US regulators weigh whether people can mix COVID booster shots

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(WASHINGTON) — U.S. regulators are considering revising the rules for COVID-19 vaccines to allow people to opt for a different type of shot for their booster than what they originally received, a move that would enable people who got the Johnson & Johnson vaccine to receive the Moderna or Pfizer dose as their next shot.

Likewise, a person who got the Moderna or Pfizer vaccine might be able to boost with J&J or the other mRNA shot.

No decision has been made, and it’s not clear how soon mixed doses could happen.

The U.S. Food and Drug Administration would need to amend its authorizations of the three vaccines available to Americans, and the Centers of Disease Control and Prevention would have to endorse the idea.

But in a meeting Friday with independent advisers, senior government officials suggested they were open to the idea.

“It does seem like there’s some consensus that this is an important option for people to have,” said Dr. Peter Marks, a senior FDA official who oversees vaccine regulation.

Amanda Cohn, a senior adviser for vaccines at CDC’s National Center for Immunization and Respiratory Diseases, said having “allowable language” from the FDA would be helpful from a public health perspective. One concern, she said, are the 15 million people who have received the J&J shot but either might not have access to a second dose or are concerned about the risk of rare but serious blood clots that the vaccine poses to women of childbearing age.

“If there’s not any allowable language in the FDA factsheets or EUA authorization, then those individuals are left behind,” she said.

While Marks said providing regulator flexibility was possible, he asked the advisory panel to weigh in on what data might be needed to make such a decision. He didn’t offer a timetable and suggested he would be interested in collecting more real-world data first.

“We don’t know from the short studies what the longer-term effects of mix and match will be. And we just don’t have those data,” he told the advisory panel.

Early results from a recent study by the National Institutes of Health found that boosting with a different shot than what was received the first time around appears to be safe and effective. What’s more is that the study found J&J recipients wound up with higher antibody levels if they were boosted with Moderna or Pfizer.

The ability to mix vaccine brands also could be of interest to male teens and young adults, who are more likely to experience heart inflammation following a shot of Moderna or Pfizer. While treatable and typically mild, there have been reports of hospitalization among that population.

Cohn said there do not appear to be any safety concerns with mixing booster doses of any type.

“I think the safety data that has been presented today is very supportive, especially in light of the culmination of the millions of doses of these products that we’ve seen given and the safety evidence from all of those vaccines,” she said.

Dr. Ofer Levy of Boston Children’s Hospital, a panel member, said the government should be ready to move forward quickly to allow for mixed boosters.

“In the real world, all these kinds of combinations or extra boosters are already happening,” he said.

ABC’s Sony Salzman contributed to this report.

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Independent FDA panel votes to authorize booster shots for Johnson & Johnson vaccine

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(WASHINGTON) — A day after voting in support of Moderna booster shots for certain at-risk Americans, an independent Food and Drug Administration advisory panel on Friday voted to move forward with Johnson & Johnson Covid-19 vaccine boosters.

The panel’s decision on J&J was broader then it was for Moderna and Pfizer as it applies to all J&J recipients 18 and older. The timing is also different: It can be administered two months after the initial shot.

For the two mRNA vaccines, the panel agreed they should be authorized for a narrower group: seniors and everyone 18 or older if they have underlying conditions or could be exposed to the virus at work. They also agreed on a timeline of six months after the second shot.

The FDA has not found an increase in concerning side effects from any of the three vaccines’ booster doses.

The conversation around boosters focuses on whether Americans vaccinated over six months ago need a boost of protection against breakthrough infections in the face of the more transmissible delta variant, though all of the three vaccines authorized in the U.S. are still proving effective against hospitalization and death.

Experts on the FDA panel were quick to highlight that success, emphasizing that the conversation around boosters should not overshadow the vital campaign to get the 66 million unvaccinated Americans vaccinated.

“The people who are in the ICU aren’t there because they haven’t gotten the third dose, they’re there because they haven’t gotten any dose,” Dr. Paul Offit, an FDA advisory panel member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in Thursday’s meeting.

Another pertinent debate that the FDA panel will take on Friday is the potential benefits of mixing and matching vaccines for booster shots. Many J&J recipients who feel the single-shot vaccine didn’t perform as well as the mRNA vaccines have been clamoring for data on their options for switching.

Early results from a highly anticipated National Institutes of Health study found that boosting with a shot different from what people got the first time appears to be safe and effective.

The non-peer reviewed study evaluated all three vaccines — Pfizer, Moderna and J&J — and found that no matter the booster, all study participants saw a “substantial” uptick in antibody levels after a booster shot.

The study also found that for J&J vaccine recipients, antibody levels were higher if they were boosted with Moderna or Pfizer than with J&J. This could indicate stronger protection in the short term, but experts also point out that antibody levels are not the only part of the immune response.

