effects of Tadalafil last?
    The effects of Tadalafil can last from 24 to 36 hours.

    Can I take more than one tablet a day?
    No. Individuals should only take one tablet in a 24-hour period.

    Do I need a prescription to get Tadalafil?
    Yes, a person must have a prescription to obtain Tadalafil. If one does not wish to visit their primary care physician, it is possible to obtain a prescription online after a virtual consultation with an online pharmacy such as https://pharmaciecanadienne.net/ or https://salecanadianpharmacy.com.

    Can Tadalafil alone cause an erection?
    No. A person must feel sexual arousal

    Summary
    Tadalafil can help people with erectile dysfunction by increasing blood flow to the penis during sexual arousal.

    Tadalafil can only be obtained with a valid prescription, issued following a consultation with the treating physician or through an online pharmacy.

    Alternative options are available for those who wish to try something other than medication to manage their erectile dysfunction.

  • Return to school is driving up Covid-19 cases in kids, but there are more tools to keep them safe this year

    Covid-19 cases are on the rise among kids in the United States as another school year gets underway.

    New cases reported among children in the last week of August were 14% higher than they were two weeks earlier, according to data tracked by the American Academy of Pediatrics. They jumped even more in the South, where classes have been in session for weeks. In contrast, overall cases for all ages were down about 17% in the same timeframe.

    Experts say that this increased transmission is to be expected — but that keeping kids in school should be the priority, and there are now enough ways to make sure it’s done safely.

    “We do see infectious diseases spread every time the school year starts. That’s been a phenomenon well-known long before Covid,” said Dr. Sean O’Leary, chair of the pediatric association’s committee on infectious diseases. “The good news is, we’re in a much different place with this pandemic than we were two years ago, or even last year, in terms of the percentage of the population that’s vaccinated.”

    Eligibility for Covid-19 vaccines was expanded to include ages 5 to 11 in November, making this the first full school year in which all school-age children could have their initial series.

    Still, vaccination rates for children lag and have changed little recently: About 61% of children ages 12 to 17 and just 31% of children 5 to 11 have their initial series, compared with about 77% of adults, according to data from the US Centers for Disease Control and Prevention.

    Children 5 and up are also eligible for a booster shot, but only those 12 and up can get the updated version. And so far, only about 10% of children ages 5 to 17 have gotten a booster.

    The slow rollout of vaccines for children is part of why pediatric cases became more prevalent during last school year, said Dr. Grace Lee, pediatrics professor at Stanford University School of Medicine and chair of the CDC’s vaccine advisory committee.

    In 2020, there wasn’t much virus circulating among children because most were learning from home, she said. But the negative effects of remote learning were coming into focus.

    An assessment conducted by the National Center for Education Statistics found that test scores among 9-year-olds plummeted in math and reading after the pandemic. And mental health-related visits to emergency rooms among adolescents saw a steep increase.

    “We needed the kids to go back in person for learning. At the same time, we didn’t have as many opportunities to offer vaccination in a timely manner to those who were going back to school. So that is really challenging,” Lee said. “Part of the reason we saw case rates jump up in pediatrics is because they were the last population to get vaccinated.”

    Now, though, there’s greater population immunity built up through a combination of vaccination and infection.

    About 4 out of 5 children in the US have had Covid-19 at some point, according to estimates from the CDC that are based on the presence of antibodies in blood samples. This is a significant jump from the end of 2021, when 45% of children were estimated to have had Covid-19.

    That doesn’t mean the potential for Covid to spread in schools should be ignored, experts say; it was still a top 10 cause of death for children last year, and there’s too much uncertainty about what’s to come.

    “We’ve now been infected, vaccinated, infected, vaccinated. Where are we going this season? I do think that we have to take it one year, one month at a time,” Lee said.

    Last year, the CDC updated its school guidance to prioritize in-person learning while maintaining layered prevention strategies such as masking, physical distancing and vaccinations for those who were eligible. Last month, the guidance was updated again, dropping recommendations for programs that require a negative test to stay in the classroom or restrict kids to one classroom, or cohort.

    Mask mandates have dropped across the county, too.

    However, while the CDC and others are more generally focused on preventing severe disease from Covid-19, experts say there are still benefits to avoiding infection, especially for kids in school.

    “We have to really take a life course approach with children,” Lee said, thinking about both the short- and long-term effects.

    In the short term, a Covid-19 infection “completely disrupts your family life and your school life and your personal life,” she said.

    “Every time someone gets sick — whether it’s Covid or flu or anything else — they’re getting further and further behind,” she said. And “the burden of infection is not equitable,” causing disparities to grow.

    Children can have long Covid, too — a direct long-term risk of infection. And if enough teachers get sick, the indirect risks from the early days of school closures can resurface.

    As a parent herself, Lee recommends that kids continue to wear masks in schools and keep up-to-date with any vaccines they’re eligible for.

    “I would say kids have been the most adaptable during the pandemic. So I’m less worried about that piece of it,” Lee said.

    “My hope is that we make schools a safe and equitable place to continue to learn and that we support our children, no matter what happens.”

  • Walk this number of steps each day to cut your risk of dementia

    Want to reduce your risk for dementia? Slap on a step counter and start tallying your steps — you’ll need between 3,800 and 9,800 each day to reduce your risk of mental decline, according to a new study.

    People between the ages of 40 and 79 who took 9,826 steps per day were 50% less likely to develop dementia within seven years, the study found. Furthermore, people who walked with “purpose” — at a pace over 40 steps a minute — were able to cut their risk of dementia by 57% with just 6,315 steps a day.

    “It is a brisk walking activity, like a power walk,” said study coauthor Borja del Pozo Cruz, an adjunct associate professor at the University of Southern Denmark in Odense, Denmark, and senior researcher in health sciences for the University of Cadiz in Spain.

    Even people who walked approximately 3,800 steps a day at any speed cut their risk of dementia by 25%, the study found.

    “That would be enough, at first, for sedentary individuals,” said del Pozo Cruz in an email.

    “In fact, it is a message that doctors could use to motivate very sedentary older adults — 4k steps is very doable by many, even those that are less fit or do not feel very motivated,” he added. “Perhaps, more active and fitter individuals should aim for 10k, where we see maximum effects.”

    But there was a even more interesting result buried in the study, according to an editorial entitled “Is 112 the New 10,000?” published Tuesday in JAMA Neurology.

    The largest reduction in dementia risk — 62% — was achieved by people who walked at a very brisk pace of 112 steps per minute for 30 minutes a day, the study found. Prior research has labeled 100 steps a minute (2.7 miles per hour) as a “brisk” or moderate level of intensity.

    The editorial argued that individuals looking to reduce their risk of dementia focus on their walking pace over their walked distance.

    “While 112 steps/min is a rather brisk cadence, ‘112’ is conceivably a much more tractable and less intimidating number for most individuals than ‘10,000,’ especially if they have been physically inactive or underactive,” wrote Alzheimer’s researchers Ozioma Okonkwo and Elizabeth Planalp in the editorial. Okonkwo is an associate professor in the department of medicine at the Wisconsin Alzheimer’s Disease Research Center at the University of Wisconsin–Madison; Planalp is a research scientist in Okonkwo’s lab.

    “We do agree this is a very interesting finding,” said del Pozo Cruz via email. “Our take is that intensity of stepping matters! Over and above volume. Technology could be use to track not only number of steps but also pace and so these types of metrics can also be incorporated in commercial watches. More research is needed on this.”

    Don’t have a step counter? You can count the number of steps you take in 10 seconds and then multiply it by six — or the number of steps you take in six seconds and multiply it by 10. Either way works. But remember, not everyone’s steps are the same length, nor are their fitness levels. What might be a brisk pace for a 40-year-old may not be sustainable for a 70-year-old.

