COVID subvariants: What to know and should you be concerned?

COVID subvariants: What to know and should you be concerned?
COVID subvariants: What to know and should you be concerned?
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(NEW YORK) — Even as COVID-19 cases and hospitalizations driven by the omicron subvariant BA.5 continue to fall in the United States, the proportion of infections attributed to other omicron offshoots is rising.

According to data from the Centers for Disease Control and Prevention, BA.5 currently makes up 67.9% of new virus cases as of last Friday.

The remaining cases are made up of BA.4.6 — which has been circulating in the U.S. for weeks — as well as newly identified subvariants like BQ.1, B.Q.1.1 and BF.7, which have been spreading mainly in Europe.

The subvariants have been attributed to an increase in infections in Europe. According to the latest weekly report from the World Health Organization, published Oct. 12, there were more than 1.66 million COVID-19 cases recorded across the continent, up from more than 1.53 million cases recorded in the previous report published on Oct. 5

Throughout the course of the pandemic, Europe has been considered a bellwether of what’s to come in the U.S.

Should we be concerned about the new subvariants? Experts told ABC News that the U.S. may see a new wave as we enter the colder weather months and move indoors and it’s important to remain vigilant.

“In the next few months, I think there’s reasonable expectation that we’ll probably see a fall wave,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “But the magnitude of that wave, I think, is still very much in question.”

What are the new subvariants?

The subvariant that makes up the most cases after BA.5 is BA.4.6. An offshoot of the omicron subvariant BA.4, it’s estimated to account for 12% of new cases, according to the CDC.

Then there are newer subvariants, which have recently begun steadily spreading in the U.S: BQ.1 and BQ.1.1, Both are offshoots of BA.5 and make up 12% of new cases together. This is a rapid rate of increase considering they made up just 3% of new cases for the week ending Oct. 1.

“It seems to have come out of nowhere,” Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, told ABC News. “But it didn’t really come of nowhere. It was first seen in Nigeria in summer and then spread to other countries in Europe and Asia, and now in the United States.”

Another offshoot of BA.5 that is picking up speed is BF.7. It makes up 5.3% of new cases in the U.S., up from 3.2% just two weeks prior.

Meanwhile, there have been reports of another subvariant called XBB, which combines multiple strains of the omicron variant and other COVID-19 variants and has been detected mostly in Asia. So far, it has not been detected in the U.S.

Not much is known about any of these newer subvariants. Preliminary data suggests they have mutations that are better at evading immunity, whether from vaccination or prior infection, and may be more transmissible.

Another reason these offshoots could be spreading more rapidly is because human behavior has changed. Travel is reaching pre-pandemic levels, children are back in school and most restrictions — including masking, social distancing and vaccinations requirements — have ended.

There is some good news. Since September, bivalent boosters that target BA.4 and BA.5 have been approved in the U.S. for those aged 12 and older and for those aged 5 and older since last week. Early data suggests the booster increases antibody response.

Because these subvariants are related to BA.4 and BA.5, it’s likely that the booster will provide at least some protection against them as well.

“I think there’s a very reasonable expectation that the vaccines, especially with the new boosters, will provide good protection,” said Brownstein. “But we’re still missing a lot of real-world data, especially given that these new sort of omicron variants of BA.5 and BA.4 are starting to take hold in various parts of the world.”

“We’ll hopefully have reasonable insight from other countries that will help inform some of the forecast for the coming months, but that data is still being compiled,” he continued.

Chin-Hong said it’s also reasonable to expect, as with previous variants, that those most at risk are Americans with the least amount of protection.

“For people who are unvaccinated, those over age 65 who’ve never gotten a booster, or people who are immunocompromised, they may become more seriously ill and die if they don’t protect themselves,” Chin-Hong said.

Should we be concerned?

Brownstein said he thinks public health officials should remain vigilant and keep tracking the spread of these subvariants but the public should not yet worry.

“I think it’s too early to tell the level of concern,” Brownstein said. “Of course, everyone should be concerned about how new variants emerge, especially when there’s uneven vaccination across the U.S and then across the globe.”

He added, “The brunt of that concern should be on public health and scientists right now, as we try to work out [what’s happening].”

Brownstein said Americans should be willing to modify their behavior — like masking indoors again — if cases spike or a new variant emerges.