Though promising, more research is likely needed on mixing and matching.

For now, the process will formally move forward with authorizing additional booster doses of Moderna and Johnson & Johnson shots for those who received the same original vaccine, as was the case with the Pfizer booster authorization.

This week’s meetings are the first step in that process for Moderna and J&J.

The FDA is expected to issue an authorization in the coming days, and then an advisory panel for the Centers for Disease Control and Prevention will meet to further discuss recommendations about who should get boosters and when.

That panel has scheduled a meeting for next Wednesday and Thursday to discuss boosters for Moderna and Johnson & Johnson.

Once that happens, CDC Director Rochelle Walensky must sign off, which typically happens within 24 hours of the panel’s recommendations. That decision is expected by next Friday at the earliest.

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All three COVID-19 vaccines still produce strong immune response eight months later, new study finds

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(NEW YORK) — All three currently authorized COVID-19 vaccines still showed signs of a strong immune response eight months later without a booster, according to a study published Friday in the New England Journal of Medicine.

The study analyzed specific markers of immunity found in the blood of people vaccinated with Pfizer, Moderna and the Johnson & Johnson vaccines.

Echoing evidence from the real world, researchers found cellular signatures suggesting that all three vaccines produce strong and long-lasting protection from severe illness.

But the analysis also hinted at differences in the way the vaccines produce antibodies — with Pfizer and Moderna antibodies spiking and then fading quickly, while Johnson & Johnson antibodies started at a lower level but remained more stable over time.

“By month eight, antibody responses were comparable for these three vaccines,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who coauthored the research.

Pfizer and Moderna vaccines rely on the same type of technology, called mRNA, while Johnson & Johnson uses a different technology, called viral vector. The two technologies prompt different types of immune responses.

Thought the pandemic, scientists have used antibodies — virus fighting proteins in the blood — as one indication that vaccines are working. But antibodies are only one part of the body’s overall immune response.

This new study is among the first to directly compare not just antibodies, but also T-cells, across all three vaccines. T-cells are also a crucial part of the immune system, and may offer longer-lasting protection even after antibodies fade.

“We think the antibodies are often more relevant preventing against infection, and the T-cells are more relevant killing the virus — so preventing severe disease,” said Dr. Todd Ellerin, director of infectious diseases at South Shore Health and an ABC News medical contributor.

“T-cell responses likely contribute to vaccine protection against severe disease,” said Barouch. “T-cell responses were relatively stable for all three vaccines for eight months.”

The study helps explain on a cellular level an observation that public health experts are seeing in the real world — protection against severe disease is holding strong, even as protection against mild breakthrough infections fluctuates over time.

“The higher the neutralizing antibody titers, the more protected you are against infection,” Ellerin said. “I think that’s why there’s an advantage to two doses of mRNA vacancies compared to the single dose Johnson & Johnson against preventing infection.”

But, Ellerin said, “When it comes to severe disease, that’s a completely different story. And they all do great.”

For scientists and doctors currently debating need for booster shots, the study underscores the fact that even 18 months into the pandemic, there’s no one test that can perfectly measure how protected a person is from COVID-19 — potentially muddying the waters about the best time to boost.

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Fungal disease on the rise in West possibly tied to changing climate patterns: Experts

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(NEW YORK) — Over the last several years, cases of valley fever, a disease common to the arid West, have been steadily creeping up.

Between 2014 and 2018, valley fever cases tripled in California alone, and the state reached a record high of 9,004 new cases in 2019.

Now, experts believe the disease may spread to other parts of the country, and it may be due to climate change.

“I have talked to some people that the cases are over the usual numbers,” Dr. George Thompson, a professor of medicine at UC Davis, said. “We’re probably up 30% [in my practice].”

Valley fever, or coccidioidomycosis, is caused by the coccidioides fungus and can manifest as a primarily respiratory illness that self-resolves, or as a more severe, systemic condition that requires immediate medical attention.

The more severe version, disseminated coccidioidomycosis, affects 5-10% of infected people and can affect the skin, joints, heart and even the brain and spinal cord. Once those areas are impacted, the disease can be difficult to treat, particularly in immunocompromised individuals.

The coccidioides fungal spores commonly reside in soil throughout California, Arizona, Nevada, New Mexico, Utah, Texas and as far north as Washington. Any disturbance of the dirt, such as construction work and burrowing animals, can send plumes of coccidiodes spores into the air, where people can inhale them.

While valley fever is historically endemic to the hot and dry southwestern United States, experts are concerned that the fungus may be on the move due to ecologic and environmental changes, among other factors.

“There’s a bit of seasonality … it’s multifactorial. There’s no question there’s been a strong, steady increase,” Dr. Andrew Comrie, a professor of climatology at the University of Arizona, told ABC News.

