(ATLANTA) — The Centers for Disease Control and Prevention was expected as early as next week to loosen its guidance on indoor masking as COVID cases and hospitalizations continue to drop and the White House considers a new nationwide strategy to move past the pandemic.
In a press briefing Wednesday, CDC Director Rochelle Walensky said the agency was looking at new metrics for relaxing pandemic guidance, including masks, and would deliver that updated guidance “soon.”
The idea would be that local communities could relax COVID restrictions, such as indoor masking, based on such factors as ICU bed capacity. While Walensky hasn’t offered specifics on what the benchmarks might entail, she has said hospitalization levels are a key barometer.
“We want to give people a break from things like mask wearing when these metrics are better, and then have the ability to reach for them again should things worsen,” Walensky told reporters.
The upcoming guidance comes as an increasing number of Democratic governors have already announced plans to lift mask mandates at the end of February or in March. Those decisions have largely been seen as a political calculation, driven by pandemic fatigue among voters.
The CDC has urged states to continue to recommend masks so long as the case number remain high, even as it considers new benchmarks. NBC News first reported on the timing of the expected guidance as early as next week.
“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we are on,” Walensky said Wednesday. “Things are moving in the right direction that we want to remain vigilant to do all we can so that this trajectory continues.”
The White House denied any political involvement in the timing of the CDC’s upcoming announcement. President Joe Biden is set to deliver his State of the Union address on March 1 in which he’s expected to lay out his own detailed plan to move the nation forward.
When ABC News asked at the press briefing if the Biden administration had pressed the public health agency for new guidance by the end of the month — ahead of Biden’s speech — a White House official insisted the CDC had not been given a timetable.
Jeff Zients, Biden’s chief COVID coordinator, said: “CDC is clearly in the lead here on the substance and the timing of masking guidance.”
(INDIO, Calif.) — Coachella is dropping all COVID-19 restrictions ahead of this year’s festival.
“In accordance with local guidelines, there will be no vaccination, testing or masking requirements at Coachella 2022,” a statement on the Coachella website reads.
The update comes after organizers announced last October that Coachella 2022 would require attendees to show either proof of vaccination or a negative test. That was amended from the initial policy announced by Coachella organizer Goldenvoice and its parent company, AEG Presents, which required full vaccination for admittance.
While no COVID-19 protocols will be enforced at Coachella ’22, its website notes that the policy is subject to change, depending on “applicable public health conditions.”
Additionally, the site now includes a “COVID-19 warning,” which cautions that the virus is an “extremely contagious disease that can lead to severe illness and death.”
“There is an inherent and elevated risk of exposure to COVID-19 in any public place or place where people are present and there is no guarantee, express or implied, that those attending the festival will not be exposed to COVID-19,” the site reads.
Coachella ’22 takes place April 15-17 and April 22-24, and will be headlined by Billie Eilish, Ye — the artist formerly known as Kanye West — and Harry Styles .
The festival hasn’t been held since 2019 due to the pandemic.
(NEW YORK) — Researchers revealed on Tuesday that an American, described as a middle-aged woman of mixed race, has likely been cured of HIV after undergoing a new transplant procedure using donated umbilical cord blood.
The patient, who needed a stem cell transplant for leukemia, reportedly developed a new HIV-resistant immune system following a breakthrough procedure in which she was genetically matched with umbilical cord stem cells that contained an HIV-resistant mutation.
She was part of a study that began in 2015 designed to monitor outcomes of 25 people with HIV in the U.S. who underwent a transplant, according to the National Institute of Allergy and Infectious Diseases.
Dr. Yvonne Bryson, an infectious disease physician at UCLA, who led the study, discussed their team’s finding along with the patient’s condition at the Conference on Retroviruses and Opportunistic Infections this week.
“Today, we reported the third known case of HIV remission and the first woman following a stem cell transplant and using HIV-resistant cells,” Bryson said in a press conference.