    Editor’s Note: Before beginning any new exercise program, consult your doctor. Stop immediately if you experience pain.

    Inside the study

    The study, also published Tuesday in JAMA Neurology, analyzed data from over 78,000 people between the ages of 40 and 79 who wore wrist accelerometers. Researchers counted each person’s total number of steps per day, and then placed them into two categories: Fewer than 40 steps per minute — which is more of an amble, like when you’re walking from room to room — and more than 40 steps per minute, or so-called “purposeful” walking. The researchers also analyzed peak performers — those who took the most steps within 30 minutes over the course of a day (although those 30 minutes did not have to occur on the same walk).

    Researchers then compared that person’s steps against their diagnosis of dementia of any type seven years later. After controlling for age, ethnicity, education, sex, socio-emotional status and how many days they wore an accelerometer, researchers also factored out such lifestyle variables as poor diet, smoking, alcohol use, medication use, sleep issues and a history of cardiovascular disease.

    The study did have some limitations, its authors point out — it was only observational, so it cannot establish a direct cause and effect between walking and a lower risk of dementia. In addition, “the age range of participants may have resulted in limited dementia cases, meaning our results may not be generalizable to older populations,” the study said.

    “Because there are often considerable delays in dementia diagnosis, and this study did not include formal clinical and cognitive assessments of dementia, it is possible that the prevalence of dementia in the community was much higher,” the authors added.

    While agreeing that the findings cannot be interpreted as a direct cause and effect, “the mounting evidence in support of the benefits of physical activity for maintaining optimal brain health can no longer be disregarded,” wrote Okonkwo and Planalp.

    “It is time for the management of physical inactivity to be considered an intrinsic part of routine primary care visits for older adults,” they added.

    Research adds up

    Indeed, recent research published in July has found many leisure activities, such as household chores, exercise, adult education classes and visiting with family and friends, affected dementia risk in middle-aged people.

    Adults who were highly engaged in physical activity such as frequent exercise had a 35% lower risk of developing dementia compared with people who were the least engaged in these activities, researchers found.

    Regularly doing household chores lowered risk by 21% while daily visits with family and friends lowered the risk of dementia by 15%, when compared with people who were less engaged.

    Everyone in the study benefited from the protective effect of physical and mental activities, whether or not they had a family history of dementia, researchers found.

    Another study published in January found that exercise may slow dementia in active older people whose brains already showed signs of plaques, tangles and other hallmarks of Alzheimer’s and other cognitive diseases.

    That study found exercise boosts levels of a protein known to strengthen communication between brain cells via synapses, which may be a key factor in keeping dementia at bay.

    “Dementia is preventable to a great extent,” said del Pozo Cruz. “Physical activity as well as other lifestyle behaviors such lack of alcohol and smoking, maintaining a healthy diet and weight and sleep can put you on the right track to avoid dementia.”

  • Updated Covid-19 boosters are rolling out now. Here’s what you need to know

    There’s a new kind of Covid-19 shot coming to a pharmacy or clinic near you.

    The US Food and Drug Administration and US Centers for Disease Control and Prevention signed off on updated boosters that target the original strain of the coronavirus as well as the Omicron subvariants BA.4 and BA.5. The hope is that these shots will improve protection against the currently circulating viruses that cause Covid-19.

    Here’s everything you need to know about the new bivalent boosters and who can get them.

    How are these new bivalent vaccines different?

    The new bivalent vaccines carry instructions to help our cells make defenses against two strains of the virus that causes Covid-19. The shots direct cells to make antibodies that bind to certain parts of the spike proteins from both the original strain of the SARS-CoV-2 virus and the BA.4 and BA.5 Omicron subvariants, which share an identical spike.

    BA.4 and BA.5 are the dominant variants in the United States, where there’s an average of 91,000 new infections each day.

    “These are vaccines that are made, manufactured and delivered identically to the Covid mRNA vaccines that most of us have already gotten,” said Dr. Gregory Poland, who leads the vaccine research group at Mayo Clinic in Rochester, Minnesota. “In a sense, you’ve just changed the blueprints.”

    Having twice the blueprints doesn’t mean you’re getting twice the dose of active ingredients, though.

    “The total mRNA content — the business part of the vaccine — that leads to the immune response is the same amount,” said Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, which makes one of the updated vaccines.

    Pfizer’s booster is a 30-microgram dose that contains 15 micrograms of mRNA against the ancestral strain and 15 micrograms against the BA.4 and BA.5 variants. It is authorized for people as young as 12.

    Moderna’s bivalent booster is a 50-microgram dose, with 25 micrograms of mRNA designed to fight the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to fight the BA.4 and BA.5 variants. It’s authorized for people 18 and older.

    The earlier mRNA shots are still the first two shots a person will get, but they’re no longer authorized for use as boosters in people age 12 and older.

    Where can I get an updated Covid-19 booster?

    Millions of vaccines are now shipping to tens of thousands of sites across the country. These include community health centers, health departments and pharmacies.

    CVS and Walgreens have started offering the shots. Both chains are scheduling appointments online, and say more slots will be added as they get shipments of the vaccines.

    The Biden administration expects appointment availability to ramp up over the first several days, with broad availability in a few weeks. People will be able to find locations at Vaccines.gov.

    “You’ll start seeing some places start giving some shots in arms over the weekend, but very relatively few because [of the] Labor Day weekend. And my expectation is over next week, or certainly over the next 10 days, you’re going to start seeing these bivalent vaccines become widely available across the country,” Dr. Ashish Jha, who leads the White House Covid-19 Response Team, told CNN.

    As with past Covid-19 vaccines, these shots will be available free of charge. But they may be some of the last Covid-19 freebies from the government, which has said it’s going to start commercializing treatments and vaccines this fall.

    Who should get an updated booster?

    Americans ages 12 and older are recommended get the new boosters as long as they’ve already had their primary series of vaccines.

    Experts say everyone needs one as protection from both vaccination and infection wanes considerably over time and in all age groups.

    “I do believe there will be benefit, essentially for everyone, with clearly more benefit for the elderly and those who have underlying conditions,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on CNN on Friday.

    Adults age 18 and older can get either a Pfizer or Moderna shot. Adolescents ages 12 and older can get an updated Pfizer shot.

    When should I get an updated booster?

    You should wait two months after your last vaccine dose to get an updated booster.

    For those who have recently recovered from a Covid-19 infection, the CDC recommends waiting at least until the illness has passed and a person is no longer contagious. For best results, it may be better to delay a booster for at least three months after symptoms started. Infection itself probably already acted like a booster; studies have shown that people have a relatively low risk of getting sick again for about three months after they recover.

    You may not want to wait as long as three months if Covid-19 levels are already high in your community or if you are reduced immune function.

    “Myself as an example, I was vaccinated, doubly boosted and infected, and I will be getting the updated BA.4/5 bivalent vaccine within three months of my having gotten infected, exactly the way the FDA has authorized and the CDC has recommended,” Fauci said.

    Can people get other vaccines at the same time as the updated booster?

    US health officials have recommended that providers offer the seasonal flu vaccine and Covid-19 vaccines at the same visit if a patient is eligible for the vaccinations. This upcoming fall and winter could host a high spread of flu and Covid-19, and administering both vaccinations at the same time has been found to be safe.

    The government is also preparing to launch a campaign that will urge Americans to get their annual flu shot along with an updated Covid-19 booster.

    One vaccine for which there are no data on administering it at the same time as others is the Jynneos monkeypox vaccine, according to the CDC’s guidance. The agency recommends that people, particularly adolescent or young adult men, might consider waiting four weeks after receiving monkeypox vaccination before receiving a Moderna, Novavax or Pfizer/BioNTech Covid-19 vaccine, “because of the observed risk” for myocarditis, inflammation of the heart muscle, or pericarditis, inflammation of the tissue surrounding the heart.

