7 facts women should know to prevent and recognize stroke

stroke

It’s telling that although stroke is the third leading cause of death for women in the U.S., and that twice as many women die of stroke than of breast cancer, most women aren’t aware of these facts.

As is the case with heart attacks, stroke is often perceived as occurring mostly in men—even though women account for 51% of all people worldwide who have experienced a stroke.

That’s why neurologist Sarah Song, MD, MPH of the Rush Stroke Program says it’s essential for women to be savvy when it comes to stroke.

Understanding your risks empowers you to take steps to prevent a stroke. And being aware of the symptoms will enable you to get treatment faster if you do have a stroke, when every second counts.

Whether you’re a woman or have loved ones who are women, Song says knowing these facts can help save lives:

1. Don’t dismiss stroke symptoms

These symptoms are commonly identified with stroke in both men and women:

  • Numbness on one side of the body and/or face
  • Weakness on one side of the body and/or face
  • Loss of vision
  • Double vision
  • Vertigo, or room-spinning
  • Slurred speech
  • Difficulty speaking or understanding language

If you notice any of these symptoms in yourself or another person, call 911 immediately, even if the symptoms don’t cause pain or they go away.

Just remember that “time is brain.” If it is a stroke, the sooner you get treatment, the better your chance of surviving. Prompt treatment also improves your chances for successful rehabilitation and recovery.

2. Strokes in young women are on the rise

It’s true that strokes most often strike older women (and men). But the World Stroke Organization reports that 8% of all strokes—and 4% of all stroke-related deaths—occur in people under the age of 44.

One potential reason is thought to be the increase in obesity among younger women. Studies have shown that women who are obese or have gained more than 44 pounds since age 18 are about 2.5 times more likely to have a stroke than women who maintain a healthy weight.

While obesity is a stroke risk factor on its own, it also contributes to other significant risk factors, including high blood pressure, Type 2 diabetes and heart disease—all of which are increasingly common in women today.

Pregnancy and childbirth can also make young women, including transgender women, more vulnerable to stroke.

Most maternal strokes happen within the first few weeks after birth, triggered by blood loss or hormonal changes. Stroke is also associated with certain complications of pregnancy, including infections and preeclampsia. And, generally speaking, clotting activity is heightened during pregnancy; if clots form in the blood vessels of the veins, they can lead to a stroke.

3. Black and Hispanic women have a higher risk of stroke

According to the Office of Minority Health, part of the U.S. Department of Health and Human Services, Black women are twice as likely to have a stroke as white women—and more likely to die from a stroke than either white women or Hispanic women.

One reason? High blood pressure, diabetes and obesity—three of the biggest risk factors for stroke—are all more common in Black women than white women.

A lesser known risk factor: sickle cell disease, a genetic disease common in Black Americans (around 1 in 365 Black Americas is born with it). Twenty-five percent of adults with sickle cell disease will suffer a stroke by the age of 45.

Hispanic women, too, experience high blood pressure, diabetes and obesity at higher rates than non-Hispanic white women, putting them at increased risk of both stroke and stroke-related deaths.

Working to improve your weight, blood pressure and cholesterol with lifestyle changes and medications can help reduce the risk not only of stroke, but of heart disease and cancer.

4. Using birth control pills can potentially raise stroke risk

The American Stroke Association reports that women who take birth control pills may be twice as likely to have a stroke as those who don’t. Birth control pills (often referred to as “the pill”) can cause blood clots to develop. In some cases, blood clots can possibly travel to the brain, causing a stroke or heart attack.

Since the stroke risk for healthy young women is low to begin with, you don’t necessarily have to forgo the pill. Your doctor can help determine whether oral contraceptives or another form of birth control is best for you.

That means identifying your other risk factors. If you take oral contraceptives, any additional risk factors—especially smoking—will increase your potential for stroke even more. The risk of stroke related to oral contraceptives also increases with age.

5. There’s a link between migraines and stroke

These crippling headaches—far more common in women than men—have been associated with an increased risk of stroke when accompanied by a migraine aura.

The reasons for this association are not well understood. But from what we do know, aura (where you experience flashes of light, light or noise sensitivity, tingling in the hands or face, partial loss of vision or other symptoms) must be associated with the headache to increase stroke risk. It may also be associated with hormonal changes.

The American Stroke Association says women who experience migraines with aura are up to 10 times more likely to have a stroke, depending on their other risk factors. Smoking and using oral contraceptives, in particular, can increase your risk significantly.

6. Women should watch their waistlines

Studies have shown that postmenopausal women with a waist measuring more than 35.2 inches and a triglyceride (blood fat) level higher than 128 mg/dL have five times the risk of stroke.

And there are other serious health risks associated with an “apple” body shape in women, including heart disease and diabetes.

There are some stroke risk factors you can’t control, like your family history, ethnicity/race and age. So it is helpful instead to focus on the behaviors you can change.

That includes making time to exercise and eating a diet rich in fruits, vegetables and whole grains. Adopting a healthy lifestyle may help prevent stroke in women, especially if you have other stroke risk factors.

7. A transient ischemic attack, or “mini-stroke,” is a warning sign

A transient ischemic attack, also known as a TIA or “mini-stroke,” causes the same symptoms as a stroke but lasts only minutes to a few hours.

Even though there may not be lasting effects from a TIA, you should still seek immediate medical help. That includes talking to your doctor about how to prevent a full-blown stroke, because having a TIA puts you at greater risk for having a stroke. A TIA is an opportunity to look for stroke risk factors that could be better controlled.

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Will Smith Wants You to Know He’s in the ‘Worst Shape’ of His Life

Baring it all. Will Smith revealed on social media that he thinks he isn’t in the best shape right now.