“This case is special for several reasons: First, our participant was a U.S. woman living with HIV of mixed race, who needed a stem cell transplant for treatment of her leukemia. And she would find a more difficult time finding both a genetic match and one with the HIV-resistant mutation to both cure her cancer and potentially her HIV. This is a natural, but rare mutation,” she said.
Bryson added that while this approach of using genetically-matched umbilical cord blood with HIV-resistant mutation opens the door to more diverse populations and studies, she confirmed there is no current routine screening in place in the U.S. for this mutation.
Previously, only two men have been cured of HIV using a bone marrow or stem cell transplant. And while this is the third known case, according to Bryson’s team, of HIV remission in an individual who received a stem cell transplant of any kind, experts in the field caution that this method is not ideal for curing the many millions of HIV-positive people around the globe today.
Bryson said there could eventually be “approximately at least 50 [people] per year that may benefit from this.”
In an interview with Community Health Center, Inc., Dr. Anthony Fauci, the leading expert in infectious disease in the U.S., whose work in HIV care and treatment innovation spans four decades, said, “I don’t want people to think that now this is something that can be applied to the 36 million people [globally] who are living with HIV.”
“This person had an underlying disease that required a stem cell transplant. … It is not practical to think that this is something that’s going to be widely available,” Fauci added. “It’s more of a proof of concept.”
While there is no practical and applicable cure for HIV on a large scale, there have been incredible strides in HIV treatment over the years that allow individuals to live a normal and healthy life.
Known as U=U, or Undetectable=Untransmittable, if an HIV-positive person begins HIV treatment and brings the virus in their body to an undetectable level, the individual cannot transmit the virus to someone as long as they remain on said treatment or medication.
Last month, the U.S. Food and Drug Administration approved the first long-acting injectable drug for HIV prevention.
Until recently, the only medications licensed and approved by the FDA for HIV prevention or pre-exposure prophylaxis, most commonly known as PrEP, were daily pills, which slow the progression of an HIV infection in the body.
PrEP is usually taken daily so that it builds up in in a person’s system, to the point that if there is an HIV infection, it prevents the virus from replicating and spreading throughout the body.
When taken as prescribed, PrEP services reduce the risk of getting HIV from sex by about 99%, according to new data from the Centers for Disease Control and Prevention. Now, individuals who feel at-risk of HIV infection have the option of taking the daily pill, or the new shot every two months, after two initiation injections administered one month apart.
On the vaccine front, Moderna recently announced that it’s launched early stage clinical trials of an HIV mRNA vaccine. ABC News previously reported that the biotechnology company teamed up with the nonprofit International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna’s successful COVID-19 vaccine.
Because bone marrow transplantation is a dangerous and risky procedure, it is considered unethical to perform on people with HIV, unless the person also has cancer and needs a transplant as part of their treatment.
Lev Radin/Pacific Press/LightRocket via Getty Images
(NEW YORK) — Nearly 1,500 New York City municipal workers have been fired over their refusal to get vaccinated against COVID-19.
That number represents less than 1% of the city’s workforce, but it appears to be the country’s largest workforce reduction linked to COVID vaccines.
Under a mandate set by former Mayor Bill de Blasio, city employees on leave without pay and those who were newly hired had been told they had until Friday, Feb. 11, to show proof of vaccination or they would face termination.
The workers on leave had to submit proof of their first dose and would then have 45 days to receive a second dose. The new workers had submitted proof of an initial dose when they were hired and were required to show they’d completed their vaccine series.
The 1,428 employees who were on unpaid leave for more than three months lost their jobs.
Data provided by City Hall Monday shows the majority of employees who were fired worked in the Department of Education, which saw 914 people let go. The Housing Authority terminated 101 workers.
Also fired were 36 New York Police Department workers and 25 FDNY employees.
Meanwhile, 939 employees on unpaid leave — about 40% of the group — opted to get vaccinated and keep their jobs.
Additionally, 99.8% of new employees showed proof of being vaccinated. Only two workers hired after Aug. 2 failed to get a COVID vaccine and were fired Friday.