Improved surveillance and diagnostic methods may be catching more valley fever cases than before, but experts believe the recent rise in known cases is, in some part, a result of changing global climate trends.

So far, research based on predictive modeling has shown that changing climate patterns may lead to coccidioides spreading as far east as Kansas and as far north as North Dakota.

These models are based on trends seen in precipitation and temperature: two factors critical to the lifecycle of the fungus responsible for valley fever.

Projections show that average annual temperature may increase by 3-6 degrees by the end of the 21st century, and rainfall is predicted to decrease further in the western and southwestern U.S. — setting up more ideal environments for coccidiodes to spread.

But climate change might not be wholly to blame for the fungus’ spread.

“It’s a lot hazier than we would like it to be,” Comrie said.

Predictive modeling can only provide part of the story based on estimates, and there is inherently a time lag between when a patient is diagnosed with valley fever and when that person was actually exposed to the fungus.

Comrie also pointed out other theories, debunking one myth in particular, which sets duststorms as the enemy. Duststorms — gigantic walls of loose dirt — commonly blow through Arizona, and people may worry that toxic fungal spores are released in the air along with the dust. However, Comrie wants to dispel that fear (overall, Valley fever appears uncorrelated with duststorms as a whole) and instead focus on rodents as potential vectors for valley fever. Burrowing mice, for example, easily disturb the soil layer where the coccidiodes fungi sit, increasing the risk of dissipating the dangerous spores.

“More disturbances means more infections,” Comrie said, which in turn means more attention needs to be given to valley fever, as experts believe it will only become more common in the country as the environment changes.

“A lot of primary care doctors are going to be the first ones to encounter the disease,” Thompson said. “It’s important for patients to know whether they need to get tested for coccidiodes.”

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Independent FDA panel votes to authorize Moderna booster for seniors and high-risk Americans

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(WASHINGTON) — An independent Food and Drug Administration advisory panel on Thursday voted unanimously to authorize Moderna Covid-19 vaccine boosters for Americans 65 and older, anyone 18 and older with underlying conditions and those frequently exposed to the virus.

The recommendation is in line with what the FDA and Centers for Disease Control and Prevention authorized for Pfizer booster shots last month.

The Moderna booster will only be a half dose, as opposed to the full dose for Pfizer, but was found to return antibody protection to the initial levels after the first two shots.

Dr. Jacqueline Miller, who presented Moderna’s data Thursday, said the company chose the half dose because it was just as effective but would “increase the worldwide vaccine supply of mRNA.”

Moderna and the FDA both said there was no evidence of increased side effects from booster doses except for more reports of swelling or tenderness in the arm where the patient was injected.

“Unsolicited adverse events did not reflect any new safety concerns,” the FDA found.

On Friday, the panel will also vote on authorizing booster shots for the third available vaccine, Johnson & Johnson. Johnson & Johnson posted a summary of its research Wednesday, making the argument for a second shot of the same dose, roughly six months after the initial single-shot vaccine.

The conversation around boosters focuses on whether Americans vaccinated over six months ago need a boost of protection against breakthrough infections in the face of the more transmissible delta variant, though all of the three vaccines authorized in the U.S. are still proving effective against hospitalization and death.

And despite the overwhelming support for boosters from the experts on the FDA panel, many were also quick to point out that the conversation around boosters should not undermine the vital campaign to get the 66 million unvaccinated Americans vaccinated.

“The people who are in the ICU aren’t there because they haven’t gotten the third dose, they’re there because they haven’t gotten any dose,” Dr. Paul Offit, an FDA advisory panel member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in Thursday’s meeting.

Another panel member, Dr. Michael Kurilla of the National Institute of Health, noted that the vaccines are still working quite well, particularly among young people, and he doesn’t see the need to offer boosters universally.

“I don’t necessarily see the need for a sort of let-it-rip campaign for boosters for everyone who’s ever been vaccinated,” Kurilla said.

Another pertinent debate that the FDA panel will take on Friday is the potential benefits of mixing and matching vaccines for booster shots.

Early results from a highly anticipated National Institutes of Health study found that boosting with a shot different from what people got the first time appears to be safe and effective.

The non-peer reviewed study evaluated all three vaccines — Pfizer, Moderna and J&J — finding that no matter the booster, all study participants saw a “substantial” uptick in antibody levels after a booster shot.

Though promising, more research is likely needed on mixing and matching. For now, the process will formally move forward with authorizing additional booster doses of Moderna and Johnson & Johnson shots for those who received the same original vaccine.

This week’s meetings are the first step in that process: The FDA itself and the Centers for Disease Control and Prevention will both need to sign off on the panel’s recommendations about who should get boosters and when for Moderna and J&J.

The first authorization, which will come from the FDA, is expected within days of the independent panel’s non-binding vote.