These 6 Celebrities Are Leading the Body-Positive Movement: Hear Their Inspiring Quotes

“I’m gonna be real wit yall – I’m in the worst shape of my life,” Smith, 52, captioned the photo via Instagram on Sunday, May 2. The actor was sporting an unzipped hoodie and tight black shorts in the post.

The Grammy winner received instant support on his shirtless post.

https://www.instagram.com/p/COZHipMhHDr/

A post shared by Will Smith (@willsmith)

“You look good!” Amy Schumer wrote in response to Smith.

His The Fresh Prince of Bel-Air costar Nia Long showed the actor some love, writing, “You still got it baby!!!” British singer Sonna Rele, meanwhile, wrote: “You’re Will Smith!! You can be in whatever shape you want.”

Jersey Show star Jenni Farley revealed that she felt the same way and shared some advice in the comments section. “Live your best life,” she wrote.

Stars Share Their Home Workout Routines Amid Coronavirus

Filmmaker Ava DuVernay, for her part, wrote: “I see no ‘worst’ here.”

The Philadelphia native has often talked about getting in shape for his movie roles. In January 2020, he spoke about his career-defining shirtless scene in 1995’s Bad Boys.

“For this scene, I wanted to have my shirt on, and Michael [Bay] was like, ‘Dude, I’m going to make you a freaking movie star, take your shirt off,’” Smith explained during an appearance on The Tonight Show Starring Jimmy Fallon at the time. “And I was like, ‘Michael, come on man,’ and he was like, ‘Dude, you don’t know, I know!’”

Bay, 56, and Smith did end up finding a compromise, with The Pursuit of Happyness star opening his shirt in the scene but not completely taking it off.

Stars Who’ve Hit Back Against Body-Shamers

“To this day, every time I see Michael he’s like, ‘Dude, I should be in for half. I made your career,’” Smith added.

Years later, Smith had to get in tip top shape for his role in Suicide Squad too. “I knew from the very beginning that this was going to be a big movie for me,” Smith told Men’s Journal in 2016.

The Cobra Kai alum ended up with a torn leg muscle early into training for the film. “It was really scary to be in that position,” he said at the time. “When you’re 47 years old, no injury is a mild injury anymore. I was stepping back to throw a blow, and my calf popped. Everyone heard it. The doctor there told me that I was going to be down for six weeks, but I couldn’t allow that.”

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Cerebral venous sinus thrombosis: What to know about rare blood clot condition

blood

Cerebral venous sinus thrombosis was reported in six American women after they were injected with the Johnson & Johnson COVID-19 vaccine, prompting federal officials to recommend a pause Tuesday in giving doses of the one-shot vaccine until an investigation can be completed.

But what is cerebral venous sinus thrombosis, and why are the U.S. Food & Drug Administration and the Centers for Disease Control and Prevention so concerned about it?

Dr. Geoffrey Barnes, a cardiologist and vascular medicine specialist at the Michigan Medicine Frankel Cardiovascular Center, told the Free Press Tuesday that the condition is an extremely rare form of stroke.

“This is a blood clot that forms in one of the veins that helps to drain blood from your head back down to your heart,” Barnes said. “It’s an uncommon place for blood clots to form, and when it forms up there, patients tend to have sort of a collection of symptoms.”

Those symptoms, he said, can include:

  • Severe headache
  • Vision changes
  • Severe nausea
  • Vomiting
  • Rarely, some people will have seizures

With these strokes, the blood clot forms in the cerebral spinal vein, he said.

“It is a pretty uncommon location,” Barnes said. “The two most common places in the body where people develop blood clots are either in the veins of the legs, or in the lungs; those are overwhelmingly where most blood clots form.”

Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said in the general population, this occurs in between 2 and 14 people per million population.

What’s different about the six U.S. women who developed this condition within 6 and 13 days of getting a COVID-19 vaccine is that they also had a low platelet count, also known as thrombocytopenia.

“The combination here—the real thing that is so notable here—is not just the cerebral venous sinus thrombosis or the thrombocytopenia,” Marks said. “Those two things can occur. It’s their occurrence together that makes a pattern, and that pattern is very, very similar to what was seen in Europe with another vaccine.”

The vaccine Marks was referencing is AstraZeneca’s, which is similar to Johnson & Johnson’s in that it’s a recombinant vector vaccine using the adenovirus, which causes the common cold, that’s modified with the genetic spike protein found in SARS-CoV-2.

While Johnson & Johnson’s vaccine was developed using human adenovirus, there have been reports of blood clots in people in other countries who received AstraZeneca’s vaccine. It uses chimpanzee adenovirus.

“We don’t have a definitive cause,” Marks said. “But the probable cause that we believe may be involved here … is a similar mechanism that may be going on with other the other adeno-viral vector vaccine. That is that this is an immune response that occurs very, very rarely after some people receive the vaccine, and that immune response leads to activation of the platelets and these extremely rare blood clots.”

For most people who are having a stroke or are treated for blood clots, the standard therapy in hospitals is to give them heparin, a blood thinner, Barnes said.

But for people who have a CVST following a COVID-19 vaccine, that’s not the recommendation.

“What we are learning about these blood clots and how they might be associated with the use of the AstraZeneca vaccine in Canada and Europe and now it sounds like potentially with the Johnson & Johnson Johnson vaccine here,” Barnes said, “is we actually need … to use a different form of a blood thinner. That’s sort of the critical piece for doctors to know about.

“Doctors need to be aware that if this very rare blood clot occurs within three weeks of somebody getting the J&J vaccine, then there’s some routine lab tests that they need to do, and they would want to start them on a non-heparin blood thinner.”

