ABC - Health News

(WASHINGTON) -- The U.S. Food and Drug Administration on Wednesday authorized COVID-19 boosters for millions more Americans, giving a green light for third shots to Moderna and Johnson & Johnson recipients.

The FDA also said it will allow people eligible for a booster to mix and match doses. So no matter which shots you initially received, you can choose your preferred brand for a third shot.

The FDA decision paves the way for the Centers for Disease Control and Prevention to make an official recommendation to the public. An independent advisory committee to the CDC planned to meet Thursday with a final agency decision expected by the end of the week.

Dr. Peter Marks, a top FDA official, said allowing people to mix boosters makes sense, particularly when people might not remember what brand they initially received.

"Most people don't know what brand flu vaccine they received. And although they're somewhat more standardized, perhaps, this is something that is probably a good next step for us to be able to have the flexibility that people can get vaccinated easily," he told reporters.

Under the new rules, if the CDC signs off, Moderna recipients would qualify for a booster shot of their choice if they are older than 65 or younger with medical conditions or a high-risk job. The FDA and CDC had already cleared Pfizer recipients to get a third shot, and now they too can choose which brand booster they want.

Marks confirmed the agency is looking at whether to lower the age of boosters for Moderna or Pfizer recipients. But he said the situation is "very dynamic" and has to be data driven.

The news was considered particularly welcome by those who had gotten the single shot of J&J, which was shown to be only 70% effective against moderate to severe symptoms. That effectiveness climbed to 94% with two doses, prompting the FDA to allow for boosters for anyone 18 and older two months after their last shot.

"That is great news," Rose Tamberino of Hudson Valley, New York, who had gotten the J&J shot, told ABC News.

After losing her brother-in-law to COVID-19 in 2020, Tamberino was among the 15 million Americans who got the one-shot dose.

But she grew increasingly nervous this summer with the arrival of the delta variant and after hearing reports that J&J was less effective and testing her own antibodies with low results.

Six days ago, frustrated that Washington hadn't acted, she took matters into her own hands. After being turned down from a medical facility because she was already considered vaccinated -- and the FDA hadn't acted yet -- she went to a pharmacy and lied. She omitted details of her past J&J shot and got a Pfizer dose.

After going rogue, her vaccine record will now be consistent with federal recommendations.

"I'm just such a by-the-book person so for me to do something like this was really out of my comfort zone, you know?" she told ABC News in an interview.

"For me to take this upon myself and just go against what the government was doing at the time, felt really strange for me," she added. "But I felt better doing it than not though, because I just wanted to be protected."

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Good Morning America

(NEW YORK) -- One day after making a surprise revelation on live television that he has multiple sclerosis , CNN anchor John King said he hopes his openness inspires people to take precautions against COVID-19 seriously.

"I'm not supposed to be part of the story, I'm supposed to cover stories," King said Wednesday on "Good Morning America, adding, "If my personal experience can help anybody or help people understand, again, that the person next to you, you may not know, on the subway, or on the bus, in a coffee shop might need your help and you can do a couple easy things to make them feel safer, if I can help with that, then so be it."

The "Inside Politics" host opened up about his own MS battle Tuesday during a segment in which COVID-19 vaccine mandates were discussed, following the death of former secretary of state Colin Powell, who died Monday morning due to complications from COVID-19.

Powell, who was fully vaccinated, was being treated for multiple myeloma, which compromises the immune system. He had also been diagnosed with Parkinson's disease, according to his spokesperson.

"I'm going to share a secret I have never spoken before. I am immunocompromised," King said on his show. "I have multiple sclerosis. So I am grateful you are all vaccinated. I am grateful my employer says all of these amazing people who work on the floor, who came in here in the last 18 months when we are doing this, are vaccinated now that we have vaccines. I worry about bringing it home to my 10-year-old son who can't get a vaccine. I don't like the government telling me what to do. I don't like my boss telling me what to do. In this case, it's important."

King, 58, who is CNN's chief national correspondent, told "GMA" that he had not planned to reveal his MS diagnosis live on-air, but felt compelled in order to help combat what he called "reckless and dangerous" rhetoric around COVID-19 vaccines and other safety measures.

"We should be willing to do hard things to help other people," he said. "Rolling up your sleeves and getting a safe vaccine is easy. Putting on a mask in a crowded place is easy. So why can't we do the easy things?"

"These steps are easy and they could help a friend or a neighbor or a stranger get through the day," King added.

Currently, just 66.8% of Americans ages 12 and up are fully vaccinated against COVID-19, according to data from the Centers for Disease Control and Prevention.

King said he has taken extra safety precautions himself during the pandemic, for his own health but also to protect his family, including his 10-year-old son, who is currently too young to receive a COVID-19 vaccine.

Studies have shown vaccinated individuals are significantly less likely to spread coronavirus to family members within a household, National Institutes of Health director Frances Collins wrote in a blog post Tuesday on the safety of the vaccines.

In addition to being fully vaccinated, the CNN anchor said he also received a vaccine booster shot.

"I don't like being told what to do. I don't want my employer telling me you have to get a vaccine. I don't want the government telling me I have to do things, but this is bigger than that," he said. "Moments in American history when we're all challenged, when we're all at risk, we're supposed to come together and set the politics stuff aside and just love thy neighbor, protect thy neighbor."

King said he has relapsing-remitting MS, which is the most common disease course, according to the National Multiple Sclerosis Society.