The City Hall data shows the two employees were from the Department of Sanitation and the Human Resources Administration, respectively.
“City workers served on the frontlines during the pandemic, and by getting vaccinated, they are, once again, showing how they are willing to do the right thing to protect themselves and all New Yorkers,” Mayor Eric Adams said in a statement. “Our goal was always to vaccinate, not terminate, and city workers stepped up and met the goal placed before them.”
He continued, “Out of all the new city employees who received notices two weeks ago, only two who worked last week are no longer employed by the city. I’m grateful to all the city workers who continue to serve New Yorkers and ‘Get Stuff Done’ for the greatest city in the world.”
A city official told ABC News that residents should not notice any disruption of services due to the firings.
ABC News’ Mark Crudele contributed to this report.
(NEW YORK) — The majority of children under age 5 are getting more screen time than is recommended by pediatricians, new research shows.
The American Academy of Pediatrics (AAP) recommends babies and toddlers up to age 2 should avoid screen time other than video-chatting, while children ages 2 to 5 should be limited to no more than one hour per day of high-quality programming.
More than 75% of children younger than 2 and 64% of kids ages 2 to 5 exceeded the recommended guidelines, according to researchers at the University of Calgary, who analyzed over 60 studies looking at more than 89,000 children around the world.
The researchers described kids ages 5 and under as the “fastest-growing users of digital media,” citing research showing that prior to the coronavirus pandemic, kids in that age group used screens for an average of around 25% of the time they are awake each day.
They found that kids under 2 consume more TV and movies, while kids ages 2 to 5 engage in everything from TV and movies to tablets and video games.
“Digital media are now a regular part of young children’s lives, and supporting families to best fit evidence-based recommendations into their daily routines needs to be a priority,” the researchers wrote.
Too much screen time can be linked to obesity when it replaces physical activity or encourages mindless eating while being on screens, irregular sleep if they are on screens more than recommended, and even violence if exposed to violent content on TV, which can significantly impact their behavior, according to an article published by the Mayo Clinic in May 2021.
Other studies have found that there can be cognitive and emotional delays in a child’s development from excessive screen time.
While regulated screen time does have some potential benefits for kids, like learning opportunities, parents should monitor their kids’ use, according to Dr. Jennifer Ashton, ABC News chief medical correspondent.
“I think when you take into account the risk versus benefit, in this age group, the risks outweigh the benefits,” Ashton said Tuesday on ABC’s Good Morning America.
Ashton recommends limiting screen time by keeping kids engaged in a variety of ways.
One tip is to make a screen time schedule that sets time aside on the weekends for activities away from computers and tablets. Making a chart for older kids so they can see where they are on their schedule is also another way to limit screen time.
Ashton also said it is important to separate eating from screen time, so kids are not consuming snacks or meals while they watch.
And finally, Ashton recommends bringing in other activities, like getting outside with kids to walk or play.
(NEW YORK) — A Missouri mom is warning fellow parents about a rare condition caused by a strand of hair that sent her 5-month-old son to the emergency room.
Sara Ward, from St. Louis, shared a Facebook post explaining that her 5-month-old son, Logan, started developing a condition called hair tourniquet syndrome on Jan. 22 and, over the course of a week, had to be rushed to his pediatrician’s office, urgent care and later, the emergency room at SSM Health Cardinal Glennon Children’s Hospital.
“This was my first time and even with being a third-time parent, I was not aware of this beforehand,” Ward, a mom of three, told ABC News’ Good Morning America.
“I had never seen this or this (had) never come up with any of my friends or family members that are moms. So I was definitely kind of in the dark on just how severe this can be,” Ward said.
For Ward, the unexpected ordeal began when she and her husband noticed that one of Logan’s toes was “looking a little bit pink.”
“We kind of didn’t really think much of it that night because he didn’t seem bothered by it at all,” she said.