Two important studies were published Monday in the New England Journal of Medicine, Barnes said, that suggest that after getting one of these COVID-19 vaccines, the body can form an immune response that binds heparin with platelets, which is one of the things in the blood that helps people form blood clots.

“We see patients who get this sort of allergic reaction, you might call it, to heparin all the time,” Barnes said. “But what’s interesting here is it seems to have developed in people who never got heparin before. And so because we’re aware of this, now we know how to immediately jump in and use some non-heparin blood thinners.”

Barnes said people who’ve recently gotten a Johnson & Johnson vaccine shouldn’t be all that concerned.

“I want to reassure people that this is an exceedingly rare event,” he said. “We’re talking about six cases that have been reported from the CDC and the FDA despite millions and millions of doses of the J&J vaccine.

“We’re talking a fairly tiny percentage of people who have developed the rare blood clot. The second thing I would say is what we’ve learned from Europe and Canada, is that there does not seem to be any role for taking aspirin or a blood thinner, you know, shortly after getting your vaccine. Again, the risk of this blood clot is so exceedingly low. that we don’t want people to have other harms from taking medicines, things like that.

“The third thing I would say is that it’s really important to understand the time course. If you just got your vaccine yesterday or the day before, it’s pretty common that you might feel for muscle aches, maybe chills, fever, headache, flu-like symptoms. That’s a sign that your body’s reacting to the vaccine as we would expect—that’s not something to be concerned about.”

For anyone who got a Johnson & Johnson vaccine a month or two ago, “you’re also out of the window where we’re not concerned about any blood-clotting risk,” Barnes said.

“But if you fall in this window of about four to five days up to three weeks (post-vaccination), that’s where we’ve heard about these very rare blood clot events and so those are the people for whom we just want to keep our antenna up.

“We want to be aware of it in case they develop these new severe symptoms.”

Those people, he explained, should go to the hospital for an evaluation if they develop symptoms of CVST, such as severe headache, vision changes, severe nausea and vomiting or seizures.

“You can be reassured that every hospital in the region has the tools needed to do this evaluation,” Barnes said. “In the rare case where this is found, we have the tools necessary to treat it, but it’s pretty unlikely this is not going to be a common event that people will experience.”

He said it’s also not a reason to avoid getting a COVID-19 vaccine.

“We know that the COVID pandemic is the most important health risk out there right now, and especially here in Michigan,” Barnes said. “We are on the front lines of that, and anything we can do to get the COVID pandemic under control is going to be really important.

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HomeGoods Secrets Only The Savviest Shoppers Know

No one can resist the allure of HomeGoods, thanks to its affordable prices and aisles filled with random items you have no idea you needed in your life until the very moment you spotted it sitting on the shelf. There have been many hours lost to the wandering of the store by this writer, and to be honest, most of the time, it is a perfect escape from what otherwise would be a very ordinary day. 

According to Philadelphia Magazine, there is an “indescribable beauty of buying crap you don’t need at a store that has it all,” which basically sums up any shopper’s experience in one neat sentence. Via The Spruce, the company revealed to loyal consumers that the store was making plans for an online venture, which is welcome news for those who like shopping in their pajamas. Now you’ll be able to get your HomeGoods fix right from your own home!

Whether you prefer to shop in person or from your couch, here’s some secrets that only the savviest HomeGoods shoppers know.

Savvy HomeGoods shoppers know a few tricks

Most savvy HomeGoods shoppers are already well aware that they are snagging a bargain when they walk through the doors, but House Beautiful revealed some tricks of the trade for even further reductions at the cash register. Most pros already know that if an item is damaged, they may be able to shave a little more off the retail price, but did you know the trick could also work if the item you are looking to buy is already discounted? The standard go-to for the store is 10 percent off any damaged item, which is basically the sales tax covered.

This next secret blew my mind! Did anyone else know that HomeGoods has an app that allows you to shop in real-time? Good Housekeeping uncovered that you could calmly browse the aisles of your local store to see what was in stock without leaving the comfort of your own home. This, my friends, is what we call a game-changer! You will easily be able to spot any new arrivals well ahead of the crowds. If you happen to stumble upon something you like on the app, don’t be afraid to call the store and ask them to hold that special item.

HomeGoods is a shopper's paradise

For another shopper’s hack, superfan Christine Lee says that you should only head to HomeGoods during the weekdays since the weekends can be jam-packed, per Apartment Therapy . Lee lets us in on a little secret: Mondays are a recovery day for most stores after a hectic weekend, so wait until Wednesday when they have had a chance to clean up and add new stock. In addition, markdowns occur on a three-month schedule, which you can easily find out by looking at the tag. “Read the label! It will show you the month and year (i.e. 1117 = November 2017),” so you’ll know exactly how long the item has been on the shelf.

If you’re wondering what time of day is best for hitting your local HomeGoods, the afternoon is prime time. According to one reddit user, “most stores get new arrivals every other day in the early morning. By noon, the latest shipment will be rolled out onto the floor.” Don’t  know your store’s delivery schedule? Ask an employee, per House Beautiful. Armed with these secrets, we fully expect you to have one very successful shopping mission on your next trip.

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The Delayed Side Effect Of The Moderna Vaccine You Need To Know About

As of February 11, 2021, Moderna had provided the United States with over 41 million doses of the 300 million it has committed to giving the country. And, according to Moderna, over 22 million Americans had received at least one dose of its vaccine.

