Health

Breakthroughs are expected and represent about 0.098% of those fully vaccinated.

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(NEW YORK) -- Although reports of breakthrough COVID-19 cases occurring among fully vaccinated Americans are garnering much attention, as the country experiences a viral resurgence, new data illustrates just how rare these breakthrough infections are likely to be, and further shows that the vast majority of those becoming severely ill are the unvaccinated.

“While anecdotal cases and clusters can conjure concern around the vaccine, when put in the larger context of how many people have been vaccinated and the sheer volume of cases in the unvaccinated population, we recognize that the vaccines are working and how rare breakthroughs actually are,” said Dr. John Brownstein, the chief innovation officer at Boston Children's Hospital and an ABC News contributor.

With more than 156 million Americans fully vaccinated, nationwide, approximately 153,000 symptomatic breakthrough cases are estimated to have occurred as of last week, representing approximately 0.098% of those fully vaccinated, according to an unpublished internal Centers for Disease Control and Prevention document obtained by ABC News. These estimates reflect only the adult population and do not include asymptomatic breakthrough infections.

Substantial vaccination coverage amid increasing COVID-19 case rates are driving an increase in "expected" symptomatic breakthrough infections in recent weeks, the CDC wrote in the document.

Experts stress that no vaccine can provide 100% protection, but they are still very effective at preventing severe illness and death.

“The risk to fully vaccinated people is dramatically less than that to unvaccinated individuals. The occurrence of breakthrough cases is expected and, at this point, is not at a level that should raise any concerns about the performance of the currently available vaccines,” Matthew Ferrari, director of the Center for Infectious Disease Dynamics at Pennsylvania State University, told ABC News.

“Some vaccinated folks may still get infected, some may still transmit. And the more vaccinated people there are, the more breakthrough cases we’ll see,” he added.

Coronavirus cases are now at their highest point since early May, according to CDC data, with the U.S. average nearly quadrupling since June to 47,000 new cases a day, largely driven by the highly infectious delta variant, which now accounts for more than 83% of new cases nationwide.

Virus-related hospitalizations have also increased, with more than 27,000 patients hospitalized around the country, though that number is still significantly lower than in January, when over 125,000 patients were receiving care at one time.

According to the White House COVID-19 Task Force, severe breakthrough infections remain rare, and nearly all of these hospitalized patients -- 97% -- are unvaccinated.

Earlier this week, the popular summer destination of Provincetown, Massachusetts, was thrust into the spotlight after at least 430 COVID-19 infections were confirmed, many of them breakthroughs, following a busy July Fourth weekend.

Confirmed cases among Massachusetts residents, stemming from the Provincetown cluster, have been found to be predominantly symptomatic, with 69% of affected individuals reported to be fully vaccinated, according to local officials. Apart from three hospitalizations -- two in state and one out of state -- symptoms from cases associated with this cluster are known to be mild and without complication, Alex Morse, the town manager for Provincetown, said.

"The transmissibility of the delta variant raises the likelihood of sporadic 'super spreader' events among vaccinated people, especially when indoors and in close proximity without masks. These events raise the risk to those unvaccinated while the vast majority of the breakthrough cases will be mild or asymptomatic," Brownstein added.

Statewide in Massachusetts, state health officials report there have been at least 5,166 breakthrough infections as of July 17. More than 4,800 of these infections resulted in no hospitalization or death. A total of 80 of these breakthrough cases resulted in death, representing 0.0015% of individuals fully vaccinated -- and 272 cases resulted in hospitalization, representing 0.006% of those fully vaccinated.

The hospitalizations and deaths that do occur among fully vaccinated individuals tend to occur among people who are older or those with serious underlying medical conditions for whom the vaccines may have reduced efficacy, experts said.

Ankoor Shah, principal senior deputy director at the Washington D.C. Department of Health, said during a Thursday press conference that the district had 200 fully vaccinated breakthrough cases of COVID-19, out of a total record nearly 376,000 fully vaccinated people, representing “only point .05 percent, which just strengthens our confidence on how great these vaccines are.”

And in New Jersey, the total number of breakthrough cases, so far, is 5,678 out of a total of 4.8 million people vaccinated by July 12, according to state data. Forty-nine fully vaccinated individuals have died as a result of COVID-19.

"It is important to point out that 49 deaths due to COVID-19 among 4.8 million fully vaccinated state residents is slightly greater than one in 100,000 fully vaccinated individuals. That means vaccines are about 99.999% effective in preventing deaths due to COVID-19," Dr. Ed Lifshitz of the New Jersey Department of Health said in a statement to ABC News.

Additionally, 27 of these individuals had pre-existing conditions, Lifshitz said, and many had more than one condition.

Of concern to some experts is the decline in daily COVID-19 tests, which makes it more difficult to track the spread of the virus. The nation is now recording just under 600,000 COVID-19 tests a day, which has ticked up slightly in recent weeks but is still much lower than at the country's peak in January, when U.S. was recording over 2 million tests a day. In addition, the CDC has, since May, ceased reporting asymptomatic or mild breakthrough cases.

According to Brownstein, the combination of the overall testing decline, the mild nondescript nature of breakthrough infections, and the general perception that vaccines are protective, means that any count of breakthrough infections is likely an underestimate.

Hence, he said, “given the efficacy of the vaccines, we recognize that even more cases will be asymptomatic, so these data only show part of the story. While asymptomatic cases are not of clinical relevance, they do help understand important patterns of transmission in the community.”

Experts concur that even with lower case levels than this past winter, the pandemic is not yet over, and it is critical to track the disease in order to attempt to slow its spread.

In a recent editorial in the Journal of the American Medical Association, experts urged the CDC to “re-energize” its testing services in light of the highly transmissible delta variant, “because without vigorous testing, the nation cannot be sure whether declining cases are a function of decreased numbers of infections or reduced numbers of tests.”

“As long as the virus is circulating, with or without causing illness, it can change and mutate, including into new strains that may be even harder to control,” Samuel V. Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation, told ABC News.

“To get ahead of the pandemic we need to track the virus more closely and collect high-quality information on how and where COVID-19 is changing," he said. "This high-quality, detailed information is crucial for COVID-19 and future pandemics."

Copyright © 2021, ABC Audio. All rights reserved.


This doctor helps Olympians with their sleep. Here are his tips to sleep like a champion.

Courtesy Dr. Jeffrey Durmer

(NEW YORK) -- Olympic teams often have coaches, trainers and physical therapists on their staff. But for the Tokyo Games, the U.S. Weightlifting team has added another role to help its athletes perform at the top of their game – a sleep performance director.

Dr. Jeffrey Durmer is Chief Medical Officer of Nox Health and a neuroscientist who specializes in sleep. Since 2013, he has been helping athletes in various sports as a sleep consultant to optimize their performance through sleep programs. This year, he is one of the first staff members on an Olympic team that solely specializes in sleep.

"All it is, is sleep doping," Durmer told ABC News. This is done by "using natural physiology and science to improve the team's abilities. I give them huge credit for thinking outside the box and finding new ways to implement an advantage which is completely legal."

Durmer said the pressure of competition and jetlag can often throw off an athlete’s sleep schedule during the Olympic Games. He also said many athletes are so focused on training as hard as they possibly can that they forget to make sleep a priority.

“I think it has changed a lot of -- the perception about sleep, where they all kind of looked at sleep, as, you know, I'll sleep when I'm dead. I can work out three times a day,” Durmer said. “What we found is that this concept of overtraining syndrome is really not about overtraining, it's about under-recovery. So if you're not recovering enough, your training itself could become a detriment.”

Durmer said the most important part of his job as a sleep performance director is educating the athletes about the benefits and necessity of sleep as a group. Then, he studies each athlete to determine what sleep patterns will give them the best competitive advantage.

