(WASHINGTON) — As soon as Tuesday, the U.S. Food and Drug Administration could authorize COVID-19 booster shots for Americans over 50 years old, two officials familiar with the matter told ABC News, though the fourth shots are likely to be only offered and not formally recommended.
The officials stressed that the details are still under discussion and could change in the next few days.
After FDA’s expected authorization early this week, the Centers for Disease Control and Prevention will give guidance on how to implement it in pharmacies and doctors offices around the country, as the process has gone throughout the pandemic.
The language from CDC Director Rochelle Walensky is expected to be that people over 50 may get a second booster shot, rather than should get a second booster shot, officials said.
In other words, the shots would be available for people to make individual decisions based on their health, risk tolerance and age. In the past, the CDC has used similar language to open up booster shots first to the most vulnerable and then to the general population.
FDA’s panel of experts will convene on April 6 to discuss the broader population and what population will need booster shots next, as well as the need for a variant-specific booster.
Officials weighing the decision are also considering that anyone who gets a booster this spring would likely get boosted again when they are recommended for the broader public later this year, potentially in the fall, according to another person familiar with the matter.
Pfizer and Moderna asked the FDA last week to authorize another booster dose — especially for elderly Americans, a group that tends to have weaker immune protection.
Pfizer asked the FDA to authorize fourth doses for people older than 65, while Moderna asked for authorization for everyone 18 and older.
ABC News’ Sony Salzman contributed to this report.
(INDIANAPOLIS) — For the first time in his life, 15-month-old Kendall Jurnakins is home.
The baby boy spent the first year of his life in the neonatal intensive care unit at Ascension St. Vincent Women’s Hospital in Indianapolis before being cleared for discharge on March 16.
Hospital staff gave the boy a joyous send-off, lining up for a cheer parade and applauding Kendall as he made his way home with his parents, Sparkle and Keith Jurnakins.
It was a long time coming for the boy and his mother, who were both so sick at one point that doctors worried they both might not make it.
Sparkle Jurnakins, 41, a mom of three, had to get an emergency cesarean section due to high blood pressure complicated by the fact that she also has diabetes and only one kidney.
So, on Dec. 11, 2020, Kendall Jurnakins was born at 25 weeks. He weighed just 15 ounces. His doctor estimated his chance of surviving at the time was close to 50-50.
“When he was born at 25 weeks and based on his weight, national data and international [data], his chance to survive was around like 50 to 60% … this is only survival, not survival with complication or long-term problems, but he actually beat some odds,” neonatologist Dr. Taha Ben Saad, who cared for Kendall, explained to Good Morning America.
Jurnakins told GMA she feared for her baby’s life at the time. “I just was scared my baby wasn’t gonna make it because they said at that small, he probably wasn’t gonna make it,” she recalled.
At 25 weeks, Kendall had various complications from his prematurity. He had respiratory distress syndrome and chronic lung disease and later had problems eating, too.
“I was going to visit him every day. He was really sick in the beginning,” Jurnakins said. “We couldn’t figure out why he couldn’t get his lungs together. So we had to, they told me that his lungs wasn’t really fully developed like they should. They was gonna have to trach it. So we ended up having to have that big surgery, a trach put in for him to be healthy.”
Kendall received a tracheostomy and was placed on a ventilator to help him breathe. He later had to get a gastrostomy tube as well for feeding.
Eight months into Kendall’s treatment, a major complication occurred — Jurnakins contracted COVID-19 and checked herself into the same hospital.
“I remember going into the hospital saying I couldn’t breathe. That was the only thing I remember,” Jurnakins recalled.
Like her son, Jurnakins had to be placed on a ventilator and get a tracheostomy. She spent two months in the intensive care unit.
“COVID almost took me out. … From August to October, I was in a coma. And then in the hospital till almost December,” Jurnakins said.
“It was very emotional when his mom got sick in the hospital,” Ben Saad said. “We thought she’s not gonna survive and then all his nurses were really worried.”
Along with her doctors and nurses, Jurnakins also credits her husband for her own survival. “Him being by my side through everything, I mean, it was so scary. Everything was scary,” she said. “From me almost dying, to my son going through what he was going through, where they were just like, ‘Oh, he’s not gaining weight. He’s not doing this.’ It was just all these ups and downs, where we were just very worried that Kendall wasn’t gonna come out of the hospital as a regular child.”
Against the odds, Jurnakins recovered and she was able to reunite with her baby boy in early December 2021.
“I thought he was not gonna remember me because he was so tiny when I went in the hospital,” Jurnakins said. “Soon as I got there, he just laid on me and looked at me the whole time. It was the best feeling in the world.”
Throughout his 460-day stay in the NICU, Kendall reached a lot of firsts — everything from his very first tooth to learning how to sit and crawl.
Today, Jurnakins said her youngest son is “a bundle of fun” and has a delightful and strong personality. “He’s Mr. Personality. If you ever meet him, you will always remember him. He’s funny, he likes attention,” she said.
When he was discharged, Jurnakins said it “was the best day of my life.”
“I couldn’t believe it. I was just like, ‘Oh, my baby really made it. Oh, we’re coming home. Oh, Lord. Thank you,” she said. “I prayed. I cried. I was happy. I was sad. I was everything but I was ready for my baby to come home.”
As she reflected on their extraordinary journey over the last 15 months, Jurnakins said she had a message for her little boy.