    The CDC adds that monkeypox vaccination “should not be delayed” due to recently receiving a Moderna, Novavax or Pfizer/BioNTech Covid-19 vaccine.

    When can younger children get an updated booster?

    Children ages 5 through 11 can still be boosted with the older, single-strain vaccines.

    Vaccine manufacturers are updating boosters for younger children now. Pfizer said it’s retooling its shots for children ages to 5 through 11 and will ask the FDA for authorization of those updated boosters in early October. It’s working with the FDA to update vaccines for children ages 6 months through 4 years.

    Until those are ready, the best way to protect babies, toddlers and gradeschoolers is to get eligible family and friends an updated shot.

    Can immunocompromised people get an updated booster?

    Yes, but that’s not all. If a health condition or a medication has lowered your immune function, the CDC recommends a two-pronged approach to boost your protection against Covid-19 — vaccination and preventive treatment with a type of passive immunity called Evusheld. Passive immunity is when antibodies are made in a lab and then given by injection or infusion to help people who can’t make enough of this protection on their own.

    Evusheld can be taken every six months and is available for immunocompromised people ages 12 and up. It requires a doctors prescription, but the treatment itself is free. The CDC estimates 7 million people may be eligible to take Evusheld, but most haven’t gotten it because they don’t know about it.

    If you need Evusheld, you should wait at least two weeks after getting a Covid-19 vaccine to take it. But after a person has taken Evusheld, there’s no waiting period for getting an updated booster.

    Are the updated Covid-19 boosters safe?

    A recent review of adverse events after mRNA booster vaccinations in adults the United States found that side effects were less common after booster doses than after second doses of the vaccine, and most were mild. About 1 in 8 adults reported a headache, fever or pain after a booster. In children and teens, commonly reported side effects after boosters were pain at the site of the injection, fatigue, headache and muscle aches.

    Very rarely, mRNA vaccines can cause myocarditis, or swelling in or around the heart. After more than 80 million booster doses given in the United States, the government safety surveillance systems received 37 verifiable reports of myocarditis. Most of these were in men.

    The highest rates of myocarditis in adults were in younger men — ages 18 to 24. For every million booster doses given to men this age, the CDC expects about that about will have myocarditis. For adolescents, the rate is slightly higher but still extremely low: about 11 cases of myocarditis for every million doses.

    Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said that to minimize this risk, officials are directing that the vaccines be given at least two months after a previous dose.

    “It seems to be associated when they’re given closer to one another,” he said.

    How do we know the updated Covid-19 vaccines work?

    The evidence for these updated vaccines is a bit different than what was behind earlier versions. These are the first Covid-19 vaccines authorized for use in people after being tested only in mice, following much the same process used each year when annual flu shots are updated.

    The FDA allowed companies to submit data from animal tests in order to speed these shots to the public. Studies in people are underway. FDA’s Marks said he expects that it will be a month or two before data on humans is available.

    Officials say urgency with these boosters is warranted going into the fall, when Covid-19 is still circulating at high levels and influenza is expected to make a return. But some vaccine experts feel that animal studies don’t provide sufficient evidence for these vaccines at this stage in the pandemic.

    “You’re asking people to get a new product for which there’s no data,” Dr. Paul Offit, who directs the vaccine education center at Children’s Hospital of Philadelphia, told CNN. “Mice data are not adequate to launch 100-plus-billion-dose effort.”

    Offit says it makes sense to use data from animal studies for updates to annual flu vaccines because we’ve used those shots for decades, and we understand what biomarkers to look for when gauging whether they work. These so-called correlates of protection are not as well understood for the Covid-19 vaccines.

    It’s not just the shots that are different, Poland said. At this point in the pandemic, our immune systems are, too. Nearly all Americans have been infected with the coronavirus, vaccinated or both. Some people have had four or five doses of vaccine.

    “So if you say to me, ‘can you assure me that getting dose five or dose six of this new vaccine in the background of having received these previous doses is absolutely safe?’ I’d say ‘no, I can’t.’ We’re extrapolating. And I think we ought to be clear about that,” Poland said.

    FDA officials point out that animal studies weren’t the only data they reviewed to make their decision. They considered two other lines of evidence.

    The first is the vaccines’ track records. The same basic vaccines have now been given to hundreds of millions of people around the world. They have been shown to be extremely effective at preventing severe disease and death from Covid-19. Risks associated with mRNA vaccination are very, very low.

    The second line of evidence comes from bivalent vaccines that may soon be used in Europe and Canada.

    Earlier this year, Pfizer and Moderna presented an independent panel of experts who advise the FDA with data on a bivalent vaccine designed to target the original strain of Omicron, BA.1. That data showed that the vaccines boosted antibody responses and were well-tolerated. Other countries have authorized these vaccines, but they will not be available in the US.

    They found that people got the biggest benefits from getting boosted, period. A booster against the ancestral strain increased neutralizing antibodies 11-fold. The scientists estimated that would increase a person’s protection against symptomatic infection over the next six months from 50% to 86.5%.

    Variant-specific boosters worked a little better, but the difference wasn’t dramatic. After those shots, protection against symptomatic infection over the next six months rose to 90.2%, just a 4.6% increase.

    Why were the shots updated?

    The Covid-19 vaccines were due for an update.

    As the coronavirus has been circulating, it has changed a lot. These changes have helped it slip past the antibodies that we made against older versions of the virus and older versions of the vaccine. As a result, it has gotten better at causing reinfections and breakthrough infections.

    The hope is that giving people updated vaccines will improve their ability to fight off the infection and shore up protection against severe disease that causes hospitalization or death.

    There is also some hope that updated boosters may slow the spread of the virus — and thus the speed at which vaccine-busting variants appear.

    The coronavirus is changing at blistering speed. In a meeting with FDA vaccine advisers last June, Trevor Bedford, a professor of epidemiology and biostatistics at Fred Hutchinson Cancer Reserach Center in Seattle, compared the speed of evolution of the viruses that cause Covid-19 to that of the viruses that cause influenza.

    Among the faster influenza viruses, he said, it takes about three years for a new strain to emerge and start showing up in testing in significant numbers. Among the variants of the virus that causes Covid-19, the Delta variant pulled off this feat in a year. Omicron did it in three to four months.

    So there is genuine concern that without something to slow transmission of the infection, we’ll be forever stuck in catchup mode, waiting for faster and potentially more dangerous variants to emerge.


  • Covid-19 rebound is probably more common than data suggests, but Paxlovid is still effective

    As the coronavirus evolves, the number of treatment options that remain effective against new variants has dwindled. Pfizer’s antiviral pill Paxlovid is one of the few that remain.

    However, some people who take Paxlovid — and some who don’t — experience a rebound case of Covid-19, with a resurgence of symptoms or positive tests just days after completing treatment and testing negative.

    And recent high-profile rebound cases, including President Joe Biden, Dr. Anthony Fauci and first lady Jill Biden, are raising questions about just how frequently this happens.

    “From the data we have so far, Covid-19 rebound is a relatively infrequent event — this is not happening the majority of the time,” a spokesperson from the US Centers for Disease Control and Prevention told CNN. “A small percentage of people with Covid-19 experience a rebound of symptoms, including those who take antiviral medication, such as Paxlovid.”

    Experts say that rebound cases are probably more common than data suggests, but it’s difficult to know by exactly how much.

    There’s a wide range of estimates for what that “small percentage” might be — from less than 1% of people who take Paxlovid to more than 10% — and definitions of a rebound case are lacking consistency.

    And a “brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status,” according to a health advisory issued by the CDC.