“If you can make if you can actually start to build that into your training routine, build your sleep routine, that actually will support all kinds of resilience, mental resilience, physical resilience, immune resilience, when you go to another country … So you can actually perform at your highest level,” Durmer said.

Due to the pandemic, athletes are not able to stay in Tokyo for as long as they normally would to adjust to the time change prior to competition. To help with jetlag, the U.S. Weightlifting has been training in Hawaii prior to the games, which will make the time adjustment much easier once they are able to enter Tokyo for competition.

Olympians are not the only ones who perform at their peak with a healthy amount of sleep, every person can benefit from a healthy sleep schedule. Durmer shared his top tips for gold medal-worthy sleep:

1. Simplify your routine: Create a bedtime for yourself that offers you at least 8 hours to sleep and set an alarm to remind you. Slow down 30-45 minutes before sleep by practicing a simple calming behavior such as meditation, reading, stretching or anything that helps you "settle.”

2. Use your own biology to your advantage: A cool core improves sleep. Lower your body temperature before sleep by taking a warm shower or bath, then rapidly cooling your body in the air. Activate your parasympathetic nervous system to fall asleep faster using meditative "belly" breathing exercises before sleep.

3. Eliminate before you add: Reduce the amount of technology, devices and non-sleep-related objects in your sleep space. View your sleep space as a sleep sanctuary where nothing's allowed in that's not for sleep. The same thing goes for sleep aids or supplements. Don't add anything until you've eliminated light, noise, heat, bed discomfort or objects that stimulate wakefulness.

4. Include sleep as part of your training: Sleep is the basis for your performance the next day, whether you're a weightlifter, student or CEO. Think about your sleep as the beginning of tomorrow, rather than the end of today.

5. Be mindful of your own sleep habits and patterns: Sleep is not a monolith. The duration and timing of your sleep are inter-dependent variables that you can control. Sleep quality may not be in your control all the time. If giving yourself enough time to sleep with a regular routine does not help you feel rested, you should seek some professional advice from a sleep physician.

Copyright © 2021, ABC Audio. All rights reserved.


Botox users getting younger after a year of Zoom meetings, doctors say

Plump

(NEW YORK) -- As cities around the world start to reopen after COVID-19 lockdowns, the effects of the pandemic are starting to show on people's faces.

Experts in cosmetic medicine say they have begun to notice an uptick in Botox treatments among younger generations. They say people, particularly women, in their early 20s -- aged from the pandemic and wearing less makeup than before -- spent so much time looking at themselves during Zoom meetings that they started to notice their "imperfections," and for the first time, turned to Botox and fillers.

"I would say that my average age of patients shifted down considerably this year, and it's now early 20s," Skinly Aesthetics founder Dr. Dmitriy Schwarzburg said. "And they're coming not just for Botox, but for all kinds of procedures that they would otherwise consider at a much later point in their lives."

Amy Shecter, the CEO of Ever/Body said, "The Zoom effect is real, and it has definitely been a catalyst for increased interest in cosmetic dermatology treatments."

According to Stacy Garrity, a nurse practitioner at Ever/Body, many of their clients over the past year have admitted that they only started to notice their fine lines because of Zoom, and now that things are opening up, they're anxious to get out of their quarantine funk and look and feel better.

The number of patients in their early to mid 20s "is a phenomenon that was not seen five years ago," Garrity said.

Schwarzburg said the pandemic accelerated what was already happening with people's interest in Botox. He said the median age of patients at his clinic has actually been declining for about four years, "and it's 100% because of social media -- especially filters." Schwarzburg said patients often come to him with photos of themselves with Instagram filters on and ask him to make them look that way. His biggest requests this year: "smooth skin, full lips, nice cheeks, sharp jawline."

Priya Patel, a physician assistant and Botox expert at Plump, agreed social media is to thank for the younger audience, and for the slow but steady de-stigmatization of Botox and cosmetic procedures in general.

"You can easily go on Instagram or TikTok and watch the procedures being done and realize like, 'Oh, it's not really what I thought it would be,'" she said. "And you can also follow those posts and see what their results look like."

But what's different about this younger population of first-time Botox users, Schwarzburg said, is that many of them are choosing to embrace wrinkle relaxers before their "dynamic lines" turn "static." In other words, it's all "preventative," whereas some years ago, it was used purely to treat an already existing "problem."

He explained that all Botox -- a protein approved by the Centers for Disease Control and Prevention and the Food and Drug Administration -- does is temporarily paralyze one's muscle receptors so that even when the brain sends the muscle a signal to move, it stays put. It takes about 12 weeks for the Botox to have full effect. Researchers also believe that the injections give the skin a chance to produce collagen to erase whatever fine lines may have developed over time. That's why those lines disappear. So, by using Botox early, millennials and Gen Zs are essentially taking control of how they age -- at least externally.

"What millennials want is for those dynamic lines to be less expressive, so they never reach the point of static lines. And they start early, so they never have to worry about developing static lines," Schwarzburg said. "That's a huge shift, I would say."

Botox clinics are adapting to this younger population

Dr. Carolyn Treasure, the co-founder of Peachy, opened the Botox clinic in New York's SoHo neighborhood at the peak of the pandemic, but has already secured a cult-like following of younger fans, including influencers, who love her services. This is not because Peachy is the only place in Manhattan to get wrinkle-relaxers -- there are hundreds -- but because clinics like hers are catering to a younger audience by making the experience of cosmetic procedures feel more trendy and casual than scary, taboo and hospital-like.

Also, Peachy uses a technology to apply Botox that was made precisely for the digital times we're living in. When a patient goes into the clinic, the nurse or doctor who will deliver the treatment first takes photos of the patient's face using an iPad. Then, Peachy's own Botox app will analyze the photos and suggest the number of Botox units that should be applied to each of the three FDA-approved points: forehead, frown lines and crow's feet. Of course, those numbers can be tweaked depending on the patient's desired look.

After the procedure -- which takes about five minutes -- the patient can sit down in the clinic's cozy, pink relaxation room, enjoy a complimentary sparkling water, ice their Botox points and take selfies on the many mirrored walls.

"Our mission at Peachy is really balancing fun and approachability with clinical excellence and scientific rigor," Treasure said. "I really try to fight against the 'Botox bar' stereotype in that we do have a clinically excellent environment and phenomenal providers and nurse practitioners who are really here to educate people on wrinkle prevention, and particularly prevention that doesn't alter or change how you naturally look. And it's a novel model of health care delivery."

Peachy, Plump, Skinly Aesthetics and Ever/Body -- with their pastel-colored decor, bright white lights ideal for photos and stylish waiting rooms -- look more like spas you want to post on Instagram than clinics where you get injected in. At the same time, many of the doctors and nurse practitioners who deliver the treatments have become social media stars, and often run in the same circles as fashion influencers or celebrities.

Treasure, who graduated from Harvard Medical School and was previously a resident at Brigham and Women's Hospital in Boston, said Peachy is like no other health care environment she's ever worked in, and that is exactly the draw. Young patients see getting Botox as a fun experience they want to brag about, whereas their parents likely believed in the myths associated with the procedure and thought it taboo.

The FDA does not recommend Botox cosmetic use in people under 18, and says any side effects are generally minor, such as redness, headache or nausea, according to the medication guide.

One common misconception is that Botox gives you a plastic or "deformed" look, but experts said that is actually the result of too much filler -- which is not the same. Another myth is that Botox is bad for the health, but Garrity said, "Neuromodulators are FDA-approved and have been used cosmetically in the U.S. since 1991. When injected judiciously and by a skilled medical provider, there is very little risk to people of any age."

