(NEW YORK) — The World Health Organization said Monday that COVID-19 remains a public health emergency but the pandemic is at a “transition point.”
The agency said its International Health Regulations Emergency Committee met on Friday to analyze data on the state of the pandemic.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus “acknowledges the Committee’s views that the COVID-19 pandemic is probably at a transition point and appreciates the advice of the Committee to navigate this transition carefully and mitigate the potential negative consequences,” the statement read.
According to a transcript of Tedros’ speech at the meeting provided by the WHO, he said there is still a high risk of COVID-19 global transmission, which means the virus is still classified as a Public Health Emergency of International Concern.
However, he said the world is in the best position it has been in — due to diagnostics, vaccines and treatments — to beat back COVID.
“As we enter the fourth year of the pandemic, we are certainly in a much better position now than we were a year ago, when the omicron wave was at its peak, and more than 70,000 deaths were being reported to WHO each week,” Tedros said during the meeting, according to a transcript provided by the WHO.
“When you last met in October, the number of weekly reported deaths was near the lowest since the pandemic began — less than 10 thousand a week. However, since the beginning of December, the number of weekly reported deaths globally has been rising,” Tedros continued. “But the global response remains hobbled because in too many countries, these powerful, life-saving tools are still not getting to the populations that need them most – especially older people and health workers.”
Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital, said the WHO’s comments show that the agency recognizes the public health emergency is winding down but that the virus’ threat remains.
“What we have to remember is the pandemic won’t end on a given day,” said Brownstein, an ABC News contributor. “The metrics around cases, hospitalizations and deaths are painting a more optimistic picture and we’re seeing more countries getting out of this acute phase.”
He added that the danger of COVID is still very real, with deaths twice as high from COVID as they are from the flu.
“If you look at data around deaths, we’re still seeing twice as many people dying from COVID than flu every season and flu is only a quarter of a year, and we’re seeing that number,” Brownstein said.
During the WHO meeting, Tedros urged groups at higher risk of severe disease and death — including those who are immunocompromised and elderly — to be fully vaccinated and boosted.
He also encouraged more countries to ramp up testing and use antivirals early on among those who test positive for COVID-19.
(NEW YORK) — School-aged children faced significant learning loss during the early days of the COVID-19 pandemic, data shows.
The finding shows that, even though we have developed new tools, like effective vaccines, to protect us from COVID-19, long-term ramifications persist.
Children lost out on about one-third of what they usually would have learned during the academic year from 2020 to mid-2022, according to a new analysis published in the journal Nature Human Behavior.
“Children still have not recovered the learning that they lost out at the start of the pandemic,” said Bastian Betthäuser, an assistant professor at the Observatoire Sociologique du Changement at Sciences Po in France and lead author of the new study, during a press briefing.
They didn’t appear to lose additional ground as the pandemic went on, he said — but governments also weren’t able to recover the initial deficits, the study said.
The new data joins a bigger-picture evaluation of how the disruptions caused by the pandemic — like school closures, widespread illness and social changes — affected children’s learning. And it’s contributing to the growing efforts to figure out the best way to move forward.
“It’s very hard to recover learning deficits, once they’re there,” Betthauser said during the press briefing.
To understand learning loss during the pandemic, researchers collected data from 42 previous studies from 15 countries, published within the March 2020 to August 2022 time frame. The researchers estimated that, collectively, students experienced a decline in knowledge and skills equivalent to approximately 35% of the overall school years’ worth of learning. These deficits remained constant for the approximately 2.5-year time period studied.
The research team saw a similar pattern when they looked at data from the United States alone.
The new study also suggested that COVID-19 increased the educational inequalities between children of different socioeconomic backgrounds.
Although most data was from high-income countries and middle-income countries, researchers found that students in middle-income countries had greater learning deficits than students in higher-income countries.
The new study also showed that math skills were harder hit than reading skills.
That might be because parents were better equipped to help their kids with reading than math, and the greater need for closer guidance in the STEM fields, the research team suggested in the study.
What contributed to learning loss?
The new study did not evaluate the actual causes of the learning losses, but experts point to a number of factors — changes to the school environment, disruption in family life, limited face-to-face instruction, reduced extracurriculars, along with many other possibilities.
“There’s been a lot of debate on how variation in academic decline plays out across states and policy choices about closing schools, but, at this point, it’s not clear that school closure policies were the main driver of the drops in performance,” Nathaniel Schwartz, director of applied research at Brown University’s Annenberg Institute for School Reform, told ABC News.
