(NEW YORK) — At least 4.4 million Americans have received an updated bivalent COVID-19 booster since the shots were rolled out at the beginning of September, newly released data from the Centers for Disease Control and Prevention shows.
Nationally, a total of 109 million Americans have received their first booster dose — representing less than 50% of those who have been fully vaccinated. Just over a third — 35% — of the total U.S. population over the age of 5 has received their first booster.
In recent months, vaccination and booster uptake have slowed significantly, with fewer Americans willing to get their shots as pandemic and vaccination fatigue set in.
Following the federal green light of the new COVID-19 booster shots, data shows there was a significant uptick in the number of Americans getting vaccinated.
On average, approximately 390,000 shots are going into arms each day across the country.
On Thursday, CDC Director Dr. Rochelle Walensky became the latest American to get the new bivalent COVID-19 booster shot.
Walensky urged others to join her in getting the vaccine, stressing that it is important to get vaccinated now, ahead of the fall and winter, in order to prevent severe disease.
“I’m here getting my updated fall vaccine because I think it’s critically important to do,” Walensky told ABC News. “We are really encouraging everybody to roll up their sleeves and get this updated bivalent vaccine.”
On Thursday, Moderna also announced that it has submitted an emergency use authorization request to the Food and Drug Administration (FDA) for the use of the company’s omicron-targeting bivalent COVID-19 vaccine in children and adolescents.
The company has completed submission of its EUA requests in adolescents ages 12 to 17 years old as well as in children ages 6 to 11 years old.
The application for the youngest Americans, ages 6 months to under 6, is expected to be completed later this year, according to the company.
At this time, children over the age of 12 are eligible to receive Pfizer’s bivalent booster and adult Americans can receive an updated booster at least two months after their last shot.
Pfizer is expected to submit a request to add authorization for children ages 5 to 11 to its offerings of bivalent boosters by the end of month.
The FDA could authorize the updated booster shots for people as young as 5 in the coming weeks and the Centers for Disease Control and Prevention may recommend them for the younger age groups shortly after.
(NEW YORK) — As the United States heads into the fall and winter, questions are arising about whether the return of masks is needed to stem a potential COVID-19 surge.
Evidence has shown COVID cases and hospitalizations tend to rise during the colder months when people congregate indoors. Some health officials warn the virus could surge again in December and January.
Currently, cases and hospitalizations are on the decline in the U.S. after having peaked in late July, according to data from the Centers for Disease Control and Prevention.
Those who are vaccinated and boosted are at much lower risk of falling severely ill and dying from COVID-19. CDC data shows unvaccinated Americans have a five times higher risk of dying compared to those who’ve received just a primary series and a seven times higher risk of dying compared to those who also received at least one booster dose.
Experts told ABC News that while vaccination is the best protection against COVID-19, some people may need to consider masking to protect themselves in case infections rise.
“My recommendation to people would be to mask when in indoor crowded spaces,” Dr. Stuart Ray, a professor of medicine at Johns Hopkins University, told ABC News. “I’ve spent a great deal of time with patients who have COVID and have not contracted the infection from what I can tell, both from antibody testing and from a lack of syndrome.”
Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center in Boston, told ABC News that masks have helped reduce COVID transmission in health care settings.
“I’ve worked in a respiratory infection clinic with COVID patients at the height of their contagiousness and they’re breathing in my face, and I haven’t gotten COVID from patients,” she said. “I really do believe that PPE works, that masks work.”
However, experts admitted it will be hard to convince Americans to wear masks again after so many cities and states have done away with mandates.
Los Angeles, San Francisco and Denver remain the three biggest cities in the U.S. where masks are still required on public transit. In most cities, only health care environments still require mask mandates.
Ray said he believes a surge, similar to those caused by the delta and the omicron variants, would be the only thing drum up support of mandates.
“I think that people are really tired of this pandemic and there is, culturally, very little appetite for mandates, for masking,” Ray said. “And so, it’s a steep climb to tell people unless there’s a particular context in which it’s important, like a health care setting when there are many vulnerable people.”
He added, “If we were to come into a highly disruptive surge, then the appetite for a mandate might change, because people realize that a bunch of essential services are being disrupted. If hospitals got stressed by the surge, then I think we might see mandates returned.”