They went about their weekend as usual, but Ward said that after a couple of days, Logan’s toe started changing color again.
“By Monday, it hadn’t improved and it was starting to look redder and we were kind of noticing this line that was going across the middle of the toe.”
That’s when she decided to take Logan to see his pediatrician and it was at the doctor’s office that she first learned about hair tourniquet syndrome.
“Hair tourniquet syndrome is when there is a piece of hair, or a thread of another material like a piece of cloth, that’s tightly wrapped around a body part. It’s usually a finger or a toe, but it also can be the genitals,” Dr. Sara Holmstrom, a board-certified pediatrician and a pediatric emergency medicine fellow at Lurie Children’s Hospital in Chicago, explained to GMA.
Holmstrom said hair tourniquet syndrome cases are “pretty uncommon overall” and noted that in a 2015 review from Lurie Children’s, only 81 cases of patients ranging in age from 2 to 22 years old were reported from May 2004 to March 2014.
“It most often occurs in young infants under six months, most frequently on the toe, and most of the time, patients do not need surgery,” Holmstrom added. At 5 months, Logan matched the typical patient profile.
At the pediatrician’s office, Ward estimated that Logan’s doctor and nurses spent about 40 minutes trying to remove the hair that had somehow gotten wrapped around his third right toe.
“They took a look and they had to use all these kinds of special instruments. They brought in these magnifying goggles and special lights and they had these long tweezers and like little scalpels,” Ward said. “They were going in there and they could not get it either. I mean they were able to get one small piece of it but they did not feel confident that they got it.”
Logan’s pediatrician then sent the family home with orders to monitor his condition and see if the toe would get better on its own.
“Within a few hours of being home, it felt like the toe was starting to swell some and we felt like it was starting to look a little bit purple, in the back of the toe,” Ward said. “So we became concerned again, and I took him into the urgent care center. And they sent us right to the emergency room.”
Ward said several doctors responded to Logan’s case and he was admitted to the hospital for an overnight stay. By Tuesday morning, when Logan’s toe wasn’t immediately improving, doctors told Ward they had to start considering surgery as a treatment option.
“I was just kind of in shock the whole time that it was getting to this point. I just really thought nothing of it in the very beginning because it didn’t seem to bother him and once we went into the pediatrician and they mentioned that a piece of hair got wrapped around it, I still thought it was going to be an easy fix and that well then, you can just go in and we’ll remove the hair right here in the pediatrician’s office. … I think that’s where a lot of people don’t understand the severity that these hair tourniquets can cause and that it can get to that point,” Ward said.
Symptoms and treatment options for hair tourniquet syndrome
According to Dr. Katie Lockwood, a pediatrician at Children’s Hospital of Philadelphia, “typically, the affected body part becomes red, swollen, and sometimes has an indentation where the hair/fiber is in a circumferential pattern.”
“You will notice some redness and swelling of a digit, or the affected area, so fingers, toes and then sometimes genitals. So, more commonly the penis in males or labia in females … Sometimes it can cause breakdown of the skin so you may see a little bit of bleeding with time,” Holmstrom continued. “And if it’s been there for a really long time, the digit can actually turn purple, so not just a red discoloration but kind of purple and signs that the blood flow has not been adequate for some time.”
“If (parents notice) their babies are really fussy and they’ve checked all the usual things – they’re fed, they don’t have a wet diaper, they’re trying to console them – as a mom of a six-month-old myself, I would say, ‘Let me just take these socks off and take a peek at the toes,'” Holmstrom added.
Both physicians noted that if manual attempts at removing the hair or thread are unsuccessful, doctors will try other methods.
“We do this in the emergency room, use a chemical solution that dissolves hair,” Holmstrom said. “So over-the-counter, that’s Nair. Veet is another brand and we actually have that in the emergency room to dissolve the hair. And then worst-case scenario, if it can’t be manually or chemically removed, then surgical removal is needed.”
Ward said Logan did not need to have surgery and the hospital discharged him once his toe swelling started to improve.