If you’re one such vaccine recipient, or if you are about to become one, you may be noticing delayed reactions at the Moderna vaccine where a healthcare professional injected it. In a recent letter to the New England Journal of Medicine, doctors noticed that just under 1 percent of study participants in a phase 3 clinical trial of the Moderna vaccine (244 of 30,420 patients) developed reactions at the vaccine’s injection site, eight or more days after receiving their first vaccine dose. Such reactions included red, inflamed and tender skin. Of all participants, 0.2 percent developed similar reactions after a second vaccine dose.

A total of 12 patients developed skin rashes between 4 and 11 days after the first dose, and, significantly, after “initial local and systemic symptoms associated with vaccination” had already cleared. “For most people who are experiencing this, we believe it’s tied to the body’s immune system going to work,” letter co-writer Esther Freeman said in a statement released by Massachusetts General Hospital.

Should you be worried if you get a rash after a dose of Moderna?

Did you develop a rash after getting your first dose of the Moderna vaccine? Freeman, the director of Global Health Dermatology at Massachusetts General Hospital, doesn’t think that developing a skin irritation should prevent you from getting your second dose of the vaccine. Moreover, says letter co-author Erica Shenoy, associate chief of Mass General Hospital’s Infection Control Unit, such rashes and skin hypersensitivity “could be confused — by clinicians and patients alike — with a skin infection” (via Massachusetts General Hospital). But, in the case of the study reported on in The New England Journal of Medicine, treating the rashes with antibiotics was ineffective. Instead, patients who developed skin reactions to Moderna were treated effectively with ice and antihistamines. More severe cases required corticosteroids. 

There’s more good news. If you develop rash after taking Moderna, Freeman and Shenoy’s research indicates that you probably won’t have to deal with the symptoms in the longterm. The 12 vaccine recipients with skin irritations mentioned in the New England Journal of Medicine saw their symptoms clear up, on average, after “nearly a week.”

You shouldn’t necessarily be alarmed if you develop a skin reaction after your second dose of the Moderna vaccine, either. Six of the 12 patients mentioned in the New England Journal of Medicine letter went on to develop a subsequent reaction after a second vaccine dose. According to a Massachusetts General Hospital’s statement, none of these reactions “was more severe than their dose one reaction.”

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Here’s What You Need To Know Before Using Rose Quartz

Rose Quartz is one of the most beautiful crystals that a person can have in their collection. In addition to its gorgeous color, it is also said to release strong vibrations that can benefit your life in a number of ways. Healing Crystals For You reports that Rose Quartz is available in multiple shades of pink, hence its colorful name. They come in all shapes and sizes, and may even be transparent. These stones hail from deposits in many countries including Brazil, Japan, and South Africa. However, they can also be found in the state of South Dakota.

According to Healthline, the use of the stone dates back to 7,000 BC. Evidence suggests that Egyptian and Roman women alike would use the crystal in their face masks due to its anti-aging properties. Of course, there are plenty of other uses for the gem. The stone is a must-have for anyone looking to use crystal energy in their lives. However, there are a few things that you should know before incorporating Rose Quartz into your routine.

Rose Quartz has many benefits

Rose Quartz is said to be a powerful crystal that includes a multitude of benefits and should be treated as such. The first thing you need to do before using the stone is to cleanse it of all negative energy. The easiest way to do so is by smudging it with the smoke from sage. There are a wide variety of uses for the gem, but the most common is love. The crystal is often called the “love stone,” and can be used in hopes of healing relationship problems, inspiring kindness and understanding, and as a form of self-care.

“Predominantly, rose quartz is a crystal of unconditional love that brings deep healing to the heart by opening the heart chakra. Once achieved, a deeper state of calmness, serenity, and peace is reached, which ultimately results in complete relaxation, encouraging the feelings of happiness and contentment,” owner of KSC Crystals and reiki master, Keith Birch, told Healthline.

Of course, others use the stone to meditate with, and even to clear their complexion. It’s also said that Rose Quartz can help with the power of positivity. “Rose quartz increases blood circulation in the body and is especially powerful when worn close to the heart. Rose quartz wards off negativity, and when carried on your person, helps to replace negative emotions with positive, returning the wearer to that place of pure love and balance,” Birch said.

How to incorporate Rose Quartz into your life

According to Tiny Rituals, there are plenty of ways in which you can incorporate Rose Quartz into your life. Using a Rose Quartz facial tool like Demi Moore could improve your skin. Meanwhile, wearing jewelry such as a necklace, bracelet, or ring made from the stone will help you attract love, joy, and abundance. The gem can also be placed around your home or office to give it good vibes and energy. It’s a popular choice when looking to Feng Shui your space, and could work wonders for opening up your heart chakra. You can even add it to your bath water to give yourself an extra boost.

Sleeping with the crystal under your pillow is another way to gain from its properties. Doing so reportedly helps you feel more energized when you wake up and increases your sense of inner peace and positivity. “Rose Quartz is widely known for its ability to improve sleep and have soothing dreams. When using a Rose Quartz crystal for better sleep and peaceful dreams, it is best advised to focus on what type of feelings you’d like the Rose Quartz to achieve before you actually go to sleep. This will help your subconscious to vibrate this energy to cooperate with the Rose Quartz stone for achieving best effects,” Calming Cosmos reports.

Now that you know all about the benefits of Rose Quartz, it’s time to choose one that best suits your life!

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Why we’ll get COVID booster vaccines quickly and how we know they’re safe

covid

The United States’ drug regulator, the Food and Drug Administration (FDA), said last week COVID vaccines updated for variants won’t need to go through full randomized controlled clinical trials.

The booster shots will only be required to undergo initial testing to check they are safe and produce an immune response. They won’t need to go through lengthy “phase 3” efficacy trials which would normally enroll tens of thousands of participants.