“I want to say, his mother fought for him like he’s a fighter,” she said. “He was a fighter forever and I fought for him.”
(NEW YORK) — Two years ago, two women — complete strangers — embarked on a remarkable journey together and today, they say they’ve become “family.” Now, they’re opening up about their story in the hopes of helping others.
Kelly Taylor Savant, 41, of Baton Rouge, Louisiana, had been trying to conceive for six years. She and her husband, Kyle Savant, found out they were expecting twins in 2014 but then Savant had a miscarriage and underwent a dilation and curettage (D&C) procedure.
Savant says the procedure later led her to develop Asherman’s syndrome, which according to the Cleveland Clinic, is a rare condition where scar tissue builds up in the uterus, which can lead to infertility. Within the six-year period, she had another miscarriage, tried in vitro fertilization, intrauterine insemination and had other surgeries, all in the hopes of possibly growing her family.
After consulting with multiple doctors and considering her options, Savant started exploring surrogacy. “When I realized I needed a carrier, I didn’t know where to start, I didn’t know what to do, I didn’t know anybody who had ever had one,” she recalled in an interview with GMA.
Then she came across a Facebook post by Jasmine Johnson Isaac, a nurse and a mom of four from Denham Springs, Louisiana.
Finding each other on Facebook
Isaac had been thinking about becoming a surrogate for a while, but didn’t know where to begin. She decided to post online and hoped that someone interested would reach out. “As a young woman, I’ve always wanted to be a surrogate,” Isaac told GMA. “I have kids of my own, and the love that I have for my kids, I just feel like other women deserve the same thing.”
The two connected and began talking online, later realizing they only lived about 15 minutes away from each other. In August 2020, they took a leap of faith and met in person for the first time.
“When we met up, she had already gotten clearance from her OB-GYN to carry, which is the first step,” Savant said. “Then we went to dinner — me, my husband, her and her husband — and I just knew someone who was going to bring their husband to dinner to meet us was probably someone who was going to follow through with their words.”
The dinner was a success and the Isaacs and the Savants agreed to team up. Savant and Isaac secured lawyers, Kristen Stanley-Wallace and Julie Udoessien, who walked them through the legal process in Louisiana, and searched for medical professionals to help them realize a shared dream.
Hanging onto hope
They started the medical clearance process in September 2020 and by April 2021, they began the embryo transfer. Then, they hit a major setback — Jasmine didn’t get pregnant.
“I at that point, honestly felt like I couldn’t do it anymore. I had tried for now going on seven years because I was still trying every month myself, like why not?” Savant said. “She actually is the one, when I called her, she said, ‘We’re doing this again.’ … And she is one of the only reasons, the most influential reason that I did a second transfer.”
For the second transfer, Savant and Isaac switched doctors, seeking the care of Dr. Warren Jay Huber of The Fertility Institute of New Orleans.
By the summer of 2021, Isaac found out she was pregnant. “When I got a solid positive, I went to the store and I purchased a teddy bear and I got a little box,” she recalled. “I put a picture of the pregnancy test inside of the box and it was pretty much telling her that it’s a good chance that they have a baby on the way.”
Isaac delivered the surprise present to Savant’s workplace and left it with a secretary while Savant was away. “She was just so excited once she found that box and just to hear her on the phone and just to hear the excitement in her voice, it was everything for me,” Isaac said.
Along with Savant, Isaac credits her mother, husband of nine years, Maurice Isaac II, and one of her close co-workers for helping her through the surrogacy journey, one she was determined to see to the end. “In the past, I’ve had a miscarriage and just the feeling like my body isn’t doing something that it was supposed to do, it took a toll on me. So of course, if I can help another woman get past that … if they have that want and desire to have a child and I can help, I want to do that,” she said.
“It’s something that my whole heart is in,” Isaac said. “The love that I have for my kids – who doesn’t deserve to experience the same joy that I have, the joys of motherhood?”
A dream realized
Isaac explained that due to blood pressure concerns, doctors decided it was best for her and the baby to be induced. On Valentine’s Day of this year, baby Ainsley Rain Savant arrived.
A nurse working with Dr. Kristin Chapman at Woman’s Hospital in Baton Rouge, Louisiana, helped capture the special moment, taking photos during labor and delivery. Savant shared them along with a heartfelt message on Facebook, writing in part, “There just aren’t enough thank you’s in the entire world. Jasmine has single handedly changed me and Kyle’s lives forever for the better and I thank God for her every day. She lives life with no fear, no regrets and a desire to make others happy! She’s simply the best.”
Savant says the big day felt surreal. “I was in shock when I saw the baby. I was immediately in love. I gave Jasmine a huge hug after and my husband did too and we have pictures of it all. I mean, it was the best moment of my entire life and Jasmine always says, ‘Kelly you don’t realize what you’re doing for me.'”
“It’s something that she’s been waiting for a very long time,” Isaac added. “So it was just so self-fulfilling for me to just do that for her. And just to see the expression on her face was enough.”
As for baby Ainsley’s name, Savant said, “We wanted to use the name Rain as a middle name just to signify the rainbow after the storm. … It’s the blessing after all of the devastation.”
A rainbow baby is a term often used for a baby born after a mother suffers a miscarriage, stillbirth or loss of an infant.
After their extraordinary journey, Isaac and Savant say they now consider each other family. “Not a day goes by since August of 2020 that we have not spoken,” Savant said, adding that she considers Isaac “the best person I have ever met.”