    It’s important to get a better handle on the specifics for both individual patients and the broader community, says Dr. Michael Charness, of the Veterans Administration Medical Center in Boston, who has collaborated with a team of researchers at Columbia University to look into cases of Covid-19 that return after Paxlovid treatment.

    People experiencing a rebound case can be contagious, so they should be aware of the possibility that they might need to reisolate in line with CDC guidance, he said. And for others, the return of symptoms or a positive test can “certainly be a source of concern for many people, wondering ‘Why is this happening to me?’”

    Tracking Covid-19 rebound

    In clinical trial documents submitted to the US Food and Drug Administration last year, Pfizer noted that “several subjects appeared to have a rebound in SARS-CoV-2 RNA levels.” Their data shows that about 2% of people showed present or persistent viral load rebound, a share that was similar among both those treated with Paxlovid and the placebo group that wasn’t.

    Pfizer does not have additional data on rebound cases beyond the clinical trials, which were conducted during a time when the Delta variant was dominant and the majority of people were unvaccinated.

    A preprint study that tracked rebound cases during the Omicron wave found that 2 to 4% of patients experienced a rebound infection or symptoms within a week after treatment, and 5 to 6% had a rebound within a month.

    A separate study published in June by researchers from the Mayo Clinic broadly aligned with Pfizer’s clinical trial data. The researchers found that about 1% of patients treated with Paxlovid experienced a rebound of symptoms, an average of about nine days after treatment. The study was retrospective and could not determine whether the patients tested positive along with the return of symptoms.

    But according to Aditya Shah, an infectious disease specialist and an author of the report, the true rate is probably closer to 10%.

    “You have to acknowledge the limitations of doing this kind of study. All these patients are home, and not every patient who has rebounded symptoms is going to contact their doctor,” Shah said. “So our study definitely had an under representation of true cases.”

    Charness also estimates that the Covid-19 rebound rate for vaccinated people who have taken Paxlovid is in a similar range, but uncertainty remains.

    “There has not been a study that gives us a clear answer. It’s probably not 50%, and it’s probably not 2%,” he said. “I wouldn’t be surprised if it’s in that 5 to 10% range for people who are treated in the 1 to 2% range in people who are untreated.”

    According to the CDC, preliminary data suggests that people with comorbidities may be more likely to experience a rebound case. However, studies to examine risk factors are “ongoing” and “there is no conclusive evidence at this time and more research is needed” they said.

    ‘Rebound is going to be an inconvenience’

    Despite the potential for a rebound case, experts agree that Paxlovid is still a good treatment option.

    If a rebound case of Covid-19 is one cost of taking Paxlovid, but it must be weighed against the costs of what could happen with no treatment, Charness said.

    The vast majority of people who have a rebound case of Covid-19 after taking Paxlovid have been found to have mild symptoms. Sometimes they may come back stronger, as in Fauci’s case, but they remain far from the levels of severe disease that Paxlovid is meant to protect from.

    “I think that, especially for people who are at significant risk for progression, it’s important to take Paxlovid,” he said. “A percentage of those people — yet to be determined — are going to have rebound. But in almost all of those people, the rebound is going to be an inconvenience. And that inconvenience, really, is not as important as the potential of avoiding hospitalization or death.”

    Both President Biden and Fauci received a second course of Paxlovid to treat their rebound cases. And just this week, the FDA requested more data from Pfizer to study patients who may need a second course of treatment.

    “While further evaluation is needed, we continue to monitor data from our ongoing clinical studies and post-authorization safety surveillance,” Pfizer said in a statement. “We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in patients at increased risk.”

    Overall, public data on Paxlovid prescriptions is scarce. According to the US Department of Health and Human Services, about 4 million courses of Paxlovid have been administered as of mid-August, but there are no additional details about the demographics or health status of those that have received it.

    In terms of rebound cases, Charness says a lot of work has been done, but many questions remain.

    “I reflect back to February and March when this was something that really wasn’t known and when people who experienced rebound were calling their providers and being told as a test must be wrong,” he said. “Between then and now, there’s been a huge dissemination of information, which is a good thing, but people aren’t 100% sure how to handle it.”


  • Many patients stop taking statins because of muscle pain, but statins aren’t causing it, new study says

    Statins are an important tool to prevent major cardiovascular problems, but many patients stop taking them because of side effects, including muscle pain. However, for more than 90% of patients on statins who experience muscle pain, the statin is not the cause of the pain, according to a study published Monday in The Lancet and presented at the European Society of Cardiology Congress in Spain.

    “Our results confirm that, in the majority of cases, statin therapy is not likely to be the cause of muscle pain in a person taking statin therapy,” said the study, led by authors from Oxford Population Health and the Medical Research Council Population Health Research Unit at the University of Oxford. “This finding is particularly true if the treatment has been well tolerated for a year or more before developing symptoms.”

    The authors conducted a meta-analysis of 19 randomized double-blind trials of statin regimens versus placebos. All trials had over 1,000 participants and at least two years of follow up. They also looked at four double-blind trials of more and less intense statin regimens.

    Study author Colin Baigent, a professor of epidemiology at University of Oxford, said that there have been many non-randomized studies which don’t involve any kind of placebo or random allocation to a statin that have produced “really quite extreme” estimates of how much muscle pain statins cause.

    “This has put patients off starting statins, or made them stop treatment when they develop muscle pain because they simply look in the paper and they see that statins cause lots and lots of muscle pain and so they stop,” Baigent said during a Science Media Center briefing. “We were really trying to deal with that problem.”

    The new study says that “even during the first year of a moderate-intensity statin regimen, it is likely to be the cause in only approximately one in 15 patients who report muscle symptoms, rising to approximately one in 10 in those who are taking a more intensive regimen.

    “In other words, the statin is not the cause of muscle symptoms in more than 90% of individuals who report such symptoms.”

    The authors found that in the first year, statin therapy produced a 7% relative increase in muscle pain or weakness, but there was no significant increase after that. The increased risk was already present within the first three months after treatment was assigned.

    There were reports of at least one episode of muscle pain or weakness from 27.1% of patients assigned a statin versus 26.6% of those who had a placebo during a median 4.3 year follow up.

    In the trials looked at by the authors, they say that statin therapy, during the first year of use, caused approximately 11 additional muscle pain reports per 1,000 patients.

    “What we conclude is that there are two things that we need to do as a profession, as a society,” Baigent said in the briefing. “The first thing is, we need to do a better job of managing patients who report muscle pain when they are taking a statin, because there’s a tendency in patients to end up stopping the statin and that has a detrimental effect on their long term health. And the second thing we need to do is we need to look at the information that is available to patients in package inserts.”

    He noted that if people were better informed about the real risks of muscle pains, then they might stay on statin therapy for longer.

    The study does have some limitations, including considerable heterogeneity in the methods used for muscle symptoms, some adverse event data not being available and most of the studies not excluding participants who may now be categorized as statin intolerant.

    In a commentary published alongside the study, Dr. Maciej Banach, a cardiologist at the Medical University of Lodz and Polish Mother’s Memorial Hospital Research Institute in Poland, wrote that the possible side effects of statins shouldn’t be a consideration when starting treatment.

    “It should be strong emphasized that the small risk of muscle symptoms is insignificant in comparison with the highly proven cardiovascular benefits of statins,” he wrote.

    The US Centers for Disease Control and Prevention says heart disease is the leading cause of death for men, women and those of most racial and ethnic groups in the United States. There is one cardiovascular disease death every 34 seconds in the country.

    Last week, the US Preventive Services Task Force announced its latest guidance on the use of statins to prevent a first heart attack or stroke.

    The guidelines are more conservative than those put out by other groups, such as the American College of Cardiology. They recommend statins in adults 40 to 75 who have at lease one risk factor of cardiovascular disease and a 10% or high risk of a heart attack in the next 10 years.