Doron said that although she supports masking, she doesn’t believe that cities and counties should reinstate mask mandates because many people take them off indoors for prolonged periods of time anyway, increasing the risk of transmission.
“In the community, we had mask mandates where you wear masks unless you’re eating or drinking and if you’ve ever traveled in an airport or on an airplane, where there when there was a mask mandate, you know that, you know, people are pretty much eating and drinking the entire time,” Doron said. “And so, it just doesn’t have the ability to do what it’s meant to do.”
In the absence of mask mandates, the experts said people may need to assess their individual risk level and decide if wearing a mask will help protect themselves and those around them.
“You to weigh your own susceptibility, your own tolerance for the risk of the long-term complications, which are still somewhat unknown and the risks that you might pose to people you care for either professionally or personally at home,” Ray said. “Now, some people may decide — and this is the judgment part — that they just don’t care that they don’t think that this is a big deal, and that they’ll just get infected and that they’re likely not to be hospitalized.”
Dr. Thomas Murray, an associate professor of pediatrics at Yale School of Medicine, said assessing the risk level also applies to kids in school, where many mask mandates have been lifted.
“Children who have higher risk, like asthma, might be an example of that,” Murray said. “What we’re really trying to balance is having kids enjoy a normal in-person school experience with the risks that go with congregating in classes when we have lots of respiratory viruses circulating.”
He said if schools don’t reimplement masking, other strategies “become critically important” for children, such as screening, testing and keeping them home if they have symptoms.
However, not all masks are created equally. For those who plan to keep wearing masks or choose to start wearing them again heading into the colder months, the experts recommend wearing a high-quality mask.
“I think that single-layer cloth masks really don’t provide much protection,” Ray said.
Doron said if you cannot get a N95 or KN95, or cannot wear one for long periods of time, a surgical mask will provide protection.
“The surgical mask does provide protection, especially if it fits you well,” she said. “And then there are ways to make it fit better, ways to fold it or and tuck it and tie the strap for your ears.”
(NEW YORK) — Although the daily death rates have ticked down slightly from August, updated federal data shows that the U.S. is still losing hundreds of Americans to COVID-19 every day, and 225,000 people in the U.S. have been lost to the virus since the start of 2022.
On average, more than 350 American deaths related to COVID-19 are still reported each day, and over the last seven days, the U.S. has reported nearly 2,500 deaths, according to data from the Centers for Disease Control and Prevention.
However, totals remain much lower than during prior COVID-19 surges, such as in January 2021, when an average of 3,500 people were reported lost to the virus on a daily basis.
The reaching of yet another grim milestone follows President Joe Biden’s remarks on CBS’ “60 Minutes” on Sunday, during which he said “the pandemic is over.”
“We still have a problem with COVID. We’re still doing a lot of work on it. It’s — but the pandemic is over,” Biden said.
Earlier this week, public health experts pushed back on the president’s assertion, telling ABC News that that pandemic is not over yet, and that Biden’s comments may be somewhat premature.
In an interview with ABC News on Thursday, CDC Director Dr. Rochelle Walensky was reluctant to directly agree with the president’s assertion that “the pandemic is over,” but with hospitalization and case rates falling, and vaccines and treatments available, she said that “we’re in a different place.”
“I think if we look at the big picture, things are very different,” she said. “We’re in a different place. Schools are open and businesses are open. We have a lot of population immunity out there right now.”
However, Walensky said that even though there are currently fewer people dying from the virus on a daily basis in the U.S., hundreds of Americans are still dying of COVID-19 every day — a fatality rate that remains too high.
“Three hundred fifty deaths a day is still too many as far as I’m concerned, but we’re in a very different place,” Walensky added.
As the U.S. heads into the fall, wastewater levels in some parts of the country have indicated a slight upturn in the percentage of COVID-19 virus in samplings. Even so, the daily average of new infections continues to hover around 55,000 cases.
However, dozens of states have moved to shutter public testing sites, with more at-home COVID-19 tests now available. Most Americans are not reporting their results to officials, and thus, experts suggest that infection totals are likely significantly undercounted.
COVID-19 testing levels have also plummeted to their lowest point since the onset of the pandemic, with approximately 350,000 tests reported each day, compared to more than 2.5 million tests reported daily at the nation’s peak in January of this year.