Schwarzburg, at Skinly Aesthetics, said those are the exact misconceptions that caused the yearslong stigma against Botox, and which millennials and Gen Zs are helping to eliminate.

"I can tell you that most of the 40-plus patients keep it to themselves or to a very close circle of friends, while 20-year-olds could be posting it as I'm doing it and then they'll tell everyone and that will generate more traffic," Schwarzburg said. "It's a lifestyle kind of achievement."

The experts also agreed that while Zoom, Instagram and TikTok have certainly pushed younger people to try out Botox for the first time, so have they. Now that medical professionals have different platforms, health, skin care and scientifically backed cosmetic procedures have begun trending.

"People are now more interested in what is results-oriented -- what has data behind it. Because in this space there's historically been a lot of pseudo-science, and that's what we're fighting against," Treasure said.

Copyright © 2021, ABC Audio. All rights reserved.


What to know about antibody tests in a post-vaccine world

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(NEW YORK) -- A Centers for Disease Control and Prevention panel once again warned consumers this week not to use commercial antibody tests to check whether or not they are immune to COVID-19. These tests, the panel said Thursday, are not consistent and can't be used to measure protection against the virus.

Antibody testing is primarily used to determine if a person has previously been infected with the COVID-19 virus. Early reports suggested that people who tested positive for antibodies after either a known or asymptomatic infection had some level of immunity. Now, most health officials agree that having a positive antibody test does not mean a person is immune to contracting the virus.

"Antibodies after a period of time start to come down again, that's not a bad thing," said Dr. Todd Ellerin, director of infectious diseases at South Shore Health. But the presence of antibodies is only part of the story when it comes to immunity.

"Your antibodies are only one part of the immune system. You have other parts of the immune system as well, such as T-cells," said Ellerin. "T-cell response is probably very important to protecting against severe disease because they can attack the virus directly."

With high-profile breakthrough infections among sports teams and Olympians, many are wondering if they still have the same level of protection against the delta variant as when they first got their vaccines.

But scientists are still searching for a so-called "correlate of protection" -- a marker in the blood that would reliably indicate protection. And they don't necessarily think it's antibodies. That means the presence of antibodies -- or even more specific antibody levels -- does not necessarily correlate with a person's level of protection.

"The correlates of protection are not known, and so it is not known whether a positive antibody test after COVID-19 infection represents protection against any variant, including the delta variant," said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

The Food and Drug Administration strongly warns against antibody tests as a way to check for immunity among people who are fully vaccinated, writing in May that "currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person's level of immunity or protection from COVID-19 at any time, and especially after the person has received a COVID-19 vaccination."

Experts agreed that this warning might be confusing for some consumers. After all, antibody testing is routinely done to test for immunity against other viruses such as hepatitis B, measles, mumps, rubella and varicella.

But COVID-19 is different, experts said.

"It is generally not recommended to use commercial antibody tests to monitor responses to vaccines, because the meaning of these assays has not been well defined in terms of whether they can predict vaccine protection or not," said Barouch.

We know the COVID-19 vaccines work not because of a blood test, but from large clinical trials that compared a group of unvaccinated people against a group of vaccinated people, finding that unvaccinated people were overwhelmingly more likely to become infected and fall seriously ill with COVID-19.

"What we generally think is that all of the vaccines get you to high-enough levels where even if they wane, you're still protected against hospitalization," Ellerin said. "Because the vaccines have done such a great job, all of them, at preventing hospitalizations, we think, based on some of the modeling studies, that you only need 3% of your average neutralizing antibody response to keep you out of the hospital."

Unfortunately, there is no commercially available antibody test that can tell us if we are truly immune to COVID-19 or how long any immunity gained through natural infection or vaccine-mediated will last.

According to the CDC and FDA, the only acceptable time to use an antibody test to check for immunity is if you have volunteered for a carefully monitored clinical study. Some people with immune compromised conditions -- like cancer or autoimmune diseases -- don't mount a good response to vaccines.

People with those medical conditions are being monitored for antibody levels using very specific antibody tests, and under the close supervision of doctors. And early data suggests that for some, a third shot might help.

No vaccine is 100% effective in preventing infections, but health officials continue to recommend vaccination as the best way to prevent COVID infections.

"Even if we find a correlate of immune protection, we want it to have clinical relevance, not just in vitro or test tube relevance," said Ellerin. "The national guidelines and I do not recommend antibody testing for the general public, but for immunocompromised patients that's a different story."

Odelia N. Lewis, M.D. is a recent graduate of SUNY Downstate's Family Medicine Residency Program and a contributor to the ABC News Medical Unit.

Copyright © 2021, ABC Audio. All rights reserved.


Maryland launches $1 million COVID-19 vaccination scholarship program

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(NEW YORK) -- Maryland Gov. Hogan announced earlier this month, the launch of the $1 million VaxU scholarship program. The effort is to incentivize those eligible, kids between 12-17 to get vaccinated against COVID-19, the governor said. Anyone between those ages who was vaccinated in the state is automatically entered to win.

Winners will receive a $50,000 scholarship for any public, in-state institution of higher education. As of July 12, the state began randomly selecting two winners and will continue with weekly drawings through Labor Day, when they will then pick four winners.

“The virus, and its variants are a dangerous threat to you,” Hogan said. “Getting vaccinated is the only way to protect yourself and to continue on our recovery.”

"The winners will receive a Maryland 529 prepaid college trust contract, which locks in today's tuition rates for the future, or a Maryland 529 College invest plan," said Gov. Hogan. "And the winner, if they decide down the line.... [that they] would like to attend a private institution or school that's outside of the state of Maryland, they can actually transfer the scholarship to the school of their choice."

The funding behind these scholarships comes from the American Rescue Plan which distributed more than $360 billion in emergency funding to state and local governments.

"Promotions like these are just one more way that we are reinforcing the importance of getting every single Marylander that we can vaccinate against COVID-19, especially our young people," said Gov. Hogan. "But those who are unvaccinated do remain at risk, especially with the new highly transmissible variants, including the delta variant which is currently circulating."

"According to our state health department, 95% of all new COVID cases reported last month were people who have not been vaccinated [and] 93% of all new covid deaths in the month of June were Marylanders who were unvaccinated," said Gov. Hogan.

The incentive comes as the delta variant spreads rampantly throughout the U.S. and vaccination rates across the nation continue to fall.

Centers for Disease Control and Prevention Director Rochelle Walensky told lawmakers Tuesday that the delta variant now makes up 83% of COVID cases, up from 50% at the beginning of this month.

Since vaccinations have become widely avaiable states have used lotteries, college scholarships and other rewards as ways to intice people to get vaccinated.

In May, Joseph Costello was announced the winner of a full-ride scholarship in Ohio's Vax-a-Million lottery. Costello's name was randomly drawn from nearly 105,000 entries among vaccinated 12 to 17-year-olds.

That same month, the mayor of Lancaster, California, offered a raffle scholarship that included a grand prize of $10,000 for teens who get the COVID-19 vaccine.

Copyright © 2021, ABC Audio. All rights reserved.


CDC advisory committee voices support for immunocompromised people getting boosters

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(NEW YORK) -- During the last year and a half, immunocompromised people have been at extremely high risk for the virus. And for many, the COVID vaccine didn't change that.

That's why a group of independent Centers for Disease Control and Prevention experts at a Thursday meeting largely voiced support for allowing immunocompromised people to talk to their doctors about getting a third shot, a booster, that could increase their antibody response to vaccines.

But the advisory committee didn't make a formal recommendation, saying more data was needed and, ultimately, regulatory allowance from the Food and Drug Administration.

About 2.7% of U.S. adults are considered immunocompromised, an umbrella category that includes cancer patients, transplant recipients, people with HIV and patients on high-dose steroids.

