Health

(NEW YORK) — The COVID-19 pandemic has had unprecedented effects on our society and even more so on our senior population, as they struggle to manage care. In some cases, they are without their loved ones being able to visit them, creating a further sense of isolation, heightened anxiety and depression due to fear of contracting the virus.

Statistics show 43% of seniors experienced loneliness during this period. While taking care of loved ones is priority, caregivers experienced higher levels of stress as they tried to manage their own needs while taking care of their loved ones, leading to further negative health outcomes.

Per research conducted by the National Rehabilitation Research and Training Center, family caregivers experienced more negative effects from the pandemic than those who weren’t, including more emotional, physical and financial burdens. Female caregivers, younger caregivers and especially families with lower incomes experienced significant issues.

The pandemic has increased our awareness on the burden our caregivers face. We would need to further create a strong ecosystem to address this issue.

Here are four ways we can address and support our caregivers as part of a care infrastructure for better health in our nation.

Most of our caregivers spend 78% of their income to take care of their loved ones, leading them to diminish their savings and retirement. There are also situations where caregivers have to leave their jobs, leading to lesser incomes, more debts, unpaid bills and reduced Social Security retirement benefits. Some solutions that have emerged include adopting policies that allow flexible work hours. Furthermore, municipalities can provide tax credits to employers offering a minimum number of weeks of paid leave to family caregivers, make tax credit eligibility criteria more accessible to middle income families and extend job protections.

Second, caregivers face enormous difficulty being able to access services within their communities such as transportation, tailored meals and in-home health services due to lack of financial stability, better nutrition education and understanding resource availability overall. According to the National Alliance for Caregiving, 27% of caregivers found it very difficult and 62% of the caregivers needed training and access to information to better understand how to take care of themselves and their loved ones. Systems need modernization and integration as it can be difficult to find all information that is needed in one place. Finally, mental health services would be critical for caregivers as well as for their loved ones they are supporting.

Caregiver burnout is significant for professional and family caregivers. The exhaustion and burden of work results in caregivers not being able to attend to their own needs and have a state of physical, mental and emotional exhaustion. There needs to be additional support for caregivers to provide relief and mitigate the risk of burnout.

Fourth but not least, we need to leverage technology. By 2020, approximately 120 million older Americans will need care at home. According to the American Association of Retired Persons (AARP), the majority of caregivers—some 45 million—will be unpaid (compared to 5 million paid caregivers), and many will care for more than one aging family member. Technologies such as telehealth and bio sensors, with their capabilities to meet members where they are and to proactively detect health concerns, could help provide education, consultation, psychosocial/cognitive behavioral therapy (including problem solving training), data collection and monitoring, clinical care delivery and social support. Better data and predictive analytics will lead to more tailored interventions. As technology is used by caregivers, it will require digital literacy as well to be as effective but could also reduce caregiver burden.

In conclusion, caregivers are an integral part of our society. They need additional support, access to mental health professionals, care infrastructure and a living wage. We need to move forward by creating solutions at the intersection of innovation, partnerships and awareness. Employers for example can create partnerships with caregiver organizations. Our caregivers need care in order to give care.

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(NEW YORK) — Just under 1 million people utilized abortion services in the U.S. in 2020, according to recent data from the Guttmacher Institute. Another report from Guttmacher in 2016 showed that 90% of abortion patients in the U.S. obtained their procedure in the first trimester.

Medication abortion is approved by the Food and Drug Administration for up to 10 weeks into pregnancy, but there is good literature that has shown it is an effective method of abortion up to 11 weeks. This means the majority of people seeking abortion services are able to get medication abortions, Dr. Deborah Bartz, a gynecologist at Brigham and Women’s in Boston, told ABC News in an interview.

The abortion pill is the most common form of abortion in first trimester pregnancies, with recent data showing that 54% of those eligible now choose to undergo medication abortion over a procedure, Bartz said.

As access to abortion continues to be restricted in many states, more may choose to self-manage their abortions for several reasons, such as not being able to afford to travel for care, according to Dr. Meera Shah, chief medical officer of Planned Parenthood Hudson Peconic.