In recent weeks, virus-related hospitalizations have continued to fall — with 30,000 virus-positive Americans receiving care in the U.S., down from about 33,000 patients in the hospital last week, according to data collected by the Department of Health and Human Services.
The number of virus-positive Americans — 4,100 — currently entering the hospital each day is down by 6.8% in the last week.
Overall, the total remains significantly lower than at the nation’s peak this past January, when there were more than 160,000 patients hospitalized with the virus.
(WASHINGTON) — Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky became the latest American to receive the new bivalent COVID-19 booster shot on Thursday, telling ABC News that, thus far, “millions” of Americans have now gotten an updated vaccine.
“There have been millions,” Walensky said ahead of the CDC’s official release of the data.
Walensky, after receiving her shot of Moderna’s bivalent booster at a CVS location in Brookline, Massachusetts, urged others to join her in getting the vaccine, stressing that it is critical to get vaccinated ahead of the fall and winter, in order to prevent severe disease.
“I’m here getting my updated fall vaccine because I think it’s critically important to do,” Walensky said.
“All the data from this new bivalent vaccine have demonstrated that it will protect you against — more likely protect you — against the strains that we have circulating right now, those Omicron BA.5 strains, as well as keep you well protected, because we’ve seen that some of that protection can wane over time. So, we are really encouraging everybody to roll up their sleeves and get this updated bivalent vaccine,” she said.
In recent months, vaccination and booster uptake has slowed significantly, with fewer Americans willing to get their shots. As of Sept. 14, approximately 109.2 million Americans have received their first booster — representing less than 50% of those who have been fully vaccinated.
Walensky reiterated that she is still strongly encouraging parents to get their children vaccinated and boosted.
“We will wait to see what the FDA says about an updated booster vaccine for 5- to 11-year-olds, and we’ll make some decisions soon thereafter,” she said.
On the heels of President Joe Biden’s remarks during his appearance on CBS’ “60 Minutes” on Sunday, when he stated that “the pandemic is over,” Walensky said that the U.S. is certainly in a “very different place” than one or two years ago, thanks to prior vaccination coverage.
Walensky was reluctant to directly agree with the president’s assertion that “the pandemic is over,” but with hospitalization and case rates falling, and vaccines and treatments available, “we’re in a different place,” she said.
“I think if we look at the big picture, things are very different,” she said. “We’re in a different place. Schools are open and businesses are open. We have a lot of population immunity out there right now.”
However, Walensky noted that even though there are currently fewer Americans dying from the virus on a daily basis, hundreds of Americans are still dying of COVID-19 every day — a fatality rate that remains too high.
Although reported COVID-19 infection rates have remained stable in recent weeks, there are preliminary indicators that the presence of COVID-19 in wastewater levels has increased in some parts of the country. In the greater Boston area, where Walensky received her shot, viral sampling in local wastewater has reached its highest level since July.
Ahead of the fall, the CDC is also closely monitoring the genomic surveillance to surveille the potential emergence of any new variants of concern.
“We will be ready to step up to the plate,” Walensky said, adding that the vaccines will “hopefully not” have to be amended.
“We’ve seen time and time again is [that] our vaccines are working pretty well against severe disease, hospitalization and death, even when variants emerge, which is why it’s so very important to go ahead and get your updated vaccine now,” she said.
There are also growing concerns among health officials over the potential of a severe influenza season, prompting Walensky to remind Americans to “protect yourself” now, in order to “prevent getting sick in the future,” by also getting a flu shot in addition to the new COVID-19 booster.
“We know over the last several years is some people did not elect to get their flu shot,” Walensky explained. “We’ve had decreased rates of flu over the last several years and probably due to many of the mitigation strategies that we have in place for COVID. When that happens, we have decreased levels of population immunity, which raises the concern that the next year, you might have a higher, larger flu challenge. We can’t predict what a flu season will look like, but we have concerns.”
(NEW YORK) — High levels of chemicals called per-and polyfluoroalky substances (PFAS) were detected in water-proof or stain-resistant school uniforms in the United States and Canada, according to a new study published Wednesday in the Journal of Environmental Science and Technology.