    According to the American Heart Association, “statins are recommended for most partients and have been directly associated with a reduction in the risk of heart attack and stroke. Statins continue to provide the most effective lipid-lowering treatment in most cases.”

  • Monkeypox vaccine strategy shift yields more supply for some, hurdles for others

    Most places in the United States with heavy monkeypox caseloads have shifted their vaccination strategies to the Biden administration’s low-dose, intradermal approach — and they are reporting varying results so far.

    Some say the shift has stretched their vaccine supply, helping them meet a growing demand for the Jynneos monkeypox vaccine. Others report a hurdle — while the new method should allow for five small doses of vaccine to be extracted from a single vial, they have only been able to extract about four.

    The situation “does vary geographically,” Claire Hannan, executive director of the Association of Immunization Managers, wrote in an email to CNN.

    About three-quarters of jurisdictions in the United States have shifted to using the intradermal method of administering monkeypox vaccine, Bob Fenton, the White House’s national monkeypox response coordinator, said in a briefing Friday.

    “As of today, 75% of jurisdictions are already applying intradermal administration of vaccine, and another 20% are working to move in that direction,” Fenton said.

    Hannan shared similar results in her email to CNN based on a recent survey of immunization managers. When asked “Has your jurisdiction implemented the intradermal vaccination strategy?,” 74% of survey respondents reported yes, 3% no, and 24% reported “partially.”

    So far, the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response has made a total of 1.1 million vials of Bavarian Nordic’s Jynneos monkeypox vaccine available for free to jurisdictions to support monkeypox response efforts.

    In early August, the US Food and Drug Administration issued an emergency use authorization allowing for health care providers to have the option of administering the Jynneos monkeypox vaccine intradermally, meaning between the layers of the skin, rather than subcutaneously, or in the fatty layer below the skin, which had been the typical way the vaccine was injected.

    Administering the vaccine intradermally requires a fifth of the dose needed for a subcutaneous injection, allowing providers to get as many as five doses out of a standard one-dose vial.

    “It’s a little too early to tell how it’s going to help with the supply meeting demand, but I think logically, you use less vaccine for one person,” Dr. Emily Volk, president of the College of American Pathologists, told CNN.

    “This is a dose-sparing approach, so it’s going to allow for the doses that we do have to be usable for many more people. So, to me that is very positive and I am actually heartened that the public health community is thinking outside the box,” she said. “It also buys time to make more vaccine.”

    More people eligible for vaccine

    The City and County of San Francisco, New York City, Fairfax County in Virginia, Cook County in Illinois and Dallas County in Texas are just some of the places with a high number of monkeypox cases that have switched to administering vaccine intradermally.

    The San Francisco Department of Public Health wrote in an emailed statement to CNN that the US Centers for Disease Control and Prevention and the California Department of Health have provided guidance on how to switch to the intradermal technique “as a safe and effective way to vaccinate more people, as well as a requirement to receive additional vaccine allotments.”

    The statement added that switching to a new technique “takes time.”

    After New York City adopted the new intradermal vaccination strategy last week, it announced that it would make more than 12,000 new appointments available to the public for people eligible for vaccination who haven’t yet received a first dose.

    “As we continue to see a scarcity of federal supply of monkeypox vaccines, we must adapt to provide a range of options to those who are vaccine-eligible, and to do so in an equitable way,” Health Commissioner Dr. Ashwin Vasan said in part in a news release last week.

    In most places, monkeypox vaccine is available for those who are considered to be at an increased risk of being exposed to the virus, including men who have sex with men.

    But in the state of Virginia, vaccine eligibility was expanded last week and now includes all people, of any sexual orientation or gender, who have had anonymous or multiple sexual partners in the last two weeks as being eligible to receive the monkeypox vaccine.

    The intradermal or ID method of administering vaccine is expected to help provide monkeypox vaccinations to this broader group of eligible people, Lucy Caldwell, a spokesperson for the Fairfax County Health Department, wrote in an email to CNN.

    The Virginia Department of Health “expanded eligibility so we do anticipate that there may be additional demands; the ID method will help us to meet the demand,” Caldwell wrote.

    The expanded eligibility was announced last Monday and the shift to vaccinating people with an intradermal injection started Wednesday.

    ‘We have more vaccine available now’

    In Dallas County, monkeypox vaccination eligibility was expanded to include adults who had been diagnosed with HIV, chlamydia, gonorrhea or early syphilis within the past 12 months or are on HIV pre-exposure prophylaxis.

    The county also had switched to the intradermal injection strategy — and in a county where supply previously couldn’t meet demand, now there appears to be a dwindle in vaccination demand and some improvement in supply.

    “We have more vaccine available now. We expanded the criteria, and the calls are slowing down a little bit. So, we have more appointments available now,” Dr. Philip Huang, director of the Dallas County Health and Human Services Department, told CNN.

    “They’re not all getting filled in,” he said about the vaccination appointments. “We’re having more no-shows.”

    Huang added that he was not surprised by the small drop in demand, as with most vaccination campaigns, there is an immediate high demand among the public to receive the vaccine and then that demand drops off over time.

    “We’ve seen it before, even with Covid vaccines, certainly,” Huang said.

    “Early on, you get the ones who really want it and then after that there are people who aren’t so anxious perhaps to get it that might still be at higher risk. So, it is sort of this fluctuation in supply and demand,” he said. “Now that we’ve had more of the doses available — and again, with the five doses per vial — it stretches out how many people can be served with each vial.”

    But some local health officials have reported not being able to extract five doses per vial.

    Getting all five doses

    Dr. Sharon Welbel, an infectious disease physician and the system director of hospital epidemiology and infection control at Cook County Health in Illinois, told CNN that she has been in meetings with public health officials in other cities who reported that they haven’t been able to get five doses out of the vials, but she said every one of her vaccinators has been successful pulling five doses per vial.

    “So far, we’ve been able to get the five doses,” Welbel told CNN.

    In some other regions, like Fairfax County in Virginia, vaccine administrators have not been able to extract all five doses.

    “Our staff have been trained and are getting between 4-5 doses (so far) from a vial. Most typically, 4,” Caldwell wrote in her email about Fairfax County.

    “To reduce wastage, we are managing our appointments at our health department district offices in multiples of 4 to match the expected doses from a vial. At our larger vaccine clinics, we are managing the number of open vials to also reduce the chance that there is significant wastage at the end of a clinic day,” she wrote.

    Once a vial of Jynneos monkeypox vaccine is punctured, it expires after eight hours and has to be discarded, according to the FDA’s emergency use authorization.

    “We also are communicating with partners to whom we have redistributed vaccine to encourage approaches to managing their appointments that will reduce potential wastage,” Caldwell wrote.

    Overall, the switch to an intradermal injection method “is stretching supply,” but not every vial is yielding five doses, wrote Hannan of the Association of Immunization Managers, who has been hearing that most vaccine administrators are extracting about three to five doses per vial.

    “It’s not an easy thing to change how a vaccine is administered and how it is extracted from the vial. Need to have the right needles and some experience to get the 5 doses,” she wrote.

    The CDC is aware that providers might not be able to extract all five doses out of a vial and allocating vials accordingly, Dr. Rochelle Walensky, director of the agency, said in a White House briefing Friday.

    “These vials may contain up to five doses,” Walensky said, adding that the CDC recognizes that not all providers will be able to get five doses out of every vial.

    “We also recognize that in some situations, they may be only able to use a single dose from that vial, because it’s administered to a child or to somebody who has a keloid reaction,” she added. “We have built in a buffer as we’ve been allocating and distributing to rest-assure that people are getting the doses they need, without anticipating that every single one is going to get five doses of a vial.”