Self-managed abortions were often risky pre-Roe, but abortion medication has offered a safe method for self-induced abortions.

Many patients in other countries have taken the abortion pill past 11 weeks, and there are several ongoing studies underway for usage of the pill beyond 11 weeks, Bartz said.

“You can take medications and induce pregnancy expulsion, essentially, at any gestation. It’s just as of right now, our literature indicates that 11 weeks is the upper limit on when we should be recommending that to most patients,” Bartz said.

The most robust and effective way to get a medication abortion is by taking two pills: mifepristone and misoprostol, Bartz said.

Mifepristone, which is taken first, blocks the hormone progesterone. Progesterone is needed for the pregnancy to grow inside the uterus. When mifepristone is taken, it begins the process of emptying the uterus.

Mifepristone can be taken at home or in a healthcare provider’s office.

The second medication, misoprostol is taken within 24 to 48 hours of the first medication. This causes uterine cramping and cervical softening and expels the pregnancy from the body, Bartz said.

Misoprostol causes cramping and bleeding, similar to a heavy period or miscarriage, to empty the uterus, according to Dr. Meera Shah, Chief Medical Officer of Planned Parenthood Hudson Peconic.

“By taking the two medications together, what an individual is doing is essentially inducing a miscarriage. There are other means of doing medication abortion, and many people in the United States and throughout the world use misoprostol only. That is also a very good regimen,” Bartz said.

The Mifepristone-Misoprostal regimen is about 95% effective if taken within the first 11 weeks of pregnancy, while the misoprostal alone is about 85% effective, Bartz said.

The process itself takes a couple of hours. The further along patients are in the pregnancy, the more complex their symptoms may be and the longer their symptoms might last, according to Bartz.

Patients typically experience bleeding and cramping, which can be more severe the further along they are in pregnancy. This typically results within one to five hours, Bartz said.

“It’s probably a little bit more intense than like the first day of a person’s period. So, a little bit heavier bleeding than a period, a little bit more cramps than a period. But, there are many patients who experience symptoms that are not much more than their period,” Bartz said.

It is recommended that patients not be alone when they take the pills in case they experience more pain than expected or have heavy bleeding. Patients are usually advised to take pain medication, like ibuprofen, and maybe an anti-nausea medication ahead of time, before the cramps start, Bartz said.

Patients also experience flu-like symptoms including fevers, chills, nausea, vomiting and diarrhea, all of which is normal with medication abortions, Bartz said.

When a person becomes pregnant, they are automatically in a higher risk category than someone who is not pregnant. So, getting an abortion of any kind puts a patient at less risk than if they continue a pregnancy, according to Bartz.

“The risk of maternal mortality associated with full term pregnancy and delivery is about 14 times higher than the risk of interrupting a pregnancy with a either medical or surgical abortion,” Bartz said.

Roughly 5% of patients experience incomplete abortions, meaning the pregnancy does not pass in its entirety. In these rare cases, the medication might not work the first time around, and they either have a continuing pregnancy or they have clinically significant pregnancy tissue that does not pass all the way, Bartz said.

“So they actually potentially would need either a second dose of the medications or to undergo the surgical the uterine aspiration procedure to bring those that pregnancy tissue out after they’ve taken that medication if it hasn’t worked. But 95% of patients, have the medication work just fine the first time,” Bartz said.

Rarely, some patients who experience severe bleeding may need to call their physician’s office or be seen in an emergency room for a blood transfusion. Less than 1% of patience experience bleeding significant enough that they would need a blood transfusion, Bartz said.

“If a patient is bleeding so heavily that she’s soaking pads a pad, an hour for a couple of hours, then we would want to see her,” Bartz said.

Another rare risk is the risk of an infection. As the cervix opens up a bit, there is a low risk that an infection could travel to the uterus, but doctors do not even prescribe antibiotics to prevent risk of infection because there is more risk from taking the antibiotic than there is of getting an infection, Bartz said.

Patients can experience mild or moderate bleeding and cramping on and off for up to a month after taking the abortion pill. Most get their next period one to two months after the abortion, according to Dr. Meera Shah, Chief Medical Officer of Planned Parenthood Hudson Peconic.

