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Monkeypox vaccine not 'a silver bullet', WHO says, as breakthrough cases emerge

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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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9th child in US tests positive for monkeypox

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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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CDC: COVID guidance was ‘confusing and overwhelming,’ organization needs overhaul

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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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World Health Organization renames two known clades of monkeypox virus

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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 City's monkeypox vaccine rollout has had some issues. What went wrong?

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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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Over-the-counter hearing aids can be sold following FDA ruling

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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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How to protect your pets from monkeypox after 1st-known case of human-to-pet transmission

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(NEW YORK) -- Monkeypox and related viruses are known for their ability to transmit between humans and animals, but with increasing global spread, the Centers for Disease Control and Prevention said that household pets may be at risk after a dog in France apparently contracted monkeypox from its owners in July, according to a report published in The Lancet journal.

This is the first reported case of human-to-pet transmission of monkeypox.

"We are still learning what different animal species may be susceptible to infection, and this new case report is important because it shows that dogs are able to get the disease," Dr. Meghan Davis, associate professor of environmental health and engineering at Johns Hopkins Bloomberg School of Public Health, told ABC News. The CDC says it's not clear if other animals, like cats, can develop monkeypox, but recommends that people sick with monkeypox take precautions around all animals to be safe.

Monkeypox cases continue to climb across the globe and in the United States, where more than 12,000 Americans have been diagnosed.

For anyone recovering at home, the CDC said it's important to stay away from other household members -- including pets -- or take steps to reduce the risk of household transmission if isolating away isn't possible.

Isolate away from pets if possible

Monkeypox transmission happens during close contact. With pets, this could be through cuddling, hugging, kissing, licking and sharing sleeping areas or food.

If you are diagnosed with monkeypox and have not yet exposed your pet -- meaning you haven't been in contact with the pet since your symptoms developed -- try to find a friend or a neighbor to care for your pet. Your isolation period may last two to four weeks. Once your skin lesions are healed, clean and disinfect your home, including washing your bedding, before bringing your pet back home.

Understandably, this may not be possible for everyone.

Hand hygiene and physical distancing can still help

If your pet stays with you while you are isolated, you can still take steps to reduce their risk of transmitting monkeypox.

"Keep your pets, just keep your distance -- and don't let your pet share your bed -- if you are diagnosed with or suspect you have monkeypox," Davis said.

Echoing guidance given when isolating at home with COVID-19, wash your hands every time you touch your pet, wear a mask and try to keep your skin lesions covered. Maintain your distance and don't let your pet get into contaminated clothes, towels or sheets.

"Pets that had close contact with a symptomatic person with monkeypox should be kept at home and away from other animals and people for 21 days after the most recent contact," according to CDC guidance.

Call your vet and try to get your pet tested for monkeypox if your pet shows signs of monkeypox infection after exposure

Though we don't understand all the symptoms of monkeypox in animals, symptoms could look like lethargy, lack of appetite, coughing, runny nose, fever and pimple-like or blister-like rashes.

If one pet gets sick, try to keep them separate from other pets or people at home -- especially from anyone in the household who is pregnant, immune compromised or a child.

Keep caring for your pet, do not abandon or euthanize your pet

Monkeypox exposure or diagnosis is not a reason to consider abandoning or euthanizing your pet, the CDC said.

The CDC also recommends that people should not put a mask on their pets, or clean or bathe their pets with chemical disinfectants such as alcohol, hydrogen peroxide or hand sanitizer. Wash your hands often and clean any contaminated bedding or other pet materials following CDC guidance if your pet gets monkeypox.

Quickly dispose of the pet's waste -- do not just leave it on the ground or in the backyard -- using a sealed, dedicated trash can, and contact your local public health department for further details on how to handle the contaminated waste.

Dr. Jade A Cobern, board-eligible in pediatrics, is a part of the ABC News Medical Unit and a general preventive medicine resident at Johns Hopkins.

ABC News' Sony Salzman and Arielle Mitropoulos contributed to this report.

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Updated COVID boosters could be available in 3 weeks, White House predicts

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(WASHINGTON) -- Newly updated COVID-19 boosters tailored to target a dominant strain of the virus will be available in the next three weeks or so, assuming the Food and Drug Administration and Centers for Disease Control and Prevention work through their processes for authorization as expected.