The European Medicines Agency hasn’t published formal guidelines, but has taken the same position. Chair of the agency’s vaccine evaluation team, Marco Cavaleri, told Reuters: “We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000.” The focus would be primarily on safety and immune response data.

This is encouraging news, because it means we could get access to booster shots much more quickly than if they went through full trials. And because drug companies will have to prove they’re using the same technology and manufacturing process as the original vaccines, we can still be assured they’ll also be safe.

Australia’s Therapeutic Goods Administration (TGA) has not yet confirmed whether it’ll do the same, but history tells us we can probably expect it to follow suit.

Why do we need boosters?

Variant strains of the virus have been detected around the world, including those originating in the UK, South Africa and Brazil. People infected with these variants have been found in Australian hotel quarantine, and the B.1.1.7 strain, first found in the UK, has escaped the quarantine system several times.

For those tested, the current crop of vaccines still perform relatively well against the B.1.1.7 strain.

And data suggest most COVID vaccines will still be somewhat useful in preventing hospitalization and death from these variants.

However, efficacy against mild to moderate illness, and against transmission of the virus, has likely dropped off sharply against some of these variants.

For example, preliminary data suggest vaccine efficacy for AstraZeneca’s vaccine dropped to just 10% against mild-moderate illness from the B.1.351 variant which originated in South Africa. Efficacy of Novavax’s shot slid from 89% to 60% against this variant. These data were from small trials and more studies are needed, but it’s still very concerning.

We don’t have solid real world data yet about the performance of the Pfizer vaccine against the B.1.351 variant.

Why don’t we need full trials again?

Drug companies have flagged the need to develop updated booster shots to cover these new variants, which would involve tweaking their sequences.

Some scientists were worried this would mean drug companies would have to go through full randomized controlled clinical trials, including large phase 3 efficacy trials, to get these booster shots to market. These phase 3 clinical trials include many thousands of volunteers and the primary aim is to determine if the vaccine can prevent people from getting the disease.

By the time these trials were completed, it may be too late to control outbreaks caused by variants, and new variants may emerge that we’d need coverage for. In a pandemic, we don’t have the luxury of time.

But the FDA has dispelled this fear. The drug regulator seems most interested in ensuring any booster shots are safe and the manufacturing process hasn’t been modified from the original vaccines it approved.

The boosters will still require smaller trials to show they’re safe and generate an immune response. The trials typically involve a few hundred people and would examine the percentage of vaccinated volunteers who make antibodies to the variants, as well as the strength of the immune response.

This would be similar to what’s done for annual flu shots, although not exactly the same. We get very different flu strains circulating every few years, but current COVID-19 vaccines and variant “boosters” could be sufficient to use for several years—we don’t know yet.

The FDA also indicated boosters won’t necessarily need to undergo animal testing before progressing to human testing, which will also save time. But this may be encouraged if results from human trials are ambiguous.

How do we know they’ll be safe and effective?

Any potential side effects from a vaccine are mostly based on how the vaccine is made, the technology and how it’s delivered.

If drug companies keep all these factors the same, and only make minor sequence changes to cover variants, then we can expect the boosters to still be very safe vaccines.

The US and EU drug regulators would like to see data where the booster is given to people who’ve already had an original COVID vaccine, given this will be the likely scenario for most people receiving a booster shot by the time they’re approved.

The boosters will probably also be tested in people who haven’t had any COVID disease or vaccine. This is to ensure the boosters can induce strong immune responses like the original vaccine.

When required, the TGA will independently review all of this data. It will also likely seek advice from internal and external experts.

It’s also unclear when booster shots will be available or if they will be necessary in the short term. Melbourne-based biotech company CSL, which is producing the AstraZeneca vaccine onshore, said this week booster shots to cover coronavirus variants probably won’t be available until the end of the year.

US pharmaceutical company Moderna has already sent a new COVID vaccine booster shot for phase 1 testing, to target the B.1.351 variant. Pfizer is also planning to develop a booster to cover this variant, either as a third dose or a reformulated vaccine.

New variants will continue to arise, but the best chance we have of stopping or slowing this process is by continuing public health measures to ensure as few people as possible become infected.

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The ACA Marketplace Is Open Again for Insurance Sign-Ups. Here’s What You Need to Know.

For people who’ve been without health insurance during the pandemic, relief is in sight.

In January, President Joe Biden signed an executive order to open up the federal health insurance marketplace for three months as of Monday so uninsured people can buy a plan and those who want to change their marketplace coverage can do so.

Consumer advocates applauded the directive. Since 2016, the number of Americans without health insurance has been on the rise, reaching 30 million in 2019. The economic upheaval caused by the novel coronavirus has made a bad situation worse, throwing millions off their insurance plans.

The move is in stark contrast to the Trump administration’s approach. As covid-19 took hold last spring and the economy imploded, health experts pleaded with the Trump administration to open up the federal marketplace so people could buy insurance to protect themselves during the worst public health emergency in a century. The administration declined, noting that people who suddenly found themselves without coverage because they lost their jobs were able to sign up on the marketplace under ordinary rules. They also cited concerns that sick people who had resisted buying insurance before would buy coverage and drive up premiums.

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The Biden administration is promising to spend $50 million on outreach and education to get the word out about the new special enrollment period. That’s critical, experts said. Although the number of people signing up for Affordable Care Act plans has generally remained robust, the number of new consumers enrolling in the federal marketplace has dropped every year since 2016, according to KFF, corresponding to funding cuts in marketing and outreach. (KHN is an editorially independent program of KFF.)