Sharing hope
Isaac and Savant say they’ve had to navigate several regulations and laws in Louisiana, which only allows for gestational carriers if certain conditions are met.
“In Louisiana, a lot of people don’t know how really strict it is,” Isaac said. “My husband actually had to be involved with it and he’s been supportive this entire time. He actually had to do lab work and testing and of course, he had to be on board with me doing it as well. I couldn’t do it without him, without him agreeing that it’s OK.”
“Jasmine and I’s hope is that this brings awareness and Louisiana can start looking at their outdated laws and maybe make some changes,” Savant said.
For others interested in becoming a surrogate, Isaac says you should be sure of your decision and recommends setting up a solid support system. “If you’re interested in becoming a surrogate, of course do not offer unless you know you’re fully on board with doing so. You don’t want to get anyone excited that you’re going to do something and then step back on it. You kind of set them back a little bit doing so.”
Savant also hopes their story offers hope to others struggling with infertility. “I think women almost feel like there’s no hope for them like, they just want to give up because it’s too hard. So I would want them to know go see your fertility doctor. Join a few surrogacy Facebook groups, research the laws in your state. Go speak to an attorney.”
“This can be done,” she added. “You just need to be persistent, stick with it, and not give up your dream. Giving up can’t be an option if you really want this.”
(NEW YORK) — March marks World Endometriosis Awareness Month dedicated to recognizing and advocating for the estimated 190 million women worldwide who suffer from endometriosis.
Taylor Keefe was 13 years old when she first saw a gynecologist.
“Every time I was on my period, I had no functionality. I would be bent over in pain for days at a time, screaming and crying,” said Keefe, now a 26-year-old clinical mental health counselor in New Jersey. “After two years of missing school and not being myself, my parents were concerned so I went to a gynecologist.”
It wasn’t until seven years later — after many more doctor visits, pain medications and various hormonal treatments — that Keefe was diagnosed with endometriosis, a disease where the tissue forming the inner lining of the uterus is found outside of the uterus such as within the fallopian tubes, ovaries, bladder and intestines.
Lesions from endometriosis can cycle monthly with the hormonal environment of the menstrual cycle and cause severe pain, infertility, and other associated symptoms in any of the affected organs such as painful urination, bowel movements, nausea, vomiting or bloating.
Following surgery at age 21, she was found to have more than 20 endometriosis implants in various organs. Keefe recalls the first thing her surgeon told her parents was, “She’s not crazy.”
“The disease itself and dealing with it has been invalidating for years because doctors invalidate it, friends and family invalidate it,” said Keefe, who said she felt validated for the first time with her diagnosis.
Endometriosis affects 1 in 10 women of reproductive age in the United States, according to the American College of Obstetricians and Gynecologists (ACOG). However, many women go undiagnosed for years due to such a broad range of symptoms and limited awareness of the disease, experts say.
“There is a lack of awareness. Women are usually treated for everything other than endometriosis when they present,” Dr. Tamer Seckin, an endometriosis surgeon in New York and co-founder of The Endometriosis Foundation of America, a nonprofit organization focused on increasing endometriosis awareness and research, told “Good Morning America.” “They get the runaround and get diverted to other specialties whether for bladder symptoms or IBS.”
Endometriosis often begins as small, scattered lesions on the inner lining of the abdominal cavity, known as “peritoneal endometriosis,” according to Seckin. These lesions can be very small in increments of millimeters and not show up on imaging tests such as ultrasounds.
“When [physician] don’t find anything, it’s easy to think the pain is in patient’s head and that’s really the crux of the problem,” Seckin said.
Endometriosis is most commonly diagnosed in women in their 30s and 40s, according to ACOG, however, it can affect adolescents as well.
Celebrities like Lena Dunham and Amy Schumer have previously publicly shared their own journeys with endometriosis and eventual hysterectomy, spotlighting the ultimate treatment for the disease for many women.
“Because I had to work so hard to have my pain acknowledged, there was no time to feel fear or grief to say goodbye,” Dunham wrote about getting a hysterectomy at age 31 in a 2018 article for Vogue. “I made a choice that never was a choice for me, yet mourning feels like a luxury I don’t have.”
Removal of the uterus, tubes and ovaries is considered the most definitive and “last resort” treatment for endometriosis, according to ACOG.
Because one can no longer bear children after a hysterectomy, it is often a difficult decision for women who have endometriosis. Removal of the ovaries also means surgically-induced menopause and this carries other health implications and consequences from low estrogen.
Therefore, many women choose to manage their symptoms with medications or fertility-sparing surgeries, where endometriosis lesions are removed, but uterus and ovaries are left behind.
However, as many as 8 in 10 women have pain again within two years after fertility-sparing surgeries, according to ACOG, because all of the endometriosis tissue was not removed.
Hysterectomy is also not necessarily a cure for endometriosis, as the disease often may have spread beyond the reproductive organs. About 10% of women return with endometriosis symptoms and 4% need additional surgery following a hysterectomy with removal of ovaries, according to a study published in Fertility and Sterility.
Non-surgical management options for endometriosis include use of birth control pills and other hormonal medications used to ease periods and pain symptoms.
“I think it’s important to recognize management versus treatment,” said Seckin, adding that while birth control pills and hormonal medications may help manage symptoms, “They don’t treat the endometriosis. The lesions don’t clear. They stay there. Treatment is removing the tissue.”