Having an abortion does not decrease your chance of having a healthy pregnancy later on, or affect your future overall health unless a rare, serious complication occurs or is left untreated, according to Shah.

 

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(ATLANTA) — Centers for Disease Control and Prevention Director Rochelle Walensky made a remarkable acknowledgment of her agency’s failures during the COVID-19 pandemic as she delivered a message to her staff Wednesday.

Her message, given in an internal video viewed by ABC News, addressed employees about the plan to overhaul the agency, following an internally initiated review which found that the CDC’s handling of the COVID-19 pandemic fell short of the crisis.

“To be frank, we are responsible for some pretty dramatic, pretty public mistakes. From testing, to data, to communications,” Walensky said to the camera in front of a blue CDC backdrop.

“As an agency, even with all the terrific work we do, we still suffer the consequences from these mistakes. After over 18 months serving in this position, learning and living the many lessons from our COVID-19 response, and receiving feedback from many internal and external interested parties, this is the right time to take a step back and strategically position CDC to facilitate and support the future of public health,” Walensky said.

Those conversations, she added, yielded “loud and clear” key principles to “promote public health action and communication; conduct and disseminate exceptional science,” and “serve our partners, prioritizing the American people first.”

“All of us collectively are being asked to look to the future and build a stronger CDC to tackle what lies ahead. This is our watershed moment,” Walensky said.

“We must pivot, take appropriate action, and lead the systemic changes required to equitably protect health, safety and security of all Americans,” she said — especially because neither the pandemic nor her agency’s response to it, is finished.

Walensky’s message, delivered in a more than 14-minute recording, follows a scathing internally initiated review of how the CDC handled COVID-19, which found its approach toward the pandemic failed to meet the moment of crisis and offered a series of changes intended to revamp the agency and make it more nimble.

That review, ordered by Walensky in April, comes after the CDC had come under frequent fire for its muddled and inconsistent messaging on COVID mitigation measures.

During interviews with roughly 120 agency staff and key external stakeholders, the review found that it “takes too long for CDC to publish its data and science for decision making,” that its guidance is “confusing and overwhelming” and that agency staff turnover during the COVID response “created gaps and other challenges for partners,” according to findings obtained by ABC News.

“The COVID-19 pandemic and our agency-wide response is not over. Our important work continues,” Walensky said in her video. “There have been too many tragic deaths from this virus and we must do all we can to prevent more.”

The threat of other infectious diseases’ spread means now is the time for public health infrastructures to shore up their defenses, she noted.

“Now the global monkeypox outbreak requires increased attention and efforts,” Walensky said. “We will continue to activate the personnel and resources necessary to fulfill our public health mission.”

In the video, Walensky promised to “develop new systems and processes to equitably deliver all of CDC science and program activities to the American people,” with “data modernization, laboratory capacity, rapid response to disease outbreaks, and preparedness within the US and around the world.”

“These changes will inform what CDC can do during a pandemic, along with every day during normal operations in our infectious and non-infectious disease portfolios to ensure a CDC science reaches the public in a timely and implementable manner,” she said.

“We must also strengthen the agency’s ability to respond to public health threats,” she said. “This is an agency-wide top priority to respond when we are called upon.”

Walensky emphasized the importance of “breaking down organizational silos in favor of a ‘One CDC mindset,'” increasing accountability and supporting equity efforts across the agency, she said.

“Change is hard. I know that. This is our time to change. And we will all need to roll up our sleeves to move CDC forward,” Walensky said, and “apply” the “COVID-19 lessons learned” by “sharing scientific findings and data faster.”

“The future of CDC is dependent upon applying the lessons learned from the last few years, whether it’s under my direction or a future CDC director, regardless of who is sitting in the seat, an honest and unbiased read of our recent history will yield the same conclusion. It is time for CDC to change,” she said.

“I recognize that our growth will involve some uncomfortable moments for many of us. We will hold ourselves accountable and we will be open to feedback,” Walensky said. “I owe it to you to work hard with the agency’s leadership to make CDC better and I’m grateful to have you in this with me.”

ABC News’ Cheyenne Haslett and Eric M. Strauss contributed to this report.