According to CDC data, the daily average of COVID-19 cases sits at 35,000 as of Oct.16 and the average estimate of new hospital admissions is 2,990 as of Oct. 15.

Brownstein said if the health care system becomes overwhelmed by a surge, city- or state-level officials might consider masking to reduce the number of patients entering hospitals.

“I think that clearly targeted masking, especially in high-risk places like health care settings and long-term care facilities, will be critical, because those places are charged with protecting the most vulnerable,” Brownstein said. “Beyond that, I think it’s going to be really driven by local level cases.”

Copyright © 2022, ABC Audio. All rights reserved.

Study: 3 in 10 uninsured Americans with diabetes may ration insulin

Study: 3 in 10 uninsured Americans with diabetes may ration insulin
Study: 3 in 10 uninsured Americans with diabetes may ration insulin
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(NEW YORK) — Nearly 30% of Americans living with diabetes who are uninsured may ration their insulin to save money, according to a new study.

Researchers at Harvard Medical School, the City University of New York’s Hunter College and consumer advocacy organization Public Citizen determined the prevalence of insulin rationing by analyzing the Centers for Disease Control and Prevention’s 2021 National Health Interview Survey in the study, published in the Annals of Internal Medicine on Monday.

Overall, researchers found that 16.5% of adults with diabetes who use insulin — some 1.3 million Americans — rationed insulin by either skipping doses, taking less or delaying buying it to save money in the past year.

Rates of insulin rationing were highest among those with no insurance, at 29.2%, the study found. Among those with private insurance, it was nearly 19%.

Rationing was lower among those with public coverage, such as Medicare (13.5%), and those ages 65 and older (11.2%), who would be largely eligible for Medicare.

Insulin rationing was also found to be more common among Black Americans (23.2%) than white and Hispanic (16%), as well as among middle-income insulin users (19.8%) than higher-income (10.8%) and low-income (14.6%), researchers found.

There was no data provided on the health consequences of insulin rationing, though prior research has shown cost-associated non-adherence to insulin can have serious negative consequences.

The study “provides the first national estimate of how many Americans with diabetes are rationing their insulin now due to cost,” Public Citizen said in a news release, noting that soaring insulin costs can average at least $1,000 each month.

Rationing insulin can put people at risk for serious and even deadly complications, experts say.

“In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug,” Dr. Adam Gaffney, a pulmonary and critical care physician at Harvard Medical School and the Cambridge Health Alliance and the lead author of the study, said in a statement. “Universal access to insulin, without cost barriers, is urgently needed.”

The findings of the study come amid policy debates around the price of insulin.

The Biden administration’s Inflation Reduction Act, which goes into effect next year, includes a provision to cap the monthly cost of insulin for people on Medicare at $35, though the bill excludes those on private insurance or the uninsured.

The initial draft of the bill would have also capped insulin costs for those with private insurance, though Republicans stripped that provision from the bill due to a technicality in the reconciliation process.

More than 37 million Americans have diabetes, according to the American Diabetes Association. Among them, 8.4 million use insulin, which costs 10 times more in the U.S. than anywhere else in the world, according to the association.

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Black, Hispanic adults more likely to be hospitalized with flu than white adults

Black, Hispanic adults more likely to be hospitalized with flu than white adults
Black, Hispanic adults more likely to be hospitalized with flu than white adults
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(NEW YORK) — Racial and ethnic minorities are more likely to be hospitalized with the flu in the United States, new federal data shows.

A new report published by the Centers for Disease Control and Prevention Tuesday looked at data from the 2009-10 through the 2021-22 flu seasons — excluding the 2020-21 season — and flu vaccination coverage from the 2010-11 season through the 2021-22 season.

They found that compared to white adults, influenza-related hospitalizations were 80% higher among Black adults.

Although there was some variation by season, during most seasons, hospitalization rates for Black adults were between 1.5 and 2.4 times the rates among white adults.

Additionally, American Indian and Alaska Natives (Ai/AN) flu-related hospitalizations were 30% higher and hospitalizations among Hispanics were 20% higher.

For AI/AN adults, rates were highest during the 2011-12 season and the 2021-22 seasons with rates 2.7 times those of white adults.

Meanwhile for Hispanics, the highest rates were seen during the 2009-10 and 2021-22 seasons and were 2.1 times those of their white counterparts.