He said he takes medication to slow the progression of the disease and considers himself "lucky," but still faces days where the MS is "very frustrating."

"Today I'm having a problem with my hands. I have not been able to really have full sensation in my legs since late in the Clinton administration," he said, noting that his MS diagnosis came several years later. "There are some days this knocks me on my you know what, there are other days it's just a little nagging."

"But it has made me stronger. I hope, I certainly hope it has made me a better person," King continued. "And it's made me aware, again, that a lot of these symptoms, a lot of the stress people are going through is hidden. You cannot see it, but we should just be aware that it's out there."

Copyright © 2021, ABC Audio. All rights reserved.


Bill Oxford/iStock

(NEW YORK) -- For Mitchell Kronenberg, answers on the Johnson & Johnson vaccine can't come soon enough.

A 42-year-old dad living outside Charlotte, North Carolina, Kronenberg enrolled in a clinical trial for the single-dose vaccine and got his shot last January. Since then, he's been patiently waiting for U.S. federal regulators to tell him what to do next to stay safe: Should he get another Johnson & Johnson shot? Switch to Moderna or Pfizer? Is his single-shot vaccination enough to protect him from spreading the virus to his unvaccinated 4-year-old son?

"Why is it taking so long? You have people out on a ledge out here," he said of the process.

The U.S. Food and Drug Administration is expected to decide as early as Wednesday whether the 15 million Americans who got the single-dose J&J shot by Janssen Pharmaceutical Companies should get a second dose. The decision comes after studies suggested effectiveness against moderate and severe symptoms climbed from 70% with one dose to 94% with two doses.

Also anticipated is a decision on possible third booster shots for Moderna recipients and whether Americans can mix vaccine brands when getting a booster.

With a decision expected soon, an advisory panel to the Centers for Disease Control and Prevention planned to meet Thursday to offer the public a final recommendation.

Typically a wonky endeavor ignored by most Americans, the FDA and CDC regulatory process is now being closely followed by millions of Americans. People describe joining private Facebook groups to swap the latest research and repeatedly getting their antibody levels checked, even if experts warn it's an incomplete measure of a person's immunity.

Some have even opted to mix booster shots on their own even without the federal government's blessing.

"Every day, I was researching, Googling, reading everything I could get my hands on," said Lynne Conway, a 59-year-old development officer for an animal shelter in Ithica, New York.

Conway said she experienced mild heart inflammation following her first dose of Moderna last March. After ruling out other causes, her doctor recommended she get the J&J so she can be fully protected against COVID-19. She got that shot in August, despite there being no official green light from regulators to mix shots in such a way.

"The relief of finally deciding to get the (J&J) vaccine, and have it over with, was monumental," she said.

J&J recipients are among those who expressed being most on edge emotionally, with the 70% effectiveness after one shot -- lower than the two doses of Pfizer or Moderna.

Jadzia Pierce, who lives outside of Washington, D.C., said she was relieved regulators were inching toward a decision. In her early 30s, Pierce isn't at serious risk of major complications from COVID-19.

But she also would like to visit higher-risk relatives this holiday season and to know she's not at risk of infecting them.

"Even if the answer is (that it puts) other people around at risk, then I guess I just won't go home," she said. "I just feel like safety is the most important thing at this point and that's really all that matters to me."

J&J declined to comment for this article, citing pending action by regulators. But last Friday, after a meeting of FDA advisors, a top company official told ABC News the J&J vaccine likely protects people by triggering the protection of a person's T-cells, which is harder to measure than antibodies.

J&J's "biggest, most impressive components are T-cells, which contribute to both efficacy and durability of our vaccine," said Mathai Mammen, global head of R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson.

For its part, the FDA says its staff is working around the clock to comb through technical data. The CDC too has to hear from its own advisory panel before making a decision.

Kronenberg, who has to travel for work as a director for a medical device company, said he still worries about spreading the virus to his son. He says he understands wanting to get it right but wishes the various agencies could get in a room together and hash it out immediately, rather convene separate meetings and reviews that can drag on for weeks.

Pierce, also in limbo having received the J&J, said she's torn on whether to be frustrated with the regulatory bureaucracy.

"I'm trying to be patient. I do realize that this stuff takes time, and I don't want to be following advice that is too rushed and not complete," she said.

ABC News' Sony Salzman contributed to this report.

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(NEW YORK) -- Getting a COVID-19 vaccine isn't just about protecting yourself, it goes a long way toward protecting your family, according to a new blog post by the director of the National Institutes of Health.

Dr. Francis Collins also noted in his Tuesday post that the data shows adults getting vaccinated helps protect those who can't get vaccines, especially children.

"This is a chance to love your family -- and love your neighbor," Collins wrote.

Collins reiterated that studies have shown vaccinated individuals are significantly less likely to spread coronavirus to family members within a household. He cited a Swedish study published in JAMA Internal Medicine Journal last week that looked at 1.8 million people from more than 800,000 families "who acquired immunity from either previous COVID-19 infection or full vaccination."

"The data show," Collins wrote, "that people without any immunity against COVID-19 were at considerably lower risk of infection and hospitalization when other members of their family had immunity, either from a natural infection or vaccination."

Specifically, the study found that households with one immune family member had a 45% to 61% lower risk of a COVID-19 infection, and that when a household included two immune family members the risk dropped 75% to 86%. With three or more immune family members, the risk of infection dropped almost 97%.