    Keloids are scars on the skin, which can occur after vaccination, and typically occur in darker skinned individuals with a familial history.

    ‘Curtailing this 2022 outbreak’

    The opportunity that the smaller shot has given to the city of Chicago to vaccinate more people was a great motivator for switching to the intradermal method, Welbel told CNN.

    “The one thing that I was particularly concerned about was the intradermal technique, because it’s not really a technique that’s used very frequently. So, I wanted to make sure that all of our health care providers who would be giving the vaccine were trained and really demanded that they do a return competency meeting that they can show us that they know how to do it,” Welbel said.

    Health care providers practiced on simulation arms and did a good job, she said. For those that didn’t, they weren’t allowed to start vaccinating people until they felt comfortable with the new technique. For those who were not able to master the technique, Welbel said they will not be giving the shots.

    The new intradermal strategy has been so successful, so quickly, Welbel said that the city of Chicago has already been able to expand the population of who is eligible for the vaccine — similar to the expanded eligibility in other large cities.

    In Chicago, people who are now eligible for the monkeypox vaccine includes anyone who has had close contacts with someone diagnosed with monkeypox regardless of sex, gender or sexual orientation, or sexually active bisexual, gay, and other men who have sex with men and transgender persons. There is no requirement that someone had to have engaged in “high risk behavior” to get the shot.

    “What makes me really excited is that we now can offer people pre-exposure prophylaxis. That’s how vaccines are developed for the most part to prevent us from getting disease,” Welbel said. “I think that’s going to be huge in curtailing this 2022 outbreak.”




  • Monkeypox transmission from humans to pets: What to know about risk, prevention

    • The World Health Organization called the recent monkeypox outbreak a “public health emergency of international concern.”
    • There have been more than 40,000 confirmed cases of monkeypox worldwide, with 12 deaths reported.
    • Until recently, the medical community believed monkeypox spread only from animal to human and human to human.
    • Doctors from Pitié-Salpêtrière Hospital in Paris recently reported the first suspected case of a human-to-animal transmission of the virus.

    The zoonotic virus monkeypox spreads from certain types of animals known to carry the virus to humans. From there, the virus transmits from an infected human to other humans.

    Now a new report in The LancetTrusted Source provides evidence of the first suspected case of a human transmitting the monkeypox virus to an animal. Doctors from Pitié-Salpêtrière Hospital in Paris recently reported the first case of a human transferring the virus to a pet dog.

    Monkeypox symptoms and outbreak

    On July 23, 2022, the World Health OrganizationTrusted Source (WHO) declared the recent monkeypox outbreak a “public health emergency of international concern (PHEIC).”

    As of August, there have been more than 40,000 confirmed casesTrusted Source of monkeypox worldwide, with 12 deaths reported.

    Monkeypox is a viral infection in the same virus family as smallpox. Symptoms of monkeypox may be similar to smallpox but not as severe, including:

    A few days after having a fever, a rash will developTrusted Source on a person who contracted the monkeypox virus. The rash normally looks similar to blisters or pimples and can appear on different body areas.

    Certain animals, including species of monkeys and squirrels, carry the virus. A human bitten or scratched by an infected animal can contract monkeypox. Additionally, a human who eats undercooked meat or a byproduct of an infected animal can also contract the virus.

    An infected human transfers the virus to other humans through close personal contact, including kissing, prolonged face-to-face contact, and sexual contactTrusted Source. Additionally, touching soft fabrics slept on or worn by a person with monkeypox can transmit the disease to another person.

    Transmission from humans to pets

    According to the study, doctors from Pitié-Salpêtrière Hospital reported two cohabitating male patients showing symptoms of monkeypox, including fever, headaches, and rash.

    Twelve days following the onset of symptoms, the patient’s male Italian greyhound tested positive for the monkeypox virus. The dog also had lesions associated with the disease. The dog owners told doctors they slept with their dog in the same bed. Doctors reportedly compared skin lesion samples from both the dog and its owners and found it was the same virus strain.

    According to Dr. Richard Silvera, associate program director of the Infectious Diseases Fellowship and assistant professor of medicine (infectious diseases) at the Icahn School of Medicine at Mount Sinai, it was not surprising to hear monkeypox could transmit to a dog. He inferred the same types of methods of human-to-human viral transmission — such as skin-to-skin contact or touching fabrics worn or slept in by someone with the disease — would also work with a human-to-animal transition.

    “So I imagine if you had a lesion on your hand and you pet your dog, you could theoretically infect the dog that way,” Dr. Silvera explained. “Or if you have lesions on your body, you slept in a bed, and then the dog also slept in that bed, that would be a way of transmitting. And the report did note that the dog slept in the bed with the infected patients, so that may have been the way the dog contracted it.”

    And Dr. Lori Teller, president of the American Veterinary Medical Association, stated that pets other than dogsTrusted Source may also be susceptible to catching monkeypox from a human owner.

    “Under experimental conditions, rabbits and mice — but not guinea pigs and hamsters — have been found to develop signs of monkeypox following oral and intranasal exposure to the virus,” she told MNT. “Young (10-day-old) rabbits also appear capable of transmitting the virus to other rabbits. Whether cats are susceptible is unclear. However, given the available evidence concerning other orthopoxvirusesTrusted Source, it would be prudent to assume cats might catch monkeypox and, accordingly, take appropriate measures to prevent infection or disease spread.”

    “In the United States and other non-endemic regions, a significant concern is the potential for spillover of monkeypox to wildlife from infected people or domestic mammals, emphasizing the importance of infection control measures to contain the disease,” Dr. Teller added.

    Protecting people and pets from monkeypox

    While the human-to-human transmission of monkeypox is one thing to worry about, now people have a concern about giving it to their animals. What can people do to protect everyone in their household — including their pets — if they have monkeypox?

    “I would apply the same kind of thinking we’re using for human-to-human transmission for animal transmission,” Dr. Silvera detailed. “If you have monkeypox and you’re living with other people or with other creatures like animals, try and isolate on a whole away from others, so not share linens, not to share a bed, even with a dog or a cat. I would not let them sleep in your bed if you have an active monkeypox infection.”

    “Hand washing will be really important,” he continued. “Washing linens separately from ones that are used by the household. And if they’re going to be in close contact wearing a mask will be the way to protect both your pets and your household.”

    Dr. Teller said initial signs of monkeypox in animals are similar to signs of other, much more common, infectious diseases. “These include fever, cough, reddened eyes, runny nose, lethargy, and low appetite,” she explained. “If you notice these signs in your pet, and the pet has had no known exposure to someone with monkeypox, the cause is likely to be something else. Even so, these signs signal your pet is sick and should be seen by a veterinarian.”

    “If your pet develops at least two of these signs or a pimple- or blister-like rash within 21 days after possible contact with someone with monkeypox, immediately contact your veterinarian,” Dr. Teller continued. “They can advise you on next steps, including testing to confirm infection. Do not surrender, euthanize, or abandon your pet because of potential exposure to an infected person.”

  • Sex differences in COVID-19

    COVID-19 affects people differently, in terms of infection with the virus SARS-CoV-2 and mortality rates. In this Special Feature, we focus on some of the sex differences that characterize this pandemic.

    All data and statistics are based on publicly available data at the time of publication. Some information may be out of date. Visit our coronavirus hub and follow our live updates page for the most recent information on the COVID-19 pandemic.

    There are many ways in which the pandemic itself affects people’s day-to-day lives, and gender — understood as the ensemble of social expectations, norms, and roles we associate with being a man, woman, trans- or nonbinary person — plays a massive part.

    On a societal level, COVID-19 has affected cis- and transwomen, for example, differently to how it has cismen, transmen, and nonbinary people. Reproductive rights, decision making around the pandemic, and domestic violence are just some key areas where the pandemic has negatively impacted women.