The report also found that Asian/Pacific Islander adults had the lowest rates of hospitalization of all the racial and ethnic groups, ranging from 60% to 90% of hospitalization rates of white adults.

Although experts say flu vaccination is the best protection against the flu, rates are lower among racial and ethnic minorities.

“Every year, the flu continues to cause severe illness hospitalization and death,” said CDC Acting Principal Deputy Director Dr. Debra Houry in a press briefing to reporters Tuesday.

“Unfortunately, flu vaccination rates have been consistently lower among black, Hispanic, and American Indian, Alaska Native adults in the United States since 2010,” Houry said.

During the 2021-22 season, 49.4% of white adults were vaccinated against flu. By comparison, just 42% of Black adults, 37.9% of Hispanic minorities and 40.9% of AI/AN adults were vaccinated.

Asian and Pacific Islander adults had the highest rate of vaccination at 54.2%.

According to the CDC, there are several reasons for racial and ethnic disparities, including lack of access to health care and insurance, which in turn leads to less vaccine access.

Another reason for the disparities is missed opportunities to vaccinate.

“For adults who reported a recent medical checkup, vaccination coverage was still lower for Black, Hispanic, American Indian and Alaska Native and adults of other races than for white adults,” Dr. Carla Black, an epidemiologist from the CDC’s Immunization Services Division, said during the press conference. “This suggests that health care providers are missing opportunities during routine medical appointments to vaccinate people from certain groups.”

She added there may be misinformation about how serious flu is and vaccine safety as well as distrust due to past racist health policies that have negatively affected America’s communities of color.

CDC officials recommend that doctors encourage their patients, including those of color, to get the flu shot and that public health officials host outreach events including town halls and pop-up clinics to increase access to flu vaccines.

Black also encouraged flu vaccination due to the risk of a potentially severe flu season this year after the U.S. had two years of little to no flu activity:

“Well, what we can so far is that we’ve had mild flu season, and this means we might be ripe for a severe season, because people are not, you know taking all the measures they took for COVID which also had an impact on flu like masking and social distancing,” she said. “People haven’t had natural disease in two years. So, you know, there’s less natural immunity out there. People are going back to work. People are traveling again; all of these factors could contribute to us having a more severe flu season.”

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UN report finds declines in women’s and children’s health

UN report finds declines in women’s and children’s health
UN report finds declines in women’s and children’s health
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(NEW YORK) — A United Nations report published Tuesday showed women’s and children’s health have backslid due to the impacts of the COVID-19 pandemic, conflict and climate change.

The report, titled Every Woman Every Child Progress Report, found that since 2020, rates of anxiety and depression, food insecurity and intimate partner violence have risen while rates of vaccination have declined.

“The impacts of COVID-19, conflicts and climate crises have raised the stakes for vulnerable communities, revealing the weaknesses and inequities in health care systems and reversing hard-won progress for women, children and adolescents — but we are not powerless to change this,” UNICEF Executive Catherine Russell said in a statement.

“By investing in resilient, inclusive primary health care systems, jumpstarting routine immunization programs and strengthening the health workforce, we can make sure that every woman and every child can access the care they need to survive and thrive,” Russell said.

The report found that at least 25 million children were either unvaccinated or under-vaccinated in 2021 — at least six million more than in 2019.

This includes routine childhood vaccinations like the diphtheria, tetanus and pertussis (DTaP) vaccine and the human papillomavirus (HPV) vaccine, which prevents against certain strains of the virus that can lead to cervical cancer.

The pandemic also forced millions of children to miss school, and the report estimates that 80% of children in 104 countries and territories “experienced learning loss because of school closures.”

Additionally, the report found that more than 45 million children are suffering from acute malnutrition, which occurs when children don’t have adequate nutrient intake. According to the report, this leaves children vulnerable to developmental delays, disease and death.

What’s more, world hunger had risen since the beginning of the pandemic, with 768 million people experiencing hunger.

The report attributes the rise in global hunger to pandemic-related economic disruption and climate change events such as drought and conflicts, including the Russia-Ukraine war.

In addition, estimates showed an increase in mental health conditions compared to years prior, including an increase in major depressive disorders of 27.6% and a 25.6% increase in anxiety disorders since the pandemic began.