Following her first surgery at age 21, Keefe underwent two more surgeries within five years for progressive disease. All of her surgeries have been excision surgeries where endometriosis lesions were removed, and her reproductive organs preserved.
She said while a hysterectomy may be in her future at some point, she hopes to experience motherhood first, saying, “Becoming a mom has been a dream my whole life.”
Keefe, who experienced a pregnancy loss last year, said she is aware of the effect endometriosis may have on her fertility. She froze her eggs at age 23, at the advice of her doctors, in case she needs them in the future to get pregnant.
“To get a positive pregnancy test was one of the happiest days of my life. I never thought I would see that,” said Keefe, adding that after her pregnancy loss, she fears pregnancy “might never be a possibility.” “This might be the pattern every single time as a result of the scar tissue and all the damage from endometriosis.”
An estimated 4 in 10 women with infertility have endometriosis, according to ACOG.
Inflammatory changes from endometriosis could block fallopian tubes or impair sperm or egg function, causing infertility.
The search for a better diagnosis
Diagnosis of endometriosis is currently made by laparoscopy, a procedure where a surgeon directly inspects the organs inside of the pelvis using a camera to look for endometriosis lesions and collects biopsy samples for diagnosis.
“Definitive diagnosis requires laparoscopic surgery which many women do not really want to undergo and I think that contributes to long delays in diagnosis,” said Dr. Christine Metz, professor at the Feinstein Institutes for Medical Research.
The need for laparoscopic confirmation of lesions for diagnosis of endometriosis is a topic of debate among experts due to the costs and inherent risks of surgery.
Researchers from the Feinstein Institutes for Medical Research, led by Metz and her colleague, Dr. Peter Gregersen, are working to develop a less invasive method to diagnose endometriosis through the use of menstrual blood samples.
According to the researchers, menstrual blood samples collected from patients with known endometriosis have distinct cellular profiles and inflammatory markers compared to samples from healthy women.
Metz said she hopes that, based on the current evidence, menstrual blood samples can be used as a screening tool prior to patients having to undergo laparoscopy for diagnosis.
“If you see that the patient has markers that are indicative of endometriosis, they would be recommended to go for the surgical definitive diagnosis,” she said.
Researchers hope this could help prevent delays in diagnosis by identifying and encouraging the subset of patients who may need laparoscopy.
While scientists continue to look for new ways to improve the diagnosis and management of endometriosis, there remain many unknowns and still no cure for endometriosis.
“There is a lack of funding, support and lack of research in this area considering that 10% of women have or experience endometriosis,” said Metz.
Seckin noted that the social stigma around periods and taboos surrounding women’s health issues contribute to the lack of awareness of endometriosis. He said he encourages his patients to speak up about their endometriosis to raise awareness.
Keefe said she has found empowerment in speaking about her endometriosis battle.
“It’s the most defeating of experiences in a lot of ways,” she said. “At the same time, we’re only going to be able to get through it if we lean on each other and we’re stronger together.”
Esra Demirel, M.D., an OB-GYN resident physician at Northwell Health, is a contributor to the ABC News Medical Unit.
(NEW YORK) — As the United States continues to face the highest maternal mortality rate among developed nations, the country’s largest city is offering new support for expectant people.
New York City will begin offering free doula access to families, Mayor Eric Adams announced Wednesday.
The city will also train more doulas — trained professionals who provide support to moms before, during and after childbirth — as part of its Citywide Doula Initiative, with the goal to train 50 doulas and reach 500 families by the end of June.
The initiative will focus on reaching birthing families in 33 neighborhoods “with the greatest social needs,” according to the city’s announcement.
As part of the effort, the city will also expand its Midwifery Initiative to nearly 40 public and private birthing facilities across the city, and has charged the city’s Department of Health and Mental Hygiene with gathering data and developing a report on births and care with midwives.
“Today, we are announcing a multifaceted initiative to help reduce the inequities that have allowed children and mothers to die at the exact time when we should be welcoming a life,” Adams said in a statement. “By expanding and investing in both doulas and midwives, we are taking the steps necessary to begin to address the disparities in maternal deaths, life-threatening complications from childbirth, and infant mortality.”
New York City has a maternal mortality rate of 49.6 deaths per 100,000 live births, according to a report released last April by the Department of Health and Mental Hygiene.
Nationally, the U.S. has faced a growing maternal mortality crisis that only increased during the coronavirus pandemic, according to the Centers for Disease Control and Prevention (CDC).
It is a crisis that also disproportionately affects women of color.
In 2020, Black women died of maternal causes at nearly three times the rate of white women, up from around 2.5 times higher than in 2019, according to CDC data.
Black women also died in 2020 at higher rates than Hispanic women, who had a rate of 18.2 deaths per 100,000 births in 2020 — a more than 40% increase from the previous year.
Pregnancy-related deaths are defined as the death of a woman during pregnancy or within a year of the end of pregnancy from pregnancy complications, a chain of events initiated by pregnancy or the aggravation of an unrelated condition by the physiological effects of pregnancy, according to the CDC.
Because of the maternal mortality rate and its impact on women of color, a growing number of Black women see having a doula, particularly a Black doula, as a potentially lifesaving advocate during birth.
Dr. Jacquelyn McMillian-Bohler, a certified nurse-midwife and assistant professor in Duke University’s school of nursing, describes doulas as bridging the communication gap between health care providers and Black female patients.