“We’re actually not really sure what happened. Some of the swelling started to come down. So we’re not sure if maybe the hair removal creams might have worked. I mean, honestly, we couldn’t even tell you because we never even really saw the hair,” she said.
Her message to other parents?
“Be aware of hairs and always be checking the toes and fingers. If (you) see that a hair strand is wrapped around it, try to remove it as quickly as you can and if you can’t get it, then seek help from your pediatrician right away,” she said.
Lockwood and Holmstrom both recommend seeking medical care or contacting a pediatrician if a child can’t be consoled after all the usual methods are exhausted. Other signs it may be time to get a doctor’s opinion is if there’s any abnormal discoloration or swelling of a finger or toe that doesn’t subside.
Ward reported that it took at least a week for Logan’s toe to “fully look back to normal” and her baby boy has recovered three weeks after the incident.
(NEW YORK) — Joan MacDonald went from struggling with stairs to being a fitness influencer on Instagram with more than one million followers — and she did it while in her 70s.
Her transformation journey began five years ago, when she said she was fatigued, suffering from painful arthritis and struggled to walk up and down stairs.
Joan MacDonald’s breaking point, she said, came when she was told by a doctor that her blood pressure was rising and she would need to again increase her medication.
Her daughter, Michelle MacDonald, a fitness coach, was visiting her at the time and challenged her to make changes to her diet and exercise to improve her quality of life.
“When Michelle gave me that ultimatum to do something about my life, I figured it’s now or never,” Joan MacDonald said. “I was sick and tired of being sick and tired. It was existing, not living.”
In January 2017, just a few weeks before her 71st birthday, Joan MacDonald flew from her home in Canada to Tulum, Mexico, where Michelle MacDonald and her husband own a gym.
She began to follow a diet program laid out by her daughter that was focused on making sure she got enough macronutrients — fats, carbohydrates and proteins — in five meals per day, rather than sporadically snacking like she had done before.
Joan MacDonald also began to workout in the gym for the first time with Michelle MacDonald, founder of The Wonder Woman, a strength and bodybuilding coaching program.
“It was tough in the beginning,” Michelle MacDonald said. “People don’t realize that [my mom] was there in the trenches, trying to figure it all out and getting frustrated.”
According to Joan MacDonald, her motivation to continue came from how much better she started to feel very quickly.
She said she lost around 10 pounds in the first month of training, and in just a few months she was able to reduce her medications by half.
Once she returned to Canada, Joan MacDonald continued with her wellness journey by tracking her food on a macronutrient-focused app and by continuing her workouts.
“I go to the gym five days a week,” she said, noting two of those days are cardio-focused workouts. “I like that routine, because it gives you something to look forward to.”
Over the past four years, she said she has maintained a 65-pound weight loss and gone off medications for high blood pressure, high cholesterol and acid reflux.
As she transformed her health, Joan MacDonald said she was encouraged by her daughter to start an Instagram account to document her progress and connect with other people.
Today, her Train With Joan Instagram account has 1.5 million followers. She also has a website and an app that offers workout and meal plans overseen by Michelle MacDonald, who specializes in coaching women of all ages.
Joan MacDonald said she hopes people who follow her journey take away that it’s never too late to change your life, no matter your age or situation.
“Nothing is magical. It’s work, but it’s work that you can enjoy,” she said. “In the end, you are going to be stronger and healthier, and that’s all that really matters.”
The MacDonalds shared five tips for people who want to transform their health, no matter their age:
1. Think about your sleep.
“We live in a culture that doesn’t prioritize sleep,” Michelle MacDonald said. “But there’s so much research that shows when you’re not getting eight hours of quality sleep, it really negatively impacts you hormonally, cognitive function and your body.”
2. Drink lots of water and eat protein with every meal.
Michelle MacDonald said most women she works with, including her mom, come to her not eating enough calories. She recommends eating five meals consistently throughout the day and including protein at every meal, with the goal of eating in total daily one gram of protein for every pound of a person’s ideal body weight, so 130 grams of protein if their ideal weight is 130 pounds.