"We long for a fuller life," said Phil Canudo, a kidney transplant recipient from Akron, Ohio, who told the CDC advisory committee on Thursday that he had no antibody response after two Pfizer shots.

"I can't wait to see my stepdaughter's new Colorado home," he said, choking up. "I want to eat a medium rare steak at the Diamond Grill."

Canudo, who spoke before the CDC advisory panel during the public comment period, said he'd been told he still must behave as if he's not vaccinated.

"I urge you, beg you even, to recommend that we be able to receive a third vaccine dose," he said. "The benefit could open up the world to us again."

At the same time, pressure is mounting as other countries, including France and Israel, already have approved boosters for those who are immunosuppressed. In the U.S., debate over booster shots for the general public has ratcheted up as the delta variant wreaks havoc.

Data presented at the meeting said a booster shot could increase antibodies in an immunocompromised person by up to 50%.

Dr. Sara Oliver, an epidemiologist with the CDC who presented the findings, also explained how immunocompromised people are a priority group for booster research because they're at greater risk of serious COVID-related consequences.

For example, in one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%. Breakthrough cases, which are expected, refer to people who test positive for COVID-19 while fully vaccinated. The vaccines are highly effective against severe disease and hospitalization, but it's possible for people to develop mild or asymptomatic illness even when vaccinated.

"We want to vaccinate. During this entire conference, we've been saying, vaccinate, vaccinate, vaccinate," said Dr. Pablo Sanchez, a member of the panel. "These people want to be vaccinated, they're not vaccine hesitant. And it seems to me that we should promote that."

He argued that the FDA should "at least allow it while we obtain more data" because "we really need to help this population out more." Patients, Sanchez argued, could end up taking matters into their own hands.

Phil, of Akron, said he planned to do just that.

"Hundreds of us lie to pharmacies and immunization sites about our previous vaccinations, trying to get an extra unauthorized dose," he told the committee. "I know that's what I'll be doing if additional doses are not sanctioned."

Another ACIP member, Dr. Sandra Fryhofer, a liaison of the American Medical Association, pointed out that there are millions of excess vaccine doses right now that aren't being taken advantage of in the U.S.

At the same time, there are immunocompromised patients doing "all they can" and still not getting protection.

"I really do share the concerns that have been expressed by our ACIP members about, you know, our patients, right now, they're immunocompromised, that are doing all they can do by getting vaccinated, by having their close contacts vaccinated, and it's not enough that they're still not protected," Fryhofer said.

The work to assess additional studies is ongoing, and the next step would be for the FDA to issue regulatory guidance.

Copyright © 2021, ABC Audio. All rights reserved.


Pediatricians' advice for parents confused about kids and face masks amid COVID-19 surge

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(NEW YORK) -- Adding to the many challenges parents faced during the COVD-19 pandemic, vaccines remain unavailable for young children leading to questions about the need for kids to wear masks.

The issue has come to a head as kids start to return to school and even different schools within the same school district may have different mask policies.

On the national level, the Centers for Disease Control and Prevention has said immunized adults and teens can go without a mask, including inside schools.

The public health agency has also said that schools can still embrace universal masking if they can't verify vaccinations or have large numbers of students too young to qualify. Children under the age of 12 are currently not eligible for a COVID-19 vaccine.

At least eight states, including Arizona, Georgia and Texas, have banned mask mandates in schools.

Meanwhile, the American Academy of Pediatrics, an organization of nearly 70,000 pediatricians, this week called for schools to enforce universal masking mandates.

"AAP recommends universal masking because a significant portion of the student population is not yet eligible for vaccines, and masking is proven to reduce transmission of the virus and to protect those who are not vaccinated," the AAP wrote in a statement. "Many schools will not have a system to monitor vaccine status of students, teachers and staff, and some communities overall have low vaccination uptake where the virus may be circulating more prominently."

Good Morning America spoke with two pediatricians from Columbia University to help clarify for parents all the advice coming in on face masks and kids.

Here are their takeaways for parents.

1. All kids above age 2 should wear face masks at schools:

Both pediatricians, Dr. David Buchholz and Dr. Edith Bracho-Sanchez, agreed with the AAP's recommendation that all people above age 2 should wear masks inside schools, regardless of vaccination status.

"It makes it simple and it makes it flawless and protects everybody," Buchholz said of a universal policy. "Wearing a mask protects yourself and it also protects others. It’s a great benefit."

Both Buchholz and Bracho-Sanchez pointed out that the AAP's and CDC's seemingly different policies can be explained by the focus of their work.

"The CDC is in general making recommendations for the whole country," said Bracho-Sanchez. "The APA, they’re pediatricians and their first thought is what makes sense for children? They’re looking granularly at kids and what makes sense for them."

2. Masks matter because kids are at risk for COVID-19:

"Our understanding of COVID-19 in children has changed dramatically [since the start of the pandemic] and it absolutely can be a very serious illness in children," said Bracho-Sanchez. "Since the start of the pandemic, there have been over 4 million children who have contracted COVID-19 and hundreds who have unfortunately passed away from it and another large amount of children who are suffering long-term COVID-19 symptoms after having had the initial illness."

COVID-19 cases have nearly tripled in the United States over two weeks, according to The Associated Press. The virus is also on the rise among children, with more than 23,000 new pediatric cases diagnosed in the U.S. last week, twice as many as the end of June, according to the AAP.

The CDC reports that among recent cases of COVID-19, 99.5% of hospitalizations are people who weren't immunized.

In addition to protecting children from COVID-19, face masks also help prevent the spread of other viruses like respiratory syncytial virus (RSV) and influenza, noted Buchholz.

3. Masks allow children to learn in person:

After more than one year of learning entirely online for many students, wearing face masks is an easy measure that will allow kids to learn in person, according to Bracho-Sanchez.

"Children have absolutely suffered from being isolated from their peers, from their friends, from other people," she said. "But that is because they have been away from other people, not because they have been wearing masks."

"You can be around other people and socializing and wear masks, or not wear masks and potentially get very sick and have to go back to learning online," added Bracho-Sanchez. "It’s in my mind a no-brainer. I would mask my own child. I would ask the adults around my child to wear masks."

4. Masks should be used along with other safety practices:

In addition to supporting their kids in wearing face masks, parents should pay attention also to the other safety recommendations that have been in place throughout the pandemic, including hand washing and social distancing, according to both doctors.

They also urge parents to continue to screen themselves and their children for symptoms each morning and to stay home from school and-or work if they are sick.

5. Kids may have bigger feelings around returning to school:

Bracho-Sanchez said that parents will want to listen to their kids in case their possible resistance to or anger over having to wear a mask is about something deeper, like anxiety over returning to school.

"We are very focused on COVID and masking but this back-to-school season is going to be about so much more than COVID-19," she said. "Some kids are really nervous. Some kids have truly fallen behind. Some kids have not been around people, so at the same time we’re having these conversations, we also have to remember that we have to protect children in so many ways."

Copyright © 2021, ABC Audio. All rights reserved.


Stanford University reports seven breakthrough cases of COVID-19 among fully vaccinated students

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(STANFORD, Calif.) -- Stanford University reported at least seven confirmed cases of COVID-19 among fully vaccinated students this week.

All seven students were symptomatic, according to the school.

"As you have seen in the national news, cases of COVID-19 have been ticking upward," Stanford University officials said in a letter to students on Thursday. "We are seeing some of this in our own community, where we are experiencing an increase in the number of student COVID cases, including among fully vaccinated individuals."