    However, sex differences — understood as the biological characteristics we associate with the sex that one is assigned at birth — also play an undeniable role in an epidemic or pandemic.

    While sex and gender are, arguably, inextricably linked in healthcare, as in every other area of our lives, in this Special Feature, we will focus primarily on the infection rates of SARS-CoV-2 and the mortality rates that COVID-19 causes, broken down by sex.

    In specialized literature, these effects fall under the umbrella term of ‘primary effectsTrusted Source’ of the pandemic, while the ‘secondary impact’ of the pandemic has deeper social and political implications.

    Throughout this feature, we use the binary terms ‘man’ and ‘woman’ to accurately reflect the studies and the data they use.

    Sex-disaggregated data lacking

    Before delving deeper into the subject of sex differences in COVID-19, it is worth noting that the picture is bound to be incomplete, as not all countries have released their sex-disaggregated data.

    A report appearing on the blog of the journal BMJ Global Health on March 24, 2020, reviewed data from 20 countries that had the highest number of confirmed cases of COVID-19 at the time.

    Of these 20 countries, “Belgium, Malaysia, Netherlands, Portugal, Spain, United Kingdom, and the United States of America” did not provide data that was ‘disaggregated,’ or broken down, by sex.

    At the time, the authors of the BMJ report appealed to these countries and others to provide sex specific data.

    Anna Purdie, from the University College London, United Kingdom, and her colleagues, noted: “We applaud the decision by the Italian government to publish data that are fully sex- and age-disaggregated. Other countries […] are still not publishing national data in this way. We understand but regret this oversight.”

    “At a minimum, we urgently call on countries to publicly report the numbers of diagnosed infections and deaths by sex. Ideally, countries would also disaggregate their data on testing by sex.”

    – Anna Purdie et al.

    Since then, countries that include Belgium, the Netherlands, Portugal, and Spain have made their data available.

    The U.K. have made only a part of the sex-disaggregated data available — for England and Wales, without covering Scotland and Northern Ireland — while Malaysia and the U.S. have not made their sex-disaggregated data available at all.

    At the time of writing this article, the U.S. still have not released their sex-disaggregated data despite the country having the highest number of COVID-19 cases in the world.

    Men more than twice as likely to die

    Global Health 5050, an organization that promotes gender equality in healthcare, has rounded up the total and partial data that is available from the countries with the highest numbers of confirmed COVID-19 cases.

    According to their data gathering, the highest ratio of male to female deaths, as a result of COVID-19, is in Denmark and Greece: 2.1 to 1.

    In these countries, men are more than twice as likely to die from COVID-19 as women. In Denmark, 5.7% of the total number of cases confirmed among men have resulted in death, whereas 2.7% of women with confirmed COVID-19 have died.

    In the Republic of Ireland, the male to female mortality ratio is 2 to 1, while Italy and Switzerland have a 1.9 to 1 ratio each.

    The greatest parity between the genders from countries that have submitted a full set of data are Iran, with 1.1 to 1, and Norway, with 1.2 to 1.

    In Iran, 5.4% of the women patients have died, compared with 5.9% of the men. In Norway, these numbers stand at 1.3% and 1.1%, respectively.

    China has a ratio of 1.7, with 2.8% of women having died, compared with 4.7% of men.

    Infection rates in women and men

    A side-by-side comparison of infection rates between the sexes does not explain the higher death rates in men, nor is there enough data available to draw a conclusion about infection rates broken down by sexes.

    However, it is worth noting that in Denmark, where men are more than twice as likely to die of COVID-19 as women, the proportion of women who contracted the virus was 54%, while that of men was 46%.

    By contrast, in Iran, where the ratio of deaths between men and women is less different (1.1 to 1), just 43% of cases are female compared with 57% cases in men.

    Until we know the proportion of people from each sex that healthcare professionals are testing, it will be difficult to fully interpret these figures.

    What we do know so far is that, overall, nine of the 18 countries that have provided complete sex-disaggregated data have more COVID-19 cases among women than they do among men. Six of the 18 countries have more cases among men than they do among women.

    Norway, Sweden, and Germany have a 50–50% case ratio.

    Other countries where more women have developed COVID-19 include:

    • Switzerland (53% of women to 47% of men)
    • Spain (51% to 49%)
    • The Netherlands (53% to 47%)
    • Belgium (55% to 45%)
    • South Korea (60% to 40%)
    • Portugal (57% to 43%)
    • Canada (52% to 48%)
    • Republic of Ireland (52% to 45%)

    Greece, Italy, Peru, China, and Australia all have a higher number of confirmed cases among men than women.

    Why are men more likely to die?

    Part of the explanation for why the new coronavirus seems to cause more severe illness in men is down to biological sex differences.

    Women’s innate immune response plays a role. Experts agree that there are sex differences, such as sex chromosomes and sex hormones, that influence how a person’s immunity responds to a pathogen.

    As a result, “women are in general able to mount a more vigorous immune response to infections [and] vaccinations.” With previous coronaviruses, specifically, some studiesTrusted Source in mice have suggested that the hormone estrogen may have a protective role.

    For instance, in the study above, the authors note that in male mice there was an “exuberant but ineffective cytokine response.” Cytokines are responsible for tissue damage within the lungs and leakage from pulmonary blood vessels.

    Estrogens suppress the escalation phase of the immune response that leads to increased cytokine release. The authors showed that female mice treated with an estrogen receptor antagonist died at close to the same rate as the male mice.

    As some researchers have noted, lifestyle factors, such as smoking and alcohol consumption, which tend to occur more among men, may also explain the overall higher mortality rates among men.

    Science has long linked such behaviors with conditions that we now know are likely to negatively influence the outcome of patients with COVID-19 — cardiovascular disease, hypertension, and chronic lung conditions.

    Why women might be more at risk

    On the other hand, the fact that societies have traditionally placed women in the role of caregivers — a role which they continue to fulfill predominantly — and the fact that the vast majority of healthcare workers are women could place them at a higher risk of contracting the virus and might explain the higher infection rates in some countries.

    An analysis of 104 countries by the World Health Organization (WHO) found that “Women represent around 70% of the health workforce.” In China, women make up more than 90%Trusted Source of healthcare workers in Hubei province.

    These data emphasize “the gendered nature of the health workforce and the risk that predominantly female health workers incur,” write the authors of a report on the ‘gendered impacts’ of the pandemic that appears in The LancetTrusted Source.

    Although we cannot yet draw definitive conclusions because sex-disaggregated data is not yet available from all the countries affected, The Lancet report looks at previous epidemics for clues.

    “During the 2014–16 west African outbreak of Ebola virus disease,” the authors write, “gendered norms meant that women were more likely to be infected by the virus, given their predominant roles as caregivers within families and as frontline healthcare workers.”

    The authors also call out for governments and health institutions to offer and analyze data on sex and gender differences in the pandemic.

    Why sex-disaggregated data are urgent

    The report in The Lancet reads, “Recognising the extent to which disease outbreaks affect women and men differently is a fundamental step to understanding the primary and secondary effects of a health emergency on different individuals and communities, and for creating effective, equitable policies and interventions.”

    For instance, identifying the key difference that makes women more resilient to the infection could help create drugs that also strengthen men’s immune response to the virus.

    Devising policies and intervention strategies that consider the needs of women who work as frontline healthcare workers could help prevent the higher infection rates that we see among women.

    Finally, men and women tend to react differently to potential vaccines and treatments, so having access to sex-disaggregated data is crucial for conducting safe clinical trials.

    As Anna Purdie — who also works for Global Health 5050 — and her colleagues summarize in their article, “Sex-disaggregated data are essential for understanding the distributions of risk, infection, and disease in the population, and the extent to which sex and gender affect clinical outcomes.”