Then, the question goes to CDC’s independent advisory panel of experts. That panel has scheduled a meeting for next Wednesday and Thursday to discuss boosters for Moderna and Johnson & Johnson. Those outside experts will weigh in with their recommendations, which are also non-binding.

Once that happens, CDC Director Rochelle Walensky must sign off, which typically happens within 24 hours of the panel’s recommendations. That decision is expected by Friday, Oct. 22, at the earliest.

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Gabby Petito’s cause of death a lesser-known sign of intimate partner violence, experts say

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(NEW YORK) — When a Wyoming coroner announced Tuesday that Gabby Petito, the 22-year-old travel blogger whose remains were recovered in September in a national park, died by strangulation, experts who study intimate partner violence said they saw a recognizable thread.

“Strangulation is not talked about as much, but it is a major risk factor for intimate partner homicide,” Kellie Lynch, an associate professor at the University of Texas at San Antonio, told Good Morning America. “And we often see it occur alongside more severe abuse.”

“When you’re talking about strangulation, that is very typically the cause of death in domestic violence cases,” Dan Abrams, ABC News chief legal analyst, said in an interview Wednesday on GMA. “It is angry. It is violent. It takes time. That is precisely what many believe happened here.”

Petito’s death was ruled a homicide and the cause is officially listed as “manual strangulation/throttling,” according to the coroner.

Petito’s boyfriend and cross-country traveling companion, Brian Laundrie, has been named by investigators as a person of interest in her death and is the subject of a massive nationwide search being directed by the FBI.

While the search continues for Laundrie, he’s also wanted on charges of bank fraud for allegedly using Petito’s credit card. Experts said the case has shined a spotlight on intimate partner violence and the many forms it can take.

Strangulation is one of the most lethal forms of domestic violence, one that can cause death within minutes, according to the National Domestic Violence Hotline, a 24/7, free and confidential resource.

It is also a predictor for future deadly violence, experts said. A non-fatal strangling in the past by a partner makes the victim 10 times more likely to be killed by them later on, according to the National Domestic Violence Hotline.

“I think people are now starting to appreciate the seriousness of strangulation, both that it’s more frequent than we realize and also that it can be more lethal than we realize,” Kiersten Stewart, director of public policy and advocacy of Futures Without Violence, a nonprofit organization focused on ending violence against women and children, told GMA. “When we train health care providers, strangulation is one of the very specific issues that we talk about to help them recognize it.”

Symptoms of strangulation can range from a sore throat and difficulty swallowing to bruising, memory loss, difficulty breathing and changes in sleep, mood and personality, among others, according to the National Domestic Violence Hotline.

Strangulation in cases of intimate partner violence is often about control, and in non-fatal cases, it may not leave as evident of a mark as other forms of physical abuse, experts said.

Stewart and other experts note that when cases like Petito’s are in the news, though extremely tragic, they can raise awareness about intimate partner violence and the many different forms it may take.

“Domestic violence is still a very serious issue,” said Stewart, noting young people between the ages of 18 and 24 experience the highest rates of domestic violence. “As a country, we have made great progress in the last 25 years, but we haven’t actually reduced homicides nearly as dramatically, and that still needs to be a real focus.”

In his eulogy at his daughter’s funeral last month, Joseph Petito referenced the issue, telling mourners, “If there is a relationship that you’re in that might not be the best thing for you, leave it now. Take care of yourself first.”

Intimate partner violence, which falls under the broader umbrella term of domestic violence, affects more than 12 million people every year, and disproportionately impacts Black and Indigenous women, according to the National Domestic Violence Hotline. It has historically been seen by many as something that happens with older, married couples, or something that involves only physical abuse, like a black eye, the organization said.

In reality, it is something that cuts across all social and demographic lines and can also occur through control and manipulation that is not as easily visible to the outside world, according to Lynch.

“We have these myths or stereotypes in our head of a typical domestic violence abuser and victim, who they are and what they act like, but everybody is at risk,” she said. “People would be very surprised to find out just how prevalent it is and how many people they know who’ve experienced it at some point.”

While acknowledging that not all details of the incident are known, both Lynch and Stewart pointed to body camera footage of Petito and Laundrie being pulled over in Arches National Park in Utah in August after a report of an alleged domestic problem.

The footage showed Petito, who appeared to be crying, at one point sitting in the back of a police vehicle, and Laundrie, at other points, talking to police officers.

Petito told police she suffers from severe anxiety and other medical conditions and that the couple’s argument had been building for days. Police labeled the incident as a “mental/emotional break” rather than a domestic assault, according to the police report.

“I don’t know how much we’re going to know about the relationship and the dynamic between the two of them, but in the video, she seemed frightened and scared,” Lynch said of Petito. “I think across all of these cases [of intimate partner violence], that’s what you’re going to see, someone is intimidated.”