The report also examined how records from helplines, police departments and other organizations showed an increase in violence against women and, specifically, intimate partner violence.

The authors said the rise could be attributed to several factors, including lockdowns forcing women to spend more time in close proximity to abusive partners, stress from the pandemic leading to violence and less access to social services.

“Almost three years on from the onset of COVID-19, the pandemic’s long-term impact on the health and well-being of women, children and adolescents is becoming evident: Their chances for healthy and productive lives have declined sharply,” Dr. Tedros Adhanom Ghebreyesus, director-general for the World Health Organization, said in a statement.

The statement added, “As the world emerges from the pandemic, protecting and promoting the health of women, children and young people is essential for supporting and sustaining the global recovery.”

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Cancer vaccine may be ready by 2030, say founders of COVID vaccine makers BioNTech

Cancer vaccine may be ready by 2030, say founders of COVID vaccine makers BioNTech
Cancer vaccine may be ready by 2030, say founders of COVID vaccine makers BioNTech
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(LONDON) — The world could be only a few years away from a cancer vaccine, according to the couple behind the Pfizer/BioNtech COVID-19 vaccine.

“We feel that a cure for cancer or to changing cancer patients’ lives is in our grasp,” professor Ozlem Tureci told BBC News in an interview over the weekend.

Her husband, professor Ugur Sahin, with whom she cofounded the German pharmaceutical company BioNTech, said he thought cancer vaccines could be widely available “before 2030.”

The husband-and-wife duo founded BioNTech in 2008 originally to develop and produce treatments for individualized cancer immunotherapy, using mRNA technology. But when the pandemic hit, they adapted this technology to create one of the first and most effective COVID-19 vaccines.

Scientists have been working on a cancer vaccine for decades. One approach is to teach the immune system to recognize and destroy cancer cells — ideally preventing cancer from growing in the first place. Further along are other types of vaccines designed to treat people who already have cancer, including one Food and Drug Administration-approved cancer vaccine for people with advanced prostate cancer.

“From the very beginning, our focus has always been on exploiting the full potential of the body’s immune system to successfully help address cancer and infectious diseases,” the company’s website says.

In this recent interview, the two professors explained that their experience of developing the COVID vaccine could help accelerate their work on a cancer vaccine as it launched the mRNA technology into the mainstream.

“What we have developed over decades for cancer vaccine development has been the tailwind for developing the COVID-19 vaccine, and now the Covid-19 vaccine and our experience in developing it gives back to our cancer work,” Tureci said, explaining that “mRNA acts as a blueprint and allows you to tell the body to produce the drug or the vaccine … and when you use mRNA as a vaccine, the mRNA is a blueprint for the ‘wanted poster’ of the enemy — in this case, cancer antigens which distinguish cancer cells from normal cells.”

“The development of several COVID vaccines in record time showed the possibilities of mRNA vaccine technology, which could one day become an effective treatment to help beat cancer,” Dr. Sam Godfrey, research information lead at Cancer Research U.K., said.

“Just as science was our route out of the pandemic, science is our route to beating cancer. We’re optimistic that, in the future, we will see mRNA technology and other exciting vaccine approaches giving doctors more treatment options to help beat cancer,” Godfrey added.

Many other pharmaceutical companies, including vaccine maker Moderna, are also working on mRNA vaccines to target specific cancers.

“Using vaccines to treat cancer is an exciting emerging field,” Godfrey said. “We’ve already partnered with Vaccitech to trial one of the world’s first therapeutic vaccines for lung cancer, and we are funding cutting-edge research learning how virus and vaccine technology might activate the immune system against cancer.”

This approach is not without roadblocks. For example, the BioNTech vaccine needs to be custom-designed for each person. However, a preliminary study in pancreatic cancer suggested the vaccine might help delay cancer reoccurrence, though more research is needed.

“Every step, every patient we treat in our cancer trials helps us to find out more about what we are against and how to address that,” Tureci said, before adding a note of caution: “We are always hesitant to say we will have a cure for cancer. We have a number of breakthroughs and we will continue to work on them.”

Copyright © 2022, ABC Audio. All rights reserved.

Monkeypox cases in US fall, hit lowest level since June: CDC

Monkeypox cases in US fall, hit lowest level since June: CDC
Monkeypox cases in US fall, hit lowest level since June: CDC
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(NEW YORK) — Monkeypox cases are continuing to decline in the United States as the outbreak keeps showing signs of receding.

