(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 The data, which is not yet peer reviewed, also found that for J&J recipients, antibody levels were higher if they received a Moderna or Pfizer booster rather than a J&J booster.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.”
(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.”
(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.”
(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.”
(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.
(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.
(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.
(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.”
(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.
(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.