And it’s not clear what the alternatives could have been, experts said. During the start of the pandemic, when much was still unknown about the virus, policy makers and school leaders across the world had to make quick decisions and adapt to a volatile landscape.
Rachel Ohayon, a former 5th grade science teacher at a New York City charter school experienced the challenges of transitioning to online school. Setting disciplinary boundaries and simulating the classroom environment in a completely new virtual platform was not easy, she told ABC News.
“I think my school had a slight advantage because we gave out chrome books to our students, so they were all set up when we went remote,” she said.
But even with these measures in place she said it was still difficult to achieve the same level of focus among her students.
School closings likely impacted more than just educational progress. Children’s learning online may have also impacted their social and emotional development according to Paul Peterson, director of the program on Education Policy and Governance at Harvard University.
“The transition back to in person learning was exhausting and stressful, we had to deal with a lot of acting out and intense emotions as children came back to school,” said Ohayon.
How do we help kids recover?
Along with understanding the learning gaps, experts are working to identify the best way to recover from them.
“There are two points of view: that we can make it up or that we can’t make it up,” Peterson said.
“I’m concerned we didn’t really think about this during the pandemic — what we would do the day schools reopened,” he said.
Peterson added that actions taken to help combat these deficits may have been insufficient and too slow.
Schools are also struggling to find staff for programs that could try to close gaps, Shwartz said.
“Schools and districts are facing a landscape where hiring for these positions is difficult, where other ongoing work is crowding out possible new programs — and truly, where many of the people in schools at both the staff and student level are often feeling drained,” Schwartz said.
Betthäuser is more optimistic.
“I wouldn’t say it’s a hopeless case at all,” he said in the briefing.
Peterson said one-to-one instruction may be the most effective type of intervention.
“My own view is that tutoring is the best intervention. It’s expensive but allows you to target the intervention to the specific child,” he said.
Parents can also use time at home to provide one-to-one support to their kid, he said.
In Ohayon’s school, they tripled the size of the guided reading program in an effort to “close the gap from remote learning,” she said.
It’s hard to balance additional instruction against the risks of overloading kids with work.
“Kids only have so much capacity to take in new material to learn new skills,” Betthauser said in the briefing.
He thinks summer time break may be a good time for targeted interventions.
“We know from the summer learning literature that there is potential for summer learning programs to help children learn and also to prevent inequalities from widening during this period,” he said.
Experts said there needs to be a collaborative effort to critically assess how these gaps can be addressed. Such actions are especially critical in lower-income settings, where access and quality of education was already compromised. Students with special educational needs may also require extra attention.
Ohayon said her biggest takeaway as a science teacher was on the “importance of connecting with students.” The best way she’s found to help her students make up their gaps is by coming up with creative ways to engage them in the classroom.
“There’s a lot that can be done,” Betthauser said in the briefing, “I think it’s important that we’re honest about the size of the problem and try to match that.”
(WASHINGTON) — The U.S. Food and Drug Administration said Thursday it is withdrawing its emergency use authorization of a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants that are currently circulating.
Evusheld, which is made by British-Swedish pharmaceutical and biotechnology company, AstraZeneca, was first authorized in December 2021 as pre-exposure prophylaxis against the virus for those who are immunocompromised and less likely to generate antibodies from vaccination.
However, the FDA said the medication does not neutralize several omicron subvariants including BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.
According to the Centers for Disease Control and Prevention, these subvariants make up at least an estimated 90% of cases in the U.S.
“This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants,” the FDA said in a press release.
“Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the press release continued.
The FDA has been warning for months that Evusheld might not be very effective, starting in February 2022 when data showed a higher dose may be able to prevent against infection from omicron subvariants BA.1 and BA.1.1 than the originally approved dose.
As recently as Jan. 6 of this year, the FDA said it didn’t believe Evusehld would be able to neutralize the XBB.1.5 subvariant “because of its similarity to variants that are not neutralized by Evusheld.”
AstraZeneca did not immediately reply to ABC News’ request for comment. In a statement, the pharmaceutical company said it is aware of the decision and that it is cooperating with the FDA.
“AstraZeneca will continue to work with the FDA and other health authorities to collect, assess and share relevant data regarding Evusheld and SARS-CoV-2 variants,” the statement read. “Evusheld currently remains authorized in other countries where it is approved for COVID-19 pre-exposure prophylaxis and treatment, including the EU and Japan.”