"These results show quite clearly that vaccines offer protection for individuals who lack immunity, with important implications for finally ending this pandemic," Collins wrote.

Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and an ABC News contributor, said Collins' message is important because there needs to be more emphasis on how getting a vaccination is an altruistic act for the entire community.

"We get a lot of focus on individual risk and side effects, and it takes our eye off the ball for the real reason we can and want the population to get inoculated," he said.

MORE: COVID-19 vaccine shots for kids under 12 may be available in November: 6 things to know
Brownstein said it's imperative that every eligible person gets vaccine shots as soon as possible since it may take a while for tens of millions of American children to be fully protected.

"Vaccines create a cocoon that ultimately protects those who aren't eligible," he added.

Anyone who needs help scheduling a free vaccine appointment can log onto

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(NEW YORK) -- The death of former Secretary of State Colin Powell due to COVID-19 complications has sparked conversations about breakthrough deaths among vaccinated individuals.

It would be inaccurate, however, to jump to any conclusions about vaccine effectiveness from a single breakthrough death such as Powell's, who was 84 years old, immunocompromised and being treated for multiple myeloma, a blood-borne cancer that "in and of itself can lead to compromised immunity," Dr. Todd Ellerin, director of infectious diseases at the South Shore Medical Center in Massachusetts, told ABC News.

In a statement, Dr. Paul Richardson, the director of clinical research at the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, said myeloma patients are "not only vulnerable to infection but once infected, they are more prone to serious complications including vascular effects and profound immune dysfunction."

Dr. Craig Devoe, chief of medical oncology and hematology at Northwell Health in New York, said that myeloma doesn't just put patients at a higher risk of severe illness but could have also put their immune system at a disadvantage for fighting off COVID-19 even when fully vaccinated “because both the disease and the treatment itself are highly immunosuppressive.”

According to his spokesperson, Powell was fully vaccinated and was being treated for myeloma, which is not curable. He had also recently been diagnosed with Parkinson's disease, which can itself be debilitating depending on the stage.

According to the Centers for Disease Control and Prevention, there have been roughly 7,000 breakthrough deaths among the 187 million vaccinated Americans, with more than 6,000 over the age of 65 in contrast to the more than 700,000 COVID-19 deaths among the unvaccinated.

"Without question, we can expect deaths," Ellerin said. "It is much more common in those unvaccinated than vaccinated. But we are seeing breakthrough vaccine deaths, especially in the elderly -- patients in their 80s and older -- or those who are immunocompromised."

No one who receives a COVID-19 vaccine is 100% protected from death, but the vaccines have shown to be extremely effective at lowering the risk of getting the disease.

The CDC recently updated its website with data illustrating the fact that vaccines are still dramatically reducing the risk of testing positive or dying of COVID-19 amid the latest delta surge. While there has been a slight uptick in COVID-19 cases and deaths since July 2021, the increase is more pronounced among unvaccinated individuals.

In August, unvaccinated people were 6.1 times more at risk of testing positive for COVID-19 and 11.3 times more likely to die from COVID-19 compared to vaccinated individuals, according to federal data pulled from 16 states and jurisdictions.

"[A breakthrough vaccine death] is not an argument for 'don't get your vaccine,'" Ellerin said. "That is an argument for 'get your vaccine because that's the best way of reducing your likelihood of death.'"

Additionally, when broken down by age, death rates in every age group were higher among the unvaccinated populations. Older Americans (80+) had the highest rate of deaths among fully vaccinated people per capita, though their risk of death was about 5.7 times lower than their unvaccinated counterparts in the same age group.

Among the breakthrough deaths, the U.S. is currently seeing what Ellerin labels "a precarious triangle" of risk factors -- old age, underlying diseases that lead to immunocompromisation and treatments for those diseases -- which make individuals more susceptible to severe COVID-19 infection.

Vaccinated people who fall into the intersection of these risk areas should also prioritize non-pharmaceutical interventions, such as masking when indoors and optimizing ventilation, experts say.

Dr. Edward Stadtmauer, director of the myeloma program at the University of Pennsylvania, told ABC News that the best way for cancer patients to prevent COVID-19 infection or limit its severity is to get vaccinated.

"If you have abnormal plasma cells to begin with or are getting therapy that might suppress or damage plasma cells, you can see why that this group of patients may have the most difficulty responding to a COVID infection and responding to vaccines," he said.

Stadtmauer said he is seeing about 70% of patients with myeloma generate COVID-19 neutralizing antibodies after vaccination.

“If there is any group of patients who should be vaccinated and get a booster, it is this group of patients,” he said.

The Food and Drug Administration on Sept. 22 authorized Pfizer COVID-19 vaccine boosters for people 65 years and older and those at risk. Powell himself was due for the booster shot the same week he fell ill with COVID-19, his spokesperson said.

"None of these are perfect strategies, but you have the best chance of survival," Ellerin said.

The misuse of the news of Powell's death to spread misinformation about vaccine failure and discourage individuals from getting vaccinated can be harmful to those immunocompromised, according to experts, who say that in order to protect those with underlying diseases, it is imperative that everyone around them gets vaccinated to curb the spread of COVID-19.

"Hopefully his life and the fact that he believed in vaccination can be a catalyst for many others to get it," Ellerin said.


Copyright © 2021, ABC Audio. All rights reserved.