As of Oct. 12, the U.S. recorded a seven-day average of 60 cases, according to the Centers for Disease Control and Prevention.

This is the lowest average recorded since June 29, which is right around the time that infections began climbing. It’s also down from the seven-day average of 443 cases recorded in early August, Centers for Disease Control and Prevention data shows.

Trends seen in cities across the country mirror those nationwide.

In New York City — the epicenter of the outbreak — the seven-day average has fallen to 2 as of Oct. 11, according to the city’s Department of Health & Mental Hygiene. This is a sharp decline from the peak of 73 recorded in late July and early August.

Similarly, in Los Angeles, the seven-day average sits at 5 as of most recent data from Oct. 3, according to the Los Angeles County Department of Public Health, which is the lowest since early July. It’s also a marked drop from the peak of 41 in late August.

Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center in Boston, told ABC News the outbreak has fallen for a few reasons, one being behavioral changes.

The outbreak has primarily been concentrated in men who have sex with men, a group that includes people who identify as gay, bisexual, transgender and nonbinary, although health officials have said anyone — regardless of sexual orientation — is at risk if they have direct contact with an infected person.

Surveys have shown that high-risk groups listened to public health advice and made changes such as reducing the number of sexual partners and anonymous sexual encounters.

“There were really substantial changes among men who have sex men,” Doron said. “High proportions said that they had made significant changes in their behavior.”

Another reason, she said, is vaccines. As of Oct. 11, more than 906,000 doses of the JYNNEOS vaccine — the only vaccine approved by the Food and Drug Administration to prevent smallpox and monkeypox disease — have been administered across the U.S., according to the CDC.

To increase the number of JYNNEOS doses available, the FDA authorized a new strategy in August to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin, allowing one vial of vaccine to be given out as five separate doses rather than a single dose.

Doron, however, said it’s too soon to claim victory over the outbreak and added that it’s important for those who are at high-risk to keep taking precautions.

“As we have learned and seen with COVID, case numbers have a certain shape and what goes down can come up again,” she said. “So, we can’t rest on our laurels and think that’s it over.”

“The public can relax to a much greater extent than public health officials and hospital officials,” she added.

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Cigna received millions of Medicare dollars based on invalid diagnoses, lawsuit claims

Cigna received millions of Medicare dollars based on invalid diagnoses, lawsuit claims
Cigna received millions of Medicare dollars based on invalid diagnoses, lawsuit claims
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(NEW YORK) — Health care giant Cigna improperly obtained tens of millions of dollars in Medicare funding by making certain Medicare Part C recipients seem sicker than they actually were, the federal government alleged in a civil lawsuit filed Monday.

Cigna submitted false and invalid diagnoses to artificially inflate the payments it would receive for providing insurance coverage to its Medicare Advantage plan members, the suit said.

The lawsuit resulted from a whistleblower complaint and seeks damages and penalties.

“CIGNA knew that, under the Medicare Advantage reimbursement system, it would be paid more if its plan members appeared to be sicker,” Damian Williams, the U.S. attorney for the Southern District of New York, said in a statement. “This Office is dedicated to holding insurers accountable if they seek to manipulate the system and boost their profits by submitting false information to the Government.”

Cigna relied on diagnoses based solely on forms completed by vendors retained and paid by the company to conduct in-home assessments of plan members, according to the lawsuit.

The nurse practitioners who typically conducted these home visits did not perform or order the testing or imaging that would have been necessary to reliably diagnose the serious, complex conditions reported, the lawsuit claims.

The nurse practitioners spent limited time with the patients and did not conduct a comprehensive physical examination. Instead, they relied largely on the patient’s own self-assessment and their responses to various basic screening questions, the government said.

There was allegedly no access to the patient’s full medical history and they typically did not obtain or review relevant medical records in advance of the visit.

Still, Cigna submitted these diagnoses to Medicare to claim increased payments and falsely certified on an annual basis that its diagnosis data submissions were “accurate, complete, and truthful,” the lawsuit said.

In response to the lawsuit, Cigna said in a statement: “We are proud of the high-quality, affordable Medicare Advantage benefits we are privileged to provide to beneficiaries nationwide in compliance with government rules. We reject these allegations and will vigorously defend our Medicare Advantage business against them. Our focus remains on serving our Medicare customers and advancing our mission of making health care more affordable, predictable, and simple for all.”