PFAS chemicals, often called “forever chemicals” because of their slow breakdown, are widely used for their non-stick properties. They are ubiquitous and found in a range of everyday products such as non-stick cookware, stain and water repellants on carpets, food packaging and personal care products such as shampoos and cosmetic products.
Researchers studied more than 72 products from nine different brands, finding that school uniforms had high amounts of these potentially harmful chemicals. The highest levels were detected in clothing that was labeled as 100% cotton or cotton/spandex.
Due to widespread use and their slow breakdown, these chemicals can build up in humans and the environment over time. Current scientific research suggests that exposure to high levels of certain PFAS may cause a range of health problems, from delays in development in children to increased risk of some cancers, with the highest risk associated with drinking or eating contaminated food over an extended time. Scientists, however, are continuing to learn about the health effects of exposure to different types and levels of PFAS.
Researchers are especially concerned about possible high exposure, especially for children.
“Our findings are concerning as school uniforms are worn directly on the skin for about eight hours per day by children, who are particularly vulnerable to harmful chemicals,” said Dr. Arlene Blum, a study co-author and the executive director of the Green Science Policy Institute.
It’s not clear if PFAS chemicals cause health problems if exposed on the skin, but researchers who led the study said that they may end up in children’s bodies through skin absorption, eating with unwashed hands, hand-to-mouth behaviors and mouthing of fabric by younger children.
“These chemicals are not well studied. We still have a lot to learn and we are not sure what harmful effects, if any, these chemicals have by skin exposure and clothing,” said Dr. Stephanie Widmer, a medical toxicologist and an emergency medicine physician.
According to the study, the PFAS levels in some uniforms exceeded the tolerable daily intake set by European regulators. In the United States, regulators have yet to set similar allowable limits for clothing. But given these concerns, bills in New York and California that require the phasing out of PFAS in textiles, including school uniforms, by Jan. 1, 2025, were passed by state lawmakers.
The Centers for Disease Control and Prevention said exposure to PFAS chemicals may be associated with increased cholesterol levels, changes in liver enzymes, decreases in infant birth weights, decreased vaccine response in kids, increased risk of birth complications in pregnant women and increased risk of some cancers.
“The reality is the health concerns that have been reported in association with PFAS cannot be ignored, and while we are learning more about PFAS and their potential dangers, we should all try to limit our exposures as much as reasonably possible,” said Widmer.
Added Blum: “Concerned parents should check if any of their children’s uniforms are labeled ‘stain-resistant.’ If so, they should ask school administrators to update their uniform policies and when purchasing new uniforms, specify PFAS-free uniform options.”
(NEW YORK) — New boosters for 5- to 11-year-olds are just weeks away from authorization, the vaccine chief at the Food and Drug Administration, Dr. Peter Marks, said Tuesday.
While primary vaccines are already authorized for children 6 months and older, the FDA has yet to authorize the newly updated booster shots — designed specifically to combat currently circulating omicron subvariants — for the youngest Americans.
Those boosters, which were authorized at the beginning of the month for everyone 12 and older, will next be authorized for children in the elementary school age range, and then later be authorized for kids under 5.
“I’m confident that we’re only a matter of weeks away” from authorizing the 5-11 age range, Marks said during an event with the COVID-19 Vaccine Education and Equity Project. Marks said that the youngest age group, kids under 5, was still “a few months away” from authorization.
“Tailoring a vaccine against the most widely circulating variant is a similar approach used against the influenza virus, and I would not be surprised if this is an approach we see, seasonally, with COVID-19,” said Dr. Alok Patel, a pediatrician at Stanford Children’s Health and an ABC News medical contributor.
But kids under 5 were just recently authorized for primary vaccines, Marks said, so many are still in the process of getting their first doses and not yet in need of boosters.
Fewer than 40% of 5- to 11-year-olds and 10% of younger children 6 months to 4 years old have started their primary COVID-19 vaccination series, according to the American Academy of Pediatrics. Marks urged parents to generally get their kids vaccinated because the updated boosters cannot be given to people who haven’t yet received a primary series.
“There are a lot of kids ages 5 to 11 out there who haven’t had their primary series, so you can’t get the updated booster until you’ve had the primary series. So it’s a good idea to think about getting your child vaccinated against COVID-19,” Marks said.