Chaz Bharj/iStock

(WASHINGTON) -- Recipients of the single-dose Johnson & Johnson coronavirus vaccine should not be concerned about the shot's lower efficacy now that boosters have been recommended, White House chief medical adviser Dr. Anthony Fauci told ABC This Week co-anchor Martha Raddatz.

"I think that they should feel good about it because what the advisers to the FDA felt is that given the data that they saw, very likely this should have been a two-dose vaccine to begin with," he said Sunday.

The FDA vaccine advisory panel unanimously recommended booster shots for the Johnson & Johnson vaccine Friday. The panel recommended all J&J recipients 18 years and older to get an additional jab as early as two months after the first dose -- key differences from their recommendations for the Moderna and Pfizer boosters which were only for Americans 65 and older or in higher risk groups.

The decision came days after early data released from a National Institutes of Health study found that boosting with a different shot than one's original vaccine appears to be safe and effective. The data, which is not yet peer reviewed, also found that for J&J recipients, antibody levels were higher if they received a Moderna or Pfizer booster rather than a J&J booster.

Raddatz pressed Fauci on whether mixing and matching vaccine boosters for J&J recipients would be a better idea.

“But, Dr. Fauci, the panel was also looking at new data that suggest J&J recipients may be better off getting a booster shot from the more effective Pfizer or Moderna vaccine. Is that a better solution?" Raddatz asked.

“That is true, the data you refer to, that if you boost people who have originally received J&J with either Moderna or Pfizer, the level of antibodies that you induce in them is much higher than if you boost them with the original J&J,” Fauci said.

He went on, “However, you’re talking about laboratory data, which very often are reflective of what you would see clinically. But the data of boosting the J&J first dose with a J&J second dose is based on clinical data. So what’s going to happen is that the FDA is going to look at all those data, look at the comparison and make a determination of what they will authorize.”

Fauci added that the FDA and Centers for Disease Control and Prevention will give people the flexibility to mix and match vaccine boosters based on their individual health situations.

Now that the FDA has recommended J&J boosters for a wider group of Americans, the question turns to when Moderna and Pfizer boosters will be expanded to the general public.

Fauci said that will depend on the data being collected by the CDC and the findings coming in from Israel, which is about a month ahead of the U.S. in its vaccine rollout.

As for vaccines for children ages 5-11, Fauci said the FDA is on track to approve the Pfizer vaccine in early November.

With kids eager to go trick-or-treating and the holidays right around the corner, Raddatz also asked Fauci about his guidance for celebrating the upcoming holidays.

“I believe strongly that -- particularly in the vaccinated people, if you’re vaccinated and your family members are vaccinated, those who are eligible, that is obviously very young children are not yet eligible, that you can enjoy the holidays,” he said. “You can enjoy Halloween, trick-or-treating and certainly Thanksgiving with your family and Christmas with your family.”

Copyright © 2021, ABC Audio. All rights reserved.


Courtesy Christine Kump

(CHANNAHON, Ill.) -- Christine Kump, of Channahon, Illinois, was newly pregnant with her second child late last year when she felt a lump in her breast.

She said it was in the same spot as a lump she had developed when she breastfed her now 3-year-old daughter, so she brushed it off as leftover scar tissue.

"When you Google it, it says it could be breast cancer, but most likely scar tissue," Kump, 34, told Good Morning America. "I thought there's no way I have breast cancer."

Kump underwent IVF to get pregnant with her second child, so she also attributed the soreness she felt in her breast to side effects from the treatment. When the soreness continued and a burning sensation developed though, Kump went to see her primary care doctor.

"The doctor sent me to do an ultrasound but she wasn't super concerned," said Kump. "A few weeks later I went for the ultrasound and then they had me do a biopsy, which I did on Christmas Eve."

A few days after the biopsy, on Dec. 29, 2020, Kump said her doctor called and told her she had Stage 3 invasive ductal carcinoma breast cancer.

"I was worried that I wasn't going to make it through the pregnancy," said Kump, who was eight weeks pregnant when she was diagnosed. "I was thinking I was going to have to write letters to my [3-year-old] daughter Susie for all of her milestones because I wasn't going to be there."

Because Kump had a history of cancer in her family, she underwent genetic testing and tested positive for the BRCA1 gene mutation, meaning she was at an increased risk for breast and ovarian cancers.

About 1 in every 500 women in the United States has a mutation in either her BRCA1 or BRCA2 gene, according to the Centers for Disease Control and Prevention (CDC).

Because of her genetic background and because her cancer was so advanced, Kump began chemotherapy once she entered her second trimester of pregnancy, a time that doctors say is safer because the baby's organs are more developed.

Kump was in the middle of her chemotherapy treatments in May, when she went into early labor.

She gave birth to her daughter, Vivian, on May 30, 2021, about three months before her August due date.

"She decided to show up super early," Kump said of her daughter, who weighed 2 pounds, 10 ounces at birth and faced complications that come from premature birth. "She was intubated for six days and then was on oxygen until she could breathe on her own."

Vivian would go on to spend the next 59 days in the neonatal intensive care unit, which was 10 minutes away from the cancer center where Kump received treatment.

"My husband and I were the only ones who were allowed to see her in the NICU," said Kump, adding that she would go from receiving chemotherapy in the morning to visiting her daughter in the afternoon. "The NICU was the safest place for me to be because it was so clean."