Evusheld is a type of monoclonal antibody treatment, which are a cocktail of antibodies that are manufactured in a lab and mimic the antibodies the body naturally creates when fighting the virus.
They bind to the spike protein, which prevents the virus from attaching to — and infecting — cells.
The FDA said if someone tests positive for COVID-19 and develops symptoms, they should contact their primary care provider and, if needed, ask to receive antiviral medications Paxlovid, molnupriavir or remdesivir, which work against the currently circulating variants.
Despite Evusheld losing emergency use authorization status, the FDA urged providers not to discard their doses of the drug.
“The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future,” the FDA said in its press release.
(NEW YORK) — A Peloton instructor is opening up for the first time about her battle with breast cancer, revealing she got a lifesaving second opinion after discovering a lump on her breast.
Leanne Hainsby, a 35-year-old cycling instructor for the fitness company, revealed on Instagram that she was diagnosed with breast cancer last August.
She wrote that she self-discovered a lump on her breast and was told “everything was OK” at a doctor’s appointment that same day.
“I trusted my gut and got a second opinion. That saved my life,” Hainsby wrote, adding to her followers, “Check, and check again.”
Hainsby, who is based in London, said that in the past six months since her diagnosis, she has undergone surgery as well as 12 weeks of chemotherapy.
She said she will next undergo two weeks of radiation.
“Treatment will continue for a long time for me, hospital visits are the norm, and I focus on one step at a time,” wrote Hainsby, who did not share what stage of cancer she is battling.
Hainsby also shared that prior to chemotherapy, she underwent in-vitro fertilization, or IVF, which can be done if there is concern that the chemotherapy medicine may cause infertility.
“I was lucky enough to be given time ahead of chemotherapy to do a round of IVF,” Hainsby wrote, adding of her and her partner, a fellow Peloton instructor, “We weren’t mentally prepared, but we got it done and we’re so grateful.”
Hainsby’s confirmation of her diagnosis at age 35 underscores the warning that breast cancer can impact women of all ages, though most breast cancers are diagnosed in women ages 50 and older, according to the Centers for Disease Control and Prevention.
In the United States, breast cancer is the second-most common cancer among women, with over 260,000 new cases reported in 2019, the latest data available, according to the CDC.
Although the risk for breast cancer in young women remains low, breast cancer found in young women can be more aggressive and more difficult to treat, Dr. Margaret Thompson, a doctor in breast services at Cleveland Clinic Florida, told ABC News in October.
Breast cancer can also be more difficult to spot in young women.
Younger breast tissue tends to be more dense so spotting tumors, even on mammograms, can be more challenging and may be misdiagnosed, according to the Cleveland Clinic.
Mammogram screenings are recommended once every two years for women age 50 to 74 years who have an average risk of breast cancer, according to U.S. Preventive Services Task Force guidelines.
Women ages 40 to 49 may choose to begin screening once every two years if they “place a higher value on the potential benefit than the potential harms” of the mammogram, according to the guidelines.
For women of all ages, when an ultrasound shows a concerning finding, a follow-up visit should be scheduled to discuss next steps with your healthcare provider.
(NEW YORK) — Autism is on the rise among young children, according to a new study.
The study, published Thursday in the journal Pediatrics, found that autism rates tripled over the last 16 years.
Researchers at Rutgers University looked at more than 4,000 8-year-olds in the New York and New Jersey areas.
They said the sharp rise in autism rates is largely due to greater awareness, better diagnosis tools and a broader definition of autism. Researchers also noted the greatest increases in diagnoses were amongst affluent children, concluding that children in underserved communities are not getting the same access to medical resources.
Autism, also known as autism spectrum disorder, is defined by the Centers for Disease Control and Prevention as a “developmental disability that can cause significant social, communication and behavioral challenges.”
On the national scale, around one in 44 children has been diagnosed with autism spectrum disorder, according to the CDC.
The disorder begins before a child turns 3 and can last through their lifetime, though symptoms may improve and vary, the CDC notes.
“You want to talk to your child’s pediatrician about this because early intervention makes a big difference,” said Dr. Jennifer Ashton, ABC News chief medical correspondent, adding, “Remember, those children [with autism spectrum disorder] grow up to be teens and adults, so the more we can help them the better their outcomes can be.”