“Our health literacy is poor across the board, and then when you add racism on top of that, it just creates another layer,” she told ABC News last year. “That’s what we’re doing with the doula, we’re trying to attack that health literacy piece that really affects outcomes.”
Dr. Ashanda Saint Jean, a board-certified OBGYN and chair of OBGYN for the Health Alliance Hospitals and Westchester Center Medical Health Network in New York, explained that doulas are a source of non-medical support for pregnant women before, during and after childbirth.
“A doula is a support person who has been trained and educated in labor and delivery,” Saint Jean said last year. “I’ve had a number of Black patients feel that having a doula is an extra layer of support where they’re able to more ask questions about their birthing experience and explore all measures to ensure a healthy outcome.”
Tayfun Coskun/Anadolu Agency via Getty Images, FILE
(NEW YORK) — Big Apple athletes and performers who haven’t received their COVID-19 vaccine shots now won’t be barred from taking the court or stage. But some New Yorkers who are still required to show proof of vaccination are calling foul on what they see as a double standard.
New York City Mayor Eric Adams announced Thursday that he was dropping the mandate that all city-based athletes and performers show proof of vaccination to take part in their game or event. Adams said his decision was based on the city’s low COVID-19 cases and hospitalizations and the city’s goal to restart its economy.
“We have to be on the field in order to win,” Adams said during a news conference at Citi Field, where unvaccinated Mets players will no longer have to worry about not playing when the baseball season begins next month.
Until Thursday’s announcement, unvaccinated athletes could not play home games, because venues required everyone to be vaccinated for entry. Visiting players and entertainers, however, were exempt.
This affected the Brooklyn Nets after its star point guard, Kyrie Irving, repeatedly refused to get vaccinated.
Irving was listed inactive during the first three months of the season but was called up in January for road games. He scored 43 points in his last game Wednesday against the Memphis Grizzlies.
Adams said the old rules put teams and performers at a disadvantage.
“This is about putting New York City performers on a level playing field,” Adams said.
Broadway performers represented by Actors Equity previously agreed to mandatory vaccinations.
“Broadway theatres anticipate no change in our protocols based on this announcement. We continue to evaluate our COVID safety protocols for audiences, cast and crew, in concert with our unions and medical experts,” Charlotte St. Martin, the president of The Broadway League, said.
The mayor added that the decision will help the venues and employees who work in the arenas and entertainment venues and local businesses.
But not everyone was thrilled with the mayor’s decision, particularly some unions representing city workers who are required to show proof of vaccination to work.
“There can’t be one system for the elite and another for the essential workers of our city. We stand ready to work out the details with the mayor, as we have been throughout this process,” Harry Nespoli, president of the Uniformed Sanitationmen’s Association, said.
City Council Speaker Adrienne E. Adams also expressed concerns about the “ambiguous messages” sent to New Yorkers about vaccine requirements.
“This exemption sends the wrong message that higher-paid workers and celebrities are being valued as more important than our devoted civil servants, which I reject. This is a step away from following sensible public health-driven policies that prioritize equity,” she said in a statement.
Earlier in the month, the mayor dropped the requirement for indoor businesses and venues, including movie theaters, to have their customers show proof of vaccination and wear a mask. He also dropped the mask mandate for schools and is set to drop the mask mandate for children 2- to 4-years old.
As of Thursday, 77.5% of all New Yorkers were fully vaccinated, and 36.3% of residents had received their booster dose, according to the city’s Health Department.
The mayor and health department have repeatedly stressed that the COVID-19 vaccines are the most effective way of preventing hospitalizations and death caused by the virus and encouraged more New Yorkers to get their shots.
(NEW YORK) — Even as most eligible Americans have yet to receive their first COVID-19 vaccine boosters, Pfizer and Moderna have now asked the Food and Drug Administration to authorize yet another booster dose — especially for elderly Americans, a group that tends to have weaker immune protection.
Pfizer asked the FDA to authorize fourth doses for people older than 65, while Moderna asked for authorization for everyone 18 and older (though company executives said the greatest need would be among older adults).
With the FDA advisory committee not slated to meet until April 6, and no vote scheduled, it could take the FDA weeks to decide whether or not to authorize Pfizer and Moderna’s fourth dose applications.
Meanwhile, many vaccine experts are not convinced fourth doses are needed so soon. Some are even skeptical fourth doses will be needed at all. And that is on top of the difficulty in getting millions to get their first and second shots, let alone their third and fourth.
“There are very few, if any, people who, in my opinion require a fourth dose,” said Dr. Anna Durbin, professor of international health and director of the center for immunization research at Johns Hopkins Bloomberg School of Public Health.
“In general, it’s too early to recommend a fourth dose, except for those who are immune compromised,” said Dr. Paul Goepfert, professor of medicine at the University of Alabama at Birmingham and an expert in vaccine design.
Roughly 3% of the U.S. population is immune compromised, and already eligible for fourth doses. But this group only includes people with very specific medical conditions, like cancer or organ transplant recipients — not the estimated 54 million adults over 65.
Not enough evidence yet for fourth shots: Experts
So far, many experts say there isn’t enough evidence to justify fourth doses, even for older adults, though more evidence could emerge in the future. Studies from Israel, a nation that has already implemented fourth doses, indicate that boosting again modestly enhances protection from infection.