Although the chances of contracting the novel coronavirus after being fully vaccinated are very rare, so-called breakthrough cases are still possible. Although COVID-19 vaccines have shown to be highly effective, they do not block the virus 100% of the time, meaning that some breakthrough infections occur after vaccination. This is normal and expected, and it's not proof that the vaccines aren't working, experts said.

However, health officials and experts alike have warned that new, more contagious variants of the novel coronavirus may be more effective at evading vaccines.

Stanford University officials said "vaccination continues to be our best defense against severe COVID-19 infection." Face masks, physical distancing and regular hand washing "remain powerful ways to prevent the transmission of COVID-19," officials added.

All students, faculty, staff, contractors and visitors are required to wear face coverings in spaces that are open to the public on the Ivy League school's 8,180-acre campus in Stanford, California, about 20 miles northwest of San Jose. Face coverings in crowded indoor spaces on campus are recommended.

Stanford University recently loosened its COVID-19 testing requirements for fully vaccinated students who are living on campus or are coming to campus frequently this summer. Those individuals are no longer required to test weekly for COVID-19 or complete daily submissions on the school's "Health Check" tool if they are verified as being fully vaccinated against the disease.

Overall, Stanford University has reported at least 257 confirmed cases of COVID-19 since the start of the pandemic. Some 8,300 students are fully vaccinated against the disease, while 330 are partially vaccinated, according to data posted on the school's website.

Stanford University's Vaden Health Services is connecting with each student who tests positive for COVID-19 to identify and notify their close contacts, who will be encouraged to get tested as soon as possible. Students who test positive will be provided with medical care and isolation space, according to the school.

"Again, vaccinations are effective at preventing severe illness. However, we need everyone to be vigilant," Stanford University officials warned in the letter Thursday. "The variants remain of concern."

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How three counties reached the highest COVID-19 vaccination rates in their state

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(NEW YORK) -- In Wyoming's Teton County, nearly 60% of residents are fully vaccinated -- almost double the statewide vaccination rate.

It's an effort that has been noticed in the state, which has one of the lowest vaccination rates in the country and where several counties have fewer than 30% of their population inoculated, state data shows.

"We have spoken to some of our other counties in Wyoming because they wanted to know what we were doing," Rachael Wheeler, the public health response coordinator at the Teton County Health Department, told ABC News.

As the highly transmissible delta variant has quickly spreads throughout the United States -- now making up over 80% of new cases -- regions with high vaccination rates are expected to fare better, medical experts say.

ABC News spoke to Wheeler and officials in two other counties leading their states in COVID-19 vaccinations about their campaigns, what they've done and where they go from here.

McKinley County, New Mexico

McKinley County, which includes part of the Navajo Nation reservation, was one of the hardest-hit regions in New Mexico early in the pandemic.

For Adam Berry, emergency manager for the county, that may have helped drive vaccinations to where, as of Monday, over 94% of residents ages 18 and up have received at least one dose, according to the latest state health department data. Statewide, that number is 72.2%.

"The spring of 2020 was our first wave; we had a pretty good surge," Berry said. "We had the highest case number in the state, especially per capita, for several weeks and months, before things tapered off late summer."

There was a longer, second surge in the winter that filled Gallup hospitals and mortuaries to capacity, he said.

"There's very few people in the county that don't know at least one person that was sick, if they weren't sick themselves," he said. "Many people know one or more people that unfortunately died due to COVID-19. So I think it's very personal for a lot of people."

Berry said there was a little hesitancy in the beginning, but that "it didn't take very long at all for a lot of people to start lining up to get the vaccine." Being able to protect themselves and their family, as well as safely see people they had not seen in a while, were big motivators, he said.

The vaccination effort has involved coordination among the county's emergency management and public health offices, state health department, health care providers, community partners and federal agencies, including the Indian Health Service.

"It was definitely a big community effort. Everybody does their part to try to get as many people vaccinated as possible," said Berry, a volunteer paramedic who also helped administer vaccines when clinics were short-staffed.

One thing that worked to the county's advantage in administering the vaccine is having a significant percentage of the county served by the Indian Health Service, he said. Nearly 80% of the county's residents are Native American, according to the U.S. Census.

"A lot of other counties in New Mexico are dependent on local health care systems and private physicians to vaccinate the bulk of their populations," he said. "We were fortunate in that aspect that we have a large presence of Indian Health Service facilities to help take care of that population, which allowed for vaccines to come in directly from the federal government to that site."

The Indian Health Service held drive-thru events at the Fire Rock Casino in Church Rock and did outreach to the Navajo Nation "to make it more convenient" to get the vaccine, Berry said.

The county has lately been focused on bringing people back for their second dose if needed, as well as vaccination efforts in those ages 12 to 16.

Since May 24, the county has reported only three COVID-19 deaths, and the seven-day average of new cases is three, down from a peak of 109 in mid-November, state data shows.

There's still a lot of mask-wearing, though life has started to "look a little more normal," Berry said. "We've come a long way in the last year."

Lamoille County, Vermont

There's stiff competition to be the top county for vaccinations in Vermont, which has the highest vaccination rate in the country.

At the moment, Lamoille County holds that distinction, with over 85% of residents ages 12 and up having received at least one dose, according to state data.

"When we saw those numbers we were very happy about it," Aaron French, director of the Morrisville Office of Local Health in Lamoille County, told ABC News. "Every county's working really hard."

Part of that effort has included reaching Lamoille County's more rural residents, who may be less inclined to drive to a vaccination clinic out of town.

"I grew up in one of those small towns, and I said, 'Why don't we talk to the town ... and set something up, and if we only get five people, we'll get five people,'" French said.

On a recent weekend, the office brought nurses to two towns and was able to vaccinate around 10 people.

"We were happy with that," French said. "And we'll continue to do that."

Health officials have also connected with local churches, schools, manufacturers and ski resorts as part of the vaccination efforts to reach the community and workforce.

As COVID-19 cases rise throughout the United States, Vermont officials said this week they have seen a small increase in the state, likely due to the delta variant, but community spread remains low due to the high vaccination rates.

Lamoille County has had two COVID-19 cases in the last two weeks, state data shows.

French said people in the county have trusted the local department of health and state department of health throughout the pandemic, which has also been a major factor in their vaccination success.

"They needed to hear from people that they could trust, and I think those local people were their local doctors and their commissioner of public health, who's a physician, and their governor," he said. "We have a number of federally qualified health care centers around here, and those physicians and nurse practitioners are very well-trusted, so their messaging out to the community and their patients were really important and helpful."

Lamoille County's lowest vaccination rates are among those ages 18 to 29, with over 58% of that population vaccinated, state data shows. That is one area the county is focusing on, French said.

The local health office has held clinics at skate parks, fairs and race tracks in the state, and health officials look to continue to do efforts like that to continue to bring numbers up.

"There's plenty of opportunity and we're just going to keep plugging away at it," French said. "I do think we can get higher than that."

Teton County, Wyoming

There has been a partisan divide in COVID-19 vaccinations, with Democrats more likely to report getting the vaccine than Republicans. Teton County is an outlier in Wyoming as a "blue dot in a red state," though Wheeler doesn't think that "can account for everything."

One major factor that helped Teton County achieve its vaccination rate -- which is the highest in the state, and higher than the national average -- started with the logistics of the rollout itself.

"We were very easily able to ramp up and hire a lot of additional vaccine staff when our demand was high," Wheeler said.

That meant hiring anyone from nurses to administer the vaccines to staff to help manage the different schedules. The county also had a lot of volunteer help at vaccine clinics, from checking people in to observing for emergency response, she said.

Teton County was also one of a handful of counties in Wyoming that had an ultra-cold freezer needed at first to store the Pfizer vaccine, the first to be issued an emergency use authorization.