That was White House COVID coordinator Dr. Ashish Jha's prediction Tuesday at an event hosted by the U.S. Chamber of Commerce Foundation.

In late June, the FDA directed Moderna and Pfizer to make vaccines for the upcoming winter that targeted the more contagious BA.5 omicron subvariant, along with the original COVID strain. That work has been underway and the next step is for the FDA and CDC to review data from the companies, once they've received it.

Neither the FDA nor the CDC has announced a timeline.

The rollout was expected sometime in September, but Jha's estimate on Tuesday was the most specific to date.

"We're going to know more about this in the upcoming weeks and these vaccines will become available by early to mid-September," he said, again including the caveat that FDA and CDC need to act before anything can be official.

"But the big picture, bottom line, is these are substantial upgrades in our vaccines," Jha said. "And those vaccines are coming very, very soon."

Jha also said that he was hopeful there will eventually be enough vaccine supply for any adult who wants a new booster to be able to get one, despite funding squabbles that forced the federal government to order only enough for the most vulnerable Americans.

"We're still working on trying to pull more resources from other places. I would like to get to a point where every adult in America who wants a vaccine can get one. I'm hopeful we will be there. We're not quite there yet in terms of how many vaccine doses we've been able to buy," Jha said.

"What's really limited us is a lack of resources, but we are pulling from other high-priority items. So my hope is that we're gonna be able to have this for every single adult in America. We will know more about that in the upcoming weeks I think," he added.

So far the U.S. has contracted for 105 million doses of the newly-updated boosters from Pfizer and 66 million doses from Moderna, the two leading COVID vaccine manufacturers for the country. Both contracts with Pfizer and Moderna include an option for hundreds of millions of more doses down the line, should the U.S. secure the money.

Between Pfizer and Moderna, if both companies were able to complete their orders, the U.S. would have about 171 million doses of the new shots. But more than 260 million Americans have had at least one vaccine dose already and would theoretically consider getting a booster.

On the other hand, demand for boosters has dropped with each campaign for people to get another shot. About 108 million people have received their first booster shot, for example.

The White House said it had pulled $5 billion to cover the cost of vaccines for this fall and winter. Between the $3.2 billion awarded to Pfizer and the $1.74 billion awarded to Moderna so far, the government has hit that ceiling.

Because fall and winter usually bring a high volume of flu cases, Jha also urged the public to get both their flu shots and updated COVID boosters as soon as they could -- or else risk a harsh winter of disease with far looser mitigation efforts than each winter of the pandemic so far.

"Our health care system is going to get into serious trouble unless we are very proactive about preventing it -- so if we do nothing and just sort of hope for the best, I think we could end up getting into a lot of trouble this fall and winter," Jha said.

People can get their flu and COVID shot on the same day, Jha noted, and he said he hopes that next year technology will have improved to the point that there's a two-in-one combination booster available for both the flu and COVID.

He also emphasized the importance of improving ventilation in businesses and schools, which was also prioritized in the latest CDC guidance issued last week.

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Novavax asks FDA for emergency authorization of its COVID-19 booster

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(NEW YORK) -- Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of the its primary vaccine series or to mix and match with a different primary series, the company announced.

"It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a statement on Monday.

"Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants," Erck said.

Although half a million doses of Novavax's vaccine have now been distributed to states, following its authorization last month, just 9,700 doses of Novavax's COVID-19 vaccine have been administered across the country, according to federal data.

The sluggish start may be, in part, due to the fact that the vaccines were not immediately made available after authorization, and thus, there could be some reporting delays.

Last month, officials from the Centers for Disease Control and Prevention signed off on the use of Novavax's COVID-19 vaccine for Americans ages 18 years and older, making it the fourth COVID-19 vaccine to be made available to the American public.

The Biden administration secured 3.2 million doses of Novavax's COVID-19 vaccine.

A number of health experts had expressed their hope that some of the individuals, who are still hesitant to be vaccinated, would be more inclined to get the Novavax vaccine, because it is based on a more traditional protein-based technology, one already used for the flu vaccine and other shots, while Pfizer and Moderna vaccine platforms tapped a new genetic technology — with messenger RNA — to produce their vaccines.