    “Understanding sex and gender in relation to global health should not be seen as an optional add-on but as a core component of ensuring effective and equitable national and global health systems that work for everyone. National governments and global health organizations must urgently face up to this reality.”

    – Anna Purdie et al

  • Is gene editing ethical?

    If you bring up the subject of gene editing, the debate is sure to become heated. But are we slowly warming to the idea of using gene editing to cure genetic diseases, or even create “designer babies?”

    Gene editing holds the key to preventing or treating debilitating genetic diseases, giving hope to millions of people around the world. Yet the same technology could unlock the path to designing our future children, enhancing their genome by selecting desirable traits such as height, eye color, and intelligence.

    While gene editing has been used in laboratory experiments on individual cells and in animal studies for decades, 2015 saw the first report of modified human embryos.

    The number of published studies now stands at eight, with the latest research having investigated how a certain gene affects developmentTrusted Source in the early embryo and how to fix a genetic defect that causes a blood disorderTrusted Source.

    The fact that gene editing is possible in human embryos has opened a Pandora’s box of ethical issues.

    So, who is in favor of gene editing? Do geneticists feel differently about this issue? And are we likely to see the technology in mainstream medicine any time soon?

    What is gene editing?

    Gene editing is the modification of DNA sequences in living cells. What that means in reality is that researchers can either add mutations or substitute genes in cells or organisms.

    While this concept is not new, a real breakthrough came 5 years ago when several scientists saw the potential of a system called CRISPR/Cas9 to edit the human genome.

    CRISPR/Cas9 allows us to target specific locations in the genome with much more precision than previous techniques. This process allows a faulty gene to be replaced with a non-faulty copy, making this technology attractive to those looking to cure genetic diseases.

    The technology is not foolproof, however. Scientists have been modifying genes for decades, but there are always trade-offs. We have yet to develop a technique that works 100 percent and doesn’t lead to unwanted and uncontrollable mutations in other locations in the genome.

    In a laboratory experiment, these so-called off-target effects are not the end of the world. But when it comes to gene editing in humans, this is a major stumbling block.

    Here, the ethical debate around gene editing really gets off the ground.

    When gene editing is used in embryos — or earlier, on the sperm or egg of carriers of genetic mutations — it is called germline gene editing. The big issue here is that it affects both the individual receiving the treatment and their future children.

    This is a potential game-changer as it implies that we may be able to change the genetic makeup of entire generations on a permanent basis.

    Who is in favor of gene editing?

    Dietram Scheufele — a professor of science communication at the University of Wisconsin-Madison — and colleagues surveyedTrusted Source 1,600 members of the general public about their attitudes toward gene editing. The results revealed that 65 percent of respondents thought that germline editing was acceptable for therapeutic purposes.

    When it came to enhancement, only 26 percent said that it was acceptable and 51 percent said that it was unacceptable. Interestingly, attitudes were linked to religious beliefs and the person’s level of knowledge of gene editing.

    “Among those reporting low religious guidance,” explains Prof. Scheufele, “a large majority (75 percent) express at least some support for treatment applications, and a substantial proportion (45 percent) do so for enhancement applications.”

    He adds, “By contrast, for those reporting a relatively high level of religious guidance in their daily lives, corresponding levels of support are markedly lower (50 percent express support for treatment; 28 percent express support for enhancement).”

    Among individuals with high levels of technical understanding of the process of gene editing, 76 percent showed at least some support of therapeutic gene editing, while 41 percent showed support for enhancement.

    But how do the views of the general public align with those of genetics professionals? Well, Alyssa Armsby and professor of genetics Kelly E. Ormond — both of whom are from Stanford University in California — surveyed 500 members of 10 genetics societies across the globe to find out.

    What do professionals think?

    Armsby says that “there is a need for an ongoing international conversation about genome editing, but very little data on how people trained in genetics view the technology. As the ones who do the research and work with patients and families, they’re an important group of stakeholders.”

    The results were presented yesterday at the American Society for Human Genetics (ASHG) annual conference, held in Orlando, FL.

    In total, 31.9 percent of respondents were in favor of research into germline editing using viable embryos. This sentiment was more particularly pronounced in respondents under the age of 40, those with fewer than 10 years experience, and those who classed themselves as less religious.

    The survey results also revealed that 77.8 percent of respondents supported the hypothetical use of germline gene editing for therapeutic purposes. For conditions arising during childhood or adolescence, 73.5 percent were in favor of using the technology, while 78.2 percent said that they supported germline editing in cases where a disease would be fatal in childhood.

    On the subject of using gene editing for the purpose of enhancement, just 8.6 percent of genetics professionals spoke out in favor.

    “I was most surprised, personally,” Prof. Ormond told Medical News Today, “by the fact that nearly [a third] of our study respondents were supportive of starting clinical research on germline genome editing already (doing the research and attempting a pregnancy without intent to move forward to a liveborn baby).”

    This finding is in stark contrast to a policy statement Trusted Sourcethat the ASHG published earlier this year, she added.

    Professional organizations urge caution

    According to the statement — of which Prof. Ormand is one of the lead authors — germline gene editing throws up a list of ethical issues that need to be considered.

    The possibility of introducing unwanted mutations or DNA damage is a definite risk, and unwanted side effects cannot be predicted or controlled at the moment.

    The authors further explain:

    “Eugenics refers to both the selection of positive traits (positive eugenics) and the removal of diseases or traits viewed negatively (negative eugenics). Eugenics in either form is concerning because it could be used to reinforce prejudice and narrow definitions of normalcy in our societies.”

    “This is particularly true when there is the potential for ‘enhancement’ that goes beyond the treatment of medical disorders,” they add.

    While prenatal testing already allows parents to choose to abort fetuses carrying certain disease traits in many places across the globe, gene editing could create an expectation that parents should actively select the best traits for their children.

    The authors take it even further by speculating how this may affect society as a whole. “Unequal access and cultural differences affecting uptake,” they say, “could create large differences in the relative incidence of a given condition by region, ethnic group, or socioeconomic status.”

    “Genetic disease, once a universal common denominator, could instead become an artefact of class, geographic location, and culture,” they caution.

    Therefore, the ASHG conclude that at present, it is unethical to perform germline gene editing that would lead to the birth of an individual. But research into the safety and efficacy of gene editing techniques, as well as into the effects of gene editing, should continue, providing such research adheres to local laws and policies.

    In Europe, this is echoedTrusted Source by a panel of experts who urge the formation of a European Steering Committee to “assess the potential benefits and drawbacks of genome editing.”

    They stress the need “to be proactive to prevent this technology from being hijacked by those with extremist views and to avoid misleading public expectation with overinflated promises.”

    But is the public’s perception really so different from that of researchers on the frontline of scientific discovery?

    Working together to safeguard the future

    Prof. Ormond told MNT that “a lot of things are similar — both groups feel that some forms of gene editing are acceptable, and they seem to differentiate based on treating medical conditions as compared to treatments that would be ‘enhancements,’ as well as based on medical severity.”

    “I do think there are some gaps […],” she continued, “but clearly knowledge and levels of religiosity impact the public’s views. We need to educate both professionals and the public so that they have a realistic sense of what gene editing can and cannot do. Measuring attitudes is difficult to do when people don’t understand a technology.”

    While advances such as CRISPR/Cas9 may have brought the possibility of gene editing one step closer, many diseases and traits are underpinned by complex genetic interactions. Even a seemingly simple trait such as eye color is governed by a collection of different genes.

    To decide what role gene editing will play in our future, scientific and medical professionals must work hand-in-hand with members of the general public. As the authors of the ASHG position statement conclude:

    “Ultimately, these debates and engagements will inform the frameworks to enable ethical uses of the technology while prohibiting unethical ones.”