Medicare Advantage, also known as Medicare Part C, provides health insurance for tens of millions of Americans who opt out of traditional Medicare through private insurers like Cigna. They receive payments from the Centers for Medicare and Medicaid Services based on demographic information and the diagnoses of each beneficiary.

CMS then uses the diagnosis data, in conjunction with demographic factors, to calculate a “risk score” for each beneficiary and, in turn, the amount of the monthly payment the private insurer will receive for covering that beneficiary. The model is intended to pay more to provide health care for sicker enrollees.

According to the government’s lawsuit, Cigna structured home visits for the primary purpose of capturing and recording lucrative diagnosis codes that would significantly increase the monthly capitated payments it received from CMS.

When identifying plan members to receive home visits, the lawsuit said Cigna targeted individuals who were likely to yield the greatest risk score increases and thus the greatest increased payment.

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Over-the-counter hearing aids available in US for first time

Over-the-counter hearing aids available in US for first time
Over-the-counter hearing aids available in US for first time
© Santiago Urquijo/Getty Images

(NEW YORK) — For the first time, hearing aids are available for purchase over the counter at retailers across the United States.

Starting Monday, under a historic ruling issued by the U.S. Food and Drug Administration, adults with mild-to-moderate hearing loss can buy hearing aids at a store or online without a prescription, medical exam or audiologist fitting — and for thousands of dollars less than they previously cost, according to the White House.

The FDA estimates the new rule could lower average costs for hearing aids by as much as $3,000 per pair, the White House said. Consumers are expected to save about $1,400 per individual hearing aid, or over $2,800 per pair.

“A person’s ‘whole health’ is a combination of many factors, including hearing, that influence physical and mental well-being,” Walmart’s chief medical officer, Dr. John Wigneswaran, said in a statement Monday. “Offering easy access to OTC hearing aids — something that seems quite small — is a solution that can improve our customer’s health outcomes and their ability to live better and healthier.”

Walgreens is now selling hearing aids at stores nationwide and online for $799 per pair. Walmart is also offering an assortment of over-the-counter hearing aids — ranging in price from $199 to $999 per pair — on Walmart.com, SamsClub.com and in over 1,000 Vision Centers in Walmart stores across Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee and Texas, as well as 474 Sam’s Club Hearing Aid Center locations. CVS is now selling over-the-counter hearing aids online, with varying options on model and price point. The company will also offer hearing aids in select CVS Pharmacy locations beginning in November, according to the White House.

Best Buy will offer nearly 20 different hearing devices online starting this week. By the end of the month, the company will offer hearing aids in nearly 300 stores across the country. Devices will range in price between $200 and $3,000.

Hy-Vee will sell over-the-counter hearing aids online and in 34 locations across Iowa, Kansas, Minnesota, Missouri, Nebraska and Wisconsin starting this week. The company plans to offer hearing aids in 100 locations by the end of the year. There will be four different models ranging in price from $499.99 to $999.99, according to the White House.

The FDA announced the move back in August, issuing a final ruling that established a new category of over-the-counter hearing aids to improve access and, in turn, lower costs for millions of Americans. The ruling followed an executive order from President Joe Biden in 2021 that called for the FDA to take steps to allow hearing aids to be sold over the counter.

“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 FDA’s Center for Devices and Radiological Health, said at a briefing on Aug. 16. “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.”

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, the FDA said.

Nearly 30 million Americans suffer from some degree of hearing loss, including nearly 10 million adults under the age of 60, according to the White House.

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How some providers work around abortion bans since Roe v. Wade was overturned

How some providers work around abortion bans since Roe v. Wade was overturned
How some providers work around abortion bans since Roe v. Wade was overturned
fstop123/Getty Images

(NEW YORK) — Some state officials as well as abortion providers are trying to find workarounds to help patients who want to end their pregnancies after the Supreme Court overturned Roe v. Wade.

Since the late June ruling, at least 12 states have ended nearly all abortion services, according to the Center for Reproductive Rights.

Some states had trigger laws banning abortion immediately after Roe v. Wade’s reversal. Others had laws written before the court’s decision that could then be enacted.