"That was really helpful early on to be able to accept all different types of vaccines that were approved under the EUA at that time," Wheeler said.

When the county expanded its eligibility to schools and child care providers, the health department held special clinics on the weekends to accommodate them. "That seemed very successful, and they were very appreciative of that," Wheeler said.

Once students were eligible, the health department held an in-school vaccine clinic before the school year let out that reached over 500 students, Wheeler said.

To reach the broader community, the health department repurposed a public transit system bus into a mobile vaccine clinic, which has been used to bring doses to worksites, like the county's trash transfer station, and, lately, parks.

"Our goal is to reduce any barriers that there might be for people to get the vaccine," Wheeler said.

Beyond vaccine access, the county hired an agency to help with its messaging around the COVID-19 vaccine. "They helped us have a more focused campaign that was consistent and looked really professional," Wheeler said.

Currently, the health department is holding a "Shots for Swag" campaign, in which residents who have received at least one dose of the vaccine can win prizes.

Through the ad agency, the health department also filmed a video featuring local doctors answering common questions about the vaccine, such as around variants, fertility and pregnancy, that "put a more local perspective to it," Wheeler said.

The health department also partnered with several community nonprofits, including Voices JH, which helped reach immigrants in the Latino and Eastern European communities in the county with resources on vaccination.

Local health officials are anticipating renewed demand for the vaccine as new age ranges become eligible, and possibly when a vaccine has full FDA approval.

For now, they're planning to bring the mobile vaccine clinic to events throughout the summer and remind employers about the service. From July 1 to July 15, the county reported 31 new COVID-19 cases, 26 of which were in unvaccinated people and included workplace "clusters," the health department said this week.

"We're still messaging to everyone that the best defense is getting vaccinated," Wheeler said. "It's how you're going to protect not only yourself, but your family, friends, co-workers, neighbors, community members."

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CDC advisory committee voices support for immunocompromised people getting boosters

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(ATLANTA) -- During the last year and a half, immunocompromised people have been at extremely high risk for the virus. And for many, the COVID vaccine didn't change that.

That's why a group of independent Centers for Disease Control and Prevention experts at a Thursday meeting largely voiced support for allowing immunocompromised people to talk to their doctors about getting a third shot, a booster, that could increase their antibody response to vaccines.

But the advisory committee didn't make a formal recommendation, saying more data was needed and, ultimately, regulatory allowance from the Food and Drug Administration.

About 2.7% of U.S. adults are considered immunocompromised, an umbrella category that includes cancer patients, transplant recipients, people with HIV and patients on high-dose steroids.

"We long for a fuller life," said Phil Canudo, a kidney transplant recipient from Akron, Ohio, who told the CDC advisory committee on Thursday that he had no antibody response after two Pfizer shots.

"I can't wait to see my stepdaughter's new Colorado home," he said, choking up. "I want to eat a medium rare steak at the Diamond Grill."

Canudo, who spoke before the CDC advisory panel during the public comment period, said he'd been told he still must behave as if he's not vaccinated.

"I urge you, beg you even, to recommend that we be able to receive a third vaccine dose," he said. "The benefit could open up the world to us again."

At the same time, pressure is mounting as other countries, including France and Israel, already have approved boosters for those who are immunosuppressed. In the U.S., debate over booster shots for the general public has ratcheted up as the delta variant wreaks havoc.

Data presented at the meeting said a booster shot could increase antibodies in an immunocompromised person by up to 50%.

Dr. Sara Oliver, an epidemiologist with the CDC who presented the findings, also explained how immunocompromised people are a priority group for booster research because they're at greater risk of serious COVID-related consequences.

For example, in one U.S. study, 44% of hospitalized breakthrough cases were immunocompromised people. An Israeli study found it was around 40%. Breakthrough cases, which are expected, refer to people who test positive for COVID-19 while fully vaccinated. The vaccines are highly effective against severe disease and hospitalization, but it's possible for people to develop mild or asymptomatic illness even when vaccinated.

"We want to vaccinate. During this entire conference, we've been saying, vaccinate, vaccinate, vaccinate," said Dr. Pablo Sanchez, a member of the panel. "These people want to be vaccinated, they're not vaccine hesitant. And it seems to me that we should promote that."

He argued that the FDA should "at least allow it while we obtain more data" because "we really need to help this population out more." Patients, Sanchez argued, could end up taking matters into their own hands.

Phil, of Akron, said he planned to do just that.

"Hundreds of us lie to pharmacies and immunization sites about our previous vaccinations, trying to get an extra unauthorized dose," he told the committee. "I know that's what I'll be doing if additional doses are not sanctioned."

Another ACIP member, Dr. Sandra Fryhofer, a liaison of the American Medical Association, pointed out that there are millions of excess vaccine doses right now that aren't being taken advantage of in the U.S.

At the same time, there are immunocompromised patients doing "all they can" and still not getting protection.

"I really do share the concerns that have been expressed by our ACIP members about, you know, our patients, right now, they're immunocompromised, that are doing all they can do by getting vaccinated, by having their close contacts vaccinated, and it's not enough that they're still not protected," Fryhofer said.

The work to assess additional studies is ongoing, and the next step would be for the FDA to issue regulatory guidance.

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CDC director stands firm on mask guidance, calls it an 'individual choice' for those vaccinated to wear one

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(WASHINGTON) -- The Centers for Disease Control and Prevention is sticking with its guidance for now that only unvaccinated people need to wear masks to be safe -- and that vaccinated people are OK to go without, CDC Director Rochelle Walensky told reporters on Thursday.

Walesnky's comments follow reports by report "The Washington Post and CNN that the Biden administration is considering another revision on masks in light of the rapidly spreading delta variant.

Walensky said "we are always looking at the data as the data come in." But, she added, CDC mask guidance hasn't changed and that -- for now -- there's no need.

"Fully vaccinated people are protected from severe illness, and we've always said that communities and individuals to make the decisions that are right for them based on what's going on in their local areas," she said.

She later added: "In areas that have high and low amounts of vaccination … if you're unvaccinated, you should absolutely be wearing a mask. If you're vaccinated, you have exceptional levels of protection from that vaccine, and you may choose to add an extra layer of protection by putting on your mask and that's a very individual choice."

Jeff Zients, the White House coordinator on COVID-19, said any public health guidance is up to the CDC.

"We will follow the science," he said.

Last May, the CDC stunned much of the country by suggesting vaccinated people could safely go without masks indoors, citing ample real-world evidence that people who are fully immunized are unlikely to get sick and unlikely to spread the virus.

Since then, a new variant of the virus has spread rapidly across unvaccinated pockets of the U.S., once again overwhelming health care workers who say victims of the delta variant are younger and sicker.

While health officials say the vaccines still work against the variant and that transmission is still considered less likely, the Biden administration has come under extraordinary pressure in recent weeks to consider doing more to curb the outbreaks and protect children under 12 who aren't eligible for vaccination.

Former Surgeon General Jerome Adams said he thinks the CDC needs to backtrack because of the nationwide rise in cases. In an opinion article for the Post, Adams said he regrets not urging Americans to wear masks earlier in the pandemic -- a decision made to protect supplies for health care workers -- and thinks the CDC should learn from that mistake.

"In hindsight, it’s clear that the message many Americans heard was that, vaccinated or not, masks were gone for good," he wrote.

Meanwhile, at least eight states have told schools they can't mandate masks, including in Florida where GOP Gov. Ron DeSantis said "there's not very much science behind it."

Numerous studies have shown that masking is extraordinarily effective at preventing the spread of the virus among unvaccinated people when done consistently.

"We need our kids to breathe. We need our kids to be able to be kids. We need them to be able to breathe," DeSantis said at a news conference Thursday.