Kump continued on with chemotherapy after giving birth, completing 16 rounds in all. She finished her last treatment in August, shortly after bringing Vivian home from the NICU.

In September, Kump underwent a bilateral mastectomy.

She will next have to undergo nearly six weeks of radiation treatment, and then will undergo a hysterectomy in January since the BRCA1 gene mutation puts her at a higher risk of ovarian cancer.

Kump said she is sharing her story publicly to both raise awareness of breast cancer during pregnancy, and to encourage women to listen to their bodies and seek help if something feels off.

Breast cancer is found in about 1 in every 3,000 pregnant people, according to the American Cancer Society.

"I was taken very seriously and was diagnosed on the first time, but a lot of women are told it's just an infection, or it's something from breastfeeding," said Kump, who, at 34, was six years below the recommended age of 40 to start annual mammograms. "If you think something is a little off, call your doctor, and if you don't like the response you get from one provider, get a second opinion. It's so important that we advocate for ourselves."

It's a message echoed by Dr. Mary Ahn, Kump's breast cancer surgeon at Northwestern Medicine.

"If you're pregnant and see changes in the breast, the majority of time it is pregnancy-related, but if there is something that feels unusual, get it evaluated. It's better to be cautious," she said. "We have be our own advocates, be aware of our bodies and, if there are any questions, address them with a medical professional."

Copyright © 2021, ABC Audio. All rights reserved.


Courtesy the Brannigan Family

(NEW YORK) -- One dad is going the extra mile for his daughter -- literally.

Chris Brannigan, 41, from England, is currently walking 1,200 miles barefoot from Maine to North Carolina in order to fund research on gene therapy for his daughter Hasti, 9, who has a rare genetic disorder called Cornelia de Lange syndrome.

Although the exact number of cases is unknown, the CdLS Foundation estimates that CdLS occurs in 1 in 10,000 live births.

"If you have a rare disease you don't have the same treatment options or the same quality of healthcare so parents like us have to fight endlessly," Brannigan told "Good Morning America." "The sad truth is there's just no money for rare disease research so it's left to families like ours to undertake these fundraising campaigns just so we can get treatments for our kids."

The disorder affects a person's growth and development, and symptoms include seizures, gastrointestinal problems, autistic-like behavior, heart defects, hearing loss, myopia, and body malformations and other abnormalities.

As a child gets older, more serious symptoms such as anxiety and self-injurious behavior may appear. The CdLS Foundation found that self-injurious behavior occurs in 60% of children and adults with the disorder.

"It gets worse over time," Brannigan said. "For my wife and I, that was really frightening."

After Hasti was born, Brannigan said he and his wife, Hengameh, "knew straightaway something was wrong."

"She looked unhealthy to us," he said. "She was jittery. She was underweight. When we got her home from the hospital, she had a seizure within the first 24 hours."

Many of Hasti’s developmental milestones were delayed. Brannigan said she didn't walk until she was almost 2 years old and didn't feed voluntarily for the first year of her life.

"There were so many indications but the diagnostic odyssey in the rare diseases world is so long and painful," he said.

At age 4, Hasti had blood tests done to check for CdLS but the results came back negative, much to the family's relief.

"I sort of did a little jump for joy because we knew how difficult a condition it was, having researched it after speaking to the doctor," Brannigan said.

To figure out what could be wrong, Hasti was then enrolled in the 100,000 Genomes Project in the U.K., where they sequenced her genome and looked for common gene errors or mutations. The project took two years, Brannigan said, and the new results showed that she did actually have CdLS.

To manage the disorder, Hasti receives a number of daily treatments, such as hormone replacement therapy via injections and speech and language therapy.

"The cycle of therapies and medical appointments is just never-ending,” Brannigan said.

The fact that CdLS is a rare disease means not much is known about it and how to treat it, which is why Brannigan said he and his wife have had to become experts on the disorder.

"If your child has something terrible like cancer, doctors know what to do because they're well-practiced in those things," he said. "But if your child has a rare disease, they just don't know and that causes a lot of anxiety for parents."

He added, "Parents have to be experts because no one else is."

The reality of having a rare disease

After Hasti received her initial diagnosis, Brannigan said he and his wife reached out to numerous doctors around the world to ask them to take a look at gene therapy as a way to help manage the disorder.

"Through online research we came to realize that other rare conditions like spinal muscular atrophy were achieving gene therapies that were transforming children's lives," he said, adding that several medical professionals said they would be willing to look into it but it would take “a lot of time” and “cost huge sums of money.”

"When we realized something could be done, we were presented with a question, which was: 'Do we do this? Do we throw everything we have at our disposal at creating a therapy for Hasti and all the other kids with CdLS? Or do we consciously not do that?'" he said. "As parents I don't think there's any other choice you can make. You can't choose to not help your child."

The family created the charity, Hope for Hasti, in order to raise the money for research into CdLS gene therapy. After consulting doctors and researchers on how much would be needed to fund the research, they set a $3 million target.

"Raising money has been incredibly hard through the pandemic so my wife and I decided that we should run a fundraising event that would help focus people on not just fundraising but also how difficult it is to manage the life of a child with a rare disease," Brannigan said.

According to Dr. Wendy Bickmore, director of the MRC Human Genetics Unit at the University of Edinburgh, gene therapy will likely not be a cure but a way to treat some of the disorder’s symptoms.