Penalties for performing abortions in states with bans vary and can include paying a significant fine, loss of a medical license or even a prison sentence.

Meanwhile, organizations and providers have come up with ways they say can help patients access reproductive care without breaking any of the new laws in place.

“What will you do if the work and the health care you provide suddenly becomes illegal?” Elisabeth Smith, director of state policy and advocacy at the Center for Reproductive Rights, told ABC News. “Do we try to muster resources and move a clinic to another state, uprooting our lives, the lives of our colleagues and employees? And how would patients get to that new clinic? So where would it be located?”

“All of those questions are incredibly difficult to answer and require a huge amount both of resources and personal determination,” Smith added.

Accessing pills in California

Legal abortions are still occurring in Arizona after a court blocked a century-old law from going into effect.

The 1901 law, which includes language dating back to 1864, provides no exceptions for rape, incest or fetal abnormalities and makes performing abortions punishable by two to five years in prison. The only exception is if the mother’s life is in danger.

Abortions can resume for at least five weeks while the case is considered by an appeals court, but one abortion clinic reportedly has a workaround — involving telemedicine appointments with doctors in California and picking up pills near the California-Arizona border — if abortions are nearly or totally banned in the state.

According to Farah Diaz-Tello, senior counsel and legal director at If/When/How, a reproductive rights organization, the arrangement is completely legal.

“If somebody receives a telehealth consultation from a provider who is legally authorized to practice in the state where [the provider] is and [the patient] actually goes into that state to receive the medications, essentially they received an abortion in that state where the telemedicine appointment happened,” she told ABC News.

She said legal questions only arise if somebody living in a state with abortion restrictions has medication abortion pills mailed to them.

“If people are in an abortion-hostile state and they’re receiving medications sent to them from other states or from outside of the country, it’s not technically legal for them to do — to obtain that medication,” Diaz-Tello said.

Anti-abortion groups have slammed the arrangement and claimed it is dangerous.

“The abortion industry’s lack of concern for women is on full display in these schemes to circumvent safety regulations in order to make a buck,” Cathi Herrod, president of the Center for Arizona Policy, a conservative lobbying group, said in a statement to ABC News.

Mobile abortion clinic

A local chapter of Planned Parenthood announced this month it is opening the organization’s first mobile abortion clinic to accommodate the number of patients who now must travel to access abortion services.

The clinic will operate in southern Illinois, where abortion remains legal, and will travel close to the borders of neighboring states, where abortion access remains restricted or gone altogether, specifically Missouri.

Dr. Colleen McNichols, chief medical officer at Planned Parenthood of the St. Louis Region & Southwest Missouri, said they’ve seen a rapid increase in the number of people seeking care outside of the bi-state area, which encompasses Illinois and Missouri.

“So before the decision, outside of our bi-state area represented just about 4% of the patients that we saw, regularly,” she told ABC News. “And now, in the three months since the decision, the proportion of folks we see from outside of that bi-state area is more than 40%. So we’ve seen a significant increase in the number of folks we’re seeing traveling really long distances to access to basic reproductive health care.”

Because of the growing demand, the mobile clinic was born. Inside the 37-foot revamped RV is two fully-functioning exam rooms, a small waiting area and a laboratory.

Diaz-Tello said it is legal for a woman to cross into Missouri to receive an abortion at the mobile clinic in Illinois.

“Essentially what those mobile abortion clinics are doing is making it easier for people to go to another state, that they don’t have to go all the way into the state, they can go to the border of their state and be able to return quickly,” said Diaz-Tello. “This is still lawful for people to leave the state to seek abortion care.”

However, some Missouri lawmakers want to close this loophole. A measure that would make it illegal to “aid or abet” an abortion, even if was performed in another state, was presented — and ultimately blocked — in the Missouri House.

Moving services across state lines

Some clinics have moved their services across state lines to areas where abortion access is largely unimpeded.

One example is the Red River Women’s Clinic, which used to be the sole abortion clinic in North Dakota and was in Fargo.

Although a judge blocked the state’s trigger law banning abortions from going into effect in August while a lawsuit plays out, Red River Women’s Clinic said it would now be performing abortions just over the border in neighboring Moorhead, Minnesota.

The right to an abortion is recognized in Minnesota’s state constitution and, in July 2022, several restrictions were permanently blocked, according to the Center for Reproductive Rights.