“There are a lot of uninsured people who even before covid were eligible for either hefty marketplace subsidies or for Medicaid and not aware of it,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. A marketing blitz can reach a broad swath of people and hopefully draw them in, regardless of whether they’re uninsured because of covid or not, she said.

Here are answers to questions about the new enrollment option.

Q: When can consumers sign up, and in which states?

The sign-up window will be open for three months, from Monday through May 15. Uninsured residents of any of the 36 states that use the federal healthcare.gov platform can look for plans during that time and enroll.

Most of the states and the District of Columbia that operate their own marketplaces are establishing special enrollment periods similar to the new federal one, though they may have somewhat different time frames or eligibility rules. In Massachusetts, for example, the sign-up window remains open until May 23, while in Connecticut, it closes March 15. Meanwhile, Colorado has reopened enrollment in its marketplace for residents who lack insurance, but anyone already enrolled in one of the state’s marketplace plans won’t be allowed to switch to a different plan until the regular open enrollment period in the fall.

At this point, only Idaho has not announced plans to open their marketplaces, said Corlette. It may still do so, however.

Q: Can people who lost their jobs and health insurance many months ago sign up during the new enrollment period?

Yes. The enrollment window is open to anyone who is uninsured and would normally be eligible to buy coverage on the exchange (people who are serving prison or jail terms and those who are in the country without legal permission aren’t allowed to enroll).

People with incomes up to 400% of the federal poverty level (about $51,500 for one person or $106,000 for a family of four) are eligible for premium tax credits that may substantially reduce their costs.

Typically, people can buy a marketplace plan only during the annual open enrollment period in the fall or if a major life event gives them another opportunity to sign up, called a special enrollment period. Losing job-based health coverage is one event that creates a special sign-up opportunity; so is getting married or having a baby. But usually people must sign up with the marketplace within 60 days of the event.

With the new special enrollment period, how long someone has been uninsured isn’t relevant, nor do people have to provide documentation that they’ve lost job-based coverage.

“The message is quite simple: Come and apply,” said Sarah Lueck, a senior policy analyst at the Center on Budget and Policy Priorities.

Q: What about people who are already enrolled in a marketplace plan? Can they switch their coverage during this new enrollment period?

Yes, as long as their coverage is through the federal marketplace. If, for example, someone is enrolled in a gold plan now but wants to switch to a cheaper bronze plan with a higher deductible, that’s allowed. As mentioned above, however, some state-operated marketplaces may not make that option available.

Q: Many people have lost significant income during the pandemic. How do they decide whether a marketplace plan with premium subsidies is a better buy for them than Medicaid?

They don’t have to decide. During the application process, the marketplace asks people for income information. If their annual income is below the Medicaid threshold (for many adults in most states, 138% of the federal poverty level, or about $18,000 for an individual), they will be directed to that program for coverage. If people are eligible for Medicaid, they can’t get subsidized coverage on the exchange.

People can sign up for Medicaid anytime; there’s no need to wait for an annual or special enrollment period.

Those already enrolled in a marketplace plan whose income changes should go back into the marketplace and update their income information as soon as possible. They may be eligible for larger premium subsidies for their marketplace plan or, if their income has dropped significantly, for Medicaid. (Likewise, if their income has increased and they don’t adjust their marketplace income estimates, they could be on the hook for overpayments of their subsidies when they file their taxes.)

Q: What about people who signed up under the federal COBRA law to continue their employer coverage after losing their job? Can they drop it and sign up for a marketplace plan?

Yes people in federal marketplace states can take that step, health experts say. Under COBRA, people can be required to pay the full amount of the premium plus a 2% administrative fee. Marketplace coverage is almost certainly cheaper.

Normally, if people have COBRA coverage and they drop it midyear, they can’t sign up for a marketplace plan until the annual fall open enrollment period. But this special enrollment period will give people that option.

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Huge Gaps in Vaccine Data Make It Next to Impossible to Know Who Got the Shots

As they rush to vaccinate millions of Americans, health officials are struggling to collect critically important information — such as race, ethnicity and occupation — of every person they jab.

The data being collected is so scattered that there’s little insight into which health care workers, or first responders, have been among the people getting the initial vaccines, as intended — or how many doses instead have gone to people who should be much further down the list.

The gaps — which experts say reflect decades of underfunding of public health programs — could mean that well-connected people and health personnel who have no contact with patients are getting vaccines before front-line workers, who are at much higher risk for illness. Federal and state officials prioritized health workers plus residents and staffs of nursing homes for the first wave of shots.

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Although officials leading President Joe Biden’s covid response have pledged to tackle racial inequities as they seek to control the pandemic, lapses in reporting race or ethnicity could hinder efforts to identify and track whether minorities hit especially hard by the pandemic are getting shots at a high-enough rate to achieve hoped-for levels of herd immunity. So far, limited data in multiple states shows Black residents are getting vaccinated at lower rates than whites.

“Every state knows where they’ve sent vaccine, and every provider has to report inventory. But as far as who is being vaccinated, that one is a little more tricky,” said Claire Hannan, executive director of the Association of Immunization Managers.

Data that eventually makes its way to the Centers for Disease Control and Prevention and other federal systems is “only going to be as good as whatever you can get out of the vaccine registries” that vary by state, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials. “They’re all different and, going into this, they were all at different stages of how robust they were.”

There are 64 immunization registries in the United States that gather information for states, territories and a handful of large cities — and they aren’t connected. Meanwhile, real-time data in the U.S. public health system is virtually nonexistent, Plescia said.