“It’s critical parents not only get their children vaccinated but stay up to date about news on upcoming boosters,” Patel said. “While data and information becomes available regarding the omicron-specific booster for kids, I would encourage parents to make sure their kids have completed their primary vaccine series to prevent any delays.”
(NEW YORK) — Cancer deaths in the United States are continuing to decline, according to a new report from the American Association for Cancer Research.
The report, published Wednesday, found that deaths from cancer have decreased by 2.3% every year between 2016 and 2019.
Overall, there has been a 32% reduction in the U.S. cancer death rate since 1991, which translates into approximately 3.5 million lives being saved, the report said.
Additionally, in 2022, there are more than 18 million cancer survivors living in the U.S., equivalent to 5.4% of the population, the report found. Fifty years earlier, there were just 3 million cancer survivors.
According to the report, the decreasing number of deaths is due to “unprecedented progress” made against cancer within the last decade.
This includes eight new anticancer medications approved by the U.S. Food and Drug Administration between August 2021 and July 2022 as well as 10 previously approved medications that have been expanded to treat other types of cancer.
Another reason is due to the decline in smoking, the report says. Rates of smoking among U.S. adults have also decreased from 42% in 1965 to 12.5% in 2020.
The report also highlights the importance of cancer screenings, which can determine if a person has precancerous lesions or cancer in its early stages.
The Centers for Disease Control and Prevention’s Colorectal Cancer Control Program — which aims to rise cancer screening rates among people between 45 and 75 years of age — saw an average increase of 8.2 percentage points and 12.3 percentage points among clinics that participated in the program for two and four years, respectively, according to the report.
“Basic research discoveries have driven the remarkable advances that we’ve seen in cancer medicine in recent years,” Dr. Lisa Coussens, the president of AACR, said in a statement.
“Targeted therapies, immunotherapy, and other new therapeutic approaches being applied clinically all stem from fundamental discoveries in basic science,” the statement added. “Investment in cancer science, as well as support for science education at all levels, is absolutely essential to drive the next wave of discoveries and accelerate progress.”
However, because cancer continues to be the second-leading cause of death in the U.S. — with an estimated 600,000 lives expected to be lost this year — the AACR is calling on Congress to increase funding for the National Cancer Institute at the National Institutes of Health and for the FDA, which oversees the regulation of anticancer medication.
The group also called for more support for programs such as President Joe Biden’s Cancer Moonshot initiative, which was relaunched in February 2022, with a goal of slashing the national cancer death rate by 50% over the next 25 years.
The good news comes despite a recent report that cancers among adults younger than age 50 have “dramatically increased” globally over the last several decades.
Researchers from Boston’s Brigham and Women’s Hospital said the sharp rise of several cancers including breast, colon, esophagus, kidney, liver and pancreas began in the early 1990s.
The Brigham study found the rise is partially attributable to early screenings for some of these cancers. Early life exposures such as people’s diet, weight, lifestyle, environmental exposure, and microbiome may factor into what’s contributing to early-onset cancer, but more information on individual exposures is needed, the study said.
ABC News’ Dr. Evelyn Huang contributed to this report.
(NEW YORK) — With doctor’s offices and pharmacies now offering seasonal flu shots and updated COVID-19 boosters, experts are urging Americans to get both, with many saying October is the best time.
While experts say October may be an ideal window to boost immunity, they are also emphasizing the importance of getting vaccinated, period — whenever you are able. It’s safe for people to get both shots during the same visit for added convenience, experts say.
White House COVID coordinator Dr. Ashish Jha told ABC News the best time to get a newly updated COVID-19 booster is “no later than the end of October for maximum protection,” which aligns with flu shot timing recommendations.
The “Goldilocks moment” for the flu shot is also October, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco. However, anyone who gets the shot in September should still expect protection during the flu season, which typically lasts until spring.
“I think my general advice is, get it [when] it’s convenient,” Chin-Hong said.
Experts also say not to worry if you can’t get your flu shot before Halloween.
“If you for whatever reason cannot get a flu shot by the end of October, it’s not too late,” said Dr. Alok Patel, a pediatrician at Stanford Children’s Health and an ABC News medical contributor.
Bad flu season on the horizon?
Some experts predict that the seasonal influenza virus — following two years of mild activity during the COVID-19 pandemic — is expected to be back in full force this season.