“Gene therapy encompasses several things,” Bickmore told “GMA.” “It can be adding back in an extra copy of the gene, which has been mutated, or it can be gene editing where you go in with these CRISPR molecular scissors and try and correct the actual spelling mistake of the genome. They both have the ultimate aim of trying to repair the genetic defect.”

All of the preclinical research will be handled by the Jackson Laboratory in Bar Harbor, Maine. According to Dr. Cathleen Lutz, the lab’s senior director, they’re working with mouse models with various genetic mutations, including one with Hasti’s specific mutation. As CdLS can be caused by any number of genetic mutations, a therapy that works for one may not work for another.

“I think we all recognize we’re in uncharted territory, no one is rushing here,” Lutz told “GMA.” “We’re trying to explore the potential for these therapeutics. Even if gene therapy turns out not to be a path forward for CdLS, we’re going to have so much information to plug into new potential therapeutics.”

In a recent statement, the CdLS Foundation announced a partnership with Jackson Laboratory to coordinate research efforts for all genes implicated in CdLS. The goals of the collaboration include advancing basic science around the disorder, creating a centralized repository of existing and new mouse models with CdLS features, and testing various treatment options.

A British army major, Brannigan calls himself the "Barefoot Soldier."

"The idea of being barefoot is to make it really difficult because Hasti's condition makes her life incredibly challenging," he said. "Things that other children find easy, she finds very hard. It seemed only fair that I do something that was equally difficult and challenging."

Brannigan has already completed one barefoot walk so far. From July 6 to August 18, 2020, he walked 700 miles from Land's End in England to Edinburgh in Scotland.

"I wounded both of my feet," he said. "It took weeks for them to heal."

His current walk will see him do 1,200 miles through 12 states over 53 days. So far, Brannigan's made it well over halfway and expects to complete the journey in late October.

"It's been incredibly painful and I think I have nerve damage in my foot," he said. "I've cut my feet. I've stood on glass. I've had more blisters than I can count. I've encountered some really challenging road conditions and it's slightly dangerous."

Though Brannigan plans to finish out the walk no matter what, the kindness he's experienced along the way has kept his spirits up. People have walked with him for parts of the journey, given him food and drink, and even housed him for a night.

"Hasti is a child like every other child who has hopes and dreams and we want her to realize those," he said. "She deserves to be happy and healthy."

Copyright © 2021, ABC Audio. All rights reserved.



(NEW YORK) -- Even before her stage two breast cancer diagnosis in 2020, Yvonne Llanes knew her strength -- and her community.

Llanes, who was first introduced to "World News Tonight" in 2017, had lost both of her legs nearly 16 years ago in a freak accident. For a decade, Llanes was confined to a wheelchair.

But, in 2017, she had made a promise to herself -- and her late father -- to walk again.

"I was just depressed. I was sad. I was mad at the world and I wanted my life back. I wanted my legs back," Llanes told "World News Tonight" in 2017.

Llanes found a community at the Hanger Clinic's Bilateral-Above-Knee Amputee Bootcamp.

With the support of fellow amputees and after months of determination, Llanes pushed herself to get out of her chair and walk across a stage in front of her friends and family.

"I met a group of amputees such as myself that were doing extraordinary things. They were up and they were walking and they were out of their wheelchairs and I was just incredibly amazed and I told myself I want to be like them," said Llanes.

"I decided enough was enough I was going to get up and get on with life," she added.

Nearly four years later, Llanes returned to the Hanger Clinic's Bootcamp for Amputees to celebrate another victory. This time, to announce that she was cancer-free.

She was diagnosed with stage two breast cancer and underwent surgeries in 2020 and 2021. Across the country, her Bootcamp family was there for her by sending photos and wearing "Yvonne Strong" T-shirts.

"All my amputee friends here have stood behind me through this diagnosis and have been very supportive of me 100%, and I just appreciate it tremendously," said Llanes on Thursday.

Llanes told "World News Tonight" Friday that the community's motto, "Decide to rise," can be applicable to anyone.

"Life is going to throw obstacles at you -- do not let those obstacles get in your way," she said. "Have faith, have courage, have hope, overcome those obstacles and never forget to decide to rise."

Copyright © 2021, ABC Audio. All rights reserved.



(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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(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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(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.

Copyright © 2021, ABC Audio. All rights reserved.


David McNew/Getty Images

(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."

Copyright © 2021, ABC Audio. All rights reserved.



(NEW YORK) -- Miscarriage -- the loss of a pregnancy -- is a common occurrence that affects countless women but remains a taboo topic for many.

Statistics differ, but according to the Mayo Clinic, for women who know they're pregnant, about 10 to 20% will experience a first trimester loss. That number is likely considerably higher, as many women miscarry before they realize that they're expecting. Additionally, one recent study indicated that 43% of women who had at least one successful birth reported having had one or more first trimester losses.

Stillbirth, the demise of a pregnancy after 20 weeks, affects about one in 160 pregnancies each year in the United States, according to the Centers for Disease Control and Prevention. About 24,000 babies in the U.S. are stillborn annually.

These numbers mean that if you haven't had a miscarriage yourself, you likely know someone who has. It's time to talk about it.

ABC News Chief Medical Correspondent Dr. Jennifer Ashton, a board-certified obstetrician and gynecologist, demystified infant and pregnancy loss for Good Morning America.

What is a miscarriage?

A miscarriage refers to a failure or end of pregnancy in any trimester. Typically, we consider a miscarriage occurring in the first and second trimester, and a third trimester miscarriage as a stillbirth. That is the lay terminology.