Stewart said she sees in the video fear from Petito, which she calls a red flag.

“You can’t always tell the first time you meet somebody what’s going on,” she said. “But once you’ve started to have a conversation, if you see somebody who’s very much afraid, like, ‘If I were to not do what he wants, what happens?’ that’s often a red flag.”

Abuse in relationships, which data shows is more often, but not always, perpetrated by men, comes down to “power and control,” according to Rosemary Estrada-Rade, director of quality assurance and innovation at the National Domestic Violence Hotline.

“It’s about that pattern of behaviors that are used within relationships to maintain that control over the other partner,” she said. “So it could be physical violence, but a lot of times it’s intimidation, manipulation, emotional abuse, financial abuse and financial control, and that can look different in different relationships.”

Signs that someone may be suffering from intimate partner violence include isolation from family and friends, appearing withdrawn or not like themselves, frequent calls or texts from their partner about where they are and who they’re with and other controlling behaviors, like withholding money or restricting a person’s ability to work, according to Estrada-Rade.

When a case like Petito’s is in the headlines, it can help draw awareness to the issue of intimate partner violence and increase education, experts said.

In Sarasota, Florida, around 30 miles from the town where police say Laundrie was last seen, calls to a local domestic violence shelter have increased 15% over the past month, compared to the same time last year. The shelter’s CEO attributes the increase to both the pandemic and headlines around the Petito case.

“Domestic violence is something that people shy away from, they don’t want to talk about it,” Jessica Hays, president and CEO of Safe Place and Rape Crisis Center in Sarasota, told “GMA.” “I think that anytime that we have an opportunity to talk about how common domestic violence is, and the warning signs and just shine a light on the fact that this is something that affects many, many people and is not the fault of the victim and that there is help and support out there, that’s a really important conversation.”

The National Domestic Violence Hotline has experienced a 46% increase in contacts in the past five years, according to a spokeswoman, who also attributed the yearslong increase in calls to a combination of factors.

“While we can’t say definitively that seeing or hearing about reports of abuse or domestic violence in the media causes an increase in contacts, we do know that news reports and even depictions of tactics of power and control in other media can help survivors recognize that they might be experiencing abuse and that they can reach out to us,” the spokeswoman said.

Experts said that is the most important takeaway, the recognition that there is help out there for everyone touched by intimate partner violence, from those experiencing it to those committing it to those trying to help.

“During this Domestic Violence Awareness Month, we really are encouraging those who feel that they may be in an abusive or controlling relationship to get help, to talk to somebody,” said Stewart. “And also, we really encourage people who may be using violence in their relationships to also reach out for help because that’s really the behavior we need to change.”

If you need help or need help supporting someone else, call the National Domestic Violence Hotline at 1-800-799-7233, or go to thehotline.org. All calls are toll-free and confidential. The hotline is available 24/7 in more than 170 languages.

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What to expect from FDA panel on boosters for Moderna, Johnson & Johnson vaccines

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(WASHINGTON) — An independent FDA advisory panel on Thursday and Friday is set to discuss and vote on whether to authorize Moderna and Johnson & Johnson Covid-19 vaccine boosters for those 18 and older.

The outside experts will also consider new data from the National Institutes of Health on the potential benefits of mixing and matching vaccines for booster shots.

Early results from the highly anticipated NIH study finds that boosting with a shot different from what people got the first time appears to be safe and effective.

The non-peer reviewed study evaluated all three vaccines — Pfizer, Moderna and J&J — finding that no matter the booster, all study participants saw a “substantial” uptick in antibody levels after a booster shot.

Though promising, more research is likely needed on mixing and matching. For now, the FDA and CDC are slated to weigh in on whether to authorize additional booster doses of Moderna and Johnson & Johnson shots for those who received the same original vaccine.

This week’s meetings are the first step in a long process: The FDA itself and the Centers for Disease Control and Prevention would both need to sign off on the panel’s recommendations about who should get boosters and when — and the earliest that could happen is the following Friday, Oct. 22.

On Thursday, the panel will discuss and vote on a potential Moderna booster, and hear presentations from both the company and FDA representatives; Israel’s director of public health health will give a presentation about the results of Pfizer booster shots in that country.

The FDA panel will ask questions and debate the benefits versus risks of a Moderna booster and an initial, non-binding vote on the Moderna booster has been scheduled for Thursday afternoon.

On Friday, the panel will discuss and vote on a Johnson & Johnson booster, in addition to hearing NIH’s presentation on mix and match booster data.

Johnson & Johnson’s posted a summary of its research Wednesday, making the argument for a second shot, same dose, roughly six months after the single-shot vaccine.

An initial, non-binding vote on the Johnson & Johnson booster has been scheduled for Friday afternoon.