Reporters at KHN examined the data being gathered versus what the CDC says is supposed to be collected for every person vaccinated, which includes: name, address, sex, date of birth, race and ethnicity, the date and location where they were vaccinated, and the shot they received (currently only two products are available, from Pfizer-BioNTech and Moderna). Not on its list: occupation, even though initial vaccine distribution largely hinges on place of work, prioritizing health care personnel, long-term care facilities and then other essential workers such as teachers, grocery store workers and firefighters.

Dr. Katherine Poehling, a pediatrician at the Wake Forest School of Medicine who’s on the CDC advisory committee that issued vaccine priority recommendations, declined to comment on whether occupation should have been a required element for reporting to the CDC.

“I think you can always wish for more data, but really what we’re going for is vaccinating everybody that wants to be vaccinated,” she said. “The fact that there was something available on day one was really remarkable,” she said, referring to a database that could track vaccine shipments and allocations by state.

Still, gaps are evident, including holes in CDC rules for reporting race and ethnicity. Race and ethnicity information are missing from at least hundreds of thousands of vaccine doses that have already been administered and reported to state public health authorities.

Texas’ vaccine data on Wednesday showed that race or ethnicity was unknown for more than 700,000 people. Virginia’s dashboard shows that data was missing for nearly 300,000 vaccinations, or 52% of vaccine doses, as of Tuesday. The same was true for tens of thousands of vaccinations in Colorado and Maryland.

In Minnesota, state law prohibits the sharing of data on race and ethnicity.

“It is important how many shots are administered, but it is critical that we get good race and ethnicity information about who is receiving it so we can identify disparities and other problems,” said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

The CDC declined to say how many of the vaccine records it had received were missing the information. In response to questions, CDC spokesperson Kristen Nordlund said the agency plans to publish race, ethnicity and other demographic data next week.

The Department of Health and Human Services did not respond to multiple requests for comment.

Dr. Marcella Nunez-Smith, chair of the Biden administration’s covid-19 health equity task force, on Wednesday conceded that the racial and ethnicity data is “incomplete” but said it wasn’t the only way to gauge progress of the vaccine rollout on the ground.

“We can think about things like neighborhoods and communities as metrics and ways to track as well,” she said. “We’re building our equity dashboard right now, and we’ll rely on government sources as well as sources of data external to government.”

The ongoing struggle for complete data shows how little has changed for the CDC since the virus appeared in the U.S. one year ago and its early efforts to collect data identifying covid-infected people were widely panned.

So far, the CDC has publicly stated how many vaccines have been distributed nationwide and how many doses administered. Its dashboard includes a breakdown of how many shots have been given by state and in long-term care facilities. Walgreens and CVS together have given more than 2.5 million doses in nursing homes and other long-term care facilities, though neither company has released data on race or whether the shots were given to patients or staffers.

State and federal health officials know where vaccines go as officials must track inventory by facility. Several states have released breakdowns of doses administered by the type of institution, providing a window into how many shots are being used in hospitals, nursing homes, pharmacies, primary care practices, public health departments and tribal health sites. And when signing up for an appointment, individuals may be asked to provide their occupation to attest they qualify for a shot under a state’s rules at a given time.

Maryland and Ohio require providers to submit data on the occupations of vaccine recipients, in a break with CDC practice. But several states contacted by KHN said they do not collect that information, such as Idaho, Michigan, Minnesota, Texas and Virginia.

Electronic health records manufacturers that provide software to hospitals and other facilities said they are scrambling to modify the software to accommodate data reporting requirements that vary by state.

Occupation is one example. Another: Texas law requires the state to collect information on all medications given “in response to a declared disaster or public health emergency,” said State Health Services spokesperson Chris Van Deusen.

Leigh Burchell, vice president of policy and government affairs at the EHR firm Allscripts, said these variations are “obstacles none of us has tackled before,” though she thinks that, overall, “successes outweigh failures” as companies have had to adjust quickly during the pandemic.

EHR systems can connect to state registries, which ultimately send vaccine tracking data to the CDC. A lack of “a coordinated, national public health infrastructure” continues to be a problem that “forces everyone to work less efficiently than would be optimal,” Burchell said.

Health IT consultant Reed Gelzer said the situation reflects the 30-year-plus failure of the public health system to modernize data collection. He said officials need look no further than chronic problems tracking childhood immunizations, handled in some states at the county level, and in others at the state level, often poorly. A national system to track immunizations has never existed, which he argues should have been discussed before the vaccine rollout.

“As far as I know, even in the earliest days of the pandemic, nobody did stress-testing of the information system,” Gelzer said.

Cerner, a major electronic health records company, says that some hospitals are using an existing workplace health system to track employees who have been vaccinated while others create a patient record for vaccinated employees as well as for patients. The systems can capture demographic details, but the data fields to do that have to be turned on and it’s unclear whether its client hospitals have done so.

The CDC and other federal agencies rely on a complicated web of systems to get data about who’s been vaccinated. State and local vaccine registries, known as immunization information systems, are the most comprehensive source of records and the “source of truth,” Hannan said.

Those registries have long-standing connections to providers’ electronic health records, said Rebecca Coyle, executive director of the American Immunization Registry Association. But they aren’t meant to capture certain information, such as a patient’s medical history and occupation.

Those state and local registries transmit data to an HHS-owned clearinghouse, where personal details are redacted.

The clearinghouse gets data from other sources, too. These include a new CDC vaccination clinic mobile app called VAMS, as well as pharmacies, prisons and federal agencies like the Department of Veterans Affairs and the Indian Health Service.