Early indicators suggest that the authorization has yet to convince a large swath of the 26 million unvaccinated American adults to get the shot.

However, experts say that although overall uptake may still be limited, there some Americans who have been vaccinated with Moderna, Pfizer, or Johnson & Johnson's COVID-19 vaccines, may feel more inclined to receive Novavax's booster.

"Having vaccine options likely plays role in improving vaccination coverage. Given so many Americans have yet to receive their boosters despite the clear indication of their impact on reducing risk of severe complication from COVID-19, that improvement in vaccine uptake may be somewhat limited," said John Brownstein, Ph.D., an epidemiologist at Boston Children's Hospital and an ABC News contributor.

Across the country, 110 million Americans — or more than half of those eligible to be boosted — have yet to receive their first booster shot, according to data from the CDC.

Similarly, although over 61 million people, over the age of 50, are eligible to receive their second COVID-19 booster shot, just a third of people have actually done so.

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New COVID bivalent vaccine expected in US in the fall

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(NEW YORK) -- On Monday, the U.K. became the first country to approve a bivalent vaccine booster shot for adults, which would target both the original COVID virus and the Omicron variant.

This vaccine, which is likely going to be available in the U.S. starting in the fall, is expected to provide increased and longer-lasting protection against COVID and the new variants.

Sony Salzman, coordinating producer for ABC News’ Medical Unit, sat down with ABC News' podcast “Start Here” to discuss what people can expect from the new bivalent vaccine, and the way forward in the country’s vaccination strategy.

START HERE: Yesterday the U.K. became the first country on Earth to approve a new type of vaccine, a vaccine that was engineered with a more recent variant of COVID in mind. Let's check in with ABC's Sony Salzman from our Medical Unit. Sony, is this a turning point? What does this vaccine do?

SALZMAN: I think it is a turning point, Brad. I think what these new vaccines are going to do is shift us into the next phase of the pandemic, where like the annual flu shot each year or season, we have to kind of predict what the virus is going to do and engineer a vaccine that is the best defense against that virus.

The U.K. government just recently authorized a vaccine that is a combination shot, it is Moderna's combo shot. This is called a bivalent vaccine. And what it does is it still protects against that original Wuhan strain that emerged in 2020, but then it also protects against the newer BA1 Omicron strain. And so it combines both of those in the hopes of providing enhanced protection against the variants that are circulating right now.

START HERE: Right, so [with] Omicron cases absolutely skyrocketed in this country because people just did not have the same level of immunity as this variant came onto the scene. So how do I get one of these vaccines, Sony? I want one of these boosters. What's happening in the U.S.?

SALZMAN: So it is coming to the U.S., too, but what we're gonna get here is actually slightly different. FDA, the Food and Drug Administration, they looked at presentations from Moderna and Pfizer and what they said is, you know, that's all well and good, but even within Omicron, we have all these subvariants right? So Omicron BA1 was the first Omicron subvariant, but now here in the U.S. and globally, actually, BA5 is the dominant variant.

What the FDA did is they asked the companies to go back, look at the formula again, and re-tweak it a little bit so that it's a better match against BA5, and that is the version that they have ordered. The expectation is that that would be authorized in September or perhaps October, and be available sometime in the fall.

START HERE: So that sounds great; I guess that it would be the strain that's a little bit more recent, but will it work better? Because I gotta say Sony, I see school about to start and I'm thinking ‘dang, wouldn’t it be nice to get a new vaccine in play before kids are all indoors spreading it to each other's families.’ Is there a balancing act here between timeline and efficacy?

SALZMAN: Well, you know, just to set expectations, Brad, I do think it's really important to remember that even these vaccines that we're talking about the ones that are re-tweaked, and they're reformulated, and they're better matches against these new variants. The virus itself has changed so much that we are not going to get a bulletproof vaccine that protects you against any breakthrough infection.

START HERE: That's no longer the expectation for these vaccines…

SALZMAN: That's no longer the expectation, that's exactly right. So, you know, maybe at some point in the future, there is some really interesting vaccine science, early stages of development here but for these vaccines, and for the way that this virus has evolved, that is no longer the expectation.