What to know about autism
People with autism have a wide variety of traits affecting communication, behavior and socialization, according to the CDC.
The “spectrum” means that there’s a wide range of symptoms and severity.
A child of any race, socioeconomic status or ethnic group can get ASD. Boys, however, are four times more likely to be diagnosed with autism than girls based on a study of children aged 8 years old. Kids that have a sibling with autism, and especially a twin, are more likely to have autism. Those with developmental disabilities or genetic and chromosomal diseases such as Down syndrome are also more likely to have ASD. There is also evidence that kids born to older parents have an increased risk of autism, according to several studies.
Autism can be identified as early as infancy, although most children are diagnosed after the age of 2. There is no medical test to diagnose autism, so doctors watch a child’s behavior and development to make a diagnosis, according to the CDC.
The American Academy of Pediatrics recommends all children be formally screened for autism spectrum disorder at their 18- and 24-month-old well-child visits. The AAP says pediatricians though will begin monitoring babies at their first well-child visit by observing their behaviors.
“It is those observations — in combination with family history, health examinations, and parents’ perspectives — that help pediatric primary health care providers identify children at risk for ASD,” the AAP says on its website.
The CDC notes that in some cases people are not diagnosed with autism until they are teens or adults.
Experts say though that early detection of ASD is key, as is early intervention.
Early signs of autism in children may include, but are not limited to, little or no smiling and limited eye contact by 6 months; little to no babbling, pointing or response to their name by 12 months; and few or no meaningful two-word phrases by 24 months, according to the CDC.
Additional signs of autism may include delayed social interactions, exhibiting repetitive behaviors or showing a limited interest in activities and sensory issues like sensitivity to noise or sound.
“Someone might have the communication delay but may not have the motor skill delay,” said Dr. Jen Clark, a New York-based clinical psychologist and specialist in autism, told ABC News last year. “They may experience sounds and lights in a very different way than you and I would and sometimes they can experience a sensory overload and they may wear headphones and this will help to make the noise not as severe, but also they may avoid certain situations where it’s just too overwhelming.”
Treatment comes in many different forms, from mental health therapy to occupational, physical and speech therapies. Sometimes medications can be helpful for things related to ASD, like mood problems or inability to focus.
(WASHINGTON) — The U.S. Food and Drug Administration announced Friday it will ease blood donation restrictions on gay and bisexual men, allowing those in monogamous relationships to donate.
The policy change comes after years of urging by public health experts, blood banks and LGBTQ advocacy groups. The new policy would address future blood shortages and remove the stigma around gay men, experts say.
Additionally, the American Red Cross and the American Medical Association have both supported a risk-based approach to donor eligibility.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
Rather than a blanket ban due to sexual orientation, the relaxation of the rule would screen potential donors on their risk of contracting and transmitting HIV.
In 1985, in response to the HIV/AIDS crisis in the 1980s, the FDA banned all blood donations from men who have sex with men.
The policy did not change until 2015, when rules were slightly relaxed to allow this group of donors to give blood as long as they abstained from sex for one year. In 2020, amid severe blood shortages during the start of the COVID-19 pandemic, the FDA shortened the abstinence period to 90 days.
The policy change means gay and bisexual men in monogamous relationships can donate without abstaining from sex as long as they test HIV negative and are practicing safe sex.
It also means the U.S. will join several Western countries, including the United Kingdom, France, Greece and the Netherlands, which have recently either dropped bans or eased restrictions.
Last month, the FDA told ABC News the evidence analyzed so far will “likely support a policy transition” that focuses screening blood donations based on each person’s HIV risk.
In 2020, the FDA launched a study called ADVANCE to look into alternative solutions to its current policy. The FDA is currently reviewing research from the American Red Cross, OneBlood and Vitalant to determine if eligibility based on an individual’s risk can replace the current time-based deferral system while maintaining the safety of the blood supply.
Experts say the updated policy will also help address the national blood shortage and, in turn, save lives. In January 2022, the American Red Cross said it was facing its worst blood shortage in more than a decade, although it is no longer in a crisis.
Despite the easing of rules, non-monogamous men are not allowed to donate even if they produce a negative HIV test, practice safe sex with condoms or take pre-exposure prophylaxis, or PrEP — a daily pill containing two medications that prevent HIV-negative patients from being infected.
ABC News’ Sony Salzman and Kiara Alfonseca contributed to this report.