Tammi Kromenaker, director of the clinic, told ABC News that she’s glad the clinic can still operate but it’s “bittersweet.”

“We fought long and hard in North Dakota and, in fact, are still engaged in legal battles and so we don’t take leaving there lightly,” she said. “And it’s still very raw and it’s bittersweet. So, even though we’re very fortunate that we found a place so close and so convenient to maintain access for our patients, it’s hard to leave a place that you fought so long and so hard for..”

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Abbott launches new infant formula recall at another plant for faulty bottle cap seals

Abbott launches new infant formula recall at another plant for faulty bottle cap seals
Abbott launches new infant formula recall at another plant for faulty bottle cap seals
Bloomberg/Getty Images

(NEW YORK) — In a new recall following a separate one which dogged them for the better part of this year, Abbott, which has been the largest infant formula manufacturer in the U.S., is now voluntarily recalling bottles of their largest, most popular kind of formula, Similac, from their manufacturing facility in Columbus, Ohio.

This recall is not for the bacterial contamination concerns which prompted the massive voluntary recall at their plant in Sturgis, Michigan, earlier this year.

The new recall in Ohio is because the bottle caps on some of their 2-ounce ready-to-feed liquid products made at the Columbus plant are faulty, and may not have sealed completely, the company said in a recall notice.

If formula bottles aren’t sealed properly, it could result in spoilage, Abbott said. Babies could develop painful gastrointestinal symptoms like diarrhea and vomiting if they consume spoiled products, according to the company.

Abbott underscores that only a “small percentage, less than 1%” of bottles in these recalled lots have faulty caps, according to a statement. The company says they “internally identified the issue and are addressing it.”

While this is yet another setback for Abbott, industry experts say it is an important part of the oversight system: for companies to rigorously self-monitor their safety and quality control processes and catch problems before they get worse.

Abbott declined to provide an exact number of bottles being recalled now, but said in the statement it “equates to less than one day’s worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply.”

Even so — that still means this recall could temporarily keep millions of bottles off the shelves, in a market still recouping from the months’ long formula crisis this spring.

Between 2 and 3 million babies in the U.S. rely to some degree on formula every day, experts have told ABC. On average, infants drink between four and six 8-ounce bottles’ worth of formula a day. That includes unfinished or spilt bottles, and naturally fluctuating appetites from day to day. Multiplied out — that means American babies need somewhere between 10 and 12 million bottles per day.

The recall from the Columbus facility impacts smaller, 2-ounce bottles, of which more are required for a day’s worth of feeding.

Abbott is still continuing production of these popular Similac products on a different production line at the facility, the company said.

Abbott’s formula industry dominance made their abrupt absence this spring a strain on the U.S. market. When their Sturgis production was shut down amid Cronobacter contamination concerns, it sent the U.S. formula market into a tailspin.

Amid the dire shortage, Abbott ramped up production at their Columbus facility in an attempt to mitigate some of the shortage.

Abbott converted manufacturing lines at their Columbus plant to increase production of Similac and Alimentum liquid ready-to-feed formula — something the company repeatedly touted to the public and in congressional testimony.

Abbott says the products included in the Columbus plant recall were distributed “primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago.”

The company advises parents to check whether formula they have was recalled at similacrecall.com, and if it is, not to use it.

Abbott says their recall includes the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution manufactured at their Columbus facility.

Abbott says this recall does not impact any of their other formula products. They say they will continue to produce Similac formula products “in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network.”

“We take our responsibility to deliver high-quality products very seriously,” Joe Manning, executive vice president of nutritional products at Abbott said in a statement. “We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.”

A Food and Drug Administration spokesperson tells ABC News the agency is “aware” of Abbott’s new recall of Similac products from their Ohio plant, and say they “don’t expect” it to impact overall domestic supply.

The agency spokesperson pointed to how FDA has relaxed their import discretion, allowing foreign formula makers to sell their products on the U.S. market, as the reason they think this latest recall from Abbott shouldn’t have the same kind of drastic impact which the massive one from earlier this year.

“Parents and caregivers have many additional formula options today thanks to FDA’s efforts and those of many of our government partners,” FDA’s spokesperson said, adding they are “more than doubling the number of formula manufacturers” making formula for U.S. infants.

 

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