The expectation is that they are going to have higher efficacy, particularly against severe illness, and also last longer so that kind of drop off doesn't happen as quickly. So that's the expectation here, but I want to be clear: either of these vaccines, whether you do a bivalent against BA1 or BA5, or anything to that effect, it's going to be better. Every scientist I've talked to says that this is the way forward.

We need to be updating the vaccines to be a better match for the variants that are circulating presently. But it's not going to be this kind of bulletproof approach where you have a vaccine that completely protects you against infection. That's not the expectation.

START HERE: Gotcha. In the meantime, we are hoping to see these Omicron-specific boosters here in the U.S. sometime in September. Sony Salzman from our Medical Unit, thanks a lot.

SALZMAN: Yeah, thank you Brad.

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6th child tests positive for monkeypox in US: What parents should know

ABC News

(NEW YORK) -- As monkeypox continues to spread across the U.S., the number of children infected with the virus is growing as well.

At least six children have tested positive for monkeypox since July, including a child in Maine and two each in Indiana and California.

The other case was reported in an infant, a non-U.S. resident, who was tested while traveling through Washington, D.C., federal officials confirmed last month.

Children under the age of 8 are among those whom the Centers for Disease Control and Prevention considers at "increased risk" for developing more severe illness if infected with monkeypox, along with pregnant people, people who are immunocompromised and those who have a history of atopic dermatitis or eczema.

Below, experts answer seven questions parents might have about monkeypox and how it may impact kids, as overall cases across the U.S. continue to climb.

1. As a parent, how concerned do I need to be about monkeypox?

At this time in the outbreak, parents "do not need to panic" about the virus, according to ABC News chief medical correspondent Dr. Jennifer Ashton, who is also a board-certified OB-GYN.

"They should be aware of what's going on with this, as they are with any medical headline," Ashton added. "They should know what's going on in their community and they should take the appropriate steps after discussing any concerns they have with their pediatrician."

2. How is monkeypox spread?

Monkeypox, also known as MPX, is spread primarily through direct, skin-to-skin contact between someone who has the virus and someone who does not, according to Dr. Richard Malley, senior physician in pediatrics, division of infectious diseases, at Boston Children's Hospital and a professor of pediatrics at Harvard Medical School.

"That could be through intimate contact," said Malley. "It could also be through just contact with somebody in the family who has an unsuspecting lesion and lesion unfortunately touches another individual."

Shared items like towels, clothes or bed sheets could also possibly spread the virus if used by someone with a monkeypox lesion, according to Malley.

"If somebody is infected with MPX, they really need to be very careful with who they interact with and how they interact with those with other people to try to avoid spread as much as possible," he said.

According to the CDC, monkeypox can also spread through contact with an infected person's respiratory secretions and prolonged face-to-face contact.

"So far it does not seem to be the major mode of transmission for this virus in the current epidemic," said Malley. "But that is of course one of the things that we need to monitor very closely."

3. Does my family need to wipe down surfaces or avoid shared spaces like playgrounds?

Because monkeypox is spread primarily through skin-to-skin contact, parents at this point do not need to overly concerned with their child becoming infected by touching things like doorknobs in public spaces or shared toys, according to both Malley and Ashton.

"While that possibility remains, I think it does not mean that parents or anyone should be concerned about touching doorknobs or going to the grocery story or touching objects that are out on the street, for example," said Malley. "That is not thought to be a very likely way for MPX to be spread, or for most viruses to be spread."

Ashton said that people who live in high-transmission areas for monkeypox may want to wipe down surfaces as an extra precaution, noting, "It is possible that this virus can be left on gym equipment, just like it can be left on clothes."

However, she added that hand washing is more important than wiping surfaces to prevent the spread of disease.

"Hand hygiene is the most important thing, not just for monkeypox but for any infectious disease," Ashton said.

4. How can I tell if my child has monkeypox?

Unfortunately, the symptoms of monkeypox can look like other viruses -- including flu and other rashes -- so experts recommend seeking medical care as soon as symptoms show, especially if your child has been in contact with someone who has monkeypox.

Typically, the disease begins with a fever, headache, fatigue, chills and muscle aches. Unlike smallpox, however, monkeypox also causes swollen lymph nodes.

Within one to three days of initial symptoms, those infected will typically develop a rash either on their face or other parts of the body, according to the CDC.

Per the World Health Organization, the lesions -- or rash -- start out as dark spots on the skin before progressing to bumps that fill with fluid.