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(SAN DIEGO) — A California girl has beaten the odds to reunite with her twin and return home with her family after a six-month stay at a San Diego hospital.

Charlotte and her twin sister, Olivia, were born to Karla and Joshua Valliere last December, but in January, Charlotte was suddenly admitted to Rady Children’s Hospital with breathing difficulties and a respiratory infection.

At first, the Vallieres didn’t know what was wrong. Olivia was healthy, and although Charlotte had been born with one lung, she hadn’t had any issues after birth.

“Her one lung grew like 1.5 sizes, so it was compensating for the lack of the second one. So [doctors] did run all the studies. She was totally fine — oxygenation, everything 100%, so we were cleared to go after four days in the hospital,” Karla Valliere told Good Morning America. “It was six weeks at home — total bliss. Everything was great … and all of a sudden she started having breathing problems.”

The Vallieres took their daughter to Rady on Jan. 29, and she was admitted and placed on an extracorporeal membrane oxygenation machine, or ECMO.

Dr. Matthew Brigger, chief of the pediatric otolaryngology division at Rady Children’s Hospital, started seeing Charlotte, who was just six weeks old at the time. Charlotte would eventually be diagnosed with tracheal stenosis and complete tracheal rings. This meant she had a birth defect with her airway where the rings in her trachea were abnormal and she had an abnormal narrowing of the trachea, or windpipe. She also had a blood vessel wrapped around her trachea.

“This set of anomalies, with the single lung, with the way the aorta was wrapped around the trachea itself and the trachea being this narrow, is actually fairly rare,” Brigger told GMA.

“We knew that she had a critical airway that if anything were to progress, trying to keep her intubated, that was gonna potentially injure the airway and give us more difficulty in repairing it. So the ECMO was sort of a bridge to surgery,” he continued.

But the surgery was a major one and in order to do it, Brigger and the rest of Charlotte’s doctors had to wait until she was big enough, since she and her twin had been born a few weeks early and therefore, Charlotte was small for her age.

“Initially I [told the parents], ‘Well, if we can get through surgery, I’m gonna give her 50-50,” Brigger said. “[But] I’m thinking more 20% of getting through surgery at the time, just knowing how much that we had to go through.”

Despite the low chance of survival, Charlotte’s surgery was a success.

“Fortunately, Charlotte’s a fighter and we got to do the surgery. She sailed through surgery,” he said.

The Vallieres said that throughout the monthslong stay in the hospital and all the ups and downs, with Charlotte’s complications, multiple surgeries and treatment, they drew strength from their own daughter.

“The thing that I think that I believe got us through was her. She never gave any sign of weakness,” the mom of two said.

After spending 185 days in the hospital, Charlotte was finally discharged on Aug. 1, and her parents and twin sister were there to celebrate and bring her home.

“It was just a lot of emotions and it was just a roller coaster. But now we have them together, so it’s worth it,” Karla Valliere added.

Today, Brigger said he doesn’t anticipate Charlotte needing a second lung at all and her future looks bright.

“Prognosis is very good. She may not be running marathons in the future but she is Charlotte so it’s hard to say. She’s proved people wrong all along. I expect her to be able to live a good life,” he said.

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(NEW YORK) — As demand for monkeypox vaccines increases, the World Health Organization (WHO) has begun to receive preliminary reports on the efficacy of the shots, which suggests there are breakthrough cases occurring, officials said Wednesday.

“We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it, and that we don’t have firm efficacy data or effectiveness data in this context,” officials said during a press conference.

Some of the reports of breakthrough cases have been among people who received a prophylaxis vaccine after exposure.

“The fact we’re beginning to see some breakthrough cases is also really important information because it tells us that the vaccine is not 100% effective in any given circumstance. Whether preventive or post-exposure, we cannot expect 100% effectiveness at the moment based on this emerging information,” officials said.

This occurrence of breakthrough infections is not new, officials noted, explaining that a limited study from the 1980s demonstrated that the vaccines offered about 85% protection against monkeypox.