President Joe Biden had caused some confusion late Wednesday when he said in a CNN town hall that he expected the CDC to issue new mask guidance that everyone under age 12 should wear masks in schools.

The CDC already issued that guidance on July 9, which calls on any unvaccinated staff and students to wear masks. Kids under 12 don't qualify for the vaccine.

When pressed on what internal discussions are under way with regard to masks, White House press secretary Jen Psaki was vague.

"It would be more concerning -- or should be more concerning to all of you and the American people if we were not having those conversations. So, there are certainly conversations about steps we can and should take," she told reporters.

ABC New's Matthew Vann contributed to this report.

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Frontline workers in Nevada say they are 'reliving 2020' as new infections surge to highest point in five months

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(LAS VEGAS) -- With coronavirus infections on the rise again in the U.S., hospitals across the country are trying to meet the needs of thousands of patients who are testing positive for COVID-19, and are in need of medical care.

One state that has seen a rapid increase in COVID-19 cases and hospitalizations has been Nevada, where case levels have swelled by nearly 200% in the last month, the state’s highest level since February, according to the U.S. Centers for Disease Control and Prevention.

“Basically, we're reliving 2020 in 2021,” Dr. Angie Honsberg, medical director for the intensive care unit at University Medical Center told ABC News. “We, unfortunately, are back to having a very high number of COVID patients. We have had a break for the last two and a half months and unfortunately, now we're back to feeling like we were back in January in February when close to half of our ICU was critically ill patients with COVID respiratory failure.”

Since mid-June, the average number of patients being admitted to the hospital each day with COVID-19 in Nevada has tripled, according to the CDC. This marks the highest number of patients seeking care in more than five months.

Although hospitalization levels in Nevada and nationwide remain significantly lower than at their peak in January, as of Wednesday, 38 states and territories are reporting an increase of 10% or more in hospital admissions over the last week, with nearly 22,000 patients hospitalized around the country, the CDC said.

In light of the state’s recent viral resurgence, Nevada joined a growing list of states on Chicago’s travel advisory list, which will require travelers to either quarantine for 10 days or present a negative COVID-19 test result.

The majority of the state's infections, according to the CDC, appear to be coming from Clark County, home to Las Vegas, where cases have been steadily increasing since June. In the last week, hospital admissions there have increased by more than 16%.

“Sadly, we're reliving a lot of what we experienced last year, in the recent weeks,” Dr. Luis Medina-Garcia, an infectious disease physician at UMC, told ABC News. “As businesses reopened, and there's more traffic of tourists to our city, this increased exposure has resulted in new cases of COVID-19 almost exclusively in the unvaccinated population.”

Thus, with cases increasing, last week, the Southern Nevada Health District also announced it would recommend both unvaccinated and vaccinated people wear masks in crowded indoor public places, "where they may have contact with others who are not fully vaccinated."

Health experts say the likely driving force behind the significant increase in cases across the country has been the highly infectious delta variant, which is now estimated to account for more than 83% of all new cases.

Although it is still unknown whether the delta variant is potentially more dangerous, this strain of the virus is more efficient at transmitting the disease, and Honsberg said it appears to more virulent, with patients becoming sicker faster.

"The current group of patients seems to get sick quicker than the patients that we saw with the earlier COVID outbreak and we're also seeing, for the most part, a younger group of patients," Honsberg said.

Some of the patients have very severe pneumonia, Honsberg added.

A similar message is conveyed by Robin Ringler, charge nurse in UMC’s Medical ICU, who said that the patients she is seeing in the ICU are very sick, many struggling to breathe, and on ventilators.

In fact, she said, some of these patients are so sick “that the doctors currently are talking about doing tracheostomy on them, and that is going to keep them on the ventilator for prolonged periods of time because they cannot breathe on their own.”

Ringer’s team is now anticipating more COVID-19 ICU admissions, with a growing number of COVID patients appearing in the emergency room.

“In the last two weeks, we've had a real increase in COVID infections in the hospital. Our COVID numbers have gone up so high. They've almost, I think they quadrupled from two weeks ago,” Ringler said. “The number of patients seeking treatment has been getting higher every week.”

The increases are a discouraging development, said Ringler, when vaccines were introduced, and cases began to decline, her team thought they may have been finally out of the woods.

According to the White House COVID-19 Task Force, nearly all of these patients, 97%, are unvaccinated.

Just 43% of Nevada residents have been fully vaccinated against COVID-19, “which is a growing concern for us, when our data shows that about 85% of our COVID-19 patients are without a history for vaccination,” added Alma Angeles, director of Critical Care Services at Sunrise Hospital and Medical Center in Las Vegas.

"We've had many patients that have told us that they wish they had been vaccinated. Sadly, it's too late by the time they get to us," Dr. Luis Medina-Garcia, an Infectious Disease Physician at UMC, told ABC News. “The death toll from this disease is unbearable. It is unspeakable the loss of life, health, and outcomes that we have had to go through. It's just sad to see people getting sick, for no good reason.”

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Half of Puerto Rico could lose health coverage if Congress doesn't act on Medicaid

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(WASHINGTON) -- Puerto Rico could lose Medicaid funding in less than two months, putting at risk roughly 1.5 million people -- nearly half the island's population -- unless Congress acts quickly.

As COVID-19 continues to batter the island -- with at least 2,561 deaths among 141,905 confirmed cases, according to World Health Organization data -- several U.S. representatives have teamed up to propose the Supporting Medicaid in the U.S. Territories Act.

"Territories get less funding through Medicaid than states do, and it has led to all sorts of adverse health outcomes, debt and a sub-standard of living in those areas," Rep. Darren Soto, D-Fla., told ABC News in an interview. Puerto Rico was getting "far less than many states, and that led to an erosion of their health care system."

The territory's annual Medicaid needs are predicted to reach about $3 billion, but due to restrictions in the Social Security Act Section 11108, Puerto Rico has instead only been given roughly $375 million in Medicaid for the year, Puerto Rican Gov. Pedro Pierluisi told ABC News.

Puerto Rico, by statute, is only set to receive 55% of what is needed to fund Medicaid each year from the federal government, according to the think tank Center on Budget and Policy Priorities. But since the island's federal block grant is small and often exhausted, CBPP reports that some years the Medicaid program is funded at less than 20%. Whatever the federal government doesn't pay for, the island is responsible.

"The funding is not the same we would be getting as a state," Pierluisi said. "You cannot plan or budget reasonably when you are facing this [Medicaid] cliff every couple of years."

The new bill states that it would extend the federal Medicaid funding to account for 76% of what is needed for five years, offering much relief during the island's ongoing economic crisis. Mississippi, the poorest U.S. state, also gets 76%.

But with a 43.5% poverty -- more than twice that of Mississippi -- and higher rates of diabetes, hypertension, asthma and more, Puerto Ricans need reliable health coverage perhaps more than ever.

Roughly 46% of the island's population relies on Medicaid, according to the Medicaid and CHIP Payment and Access Commission, and almost 44% of Puerto Ricans live in poverty.

"We need that money to provide good medical and hospital services to our population," said Jorge Galva, executive director of the Puerto Rico Health Insurance Administration. "There is a dire need to provide the full complement of Medicaid services."

Providing care, Galva added, is made even more difficult as thousands of physicians and other health professionals continue migrating to the U.S. mainland, where they typically receive better pay and enjoy a higher standard of living.

Even with an increased amount of Medicaid funding for Puerto Ricans, Galva said, this wouldn't be enough to help the island offer some of the federally mandated services, like nursing home care, home health care and nonemergency medical transportation.

"Over the years," Galva continued, "the gap between the cap on the federal funds for our Medicaid program and the needs of the program grew bigger and bigger and bigger. As a territory, and under the present state of the law, Congress is fully allowed to discriminate and make differences between the treatment to territories and states."