How common is it?

There are a lot factors that go into determining a woman's risk for having a miscarriage, but in general, singular miscarriage is incredibly common. Most women can or will suffer a miscarriage a lot of times even before they even know that they're pregnant.

Is age a factor?

Age can always be a factor. In general, we have to remember that age is one very important factor when you talk about fertility.

What are the symptoms?

Sometimes a miscarriage will produce no symptoms. Sometimes they're called "incomplete abortions," a type of miscarriage where the cervix dilates, bleeding starts, but the cervix doesn't close again, causing significant blood loss. This is a surgical emergency that needs to be treated with a D&C. Sometimes we refer to a "threatened miscarriage," as a "threatened abortion," which means there might be bleeding, but there's still a heartbeat. We don't totally understand what causes it, but we do know that sometimes women will have no symptoms at all. Other times there can be heavy bleeding, or cramping.

What is a "missed miscarriage"?

Usually when we use the term "missed abortion" or "missed miscarriage," that means the pregnancy is still within the uterus and it's just picked up that there's no heartbeat.

What happens once the miscarriage is diagnosed?

I think the first thing for women, if they're told they've had a miscarriage, is to take a minute and really kind of process that as much as possible from an emotional or psychological standpoint. There's rarely a time pressure to act or do anything unless the woman is bleeding excessively or hemorrhaging with a miscarriage which can occasionally happen. It's not common but it can happen. Otherwise, there is time to think, breathe, process the information initially as best as possible and then make your decision about how you want to proceed.

If we're talking about a first trimester miscarriage, basically the options given to women are to do nothing and wait for it to pass on its own, or undergo surgical evacuation which is called a suction D&C, or dilation and curettage. Usually we don't give medication in the first trimester to evacuate the pregnancy.

Why have a D&C?

A surgical procedure is much more controlled. It's scheduled. The woman is under light sedation, so she doesn't feel any pain. It takes literally minutes. There's very minimal cramping and bleeding afterwards, so she can go about her day, go home to other children, go to work the next day. But it's an individual choice and every woman has to decide with her physician which is right for her.

How much does a D&C cost?

The cost of a D&C is going to vary. It could be over $1000 in some cases, it could be free in other cases.

Is the woman sedated for a D&C?

During a surgical suction D&C for a miscarriage, the woman is definitely under some type of sedation. The uterus is in the pregnant state, and we are using sharp instruments to suction out the pregnancy, so there is a risk of perforating the uterus. The woman really needs to be sedated. It's not only more humane for the patient, but it's definitely safer for the surgical procedure.

Does a woman always need to seek medical attention if she's having a miscarriage?

In general if a woman is diagnosed with a miscarriage, she needs medical follow-up and likely medical management of that miscarriage. Rarely miscarriages that don't pass on their own can become infected and the woman can develop an infection in her uterus. But whether that miscarriage is managed expectantly and the woman is given a chance to pass the pregnancy on her own at home or if it's managed medically will differ case by case, patient by patient.

When can a woman try to conceive again after a loss?

There are rarely any medical reasons for a woman to wait. Sometimes there may be, but the vast majority of women are told when they're emotionally and physically ready. That will differ woman to woman but there usually is no reason why a woman can't try to conceive after getting maybe one period after a miscarriage. Sometimes it happens on its own literally the following month.

Is it true that a woman is more fertile for three or so months following a miscarriage?

The data on this is not clear-cut. In general, there is approximately a 20% fecundity rate per month in young healthy women, meaning there is a 20% chance of conception in any given month.

How soon after a miscarriage would you expect a woman to get pregnant again?

It totally varies. It can happen the next month, or it may take several months or longer.

What happens if a woman has multiple miscarriages in a row?

We call multiple miscarriages in a row recurrent pregnancy loss. It used to be that a woman needed to have three miscarriages in a row before a formal or aggressive workup was done, but now we've kind of dialed that back to even two losses. There's a very well-constructed, well-defined algorithm that we follow to investigate what caused those losses. It involves looking at the anatomy, looking at the genetics of both the man and the woman, doing a variety of blood tests, hormonal tests, sometimes screening for various types of infections, and in some cases, the pathology report from a previous miscarriage can show if there's a genetic or chromosomal cause. But again, this is a very standard workup that any OB-GYN is familiar and accustomed to doing.

Is there anything a woman can do to prevent a miscarriage and/or lower her risk of having one?

For women at average risk, the best recommendation is to be in as good a state of overall health as possible before and during pregnancy. This means not smoking or drinking alcohol while pregnant, exercising regularly, having weight in healthy range, and getting 7-9 hours of sleep a night. For women with high-risk pregnancies, certain medications may help lower risk of additional miscarriage in women who have had recurrent pregnancy loss.

What is vanishing twin syndrome?

Vanishing twin syndrome refers to a pregnancy that starts with twins and then one of the twin pregnancy stops and basically that gets reabsorbed into the placenta, the amniotic sac. When the end of the pregnancy comes, there's just one baby, a singleton that's delivered. We don't totally understand why this happens, so it's hard to pinpoint how common it is.

What is an ectopic pregnancy?