“[The] vaccine is not a silver bullet,” officials said, “that every person who feels that they’re at risk and wishes to lower their own level of risk [has] many interventions are at their disposal, which includes vaccinations where available, but also includes protection from activities where there may be a risk — reducing [the] number of sex partners, avoiding group sex or casual sex, and, specifically, when a vaccine is, in fact, administered, waiting until that vaccine has the time to produce a maximum immune response.”

Earlier this month, the Biden administration announced it would move forward with a plan to increase the U.S. monkeypox vaccine supply by as much as five times, using an injection method that requires less vaccine per shot.

Across the country, federal data shows that more than 634,000 doses of the JYNNEOS vaccine have been shipped to states and jurisdictions as of Aug. 12.

The number of monkeypox cases identified across the globe continues to grow, with the total jumping by 20% in the last week, according to the WHO.

Globally, more than 38,000 cases of monkeypox have now been confirmed, according to the CDC, including more than 13,500 cases in the U.S.

The majority of cases, in the current monkeypox outbreak, have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that anyone can contract the virus.

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(NEW YORK) — A child in Oregon has tested positive for monkeypox, state health officials announced Wednesday, marking the ninth reported pediatric case in the U.S.

“We have a known connection to a previously diagnosed case,” Dr. Dean Sidelinger, health officer and state epidemiologist at the Oregon Health Authority, said in a press release. “This child did not get the virus at school, child care or another community setting.”

The case has been linked to an adult monkeypox infection that was confirmed last month, officials said, adding that public health authorities received the positive test result on Aug. 15.

Health officials have initiated a case investigation and are conducting contact tracing to determine potential exposures. No additional information on the case will be disclosed at this time, due to patient privacy.

A total of 116 presumptive and confirmed cases of monkeypox have been reported in Oregon, including 112 men and four women.

In total, at least 7 U.S. states and jurisdictions have reported pediatric monkeypox cases.

Earlier this week, health officials in Harris County, Texas, confirmed to ABC News that a presumptive case had been identified in a child under the age of 2.

Officials reported the child has been completely asymptomatic, according to the child’s parents, with no other symptoms other than a residual rash. The child is expected to make a full recovery, and is doing “very, very well,” Harris County Judge Lina Hidalgo said during a press conference on Tuesday.

“I understand that it’s a very scary thing, and parents have concerns, and what we need to make sure is to be vigilant and understand the risks, not assume the worst. But this reminds us that this is very real,” Hidalgo said.

The family has also been fully cooperative, and is assisting with contact tracing, though the child has not been in any day care or school settings. Thus far, no one else in the child’s circle has been identified as positive for monkeypox, according to officials.

How this child contracted monkeypox is still unknown, Hidalgo said.

“I understand this is a very, very worrisome for parents, especially as school is starting back up knowing that a child in our community has now contracted or as a presumptive positive for the monkey pox virus. It opens up a lot of questions about how this is spread. It makes people very worried. It makes things very tangible,” Hidalgo added.

Although this is indeed a “rare” case, Hidalgo noted that “we always knew that any person in this community can contract monkeypox. We knew that it was possible for a child to be exposed. Anyone can get this virus, so this isn’t entirely unexpected.”

The news of the positive pediatric case in Texas comes after a child in Martin County, Florida, tested positive for monkeypox, according to state health data. The child in Florida is between the ages of 0 and 4 years old, according to the state health data.

Officials in Maine also announced Friday that they, too, had confirmed a positive monkeypox case in a child. No further information about the case has been released due to concerns over patient privacy, officials said.

“Maine CDC [Center for Disease Control and Prevention] is working to identify any others who may have been exposed and make vaccination available to close contacts,” officials wrote in a press release.

In addition to the cases in children reported in Maine and Florida, two cases have been confirmed in California, as well another two in Indiana, and a case in a non-U.S. resident reported in Washington, D.C.

The majority of cases in the current monkeypox outbreak have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that anyone can contract the virus.

The Centers for Disease Control and Prevention has previously warned that there has been some preliminary evidence to suggest that children younger than 8 years old are at risk of developing more severe illness if infected, alongside pregnant people and those who are immunocompromised.

However, last week, in an effort to protect the youngest Americans, the Food and Drug Administration issued an emergency use authorization that allows health care for children under 18 who are at high risk of monkeypox to be vaccinated.