Malley said parents should seek medical care for any type of rash on their child's body that does not look like something they have had previously.

"The rash of MPX, as we are now learning, can look very different in different individuals for reasons that we don't quite understand," said Malley. "You really need to be cautious with anything that might look like a MPX rash."

Monkeypox is diagnosed by testing the lesions to identify whether genetic material of the virus is present, according to Malley.

5. Why are children at increased risk with monkeypox?

Experts are not sure, Malley said.

It may be due to their immune systems and the fact that "younger children are sometimes more susceptible to some viral infections," he explained.

In Africa, where monkeypox originated, the most severe but rare cases of the virus have typically involved inflammation of the brain, according to Malley.

Ashton said that while there have so far been no deaths associated with monkeypox in the U.S., it's important to stay vigilant as the disease spreads.

"As the numbers grow, based on sheer math, it is not impossible that we will see a death here in the U.S.," said Ashton, adding that monkeypox has a "spectrum of severity" when it comes to complications. "There have been deaths in Africa associated with monkeypox."

6. Is there a monkeypox vaccine for kids?

The current vaccine for monkeypox is available to people ages 18 and older. However, the JYNNEOS vaccine can be offered to younger people on a case-by-case basis via a special permission process through the U.S. Food and Drug Administration to those with known monkeypox exposure.

Antiviral medications such as Tecovirimat are currently being used for treatment of monkeypox, which is available for children.

More common treatments may also be used to help treat patients who are experiencing pain due to monkeypox lesions, according to Malley.

7. How should I best protect my child from monkeypox?

The best thing parents can do for both themselves and their child, according to Malley, is to pay attention to the virus -- but try not to panic.

"I think it would be very unlikely that daycare or a camp or school would be a major focus of transmission of this virus as we understand it currently," he said. "But of course, it's important for all of us to be vigilant."

Malley said the key for parents concerned about monkeypox is to be aware of their child's surroundings and not interact with people they know have been infected with monkeypox.

"The importance for parents is that if they know anybody in their surrounding, in their environment, in their family who has a suspicion of being infected with MPX, then of course that individual needs needs to isolate themself," he said. "In general, people who have been diagnosed with MPX have been told and are being very careful because they do not want to be responsible for transmission."

The CDC has released safety guidelines for people with monkeypox, urging those infected with the virus to "remain isolated at home or at another location for the duration of illness."

According to Malley, monkeypox lesions are considered to be infectious until they are fully crusted over.

ABC News' Arielle Mitropoulos and Cheyenne Haslett contributed to this report.

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New York City officials host monkeypox town hall as disease continues to sweep city

Spencer Platt/Getty Images

(NEW YORK) -- New York City officials are holding a town hall Monday to discuss the ongoing monkeypox outbreak as cases continue to climb and thousands of vaccine appointments over the weekend were swept up within minutes.

Currently, there are more than 2,300 confirmed cases in the Big Apple with Manhattan having the most at 917, according to data from the city's Department of Health and Mental Hygiene.

Brooklyn has the second-highest number of cases at 472, followed by the Bronx with 310, Queens with 278 and Staten Island with 13. It's unknown which boroughs the remaining cases are from.

In response to the outbreak, the NYCDOHMH will be holding an event in the Bronx with Dr. Madhura Ray, director of the department's Data and Analytics for Childcare, to discuss vaccination sites, testing, outreach for at-risk populations and preventative measures.

The event is being held in partnership with Bronx Borough President Vanessa Gibbons -- who will be hosting the town hall -- and Destination Tomorrow, an LGBTQ advocacy group.

"[Gibbons] has been concerned over the slowness in getting vaccinations and concerned about awareness," the borough president's press secretary, Arlene Mukoko, told ABC News. "We want people to fully know what [monkeypox] is, how it can get transmitted. The New York City Department of Health is saying anyone can get it so how does that work? How is outreach going?"

She continued, "We want to make sure everyone is getting treated in a way that is empowering. It's a community conversation."

Of all New York City cases with available race/ethnicity information, Black and Hispanic people have made up nearly 55% of documented infections -- particularly relevant in the Bronx, which is largely made up of Black and Hispanic residents, according to the most recent U.S. Census data.