Ectopic pregnancy basically refers to a pregnancy that is located anywhere other than the uterine cavity. The most common place for an ectopic to be located is actually in the Fallopian tube, but there can be ectopics that are located in the cervix, which are incredibly rare and very dangerous, because of the risk of life-threatening hemorrhage. There can occasionally be an ectopic on the outside of the ovary, where it meets the Fallopian tube, and then there can be, rarely, abdominal pregnancies where the pregnancy implants in the abdominal cavity. That is extremely rare.

How common are ectopic pregnancies and how are they diagnosed? How are they treated?

Most cited literature puts the risk of ectopic at about 1 in 50 pregnancies. To be clear, most ectopics are treated successfully but ruptured ectopic pregnancy is the number one cause of maternal death in the first trimester. We don't know what causes ectopic pregnancy, but the vast majority of women who have an ectopic pregnancy have an anatomic problem with their Fallopian tube or evidence of infection or scar tissue in the Fallopian tube.

Usually ectopic pregnancies are diagnosed on either blood testing or with a routine ultrasound. It can be difficult. Typically we look for a doubling or at minimum about a 66% increase in HGC, which is the main pregnancy hormone, over a 48-hour period. Then we correlate that with what we see on an ultrasound which we can check roughly every week in the first trimester. Looking every day by ultrasound doesn't really tell us anything. If it doesn't rise appropriately or if we don't see a confirmed pregnancy in the uterus at the time when we expect to see one, then we make the diagnosis of ectopic pregnancy.

In terms of treating an ectopic, there are basically only two options: an injection of a chemotherapy drug called methotrexate, which will stop the pregnancy because it targets rapidly dividing cells, or surgery. There are certain criteria for one versus the other, but if the ectopic is picked up after a certain point, then laparoscopic surgery is performed. Occasionally if the ectopic has caused a rupture in the Fallopian tube, the tube does need to be removed, but the woman can still get pregnant on the other side.

What is a chemical pregnancy?

We use that term when we have someone who's had a positive pregnancy test, but we never actually see a pregnancy develop to the point of certain ultrasounds findings. We look at ultrasounds in stages in the first trimester. First we see a little sac inside the uterus. Then we see literally something that looks like a ring -- we call it a yolk sac. Then we look for something that we call a fetal pole, which literally looks like a tadpole. And then we look for a heartbeat. Typically you don't expect to see a heartbeat until about six-and-a-half or seven weeks, but that is highly dependent on the technology used, the skill of the ultrasonographer, the woman, various factors.

So if it's a desired pregnancy, many healthcare providers will wait, as long as the woman's not having any symptoms, until we see these signs. When we diagnose a chemical pregnancy, it's because there's usually a positive urine test and then the pregnancy hormones just kind of stop, so we never really see anything in the uterus. We don't know how common this is, but everyone -- midwives and obstetricians -- sees it in their practice.

What is a stillbirth?

Those are oftentimes the most emotionally agonizing types of loss, but to be clear, a miscarriage or loss of a pregnancy in any trimester, they're all upsetting. A stillbirth, generally we're talking about third trimester loss. In terms of how common a stillbirth is -- the cited statistic is 1%, or over 20,000 stillbirths in the country every year. Those numbers may be a little bit in question but what's not in question is that stillbirths can and do happen. Sometimes there are known risk factors. Sometimes they happen with no known explanation or risk at all.

Most of the times third trimester fetal demise is diagnosed on a routine visit to a midwife or OB or actually in labor and delivery. At that time the management of a stillbirth is to induce labor to allow a woman to deliver the fetus.

Is anybody at fault for a miscarriage?

A lot of people feel shame and stigma and don't want to talk about it or feel they can't talk about it openly, and I think, unfortunately, a major reason for that is that a lot of women in particular feel that something is wrong with them or they did something wrong or it's their fault in some way. That is rarely, if ever, the case. The reality is, miscarriage happens. And that is incredibly painful and upsetting for the couple. It's no one's fault. I think it's one of the many topics in medicine that we need to de-stigmatize and we need to bring out of the shadows and make it more acceptable to discuss because it's so common and so many people, unfortunately, experience it.

What would you say to a woman who blames herself?

For some women who have suffered a miscarriage who on some level blame themselves or feel that it makes them less of a woman or that it's a fault or flaw in them, all I can say as an OB-GYN is that's not true. It's not your fault. It doesn't make you flawed. And it certainly doesn't make you less of a woman. I think it's also important to remember that a miscarriage is a painful loss for the other partner in that couple, and that that partner can grieve the loss of a pregnancy even if he or she wasn't carrying the pregnancy. So I think that we need to start expanding our sensitivity when it comes to this and a big part of that is how we look at pregnancy in this country -- that it's always the "Hollywood pregnancy," and it's so easy and then couples get this perfect baby and that's not reality. For most people who suffer miscarriage, it seems that everywhere they turn, they're looking at that Hollywood pregnancy, or they're seeing women who have seemingly no issue with fertility. But it's important to remember that optics are rarely reality.

What should and shouldn't I say to a friend who's suffered a miscarriage?

You don't really have to say anything. You can just be with the person. You can offer them emotional support with just a gesture like a hug. What not to say? "You can always try again." Or, "There will be other pregnancies." I think it's really important to understand that a miscarriage in any trimester is a loss, and that is incredibly emotional and painful for the woman who was pregnant and for her partner. So saying things like, "You can always try again" or "You can always have another baby" doesn't help. It does a lot of damage.

Copyright © 2021, ABC Audio. All rights reserved.



(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.

Copyright © 2021, ABC Audio. All rights reserved.


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