In addition, Michelle MacDonald recommends drinking at least three liters of water for day, for most people.
“Drink more water, and pace it out,” she said. “Drinking mindfully is an easy way to attach yourself to this idea that you’re taking care of yourself.”
3. Get active.
Start by just walking, aiming for 10,000 steps per day, which can be broken up and completed throughout the day, according to Michelle MacDonald.
Once a person is ready, she recommends adding in 45 minutes of strength training a few day per week.
“Train with intention, not lifting the same weight forever,” she said. “If you want to use the weights to change your body, you want to do that with intention and try to push yourself.”
4. Focus on a positive mindset.
Joan MacDonald said she continually works on having a positive inner dialogue in order to help her reach her goals.
“Mindset is something that I am still learning, and I know that it’s a very strong factor in everything,” she said. “It’s something you really have to work at.”
Both she and her daughter recommend journaling in the morning to set intentions and start off the day with a clear head.
5. Document your progress.
Take a photo of yourself on the day you start your journey, and keep documenting your progress, Michelle MacDonald recommends.
“Have a starting photo … and take photos every week,” she said. “You may not feel changes, but you’ll see them.”
(NEW YORK) — New York City began distributing free, at-home COVID-19 test kits across the five boroughs Monday.
Tests, made by the company Flowflex, will be available at 27 public library branches and 14 cultural landmarks including the American Museum of Natural History, the Brooklyn Children’s Museum and the Staten Island Zoo.
Across the city, there are 13 sites where tests can be picked up in Queens, 10 in Brooklyn, seven in Manhattan, six in the Bronx and five in Staten Island. More sites are expected to be added over the next few weeks.
“Our mission remains to make testing resources accessible for all New Yorkers to safely and confidently manage the pandemic,” Dr. Ted Long, executive director of the NYC Test & Trace Corps, said in a statement. “Distributing at-home tests at cultural sites and libraries provides familiar, prominent locations for people to pick up the resources they need to know if they have COVID-19 and to return to the beloved destinations that make our city so special.”
He continued, “I am grateful for our cultural and library partnerships and excited to see them lead New York City safely forward.”
Test & Trace will be delivering kits to the libraries and cultural sites once a week, and supplies are available on a first-come, first-served basis.
“We will have sent out over 350,000 tests by end of week. [Distribution] to each site varies, but we are confident that we can meet demand,” a spokesperson for NYC Health + Hospitals, which oversees Test & Trace, told ABC News in a statement.
Test kits are limited to one per person and, although distribution will be up to the individual site, Test & Trace is recommending one per day, the spokesperson added.
Test & Trace said its website will be updated daily with the hours and locations of sites where the tests are available.
The new program comes just two weeks after Mayor Eric Adams said the city will be offering free at-home, same-day delivery of COVID antiviral pills for those with mild to moderate symptoms.
The city is also pushing for more residents to get vaccinated. Over the weekend, Adams announced the return of cash incentives including a $100 gift card for anyone who gets their first dose or is boosted at a city-run or SOMOS Community Care site through the end of February.
The gift cards will be eligible for use through March 31.
Mike Coppola/Getty Images for American Heart Association
(NEW YORK) — Actress Susan Lucci is opening up about her battle with heart disease.
The 75-year-old, best known for her role as Erica Kane on the ABC daytime drama All My Children, told Good Morning America’s Amy Robach that she recently underwent an emergency heart procedure for the second time.
“I was having kind of a shortness of breath,” said Lucci, adding that she soon also felt discomfort around her ribcage and her back, similar to symptoms she had three years ago with her first heart scare.
“I thought, ‘This is crazy. These are the same kind of symptoms that I had three years ago but it can’t be,'” she said. “But when I lay down, I started to feel a sharp coming-and-going pain in my jaw.”