(NEW YORK) — Randy Gonzalez, the Texas father behind the popular “Enkyboys” account on social media died Wednesday at age 35, his mother Beatrice Gonzalez and brother David Gonzalez confirmed to ABC News.
Gonzalez’s death came less than one year after he announced he had been diagnosed with stage 4 colon cancer.
Gonzalez and his son Brice became famous on TikTok for their funny father-son comedy bits and dances.
“At first, we were kind of shy but we broke out of that shell because people love Brice so much and then they love the duo of the father and son, so we were just like, ‘Let’s go! Let’s do it!'” Gonzalez told Good Morning America back in 2020 about the rise of “Enkyboys.”
Last April, Gonzalez revealed in a video post that he had been diagnosed with stage 4 colon cancer in November 2021.
“I kept it to myself and I felt like it was selfish because I didn’t want to tell everybody my business because it was personal. But I feel like I can use my situation to give awareness for young men like myself because I’m only 34, and they say it’s very rare for a young guy like myself to catch colon cancer,” Gonzalez said in the video at the time, adding that a doctor had told him he had a life expectancy between two and five years.
“I didn’t know how to take it. You know, it was devastating,” Gonzalez continued.
In the video, Gonzalez also opened up about one of his initial symptoms that led him to see a doctor in the first place.
“I want to help other people and start awareness for young men to go get checked for colon cancer, to go get a colonoscopy. How I figured out, I was having a problem with my upper abdomen and I was always in pain,” he said. “And luckily, my wife told me to go get a colonoscopy because I was just gonna get an EGD [esophagogastoduodenoscopy] through my throat because they thought it was a ulcer or something. But long story short, I wanted to start awareness of colon cancer for young men to start, to go get checked in the early ages, 30 years old.”
Since then, the “Enkyboys” social media accounts have featured posts aimed at raising colon cancer awareness, with Gonzalez sharing the symptoms he experienced, such as abdominal pain and constipation, and taking fans along as he underwent chemotherapy treatments.
According to the Centers for Disease Control and Prevention, colon or colorectal cancer is a type of cancer originating from polyps in the colon or rectum. In the U.S., it has become the second-leading cause of cancer-related deaths.
The disease can affect men and women of any racial and ethnic background. People at increased risk of developing colon cancer include individuals with a family history of colon polyps or colon cancer and those with bowel diseases like Crohn’s disease or ulcerative colitis. Lifestyle can also play a role and increase a person’s risk, such as a diet high in fat and low in fiber, the use of alcohol and tobacco and a lack of physical activity.
Last year, a major study showed that more young people, including more individuals of non-Hispanic Black and Hispanic descent and those between the ages of 20 and 29, have been getting diagnosed with late-stage colon cancer in recent years, prompting doctors to call for more early detection and colon cancer screenings of individuals younger than 50.
Who should get screened for colon cancer?
The U.S. Preventive Services Task Force and CDC currently recommend that people between the ages of 45 and 75 get regular colon cancer screenings, while those older than 75 should consult with their doctor before getting a screening. If at increased risk due to family history of colon polyps or colon cancer or for those with bowel diseases, screening may start before the age of 45, but this should be discussed with a doctor beforehand. A screening can consist of a stool test, a flexible sigmoidoscopy where a doctor places a tube in the rectum to check for polyps, a colonoscopy, or a CT colonography or virtual colonoscopy.
What are the symptoms of colon cancer?
An individual with colon cancer may not always exhibit symptoms initially, according to the CDC, and they can vary. Symptoms include:
Abdominal aches, pain or cramps
Bowel habit changes, including a feeling that the bowel does not empty entirely
Blood in the stool
Constipation
Diarrhea
Unexplained weight loss
Gonzalez is survived by his wife Kimberly and their three kids, son Brice and daughters Lauren and Nylah. Kimberley Gonzalez and her daughters also have their own TikTok and social media accounts called “Enkygirls.”
(WASHINGTON) — FDA’s Deputy Commissioner for Food Policy and Response, Frank Yiannas, has announced he is resigning from his post. His departure comes in the wake of last year’s infant formula shortage, throughout which Yiannas held a prominent leadership role.
The decision also comes amid the ongoing HHS-OIG audit into whether the FDA responded adequately to the mounting crisis, as ABC News was first to report — and whether the agency followed proper recall protocol once a deadly bacteria had been detected inside Abbott’s Michigan formula plant.