A typical pre-pandemic year would see around 8% of the U.S. population sick from flu, according to the Centers for Disease Control and Prevention. Deaths can exceed more than 50,000, as they did most recently in the 2017-2018 season.
Those most at risk of severe illness from influenza are the elderly and immunocompromised.
“What we’re concerned about, of course, are people who are older, over age 65. They account for about 15-17% of the population but 80% of the [flu] deaths and hospitalizations,” said Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center.
But even young, otherwise healthy people benefit from the flu shot, which also lowers the risk of spreading the virus to others.
“A lower risk does not mean no risk. By getting vaccinated, you really do reduce the likelihood that you will be the dreaded spreader,” Schaffner said.
Meanwhile, becoming ill with the flu can not only put a damper on holiday plans, but it also often leads to unwanted symptoms that last for multiple days.
“For anybody who’s gotten the flu, it’s definitely not a walk in the park,” Chin-Hong said.
Getting vaccinated in October or early November is ideal because “[you want] your annual vaccination to extend throughout the winter, well through February into March, and even into April,” Schaffner said.
“The only other sort of change with the timing might be for people who are pregnant,” Chin-Hong said.
He explained that pregnant women may want to try and have a flu shot before delivery, which allows the newborn to benefit from the mother’s antibodies, especially given that infants under 6 months old cannot be vaccinated.
Experts say flu shots may be especially important for children this year given concerns about how the relaxation of pandemic-era restrictions may impact children.
“Given the fact that schools are back open, COVID-19 restrictions have been lifted, and kids are back to their normal rambunctious selves [they] are at risk of catching influenza this year,” Patel said. “Parents should not generalize influenza as a common cold. Thousands of kids are hospitalized every year from influenza with young infants and kids with underlying medical conditions being at highest risk.”
Updated COVID-19 boosters may also become annual shots
The Food and Drug Administration recently authorized the first updated COVID-19 booster shots — the first major upgrade to COVID-19 vaccines. Because protection from COVID-19 fades slowly over time, the White House has previously stated that variant-specific COVID shots may also become an annual reality, similar to seasonal flu shots.
The new COVID-19 boosters are designed to be a better match against currently circulating COVID-19 variants, and are currently authorized for everyone 12 and older who had their last COVID-19 shot at least two months ago. People previously infected with COVID may also consider waiting 90 days before receiving their booster shot, according to the CDC. The authorization of updated boosters for younger children is expected in “a matter of weeks,” according to Dr. Peter Marks, the director of the group within the FDA responsible for assuring the safety and efficacy of vaccines.
Although it is not clear if there will be another COVID-19 surge this fall, more than 350 people still die every day of COVID-19. Compared to young adults, those over the age of 65 are 60 times more likely to die from COVID-19, according to the CDC. The death rate is 340 times higher for those over the age of 85.
Is it safe to get the COVID booster and flu shot at the same time?
Experts say that getting both your COVID booster and flu shot at the same time won’t weaken your body’s immune capacity to fight either virus.
“If you give the body two signals, it’s not going to make less [immunity] because it’s concentrating on another signal,” Chin-Hong said.
Although children under 12 are not yet eligible for the new booster shots, many are still getting their original COVID-19 vaccines, which are authorized for children 6 months and older.
Similar to the guidance for adults, pediatricians say it’s safe to give young children COVID-19 shots and flu shots in the same doctor’s visit.
“This may even be a more convenient option for busy parents,” Patel added.
(WASHINGTON) — An internal review of the Food and Drug Administration’s actions leading up to the infant formula crisis finds a combination of human error, antiquated technology, and poor communication and accountability amongst an already threadbare food workforce all contributed to a perfect storm of problems which exacerbated the supply shortage.
The issue was only worsened by the FDA’s lack of a robust mandate to strong-arm industry players’ compliance, the review found.
During more than 40 interviews with over 60 FDA staff and leadership “directly involved with the events that transpired” the review found “inadequate processes and lack of clarity” may have delayed the agency’s response to contamination concerns at at infant formula maker Abbott’s facility in Sturgis, Michigan; and that at several junctures, critical information slipped through the cracks of agency awareness.
In a statement, FDA Chief Robert Califf said the agency didn’t have the power to force the industry’s hand.