Most of New York City's infections have occurred among men between ages 25 and 44 who identify as LGBTQ, according to data from the NYCDOHMH.

Health officials, however, have stressed that anyone is at risk if they have intimate contact with an infected patient or come into contact with their lesions.

It comes just one day after more than 6,000 new vaccine appointment slots across the city were filled in under one hour, according to Manhattan Borough President Mark Levine. He decried the lack of supply and called on health officials to increase the number of available doses.

"There are still many people at risk who haven't been able to access this vaccine. We need more supply for NYC [as soon as possible]," he tweeted Sunday.

Copyright © 2022, ABC Audio. All rights reserved.

Boy born with one-in-a-million condition takes first steps with prosthetic leg

Dawn Miranda

A Chicago toddler who was born with a one-in-a-million condition that left him without part of his right leg is now walking thanks to a prosthetic leg.

Dakari Miranda, who will turn 2 this fall, took his first steps this month, less than eight months after undergoing an hours-long surgery to have most of his right leg amputated.

Dakari was born without a tibia, or shinbone, in his right leg, a rare condition known as tibial hemimelia.

His mom, Dawn Miranda, said she learned her son had the condition while she was 20 weeks pregnant, and that from the start, doctors spoke with her about possibly needing to amputate her son's leg.

"Once we found that out, I was distraught," Miranda told Good Morning America. "That was like the scariest thing I'd ever heard."

Miranda said she initially worried about what kind of future Dakari would have, and whether he would be able to run and play with his siblings and friends.

As she began research the condition and later joined a Facebook group of parents and people with tibial hemimelia, she said she grew optimistic about her son's future.

"I just started to realize that Dakari is going to be great," said Miranda, adding that she was also encouraged by Dakari's orthopedic surgeon, Dr. Romie Gibly, who told her that one day Dakari could be a field goal kicker for the Chicago Bears. "He made me feel like don't think because Dakari not going to have the rest of his leg, that his life is over."

After Dakari was born, Gibly, a board-certified pediatric orthopedic surgeon at Lurie Children's Hospital of Chicago, presented Miranda and her husband with two options.

They could either try to preserve the foot and build a leg for Dakari through multiple reconstructive surgeries and lots of rehabilitation work, or they could perform an amputation and fit Dakari with a prosthetic leg that would allow him to start walking immediately, and on schedule for him developmentally.

Both Miranda and Gibly say the decision to amputate Dakari's leg became clearer after they saw the difficulties he had in trying to crawl and walk with his foot the way it was.

"Over that first year of life, it became really apparent pretty quickly that the foot was really just getting in his way," said Gibly. "It just kind of flopped around and he didn't really have any control over it, and it really prevented him from getting moving."

In December, Gibly oversaw the surgery to amputate Dakari's leg from below the thighbone.

Soon after the surgery, once his surgical cast was removed, Dakari was able to crawl and move, according to both Gibly and Miranda.

"When we went to get the cast off, the kid shot down the hall like a sprinter," said Miranda, adding that seeing Dakari's joy was a relief after having to make the decision to amputate his leg. "He was on the move and it was almost like he wanted to say I appreciate it, like thank you so much."

Over the next several months, the team at Lurie Children's Hospital worked to design, fabricate and fit a prosthetic leg for Dakari.

"[Adults] say that losing a limb is like losing a family member and having to relearn to walk using a prosthesis at an older age is difficult," said Breanna Baltrusch, a board-certified prosthetist and orthotist who treated Dakari. "For Dakari, he’s not going to know any different. His first steps are with a prosthesis."

She continued, "Most pediatric patients become fantastic prosthetic users because they’ve learned to acclimate to the prosthetic from the start."

Dakari will need to have his prosthesis adjusted over the years as he grows and may need future minor surgeries, but he is not expected to have any limitations due to the amputation, according to both Baltrusch and Gibly.

"He's done with the hard work so he can just move on and learn to walk and make progress," said Gibly. "And probably the biggest factor for him is [his] family, who are engaged and interested and enthusiastic and supportive."

Deavinna Edwards, 16, Dakari's older sister, said she can already play more with Dakari because it's so much easier for him to move.

She said she has big dreams for her brother to achieve whatever he wants in life, and looks forward to cheering him on.