Local officials are calling on lawmakers to address what's seen as the U.S. neglecting Puerto Rico because it's a territory, not a state.

"It's a matter of fairness and equity that we receive funding in parity with the states and allow Puerto Rico to provide its medically indigent population with all the services they need and deserve," Galva said.

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Doctors treating depression see promise in ketamine, a cheap drug already approved for anesthesia

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The anesthesia medication ketamine is showing increased promise as a treatment for people experiencing depression who haven't found relief with other prescription medications.

Though ketamine is known for its recreational use as a party drug, it can also be prescribed legally by doctors. In recent years, ketamine has become more accessible for those struggling with depression. In 2015, there were fewer than 60 ketamine clinics in the U.S. Three years later, there were more than 300, according to the journal of Psychiatry and Clinical Neurosciences.

Generic ketamine isn't specifically approved as a depression treatment, but U.S. doctors are often allowed to prescribe Food and Drug Administration-approved medicines "off-label" for another use.

A growing body of evidence has shown ketamine, which has been used since the 1970s in the field of anesthesia, can be successful in treating depression and suicidal behaviors. In fact, ketamine is part of a growing field of research into whether drugs that have traditionally been viewed as illegal psychedelics or party drugs could, in certain contexts, help people with depression, post-traumatic stress disorder and other behavioral health and psychiatric disorders.

In 2019, the FDA approved Spravato, a ketamine-related nasal spray drug, given in conjunction with antidepressants that has been shown to help people with treatment-resistant depression. But many clinics offer generic ketamine, often in the form of intravenous infusions.

Dr. Steven Mandel, founder and president of Ketamine Clinics Los Angeles, said because ketamine is already a low-cost generic drug, it's unlikely that a pharmaceutical company would pay for the process that would be needed to get the drug approved specifically as a depression treatment.

"For a medicine like ketamine that is already approved and available, adding a new indication for the treatment of depression would probably cost tens of millions -- if not hundreds of millions -- of dollars," Mandel said. "No one wants to spend that money."

But ketamine's unique status can create problems for patients. Ketamine's use for depression is off-label and it is typically not covered by health insurances. Because of this, "there are some access issues," said Dr. Panagiota Korenis, a psychiatrist and associate professor at the Albert Einstein College of Medicine.

"It's often limited to a subset of the population that can pay out of pocket or be a part of a trial," she said.

There are also certain risks associated with ketamine.

"It is a drug that can be abused potentially," said Korenis, who noted that patients typically need to be treated in the clinic and typically cannot take multiple doses of the medication home with them.

Nevertheless, Korenis is hopeful ​that ketamine may prove itself as another powerful option for those with depression.

"Ketamine certainly is being shown to be a medication of interest and one that has potential for the future," said Korenis.

Experts debate whether ketamine is a psychedelic and able to produce similar altered states of consciousness as MDMA and psilocybin, which have shown healing properties in some studies.

But many clinics are opting to administer ketamine in a manner similar to psychedelics in clinical trials. Ketamine-assisted psychotherapy, or KAP, is a combination of ketamine and therapy that is similar to psychedelic-assisted therapy used in recent carefully controlled clinical trials.

For example, MDMA, also known as molly or ecstasy, is a psychedelic drug that is now being studied in controlled therapy settings as a possible treatment for PTSD. But no psychedelic treatments are FDA-approved, meaning doctors cannot administer them outside of a clinical trial. MDMA is illegal for recreational use in the U.S.

For those who are unable to get into a clinical trial of psychedelics like MDMA and psilocybin, KAP may be the closest legal equivalent.

"Ketamine works for depression and suicidality -- it works quickly, it's safe," said Mandel. "For the other medicines, we just don't know. They seem to have great early promise, but we do need a lot more data and a lot more time before we can fully embrace them."

Psychedelics like MDMA and psilocybin may require a couple of more years until they receive FDA approval, according to Rick Doblin, Executive Director of the Multidisciplinary Association for Psychedelic Studies. In the meantime, Mandel hopes more patients learn about ketamine as an option for depression.

"Ketamine should be available to anyone suffering from these afflictions," said Mandel.

Nicholas Nissen, M.D., is an author, host of the "Brain Health with Dr. Nissen" podcast and a contributor for the ABC News Medical Unit.

 

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Why we're seeing more breakthrough COVID-19 infections and what that means

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(WASHINGTON) -- With more than 161 million people now fully vaccinated in the U.S., experts say we are bound to see reports of breakthrough infections, meaning people will test positive for COVID-19 despite being fully vaccinated.

These breakthrough COVID-19 cases aren't proof the vaccines aren't working, experts said, but are normal and expected. All evidence suggests that even in the face of the new, highly-transmissible delta variant, COVID vaccines are still working as they should to dramatically decrease the risk of hospitalization and death.

"When you hear about a breakthrough infection, that doesn't necessarily mean the vaccine is failing,” Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said before Congress on Tuesday.

COVID-19 vaccines are highly effective, but they do not block the virus 100% of the time, meaning that some breakthrough infections occur after vaccination.

“I think people need to appreciate when you talk about breakthrough infections that the original data from the clinical trial -- the efficacy data was based on preventing clinically apparent disease, not preventing infection, such as a symptomatic infection," Fauci said.

Despite many high-profile cases of breakthrough infections with mild or no symptoms, including among Olympic athletes and some politicians, the overall number is very low compared to the number of people vaccinated.

And the number of people who have been hospitalized or died after being fully vaccinated is even lower, according to the U.S Centers for Disease Control and Prevention (CDC) and state health departments. This demonstrates that vaccinated people are far less likely to die of COVID-19 compared to unvaccinated people.

That doesn’t mean severe illness as the result of an infection isn’t possible, but this tends to happen in people who are elderly or otherwise immune-compromised, experts said.

“Out of 157 million fully vaccinated in the US, there were 4,909 hospitalizations and 988 deaths,” Dr. Carlos del Rio, infectious disease physician and professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine, said during a press briefing on Monday.

“Of course we will see some breakthrough infections that lead to severe illness, more in vulnerable populations with underlying chronic conditions who couldn’t mount a response to vaccines because they couldn't,” Dr. John Brownstein, an infectious disease epidemiologist at Boston's Children's Hospital and an ABC News contributor, told ABC News.

Although studies on this aren’t completed, Fauci said last week that the risk of a vaccinated person spreading COVID to someone else is assuredly far less than an unvaccinated person spreading COVID.

"You could make a reasonable assumption that the rate of transmissibility from the asymptomatic vaccinated person to an uninfected person would be less likely than if the person was unvaccinated," Fauci said at a White House COVID-19 Response Team briefing last week.

The overall number of breakthrough infections is rising, but that could be because more people overall are getting vaccinated, resulting in more breakthrough cases, Dr. Shobha Swaminathan, an associate professor and infectious disease expert at the Rutgers New Jersey Medical School, told ABC News.

“As the number of infections in the U.S. increases, there may be a slight increase in the number of ‘breakthrough’ infections,'' Swaminathan said. “However, the majority of infections continue to be reported among those who have not been vaccinated.”

Experts said the delta variant could be contributing to these cases, but for now, research is ongoing.

“If it causes an increased rate of breakthrough infections, that’s unknown,” adds Brownstein.

But experts feel reassured by what they do know, that even with the highly-transmissible delta variant sweeping the country, more than 99% of COVID-19 deaths are among people who are unvaccinated.

Alexis E. Carrington, M.D. is an ABC News Medical Unit Associate Producer and a rising dermatology resident at George Washington University. Sony Salzman is a Coordinating Producer for ABC News Medical Unit.

 

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