In the study, 18% and 20% of healthcare workers who got a fourth shot of Pfizer or Moderna, respectively, developed an omicron infection. Among those with three shots — about 25% developed an omicron infection.
Although the existing COVID-19 vaccines are overwhelmingly safe, they do come with temporary side effects and the rare risk of temporary heart inflammation called myocarditis among young men.
“Unless there’s clear evidence something is of value, don’t give it,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
With Moderna and Pfizer now submitting fourth-dose booster data to the FDA on an ongoing basis, the FDA has convened meetings of its outside vaccine advisors to discuss the future of COVID-19 booster shots, how often they might be needed and whether variant-specific versions could be more beneficial.
With the FDA advisory committee not slated to meet until April 6, and no vote scheduled, it could take the FDA weeks to decide whether or not to authorize Pfizer and Moderna’s fourth dose applications.
Emphasis on boosters misplaced
For Offit, a vocal member of the FDA’s advisory committee, the national emphasis on booster shots has been somewhat misplaced. The primary goal of vaccines should be to protect against serious illness, he says, which overall, primary vaccines are still doing.
When the vaccines were first launched in December 2020, emphasis was placed on their ability to protect against COVID-19 infection. But now, with the passage of time and emergence of new variants, many vaccine experts argue this was always an impossibly high standard to maintain, and moving forward, the emphasis should be on their ability to protect against severe disease.
Now, more than a year later, data shows that boosters may shore up the body’s defenses against mild infections — but only temporarily.
“These vaccines continue to demonstrate high protection against hospitalization and severe disease,” Durbin agreed. “Prevention of infection, in my opinion, is not the metric that we should use.”
“We’re going to have to learn to live with mild disease at some point,” said Offit. Frequent boosting “is not a reasonable thing to do, and it’s not something most people will do anyway.”
Tailored vaccine may be better
A better approach, said Durbin, would be to roll out a tweaked vaccine that is a better match against the new omicron variant. Vaccine makers agree, with Pfizer and Moderna both studying new versions of their vaccines they hope will work better and offer more durable protection against current and future variants.
“We can’t have vaccines every five, six months,” said Pfizer CEO Albert Bourla, speaking on CNBC.
But until they have new-and-improved boosters ready to go, Pfizer and Moderna executives argue fourth doses will be needed by at least some older Americans soon.
In the United States, vaccination rates have stalled. Roughly a quarter of eligible adults have yet to receive their first vaccine doses, while about half of vaccinated adults have yet to receive their first boosters.
Dr. Anthony Fauci told ABC affiliate KGTV that older Americans might need a fourth dose “sooner or later,” but not yet.
The effectiveness of three shots is “holding pretty strong at around 78% efficacy against hospitalization,” Fauci said, “but if it goes any significantly lower than that, you certainly would consider the possibility of a fourth dose boost particularly among elderly and those with underlying diseases.”
At a White House briefing Wednesday, Fauci said fourth shots for older adults might be considered soon, but for the general population won’t be considered until “the beginning of fall, end of summer.”
While many vaccine experts have predicted that COVID-19 vaccination will become an annual shot, like the flu vaccine, others are still hopeful that three shots could be the magic number for many Americans.
“I do think three doses will be enough for some individuals,” said Goepfert, “but it depends on the new variants that will come next.”
(NEW YORK) — Jennifer Dornan-Fish is marking two years grappling with the long-term impacts of COVID-19 on her body.
She said her road to recovery from the virus has been mired in a “bewildering array” of agonizing and debilitating new symptoms — which gradually emerged after she had already fended off her initial infection.
A couple weeks after testing positive in March 2020, it seemed like Dornan-Fish had made it mostly out of the woods. However, the healthy 46-year-old said she struggled with COVID fatigue and labored breath but avoided hospitalization.
She said she was “convincing myself I was on the mend” and was anxious “to jump back into” her busy life finishing her next book and homeschooling her son. But then, “everything started going haywire.”
Dornan-Fish told ABC News her doctors have diagnosed her with Post-Acute Sequelae of SARS-CoV-2 infection (PASC) — the official term for long COVID symptoms. She has been tested for autoimmune issues like lupus, multiple sclerosis, Ankylosing spondylitis, along with blood cancers, to rule other, non-COVID causes out.
“It wasn’t like I just crashed all at once,” Dornan-Fish, now 48, said. “One little thing went wrong. Then another. And it just got worse and worse until – I have honestly very little memory of the first few months. I was so out of it.”
She began getting painful, itchy rashes on her thigh and shoulder, and her gums.
Then came “coat hanger pain” in her shoulders and neck. Then the brain fog. The front of her throat felt tight, as though an invisible hand was clamping down on her breath.
“I call it the ‘COVID choke,'” she said.
“I could barely talk,” she said. “The brain fog has really, to be honest, been the most disturbing symptom of them all. I make my living writing, thinking, so to not be able to do that was terrifying.”
Getting out of bed for more than a few minutes would take everything she had.
“My husband had to feed me, he would bring me meals. I could barely sit up. I couldn’t wash myself. I couldn’t take care of my child,” she said. “I was just surviving.”
In that first year of the pandemic, scant medical treatment existed for the mysterious virus which had overrun intensive care units around the world — let alone a tried-and-true way to fight COVID’s prolonged effects.
Dornan-Fish saw a “round-robin” of specialists — a “trial and error” process, which she said has been exhausting.
“I tried a million different things,” she said.