Once the FDA advisory panel votes on recommendations for each booster, the FDA itself needs to formally amend the current emergency authorization. FDA career scientists are expected to authorize boosters for Johnson & Johnson and Moderna within days of the independent panel’s non-binding vote.

Then, the question goes to CDC’s independent advisory panel of experts. That panel has scheduled a meeting for next Wednesday Oct. 20 and Thursday Oct. 21 to discuss boosters for Moderna and Johnson & Johnson. Those outside experts will weigh in with their recommendations, which are also non-binding.

Once that happens, CDC Director Rochelle Walensky must sign off, which typically happens within 24 hours of the panel’s recommendations.

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Why experts say monoclonal antibodies aren’t vaccine substitute

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(NEW YORK) — Despite more than 187 million Americans being fully vaccinated against COVID-19 and data and attestations from researchers and public health officials that the vaccines are safe an effective, a small and in some cases vocal minority of Americans are reluctant to get the shot.

The reasons vary, but a number of those people are instead turning to treatments after they are diagnosed that have far less evidence to support their safety and effectiveness, including monoclonal antibodies — a trend that experts say is worrying.

Currently, over 1 million doses of monoclonal antibody infusions have been given in the United States. Use of monoclonal antibodies gained steam during the delta variant surge over the summer when Florida and other states opened clinics to administer the drugs in an attempt to keep sick people out of overwhelmed hospitals.

Monoclonal antibodies have been authorized for post-exposure prophylaxis, meaning they are used shortly after someone tests positive in order to prevent progression to severe disease. The antibodies range in effectiveness depending on type, but some have been shown in to reduce COVID-related hospitalization or death by up to 85%.

COVID-19 vaccines have been tested in large clinical trials with hundreds of thousands of people. The CDC says over 215 million people have safely received at least one dose of a COVID-19 vaccine, including 187 million who have been fully vaccinated, either with the one-dose Johnson & Johnson shot, or two dose mRNA vaccines.

All three COVID-19 vaccines have gone through the most intensive safety monitoring in U.S. history by government agencies, fully independent safety monitoring boards, vaccine manufacturers and academic researchers. The Pfizer COVID vaccine is currently FDA authorized for people 12 and older. The Moderna and Johnson & Johnson vaccines are authorized for those 18 and up.

Common side effects of the COVID-19 vaccine include pain or swelling at the injection site. Fever, muscle aches, chills, fatigue or headaches can also occur but should go away within a few days. More serious health problems, such as unusual heart rhythm or blood clots, are exceedingly rare — and in fact, are more likely to happen to an unvaccinated person who becomes sick with COVID-19 than with the vaccine itself.

‘More concerned with treatment rather than prevention’

Many vaccine holdouts in the U.S. have cited the vaccines’ emergency use authorization status — a special FDA pathway helps accelerate the often-slow regulatory process during a national emergency. Pfizer’s vaccine is now fully FDA approved for people 16 and older, while Moderna and Johnson & Johnson are still under emergency authorization, awaiting approval.

However, some experts interviewed by ABC news say some patients who won’t get vaccinated also ask for monoclonal antibody treatment after the are diagnosed with COVID, which has the same emergency use authorization. Doctors say they are perplexed about why some people pursue monoclonal antibody treatment which is supposed to reduce the risk of hospitalization in high-risk vulnerable people instead of prevention.

“People are more concerned with treatment rather than prevention,” said Rupali Limaye, Ph.D., the director of behavioral and implementation science for the International Vaccine Access Center at Johns Hopkins School of Public Health.

“When they are in the hospital and needing COVID treatment, their options are limited — but they know they need treatment to fight COVID. Decision-making is very different related to preventative behaviors,” said Limaye.

What to know about monoclonal antibodies

The FDA has granted emergency authorization status to four antibody treatments for COVID-19. These antibody treatments are most helpful in mild to moderate disease. Not all antibody treatments are equally effective, and some have lost their potency in the face of new COVID-19 variants.

According to the FDA, monoclonal antibodies are laboratory-made proteins designed to mimic the immune system’s ability to fight disease particles known as antigens. For example, sotrovimab is a monoclonal antibody that prevents COVID-19 infection by blocking the virus’ spike protein.

The data supporting these antibodies is much more limited than the extensive data supporting currently approved and authorized vaccines.

“Monoclonal antibodies are an important treatment option for high-risk patients. However, the idea that they can be used as a prevention tool is severely misguided,” said Dr. Andrew Pavia, Infectious Diseases Society of America fellow, NIH COVID treatment guidelines panel member and chief of pediatric infectious diseases at the University of Utah School of Medicine.

“They are no substitute for cheap and effective prevention tools like masks and vaccines,” said Pavia.