Across the globe, nearly 32,000 cases of monkeypox have now been reported, including nearly 12,000 cases in the U.S. — the most of any country, according to the CDC. All but one U.S. state — Wyoming — have now confirmed at least one positive monkeypox case.

Monkeypox primarily spreads through prolonged skin-to-skin contact with infected people’s lesions or bodily fluids, according to the CDC. In addition to lesions, which can appear like pimples or blisters, the most common symptoms associated with monkeypox are swollen lymph nodes, fever, headache, fatigue and muscle aches.

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(ATLANTA) — A scathing review of how the Centers for Disease Control and Prevention handled COVID-19 has found that its approach toward the pandemic failed to meet the moment of crisis, and offered a series of changes intended to revamp the agency and make it more nimble.

“For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations,” CDC Director Rochelle Walensky said in a statement on Wednesday.

A fact sheet outlining the review, obtained by ABC News and confirmed by the CDC, said that the “need for change came through loud and clear.”

Walensky ordered the review in April after the CDC had come under frequent fire for its muddled and inconsistent messaging on COVID mitigation measures.

During interviews with roughly 120 agency staff and key external stakeholders, the review found that it “takes too long for CDC to publish its data and science for decision making,” that its guidance is “confusing and overwhelming” and that agency staff turnover during the COVID response “created gaps and other challenges for partners,” according to findings obtained by ABC News.

And while Walensky also defended, in part, the overwhelming job of handling the pandemic, the center said the country’s public health infrastructure is “frail.” The review also revealed the CDC’s “operating posture” was “not adequate to effectively respond to a crisis the size and scope” of COVID.

The CDC’s goals going forward will focus on improving “accountability, collaboration, communication, and timeliness” within and outside the agency, the report said.

“As a long-time admirer of this agency and a champion for public health, I want us all to do better and it starts with CDC leading the way,” Walensky said in a statement.

As part of the suggested solutions, Walensky committed to sharing scientific findings and data faster, rather than at the typical speed for academic publication.

“Produce data for action” rather than “data for publication,” said a CDC briefing document summarizing the changes.

The new recommendations also put a large emphasis on improving public health communications to the American people. “The website is not easy to navigate,” the document said.

To spearhead the next steps towards the agency’s overhaul, Walensky intends to appoint former Obama administration Deputy Health and Human Services Secretary Mary Wakefield to oversee the shift and “help implement the vision.”

The review also outlines plans to create a new executive council reporting to Walensky, which will “determine agency priorities, track progress, and align budget decisions, with a bias toward public health impact.”

Walensky did not provide a timeline for the changes, but said she will provide regular updates internally.

“None of these challenges happened overnight,” CDC said in a statement. “The work ahead will take time and engagement at all levels of the organization.”

ABC News’ Eric M. Strauss contributed to this report.

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(GENEVA) — The World Health Organization renamed the two known clades, or lineages, of the monkeypox virus Monday.

Director-General Tedros Adhanom Ghebreyesus said the lineages will be referred to going forward using Roman numerals.

“The clade formerly known as the Congo Basin or Central African clade will now be referred to as clade I, while the West African clade will be called clade II,” he said during a news conference.

Subsequent lineages will be named using Roman numerals for the clade and lowercase letters will be used for the subclade.

The WHO has been in talks to rename the virus itself due to concerns about stigmatization.

The decision Monday comes as an outbreak of monkeypox spreads around the world with more than 35,000 cases reported to the global health agency.

In the United States, there are more than 12,600 cases across 49 states, the District of Columbia and Puerto Rico, according to the Centers for Disease Control and Prevention.

The majority of cases in the current outbreak have been reported during intimate contact among men who have sex with men, a group that includes people who identify as gay, bisexual, transgender and nonbinary.

However, the CDC has warned that anybody is at risk of monkeypox infection if they have skin-to-skin contact with a monkeypox patient or make contact with an infected person’s lesions.

At least eight cases among children in six states and D.C. have been reported as well as one case among a pregnant woman.

To avoid infection, the CDC recommends limiting the number of sex partners, avoiding spaces with intimate sexual contact with multiple partners, using condoms and gloves during sexual contact and being fully clothed when attending events such as festivals and concerts.