She started getting new allergies: she was hospitalized for a reaction to baby aspirin, which she had been taking to avoid the blood clots she had heard were associated with COVID. She had a reaction to her family’s longtime kitchen cleaner.
“I almost went into anaphylaxis from a scented trash bag,” she said.
About nine months out from her initial COVID infection, Jennifer started having tremors.
“My doctor called them ‘seizure-like,'” she said. “We don’t know what they were.”
Over time, her allergies seemed to start improving. Her brain fog got a little better. But the tremors got “much worse,” and took new forms.
“I’m not actually shaking on the outside, but it feels like a vibrating cell phone in my chest. Or, like there’s an earthquake inside me,” she said.
“For a little while — and it has gotten better — but a bird would cheep outside the window, and I would jump,” she said. “Not to be glib, but I’ve lived in the jungles of Belize and have killed poisonous deadly snakes with machetes. Like, I do not jump at cheeping birds.”
Her son, now 13 years old, has seen how post-COVID has ravaged her health.
“He sometimes says, ‘mom, when you’re better, I can’t wait ’til we play this game again,'” she said. “‘When you’re better–‘ it breaks my heart.”
What was once understood as a respiratory virus has emerged, for many, as an all-out attack on the system. Researchers are pushing to find better treatments to help long-haulers — and better answers to understand why they’re impacted for so long, with more than a billion federal dollars devoted to studying COVID’s prolonged health consequences.
Some theories from experts include a person having a particularly high viral load when they first get sick; or lingering COVID viral particles sticking around in the body even after a person has “cleared” their initial infection; or another virus that was previously latent getting reactivated, like Epstein-Barr.
After even a mild initial infection, many COVID survivors across a diverse age group still report exhaustion, cognitive problems and other symptoms. Studies so far estimate as much as 10% to 30% of people who get COVID may later develop long-hauler symptoms.
It has not been a comfortable adjustment for Dornan-Fish. Before COVID, she recalled being able to hike and run for more than 10 miles at a time.
“Before COVID, I took a daily multivitamin,” she said. “Now I take four medications, eight supplements, every day. Two years later, I still have tremors, rashes, crushing fatigue, nerve pain and a swelling throat.”
Of the treatments she has tried, it’s “hard to tell whether it’s my body naturally healing? Or are these things that I’m trying working?” she said.
Meanwhile, physicians have focused on managing symptoms. While firmer treatment protocols are under review, at this time, there are no conclusive data or recommendations regarding the use of supplements in the treatment of long-COVID.
At first Dornan-Fish said she took a beta blocker, a medication sometimes used for postural orthostatic tachycardia syndrome (POTS), which helps to reduce heart rate. That seemed to help, she said, but had to stop when it dropped her blood pressure too low.
D-ribose, a carbohydrate naturally produced by the body and supplement aimed at boosting energy, was the first thing she said helped her move around more regularly. She’s been taking high-dose B vitamins, CoQ10, and NADH, which she said have helped boost her energy. She’s been taking Dexedrine for the brain fog — a stimulant approved by the Food and Drug Administration to treat ADHD and narcolepsy, which works by increasing the release of neurotransmitters involved in memory, attention and mood.
She has also taken Ketotifen — an eyedrop antihistamine. She said she has also taken DHA; D and K vitamins; and Floradix for anemia.
She said meditation and breathwork have also helped calm her autonomic nervous system. Gradually, Dornan-Fish has felt some of her strength return.
“I’m ready for a game changer,” she said. “It doesn’t have to be a silver bullet, but I would definitely like something that makes a more significant difference in my ability to function.”
(NEW YORK) — One mother is dedicated to reaffirming that her daughter is beyond beautiful.
Nicole Hall’s daughter, Winry, was born with an extremely rare birthmark called congenital melanocytic nevi, or CMN. As such, the 13-month-old has a trait that makes her distinct from other children.
“When they first handed her to me, I thought it was a bruise,” Hall told ABC News’ Good Morning America. “It was then quickly apparent to my husband and I that it was not a bruise. And like the name, I thought it looked a lot like a mole.”
According to the report by the National Organization for Rare Diseases by Dr. Harper Price of Phoenix Children’s Hospital and Dr. Heather Etchevers of Marseille Medical Genetics, CMN can be light brown to black patches, can present in various ways, and may cover nearly any size area or any part of the body.
Instead of being sad about her daughter’s circumstances, Hall said she utilized the power of social media to promote awareness about CMN and to encourage others that being “different” is your superpower.
“For a lot of people, this is the first time seeing a birthmark like hers and that’s part of why I enjoy sharing,” Hall said. “This is a good conversation for parents with their children to see kids have differences, or for those parents who do have a kid that looks like Winry or has any kind of a birthmark to see their child represented.”
According to the Children’s Hospital of Philadelphia, Winry’s diagnosis could put her at a higher risk of developing melanoma. But Hall said she worries less about the risk of cancer than about the frequency of bullying she may experience as she gets older.
Still, Hall said she stays on top of things by taking extra measures to protect her skin.
“Her health and happiness are our top priority. We have to monitor her with sunscreen. I’m careful with hats and that sort of thing,” Hall said. “I know our regular dermatology appointment is probably going to be our best friend growing up.”
Her mom said Winry’s character is what truly sets her apart.