Other COVID treatments under EUA include tocilizumab, a monoclonal antibody that is not directed toward the virus but instead reduces inflammation in already hospitalized patients. Remdesivir, an anti-viral, is FDA approved for hospitalized patients over 12 but under EUA for kids less than 12.

All of these treatments require an infusion and a trip to a medical center. Now, pharmaceutical companies are also working on easy-to-prescribe pills that can ease symptoms for people who are already sick, but doctors stress these are also not a replacement for a vaccine that can help prevent disease in the first place.

Ways to boost vaccination

Doctors interviewed by ABC News say their patients want an easy solution that will protect them from COVID-19. For most, that’s a vaccine. For others, misinformation surrounding vaccines can stand in the way, prompting them to seek alternatives.

“Hesitancy falls on a continuum. That means that those that are hesitant may refuse some vaccines, may accept vaccines but be unsure about the decision or may have concerns. There are validated scales that measure attitudes related to safety, efficacy, past vaccine behavior and vaccine intentions.” said Limaye.

The CDC suggests providers ask vaccine-hesitant patients a scaled question, for example, “On a scale of 1 to 10, how likely are you to get the COVID vaccine? (1 = never and 10 = vaccine appointment is already set).” The goal is to help patients become more aware and move toward higher numbers on the scale.

For example, if a patient says that they are a three on the scale, providers can ask why and why not a lower number? This helps patients to reiterate the benefit of vaccines instead of explaining why they have not gotten it. Providers can then further follow up by asking, “What would help to go to a four or a five?”

While there are many successful ways to talk to people about the COVID vaccine — all methods center around a common theme of empathy, curiosity and open communication to help end the pandemic.

ABC News’ Sony Salzman contributed to this report.

Jess Dawson, M.D., a Master of Public Health candidate at Johns Hopkins Bloomberg School of Public Health, is a contributor to the ABC News Medical Unit.

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Woman who struggled for months with weight gain diagnosed with 17-pound cancerous tumor

Courtesy of Amanda Shoultz

(DALLAS) — Amanda Shoultz said she spent most of the past year trying to lose weight after noticing that her stomach kept getting bigger.

“I started working out more. I was dieting more and, oddly enough, I was losing weight but I was gaining inches in my stomach,” Shoultz, 29, told Good Morning America. “For the longest time, I thought, ‘Oh, I just must gain weight in my stomach.'”

When Shoultz, of Dallas, Texas, went to her annual checkup with her primary care physician in February, she said she was shocked at the number she saw on the scale.

“I remember telling her, ‘The next time you see me I’m going to be 10 pounds lighter,'” said Shoultz. “I just assumed it was my fault. That I had done something wrong.”

Shoultz’s blood work from her doctor’s appointment came back normal, so she said she kept changing her diet to see if she had an allergy that was causing her stomach to bloat.

“I gave up all dairy products because I thought it was a lactose allergy, and nothing changed. Then I gave up gluten. I love bread but I was willing to do anything,” she said. “That didn’t work so then I gave up meat. None of that helped.”

Shoultz said she did not feel any pain beyond the discomfort of her stomach getting so much bigger than usual.

By August, nearly eight months after first noticing the growth, Shoultz was referred to a gastroenterologist by a colleague at Baylor Scott & White Heart and Vascular Hospital, where she works in public relations.

“By the time I saw my GI [gastroenterologist] doctor, my stomach was hard as a rock,” she said. “My mom said you could have punched me in my stomach and broken your hand it was so hard.”

After several tests that did not find anything definitively wrong, Shoultz underwent a CT scan in late September.

“About four hours later, I got a call from my doctor who told me I had a 33-centimeter tumor in my abdomen,” she recalled. “And within two days of that, I was already meeting with the surgeon.”

Doctors discovered that Shoultz’s tumor was cancerous. She was diagnosed with liposarcoma, a rare form of tumor that, in most cases, does not present any symptoms until the tumor grows large and invades other organs or tissues, according to the National Institutes of Health (NIH).

In Shoultz’s case, the tumor had formed around her right kidney and adrenal gland, but she experienced no symptoms to indicate that cancer was growing inside her.

“I’m 29 and otherwise perfectly healthy,” she said. “I had no other symptoms other than my stomach.”

On Sept. 27, Shoultz underwent a two-hour surgery to remove the tumor, which doctors discovered upon removal weighed 17 pounds.

Doctors also had to remove Shoultz’s right kidney and part of her adrenal gland. Because the cancer had not spread to other parts of her body, she did not have to undergo further treatment, like chemotherapy or radiation.

“Once I left the hospital, my stomach was back to normal,” said Shoultz. “Now I’m just eating all the food that I missed when I gave it up for a year in order to put some weight back on.”

Shoultz said she is sharing her story publicly because she wants other people, particularly women, to know the importance of knowing and listening to their own bodies.