“The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention,” Califf said.
The internal review echoed that sentiment: “a confluence of systemic vulnerabilities” here demonstrated the need for more investment in modern tools and tech to prepare for future public health challenges.
FDA’s limited mandate and resources prevent them from managing “supply chain issues and shortages of critical food products,” the review said, especially when it comes to a supply chain like that of baby formula, which had already been strained by the Covid pandemic — and which Abbott’s recall and pause in production further stressed.
The review also noted that the contaminant and illness at the heart of Abbott’s massive shutdown, Cronobacter sakazakii, is “poorly understood” and lacks thorough federal oversight — and that those “scientific gaps” in understanding Cronobacter “hindered the FDA’s response throughout the incident.”
The discovery of Cronobacter inside Abbott’s Sturgis plant prompted a massive voluntary formula recall in February, after four babies who had consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants subsequently died, although Abbott maintains there has not been conclusive evidence that its formula caused the infant illnesses, since none of the Cronobacter strains found at their plant matched the two samples genetically sequenced from the sickened infants.
Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a pattern of serious operational deficiencies and consumer complaints — which led to its closure.
In a statement to ABC News regarding the internal review, an Abbott spokesperson said, in part, they “will continue raising the bar” on their formula’s regulatory requirements “by working with FDA and industry partners to further advance infant formula safety and processes.”
Abbott’s shutdown ricocheted across the country, exacerbating the supply shortage and forcing families to scramble for alternatives in the hyper-concentrated formula market.
FDA’s Califf has previously noted some of the points outlined in the report released Tuesday: that the response was “too slow,” with “decisions that were suboptimal along the way,” while warning that FDA’s workforce is “very tired, overworked,” and the agency’s food safety arm is underfunded.
Califf has also previously underscored FDA’s lack of authority to “compel companies to give us information,” and has pointed the finger instead at Abbott’s failure to be upfront about the issues at their plant.
Critics of FDA’s response have previously pointed out that there was a brewing problem in the formula market before Abbott’s shutdown — and that the administration had plenty of warning signs both about the pandemic supply chain issues and about Abbott’s quality control problems long before things reached a boiling point this spring.
But this report contains several new details about repeated fumbles in the response, including crucial delivery system errors and a need for better staff communication at the FDA.
The review says FDA found that some samples taken from Abbott’s Sturgis plant after their contamination concerns came to light “were delayed in transit by third party delivery companies.”
The review comes after FDA leadership revealed this spring that a whistleblower complaint from a former Abbott employee detailing a “litany of violations” at the Sturgis plant had remained in limbo for months. That complaint had been sent to the FDA last October, but was not delivered, seen or escalated until four months later — because of, what the FDA has said, was “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”
The new internal review now says that such gaps in coordination between systems (though here, punting accountability to a “third party,”) “makes it difficult for the agency to connect related submissions and rapidly identify emerging safety and quality issues.”
“The FDA should evaluate procedures for shipping and testing samples sent to regulatory laboratories and consider whether changes should be made to analytical capability and capacity, and ways to enable immediate notification and escalation of analytical results for significant public health threats,” the review says.
The review adds that the agency is “collecting an inventory of every entry point for consumers, whistleblowers, other government agencies, clinicians, and other members of the public to facilitate notification to the FDA of their concerns about product safety and quality,” which will help “streamline” safety concerns to “rapidly assess emerging safety signals.”
The internal review ultimately identified five major findings for FDA to improve upon, including the need for more modern data technology which “allows for the access and exchange of data in real time to all the people involved in response.”
“The lack of coordination between systems makes it difficult for the agency to connect related submissions and rapidly identify emerging safety and quality issues,” the report says, and “inadequate processes and lack of clarity related to whistleblower complaints may have delayed the FDA’s response to those complaints.”
The review also underscores the need for FDA to optimize its emergency response capabilities to handle multiple concurrent public emergencies. FDA “lacks procedures for facilitating this complex coordination of staff on response activities that expand beyond the established foodborne outbreak response policies and procedures,” the review found.
The review also blames Covid infections at the manufacturing facility which “delayed the FDA’s in-person response to complaints raised” regarding Abbott’s Sturgis plant, and underscores the need to strengthen FDA’s food workforce including more training, staffing, equipment, funding and regulatory authorities “to fulfill the FDA’s mission.”