A limited slice of the data then moves to another CDC repository known as the “Data Lake,” where it can be analyzed and reported to the CDC and Tiberius, a separate software platform developed by federal contractor Palantir for former President Donald Trump’s Operation Warp Speed effort. The Data Lake also receives information on shipment and vaccine orders from the CDC’s VTrckS system.

On top of that dizzying array of tools, many states use another, third-party software system, PrepMod, to manage vaccine inventory, appointments and reporting.

When asked whether not having data on occupations could hinder tracking whether priority groups have received their shots, Nordlund of the CDC said it’s unnecessary to vaccinate all individuals in one phase before initiating the next.

“This means ideally hitting a sweet spot that maximizes getting vaccine into arms while also being mindful of the priority groups,” Nordlund said, “especially because these are people who are higher risk for complications from covid-19 or are more likely to be exposed to the virus because of their jobs.”

Lawmakers recently attempted to address the nation’s antiquated public health data infrastructure, partly by appropriating $500 million under the CARES Act to the CDC. In an August letter to Rep. Lucy McBath (D-Ga.), former CDC director Dr. Robert Redfield said the agency would use the funds to update how state and health departments report data to federal officials, improve the CDC’s own data infrastructure, and develop new standards for public health reporting.

Additionally, tucked into the massive year-end spending bill Congress passed in late December was a requirement that HHS expand and improve public health data systems used by the CDC and award grants to state and local health departments to upgrade their infrastructure.

The Biden administration has made promises to strengthen the federal government’s approach to data collection on vaccination efforts.

KHN data reporter Hannah Recht and KHN correspondent Lauren Weber contributed to this report.

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More than half of Americans know someone infected or ill with COVID: Poll

(HealthDay)—More than half of all Americans have been personally affected by COVID-19 at this point in the pandemic, according to a new HealthDay-Harris Poll survey.

The national survey was conducted by The Harris Poll between Oct. 8 and 12. It found that 55% of U.S. adults now say they know someone in their immediate or extended network of family and acquaintances who’s been infected, hospitalized or passed away from COVID-19.

About two in every five people said they’d had even more direct experience with COVID-19, with either themselves or someone very close to them falling ill, being hospitalized or dying.

“By now, we’re all accustomed to regularly seeing the sobering figures for COVID infection and death rates, but these findings translate to something so much bigger in terms of the full and relentless impact of the virus on millions of Americans,” said Robyn Bell Dickson, managing director of The Harris Poll.

These results come in the midst of a COVID-19 resurgence in the United States, with the nation averaging 59,000 new cases a day. There have been more than 8.3 million reported infections, and around 220,000 U.S. deaths caused by COVID-19.

The online poll of 2,021 U.S. adults also found that 39% reported a direct impact on their lives from the pandemic, including:

  • Having personally had COVID-19 (7%) or being hospitalized (4%) from their infection.
  • Residing in a household with someone who had COVID-19 (6%).
  • Having a close friend, family member or loved one who became infected with COVID-19 (34%), was hospitalized (19%), or passed away (13%).

Overall, more than one in 10 adults have a loved one who has passed away due to COVID-19, the survey found.

Shifts in outlook

People who’ve been personally affected by COVID-19 tend to see the pandemic differently from those who’ve so far remained relatively untouched by the virus, the results showed.

Those who have direct experience with COVID-19, either personally or through a loved one, are more likely to be very concerned that they or a loved one will die from COVID-19. Nearly two-thirds (64%) reported this high level of concern, versus 52% of those with no direct experience or whose only experience is through an acquaintance.

Those without direct experience are also likely to be more optimistic that the pandemic will be under control by early 2021, 56% versus 49% of those with direct experience.

Adults whose personal experience of COVID-19 was more severe, with either themselves or a loved one struggling for life in a hospital or dying, were also more likely to agree with these statements:

  • I wish more people took COVID-19 seriously (87%, versus 80%).
  • I am extremely worried about getting COVID-19 (78%, versus 59%).
  • I am very concerned that I or a loved one will die from COVID-19 (73%, versus 53%).

“It makes sense that people who have experience with the disease will carry a different outlook with them, given that at the beginning of 2020 no one knew much at all about the burgeoning threat of coronavirus,” said Lynn Bufka, senior director of practice transformation and quality at the American Psychological Association.

“As people have more experience with COVID, they are finding the messages regarding the pandemic to be more consistent and mapped on to their own experience,” Bufka said.

Anxiety and resilience

The growing number of people who have personal experience with COVID-19 is adding to the uncertainty that already disrupts the daily lives of all Americans, Bufka said.

“Collectively, we’re all faced with this pandemic, not knowing when it will end. We have no way to put some predictions around it and feel comfortable with those predictions,” she added.

“We’re all sitting in a period of uncertainty with the pandemic, with the economic impact of it, and then you layer in other issues like grappling with systemic racism and the political discourse, there are just a lot of things that are elevating our levels of uncertainty,” Bufka continued. “We know that uncertainty is connected to anxiety. It would not be surprising at minimum to see more individuals struggling with anxiety right now, because it’s harder to feel safe, secure and in control when so much feels outside of your control.”

People also are dealing every day with feelings of loss and grief, ranging from things as profound as illness and death down to the simple need for a regular routine, Bufka said.

“Routines help us in so many ways because they make our lives predictable. They make things less uncertain. They also free up our mental space for tackling the things that are novel,” Bufka said.

“If your schedule changes dramatically or if the kinds of decisions you’re having to make vary day to day, that takes mental energy, which is harder to deal with,” she explained. “So we see people struggling with decision making, with handling novel problems, all of that because mentally, cognitively, their attention is taken with what they’re dealing with in the pandemic.”

It’s also becoming harder to expect help from those around you, she suggested.

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