Last week, researchers from Sorbonne University and Bichat-Claude Bernard University Hospital in France published a case report of a dog that developed monkeypox after being exposed to its owners, which were diagnosed with the disease.

The CDC has since updated its website to state dogs can be infected by humans. It’s unknown if other pets, such as cats, hamsters, gerbils and guinea pigs, can be infected.

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(NEW YORK) — Since the monkeypox vaccine began being distributed in New York City, the rollout has been plagued with issues.

The city’s Department of Health and Mental Hygiene has cycled through several scheduling platforms in a matter of weeks, which have experienced crashes as people tried to book appointments.

Additionally, the demand for the vaccine has far outpaced the supply. Whenever the city has released a few thousand vaccine appointment slots, they have been filled up within a matter of hours, sometimes minutes, officials said.

“My general thought about the rollout is that it is a hard situation,” Dr. Dana Mazo, an infectious diseases specialist and clinical associate professor of medicine at NYU Langone Health, told ABC News. “The good news is that there has been a high demand, that the high-risk communities are definitely interested in the vaccine. And so that is good.”

“But when there is a limited supply, we are put in a hard situation and all of us feel the difficulties,” she added.

Shortage of vaccine doses

The U.S. Department of Health and Human Services said in mid-July it had ordered nearly 7 million doses of the JYNNEOS vaccine, which is a two-dose vaccine approved by the U.S. Food and Drug Administration to prevent smallpox and monkeypox. However, they will not all be available until mid-2023.

As of Tuesday, the Biden administration has shipped more than 630,000 doses to states, according to HHS data. An additional 786,000 doses have been allocated, but it will take several weeks to distribute the doses.

So far, New York City has received more than 77,800 doses, HHS data shows, but local health officials estimate that as many as 150,000 residents may be at risk for monkeypox exposure.

Dr. Bruce Y. Lee, a professor of health policy and management at City University of New York School of Public Health, said there are only so many doses that can be sent to the city and state when other places are suffering from large outbreaks.

“New York City obviously has had the most cases, but then you’ve had a lot of cases in other places like California, Illinois, Florida, for instance,” he told ABC News. “So how then do you determine how much of those vaccines are supposed to be in New York versus the other locations?”

There have been some attempts to try to stretch out the supply. The Department of Health and Mental Hygiene said it is prioritizing administering first doses to get as many people as possible at least some level of protection.

“If you have received the first dose, you will be contacted about scheduling the second dose in the coming weeks,” the department states on its website. “You can wait longer than four weeks between doses.”

To increase the number of JYNNEOS doses available, the FDA authorized a new strategy to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin.

This will allow one vial of vaccine to be given out as five separate doses rather than a single dose.

In theory, this should work because the supply would be quintupled and, for example, 6,000 slots being opened would now increase to 30,000 slots, experts said.

However, there are a few roadblocks. Administering vaccines intradermally is a skill that most health care workers are not trained or experienced in, although it can be taught.

It also would require patients to be told that this way of administering is under emergency use authorization rather than full FDA approval.

“The concern is whenever you do things that are off label or splitting doses you have to make sure you get the same efficacy, you get the same protection,” Lee said. “If you do split doses that basically convert the same amount of vaccine to like multiple doses for a greater number of people, we have to ask ourselves what will be the impact in terms of protection?”

The Department of Health and Mental Hygiene has not stated whether it intends to adopt this strategy.

Glitchy websites and slots filled within minutes

Another problem that has plagued the rollout is the multiple websites that resulted in crashes and glitches as people intend to access them.

In June, the Department of Health and Mental Hygiene partnered with MedRite, a chain of urgent care centers, to operate the appointment scheduling website.

The website was scheduled to launch on July 6, but some people were able to access vaccine appointments before the launch time. Officials quickly took down the portal but, when it went back up again, it crashed.

Next, the department turned to Affiliated Physicians, a health care provider, to schedule vaccine appointments.

The website went live on July 12. Less than half an hour later, the health department tweeted the site was down due to a “high level of traffic.”

Eventually, the department switched over to VAX4NYC, the portal that was used for scheduling COVID-19 vaccines.