Additionally, the FDA is preparing to give an update later this month on steps it plans to take to strengthen its foods program, following an independent review that found it lacks leadership and mission clarity.
An FDA spokesperson tells ABC News that “by the end of February,” they will also offer additional updates on how they’re improving their organizational structure — including how Yiannas’ position responsibilities will be handled moving forward.
Yiannas had been in his role since December 2018. His resignation will be effective February 24, writing in a tweet he is “honored to have served the American public, alongside each and every one of you, over these past four years.”
Yiannas was among the senior officials who was involved in responding to the formula crisis and admitted to lawmakers in May 2022 that a string of internal failures and communication breakdowns at his agency contributed to how bad the situation had grown.
Lawmakers and the public alike repeatedly pushed for further clarity on why it took so long for federal regulators to respond to the mounting crisis.
Months before Abbott’s massive formula recall in February of last year, there had already been warnings about quality and safety concerns at the key facility.
There had been a whistleblower report alleging a “litany of violations” and safety issues at Abbott’s key plant sent to the FDA in October 2021 — however, as Yiannas said under oath before Congress in May 2021, he and other FDA leaders didn’t learn that report for months. The agency blamed their mailroom and called it an “isolated failure” that was “likely due to COVID-19 staffing issues.”
Yiannas said the complaint was not immediately escalated, and he didn’t see it until mid-February, roughly four months after it had been sent.
By that time, as ABC News has reported, reports of infants getting sick and hospitalized after consuming Abbott’s formula had already been emerging, including one who had already died — in addition to the quality and safety concerns flagged at their Sturgis facility.
However, Abbott maintains none of the bacterial strains found at their plant matched the samples genetically sequenced from the hospitalized infants, and that there is no conclusive evidence that its products contributed to the ultimate death of two infants.
“Why is it then, if you’re the deputy commissioner for food policy, you didn’t get the report?” Rep. Gary Palmer (R-AL) asked during the previous May hearing. “How is it that it got tied up in bureaucracy and it didn’t get to the person who arguably should be responsible for responding to it?”
“Yeah, I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” Yiannas said. “As you’ve heard the commissioner state, I know there’s going to be a review, and we’re going to try to get to the bottom of it.”
Yiannas’ boss, FDA Chief Robert Califf, acknowledged the response to the formula crisis had been “too slow,” and that “there were decisions that were suboptimal along the way.”
In his resignation letter, tendered to Califf on Wednesday, Yiannas does not own any responsibility for the agency’s missteps during the formula crisis — rather, he touts his achievements.
“In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the foods program that you and I both inherited, significantly impaired FDA’s ability to operate as an integrated food team and protect the public,” Yiannas’ letter says.
“It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability more prevalent, and – very importantly – the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position.”
In a statement to ABC News, the FDA thanked Yiannas for his “service and dedication.”
“The FDA can confirm Frank Yiannas has resigned from his position as deputy commissioner for Food Policy and Response effective February 24. The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission,” the agency said. “Mr. Yiannas has served as a valued member of the agency’s leadership team, spearheading important initiatives including the New Era of Smarter Food Safety to help create a safer and more digital, traceable food system for our country.”
ABC News’ Anne Flaherty contributed to this report.
(WASHINGTON) — A panel of public health experts for the Food and Drug Administration convened for an all-day meeting on Thursday to discuss whether the U.S. is ready to start treating COVID boosters like an annual flu vaccine, a move that would normalize COVID shots as permanent public health upkeep.
Creating a yearly COVID shot schedule would mean updating the shot once a year and hoping that it matches whichever variant is circulating that upcoming winter season, similar to how the flu shot schedule works. No longer would public health agencies and vaccine companies attempt to reactively update the COVID vaccine when variants come on the scene.
It would also eliminate the two-shot primary series for most unvaccinated people, in favor of a mainstreamed program.
“This is a consequential meeting to determine if we’ve reached a point in the pandemic that allows for simplifying the use of current COVID-19 vaccines,” Dr. David Kaslow, director of the FDA’s Office of Vaccines Research and Review, told the group of advisors on Thursday.
Dr. Peter Marks, the FDA’s vaccine chief, said the virus has evolved so rapidly that the FDA has constantly needed to revise its approach. Now, he said, it was time to determine if they could do that on a schedule rather than at the whim of the virus’ evolutions.