"In high school, he could probably be on the swim team and be like Michael Phelps or play basketball or he can follow in my footsteps and play volleyball," she said. "I can see he's really more comfortable and confident now."

Miranda said that as Dakari continues to improve, she wants other parents of other kids with rare conditions to see him and know that they are not alone.

"The rareness of your child is one-in-a-million but it's not one-in-a-million that you have people on your side," she said. "We're here. We can help you get through it, and it will just be better."

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What to know about the spotted lanternfly, the insect experts say to squish

Getty Images

(NEW YORK) -- Scientists have a message about the spotted lanternfly: If you see one, squish it.

While that may sound harsh for bug lovers out there, experts say spotted lanternflies can be devastating to agriculture.

"It's a good idea if you can kill them, to do that," Brian Eshenaur, a senior extension associate for ornamental crops at Cornell University's pest management division, told ABC News.

The New York City Parks Department offers similar guidance on its website.

"Harming our city's wildlife is broadly prohibited, but in an effort to slow the spread of this troublesome species, the current guidance remains: if you see a spotted lanternfly, please squish and dispose of this invasive pest," the department says.

New York state's Department of Agriculture and Markets, Department of Environmental Conservation and the Office of Parks, Recreation, and Historic Preservation launched a program this year to train volunteers on how to identify and track the invasive species in the state.

The invasive species originated in Asia but was first found in the U.S. in Pennsylvania in 2014 and soon after in other states in the Northeast, including Connecticut, Delaware, Maryland, New Jersey, New York and Virginia.

The insect, known scientifically as the Lycorma delicatula, feeds on at least 70 different species of trees, as well as vines and shrubs, including fruit trees, grapevines and several hardwoods, according to a report from the University of Michigan.

The lanternfly isn't dangerous to people and pets, experts say. The insect is viewed as more of a nuisance since they don't bite or sting.

So if you plan on being vigilant for spotted lanternflies this summer, here are some key things to know.

Keep an eye out in backyards and parks

The bugs gather in large numbers and can be found in backyard trees and in parks, where they feed on trees and ooze a sugary substance called honeydew, which then can cause a sooty mold that can land on lawn furniture or your car, Eshenaur said.

The female lantern fly can lay between 30 and 50 eggs each, usually between September and October. The eggs hatch in the spring, where baby lanternflies called nymphs emerge, before becoming fully grown around July, according to the Washington State Noxious Weed Control Board.

They favor warmer temperatures

Climate change could exacerbate the problem, experts say.

"The spotted lanternfly needs a long growing season to complete their lifecycle," Eshenaur said. "With earlier spring and later fall frost that could favor the development of the lanternfly and increase the range in which they can survive at."

Insect development depends on the temperature, Kelly Oten, assistant professor in the Department of Forestry and Environmental Resources at North Carolina State University, told ABC News.

"As the temperature is warm, their development increases, which means they're going to actively feed for longer periods of time, potentially causing more damage," Oten said.

They're a threat to agriculture

Wine lovers, here's some bad news.

The spotted lanternfly can be devastating to the multi-billion-dollar wine industry since they feed on grapes, reduce their crops and diminish the quality of grapes, according to Oten.

Overall, they're a huge threat to agriculture. If the species were to spread through Pennsylvania, the expected losses to the state's economy would be nearly $554 million a year and potentially lead to the loss of 4,987 jobs, according to a 2019 impact study from Penn State University.

For forestry, the estimated economic loss could be up to $152.6 million annually throughout Pennsylvania, the study found.

What to do if you see one

Killing the pest if you encounter it isn't the only way to address the problem.

People should check outdoor items for spotted lanternfly eggs, which can look like a mass covered with gray wax. Scrape them off, put the mass in a plastic zippered bag with hand sanitizer and throw it out, the U.S. Department of Agriculture says.

While spotted lanternflies can't kill trees, they can cause damage to them. People can also use insecticides approved by the Environmental Protection Agency, which can kill lanternflies and not harm trees.

Copyright © 2022, ABC Audio. All rights reserved.

Polio discovered in New York City wastewater samples

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(NEW YORK) -- Health officials announced Friday that polio has been detected in wastewater samples in New York City.

It comes just a few weeks after a case of polio was detected in Rockland County, located north of the city.

Story developing...

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