Dr. Amish Adalja, senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, said VAX4NYC should have been used from the start.

“[The health department] should have used systems that anyone had been familiar with,” he told ABC News. “That was a tried and tested system and had been working fine rather than contracts with certain companies, where they’ve had glitches.”

He continued, “A new system that people had to learn on the fly when there was such demand, I think is not ideal when you’re trying to be as efficient as possible with a resource that was in a very limited supply.”

During a City Council oversight hearing last week looking at “failures of New York City’s technological response under critical demand,” Matt Fraser, the city’s chief technology officer, said the Department of Health and Mental Hygiene contracts with MedRite and Affiliated Physicians were drafted under the administration of former New York City Mayor Bill de Blasio.

“This vendor had been previously cleared by another administration,” he said during testimony. “Our look at this is that it’s a vendor that’s done similar work in the city for this purpose, and unfortunately, it did not work out this time.”

Questions have also arisen over MedRite’s role due to being cited for fraud in the past. In 2016, then-New York State Attorney General Eric Schneiderman settled with MedRite after paying for fake positive reviews on various websites.

“I would just say that this is an important question to ask: how was the trust established that they would be able to deliver in an emergency situation when they’ve already been deemed a fraudulent company?” Adalja said. “They should have articulated the rationale. ‘This is why we use it, and we know we’re going to use it, or they should have said that upfront’ They should be transparent about their decision-making process.”

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(NEW YORK) — Hearing aids can be sold over the counter in an effort to increase access and lower costs, the U.S. Food and Drug Administration announced on Tuesday. The move will allow those with mild to moderate hearing loss to directly purchase hearing aids from retailers.

Previously, those with mild to moderate hearing loss needed a prescription to receive a hearing aid, which required a medical exam, possibly by a specialist such as an audiologist.

Not only can this process be costly, but it can also take time, depending on provider availability, experts said.

The news was celebrated by the Hearing Industries Association, a group representing hearing aid manufacturers and other industry stakeholders, which said in a statement the “change will expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss.”

“In the United States, we see wealthier individuals being able to access hearing aids and individuals who are living at or below federal poverty level struggling to access hearing aids,” Dr. Nicholas Reed, assistant professor at Johns Hopkins University Bloomberg School of Public Health, told ABC News.

This ruling came just prior to President Joe Biden signing the Inflation Reduction Act on Tuesday, which proponents claim will further reduce drug prices and keep health insurance affordable for millions of Americans.

When will they be available?

“Americans could see over-the-counter hearing aids available as early as mid-October,” FDA Commissioner Robert Califf said at an FDA briefing Tuesday.

Califf said the ruling will clarify the regulatory requirements for hearing aids and personal sound devices, also referred to as PSAPs. He said it will take time for manufacturers to ensure that they are meeting these new requirements.

“These actions reflect the FDA’s commitment to safely lowering barriers to access, providing consumers with greater choices to lower prices, and helping to facilitate innovation in hearing aid technology,” Califf said.

Who can use them?

“The new over-the-counter category applies to certain air conduction hearing aids, intended for adults aged 18 and older who have perceived mild to moderate hearing loss,” Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, said at an FDA briefing Tuesday.

Air conduction hearing aids are worn inside the ear or on the ear, with an inside the ear component and amplified sound into the ear canal. In an effort to prevent further hearing loss, these devices will have sound limits.

“Hearing aids for severe hearing loss or for users younger than age 18 will be prescription devices, to assure patient safety as well as effectiveness,” Shuren said.

What are the implications?

“The FDA estimates this rule will save consumers on the order of about $1,400 per individual hearing aid, or almost, or over $2,800 per pair. And that’s the direct savings,” Brian Deese, White House Director of National Economic Council, said at the FDA briefing Tuesday.

While these are just estimates in savings, Deese also believes this ruling will increase innovation and competition in the market.

“The requirement to see a doctor or a hearing specialist was an example of what economists call a barrier to entry. It was a regulation that kept more companies or more innovators from entering the market to compete,” Deese said.

Emma Egan is an MPH candidate at Brown University and a contributor to the ABC Medical Unit.

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