Lucci said when she called her doctor, he told her to go to the emergency room.
After undergoing several tests, Lucci’s doctor told her that she experienced an 80% blockage in one of her arteries due to plaque buildup. She was rushed to a cardiac catheterization lab, where another stent was put in to open up the blockage.
“She wasn’t having a heart attack this time and she wasn’t unstable,” Lucci’s doctor, Dr. Richard Shlofmitz, chairman of cardiology at St. Francis Hospital in Roslyn, New York, told GMA. “But she had symptoms that were certainly concerning to me that something might be wrong.”
Shlofmitz said if Lucci waited for her symptoms to get worse, it could have turned into a major emergency.
According to the Centers for Disease Control and Prevention, cardiovascular disease is the leading cause of death for women in the U.S. About 1 in 16 women age 20 and older have coronary artery disease, the most common type of heart disease in the U.S.
The CDC says that heart disease may sometimes be “silent” and not diagnosed until other symptoms are present. To lower your chances of heart disease, doctors suggest managing stress levels, getting blood pressure checked regularly, check for diabetes and to quit smoking. Other ways to lower your risk of heart disease include being active, eating healthy and limiting alcohol intake.
Now Lucci, an advocate for the American Heart Association’s Go Red for Women campaign, is urging other women to listen to their bodies.
“Listen to your heart and act on [the symptoms],” Lucci said. “Give yourself permission to take good care of yourself. Be your own best friend. Be your own advocate. You’ll save your life.”
(WASHINGTON) — The Food and Drug Administration has authorized a new monoclonal antibody treatment for COVID-19, shown to hold up against the omicron variant and BA.2 subvariant.
The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital.
The authorization comes after months of explosive spread of the omicron variant has squeezed an already finite arsenal of COVID-19 medicines.
Lilly’s previous monoclonal treatment was one of the two the government bought in bulk that have been shown to fail against omicron, leaving the federal government scrambling to stock up on functional omicron therapies. Meanwhile, the treatments that have been shown to work against omicron have been scarce — forcing difficult choices about which patients in need should get that limited supply.
On the eve of authorization, the Biden administration announced it had purchased 600,000 doses of bebtelovimab for at least $720 million. The plan is to get roughly 300,000 doses out this month, and another 300,000 in March. The contract also includes a future option for 500,000 more doses, if necessary.
The authorization brings the number of treatments for omicron in the U.S. to four, though production is still ramping up. The other options include the monoclonal therapy sotrovimab, from Vir Biotechnology and GlaxoSmithKline; and two antiviral pills, Pfizer’s Paxlovid and Merck’s Molnupiravir.
Daniel Skovronsky, Eli Lilly’s chief scientific and medical officer and president of their research labs, said in an interview with ABC News that the company began working on the therapy more than a year ago — long before omicron emerged — in hopes of being “future proof” for a range of variants and anything else that might come down the road.
It was meant as a “break glass in case of emergency” solution, Skovronsky said.
But once the new variant caught on, which the mainstay treatments failed against, getting a new one authorized suddenly became critical.
“Once omicron was identified, there was urgency in making sure that this antibody worked against it, and working with the government to try and make it available as quickly as possible to patients,” Skovronsky said. “It’s an unusual situation where you’re trying to fight a disease that in some sense doesn’t exist yet. … We can’t protect ourselves from something wholly new that the world has never seen before.”
Lilly’s new drug is authorized to be given as an intravenous injection from a health care provider — a notable change from the arduous hourslong infusion that came with previous monoclonal antibodies, a process that requires a great deal of clinical manpower. It must be administered within seven days of symptom onset.
“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement, calling the new emergency use authorization “an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”
“We’re already working on the next generation antibodies, looking for things that bind in different ways than bebtelovimab so that in case this one ultimately is overcome by virus mutants we’ll have something else to offer,” Skovronsky said. “You have to stay one step ahead of this virus.”
ABC News’ Eric M. Strauss and Anne Flaherty contributed to this report.