It also emphasizes the importance of closing knowledge and oversight gaps on Cronobacter and translating that knowledge into “appropriate control measures.”
Those gaps in understanding “hindered the FDA’s response throughout the incident,” the review said.
It also noted, FDA oversight should focus on accountability within the infant formula industry, which employs “dated technology and record keeping practices that can cause delays in collecting critical information needed to perform and define the scope of recalls.”
Moreover, the FDA lacks robust enforcement teeth to make sure companies are adhering to best practices of strong food safety culture, the review said; manufacturers aren’t required to make Cronobacter isolates available to the FDA for sequencing and uploading into the national database, which “limits the data available to help identify clusters of illness and potential sources of contamination.” Without further authority “it will be difficult for the FDA to identify early signals of potential safety issues and work with manufacturers to mitigate these hazards.”
FDA’s Califf had asked for this review to be done; the agency will “form working groups charged with implementing the recommendations,” and a year from now, FDA’s progress on the above recommendations will be assessed, the review said.
Meanwhile, the U.S. Department of Health and Human Services’ Office of Inspector General has also launched its own audit into how the FDA responded leading up to the recall and closure of Abbott’s Sturgis plant — and whether they followed proper recall protocol once deadly bacteria had been detected inside the plant. Findings from OIG’s audit are expected sometime in FY 2023.
The FDA says they are working with the OIG and “looks forward” to their “findings and recommendations.”
(FLINT, Mich.) — Five years after a water crisis rocked Flint, Michigan, a significant number of residents are suffering from post-traumatic stress disorder or depression and some may be suffering from both conditions, a new study finds.
Researchers from the Medical University of South Carolina in Charleston surveyed a sample of 1,970 residents aged 18 and older living in Flint, which is 430 miles northwest of Detroit, between 2019 and 2019.
They found that nearly one in four — 24.4% — met the criteria within the past year for PTSD and more than one in five — 22.1% — met criteria for depression. An additional 14% met the criteria for both disorders.
That means among a city of more than 80,000 people, 22,600 Flint residents may have had depression, 25,000 may have had PTSD and 14,300 may have had both.
What’s more, the prevalence of depression and PTSD are about three-fold and five-fold higher than the prevalence among the general U.S. population, respectively.
The Flint water crisis, which lasted from April 2014 to June 2016, occurred after emergency managers appointed by then-Gov. Rick Snyder decided to change to the city’s water supply from Lake Huron and the Detroit River to the Flint River to save costs.
Residents immediately raised concerns about their water quality. The Flint River is highly corrosive to lead plumbing and officials did not apply corrosion inhibitors to the water, resulting in lead being leached from the old pipes.
As a result, tens of thousands of people were exposed to dangerously high levels of lead. There were also outbreaks of Legionnaires’ disease — a severe form of pneumonia caused by inhaling Legionella bacteria in small droplets of water or accidentally swallowing water containing the bacteria — that sickened 87 and killed at least 12.
The study found residents who believed the contaminated water harmed their or their family’s health, or had low confidence in public officials, were at higher risk of PTSD and depression. Those with an annual household income of less than $25,000 were also at higher risk.
What’s more only about one-third, or 34.8%, were offered mental health services. Of those offered services, 79.3% used them.
The team did say its study had some limitations, including not accounting for pre-existing mental health conditions and the potential diagnoses not being made through interviews with a psychologist or psychiatrist.
The authors, however, believe people who suffer environmental disasters may require long-term mental health services. Additionally, despite restoring the water supply to Lake Huron and efforts to remove lead from city pipes, the team says mental health services have not matched the need in the community.
“Environmental disasters, such as the Flint, Michigan, water crisis, are potentially traumatic events that may precipitate long-term psychiatric disorders,” they wrote. “The water crisis was associated with acute elevations in mental health problems in the Flint community, but long-term psychiatric sequelae have not yet been evaluated using standardized diagnostic measures.”
The study comes as another city — Jackson, Mississippi — suffers its own water crisis.
Floods in late August caused the city’s main water treatment to fail, leaving all 150,000 without access to clean water for drinking, cooking or cleaning.
ABC News’ Dr. Anna Yegiants contributed to this report.