“I knew that something was wrong because I’ve always had a hard time gaining weight,” said Shoultz. “When I was getting so large in my abdomen and I couldn’t control it, that’s when I knew something was off.”

“We preach it at the hospital, don’t die of doubt,” she said. “No one else is going to need to fight for you, so fight for yourself and find a care team that is going to care for you through the journey.”

It’s a message echoed by Dr. Robert Mennel, an oncologist with Texas Oncology at Baylor University Medical Center in Dallas, who is treating Shoultz.

“There is a whole group of these sarcomas that tend to occur in younger people and a lot of times they have symptoms that are sort of very nondescript symptoms,” he said. “If somebody comes in and they have some abdominal discomfort and it’s somebody who’s in their 20s or so, most physicians think that’s probably not much and it will pass.”

“We can’t do scans on everybody, but if you really feel that something is wrong, just be persistent to get this evaluated,” added Mennel. “And make sure you’re going to somebody who has experience and really knows what they’re doing.”

“The takeaway would be that if you feel that something is not correct, see a physician or health care provider to let them evaluate it,” he said. “And if you really feel that they’re not evaluating it, or if you really feel that something’s wrong, pursue your desire to get it looked at and worked up.”

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FDA recommends restaurants, food manufacturers cut back on use of salt

iStock/alvarez

(NEW YORK) — The U.S. Food and Drug Administration has released sweeping new guidance for the food industry to voluntarily reduce sodium in processed, packaged and prepared foods in an attempt to reduce Americans’ consumption.

“The FDA is issuing a final guidance, ‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,’ which provides voluntary short-term sodium reduction targets for food manufacturers, chain restaurants and foodservice operators for 163 categories of processed, packaged and prepared foods,” the agency announced.

Acting FDA Commissioner Dr. Janet Woodcock lauded the new sodium reduction guidance in a press conference Wednesday morning. She said it is a “critical step” in improving Americans’ nutrition, reducing the burden of diet-related chronic diseases and advancing health equity, predicting the effort would “become one of the most significant public health nutrition interventions in a generation.”

The guidance is intended to provide measurable voluntary short-term goals over the next two and a half years to reduce excess sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.

ABC News chief medical correspondent Dr. Jennifer Ashton said the news from Woodcock and Susan T. Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, is “really targeting the food industry.”

The current salt intake recommendation of 3,000 milligrams per day is now set to a goal of 2,300 milligrams a day over the next two and a half years.

“Right now, it is clear that diet is a major contributing factor to not only our obesity, but high blood pressure, which, of course, then increases the risk for heart attack [and] strokes,” Ashton said.

Woodcock voiced hope that this voluntary guidance that targets the food industry itself — rather than leaving the onus on individuals — will help level the playing field for Americans who may not be well-equipped to police their nutrition alone, especially with sparse healthy food options in food deserts and due to some healthier food options being cost-prohibitive for lower-income families.

“The problem is so cumulative — it’s the tomato sauce, the cheese, the bread, the salad dressing, and pretty soon your whole meal has hidden salt in it. And it’s really hard right now for people to manage that on their own,” Woodcock said. “Most of the salt in the diet, the sodium in the diet, it comes from processed or packaged or prepared foods — not from the saltshaker.”

“Sodium is widely present in the American diet (most commonly, but not exclusively, as a result of eating or drinking foods to which sodium chloride, commonly referred to as “salt,” has been added),” according to the FDA. “More than 70% of total sodium intake is from sodium added during food manufacturing and commercial food preparation.”

During the same press conference, Health and Human Services Secretary Xavier Becerra underscored Woodcock’s point that neglecting to address sodium consumption would carry high human and economic costs. He added that the COVID pandemic has shown the importance of taking better care of one’s health.

“The pandemic has graphically illustrated why today’s announcement is so important and why it’s so important that we take care of our health,” Becerra said, adding the consequences of Americans’ sky-high sodium intake could be “catastrophic personally and for the country.”

Mayne said that this issue impacts all age groups with “more than 95% of children age two to 13 who exceed recommended sodium limits for their age groups — even baby food — which carries long-term ramifications for children’s health and development,” she said.

But being that this is voluntary, truly capping sodium intake effectively will require a groundswell of both industry cooperation and consumer demand to help drive the initiative.

When asked whether there would need to be more teeth behind such policy, Woodcock said the government would monitor the impact of this current guidance over time, pointing to the importance of public support.

“If we don’t see success, then we’re going to have to evaluate what else we should do,” Woodcock said, without ruling out the idea of further, more stringent future measures.

“We have a plan to monitor and then to ratchet it further down, and what we learn over the next several years will tell us what magnitude of steps we can take,” Woodcock said. She acknowledged that “this change won’t happen overnight” and will require “an iterative approach that supports gradual reduction in sodium levels, broadly across the food supply, over time.”

 

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