“She just radiates joy. She’s almost always laughing or shrieking. She is just the happiest baby I have ever seen,” Hall said. “She’s a big talker already. We haven’t got a whole lot of words out, but she tells you like it is and she’s already getting a little bit of sassiness, so I think we’re gonna have a lot on our hands.”
The massive following she has cultivated on TikTok has allowed Hall to virtually meet people from across the globe with a similar background to her daughter.
“We’ve got to talk to several people from Brazil with birthmarks,” Hall said. “One of them has one that is almost identical to Winry and it’s been so fun to talk to her because she’s almost exactly my age.”
(NEW YORK) — Two years into the coronavirus pandemic, children under age 6 may be one step closer to being eligible to get vaccinated against COVID-19.
Moderna said Wednesday it plans to seek emergency use authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine in young children “in the coming weeks.”
Pfizer’s vaccine is authorized in children 5 and older, but children 4 and younger don’t have access to vaccination.
Moderna released new clinical trial data showing its vaccine generated a strong immune response in children ages 6 months to 6 years old, with no significant risks.
Moderna’s vaccine in children is a two-dose, 25-microgram shot, about a quarter of the dose used for adults, given 28 days apart.
Moderna’s COVID-19 vaccine is currently only available for people ages 18 and older.
Here are nine questions answered about the COVID-19 vaccines and kids as families seek to make the best decisions.
1. What is the science behind the COVID-19 vaccine?
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.
The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.
This same type of vaccine has been authorized for Ebola and has been studied extensively for other illnesses and for how it affects women who are pregnant or breastfeeding.
Neither of these vaccine platforms can cause COVID-19.
2. What is the status of vaccine eligibility for kids?
Children ages 5 and older are now eligible to receive Pfizer’s two-dose vaccine.
Children ages 12 and older are also eligible to receive a Pfizer vaccine booster shot.
Pfizer is expected to have more information on the efficacy of a three-dose regimen for kids under age 5 in March or April. The company announced in February that it would postpone its application to the FDA for a vaccine for kids under 5 and instead continue with its study on the three-dose vaccine and seek authorization when that data is available.
The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.
Moderna said on March 23rd it plans to seek emergency use authorization from the FDA for its vaccine in children under age 6 “in the coming weeks.”
3. Why do kids need to be vaccinated against COVID-19?
While there have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and they can also transmit the virus to adults.
A total of 11.4 million children have tested positive for the virus since the onset of the pandemic. Child COVID-19 cases have “spiked dramatically” during the omicron variant surge, with more than 3.5 million child cases reported in January.
According to the CDC, unvaccinated 12- to 17-year-olds had an 11 times higher risk of hospitalization than fully vaccinated adolescents.
“We know that COVID does not spare kids,” ABC News medical contributor Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital, said in December. “Maybe it’s less severe than their adult counterparts but we also know that the virus has had real significant impacts on morbidity and mortality in kids.”
“We also know that kids play an important role as vectors of spread,” he said. “And especially in light of increases we’re seeing right now, with increases of cases in kids in record numbers, infections among kids further perpetuate community transmission and further create risks for those who would be the most vulnerable of the virus.”
4. Do kids experience the same vaccine side effects as adults?
Adolescents experienced a similar range of side effects to Pfizer’s vaccine as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August.
None of the children in Pfizer’s clinical trials of kids ages 5-11 experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.
5. Is there data showing COVID-19 vaccines are safe for kids?
The CDC released three studies in December showing COVID-19 vaccines are safe and effective for children.
One study, which evaluated the safety reports of more than 42,000 children ages 5 to 11 who received a Pfizer shot, found the side effects from the Pfizer vaccine were mostly mild and temporary. It also found that myocarditis, a heart inflammation side effect that has been associated with the mRNA vaccines in very rare cases, does not appear to be a risk.
A second study, which looked at data from 243 children ages 12 to 17 in Arizona, found the Pfizer vaccine was 92% effective at preventing infection. The study, conducted between July and December when delta was the dominant variant in the U.S., also found that adolescents who developed COVID-19 reported a lower percentage of time masked in school and time masked in the community.
The third study, also conducted when delta was dominant, found that among children ages 5 to 17 hospitalized due to COVID-19, less than 1% were fully vaccinated against the virus.
6. How effective are the vaccines in children?
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Marks confirmed on May 10 that after a trial with more than 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.
7. Do kids get the same dose of the vaccines as adults?
In Pfizer’s clinical trial, children between 6 months and 5-years-old received two doses of 3-microgram shots, a tenth of the dose given to adults, three weeks apart.
Kids ages 5 to 11 are given a 10-micrograms dose of the Pfizer vaccine, one-third of the adolescent and adult dose. Like with adults and adolescents, the pediatric vaccine is delivered in two doses, three weeks apart.
For 12-to-15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.
The FDA and CDC have recommended the Pfizer booster shots now available for kids ages 12 and older be administered five months after the primary vaccine series.
8. Could COVID-19 vaccines impact puberty and menstruation?
There is currently no clinical evidence to suggest any of the COVID-19 vaccines can have long-term effects on puberty or fertility.
9. Where can kids get vaccinated against COVID-19?
Vaccines are accessible at pediatricians’ offices, children’s hospitals, pharmacies like CVS, Walgreens and Rite-Aid and school and community-based clinics.
ABC News’ Sasha Pezenik, Anne Flaherty, Eric Strauss, Cheyenne Haslett and Jade A. Cobern, MD, a member of the ABC News Medical Unit, contributed to this report.