“We’re now in a reasonable place to reflect on the development of the COVID-19 vaccines to date to see if we can simplify the approach to vaccination in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward,” Marks said.
The goal, FDA officials said, would be to deliver simpler messaging in the hope of reaching more Americans.
The way it stands now, people get different numbers of vaccines depending on their age and prior vaccination status. For example, unvaccinated people get their initial series in two shots, a few weeks apart, while vaccinated people have been encouraged to get a booster every few months, depending on how old they are.
The plan proposed by the FDA is to recommend every American get a single shot every year, with a few exceptions.
It’s based on the idea that the vast majority of Americans already have some immunity in their system, either because they’ve been exposed to COVID itself or gotten vaccinated.
“Presumably, at this point in the pandemic, most of the general U.S. population have been sufficiently exposed to spike protein, either to infection, vaccination or both, such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness,” Kaslow said.
But older, high-risk and immunocompromised Americans could still be recommended to get two shots a year, as could young children when they reach the age eligible for vaccinations.
“It could be that more than one dose is needed for high-risk older adults, persons with compromised immunity and young children who have not yet been completely immunized. At this time, those risk based adjustments remain to be determined,” Kaslow said.
Responding to the proposal, some experts on the panel emphasized that people who haven’t had COVID or been vaccinated might still need to get two shots to shore up their immunity.
But the members were broadly supportive of the move to simplify the COVID vaccine schedule.
“I certainly support this approach. Simpler is better,” said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego and a member of the FDA’s panel.
“I think this is definitely the way to go as soon as we can figure out how to do it,” he said.
More data is necessary to decide exactly who will be protected enough by one dose, experts said.
“My general feeling from the committee is that we need more data to figure out exactly who should get the two-dose schedule, who should get the one,” said Dr. Stanley Perlman, an infectious disease expert with the University of Iowa and a member of the panel.
“So all that kind of information will help determine this immunization schedule, but in general principle, the committee was supportive of going forward with this,” Perlman said.
The FDA will likely not make any concrete decisions until later in February, after a panel of experts at the Centers for Disease Control and Prevention has a similar public discussion on the newly-proposed schedule.
And just which variants the updated booster would target for next season won’t be decided until this summer, likely in early June, for distribution sometime in the fall.
Of course, the reality is that a small percentage of Americans have opted to get the current booster — around 16%, despite recent CDC research showing that it can cut risk of symptomatic infection by around half. And because less and less people have opted for a booster shot each time one has been recommended, the appetite could be lower by next fall.
But Marks, the FDA’s vaccine chief, was optimistic that aligning the COVID vaccine on a yearly schedule with the flu shot could encourage more people to make it a routine.
“If we can see the influenza vaccine and the COVID-19 vaccines occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected, and reducing the amount of disease we see,” Marks said.
“So I think that overall, this seems like a reasonable way to go.”
ABC News’ Nicole Wetsman and Youri Benadjaoud contributed to this report.
(WASHINGTON) — The U.S. Food and Drug Administration announced Thursday that it will not review or allow the marketing of cannabidiol, or CBD, products as food items or dietary supplements.
Up until recently, the health agency has not allowed any company to make claims about health benefits from wellness CBD products.
The FDA said after “careful review” it has determined that its current framework for evaluating food and supplements is not set up well for CBD because of safety risks and that substances, including CBD, have to meet specific safety standards to be lawfully marketed as a dietary supplement or a food additive.
“The use of CBD raises various safety concerns, especially with long-term use,” FDA Principal Deputy Commissioner Dr. Janet Woodcock said in a statement. “Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system.”
The statement continued, “CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”
Woodcock said animals are also at risk of side effects from CBD. People might not know they’ve been exposed to the ingredient if they consume meat, milk and eggs from animals fed CBD, she said.
“Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food,” she said.
The FDA said it plans to “work with Congress” to create new rules for regulating these products, which could include requiring clear labels, preventing contamination, content limits and even a minimum purchase age.
CBD and tetrahydrocannabinol, or THC, both come from the cannabis plant. While THC is the main psychoactive ingredient that gives users the “high,” CBD is believed to behind therapeutic effects associated with marijuana such as relief from nausea and pain relief.
The agency also announced it is denying three petitions submitted by citizens asking CBD products to be marketed as dietary supplements.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” Woodcock said. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
ABC News’ Eric Strauss contributed to this report.
