Abbott launches new infant formula recall at another plant for faulty bottle cap seals

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(NEW YORK) — In a new recall following a separate one which dogged them for the better part of this year, Abbott, which has been the largest infant formula manufacturer in the U.S., is now voluntarily recalling bottles of their largest, most popular kind of formula, Similac, from their manufacturing facility in Columbus, Ohio.

This recall is not for the bacterial contamination concerns which prompted the massive voluntary recall at their plant in Sturgis, Michigan, earlier this year.

The new recall in Ohio is because the bottle caps on some of their 2-ounce ready-to-feed liquid products made at the Columbus plant are faulty, and may not have sealed completely, the company said in a recall notice.

If formula bottles aren’t sealed properly, it could result in spoilage, Abbott said. Babies could develop painful gastrointestinal symptoms like diarrhea and vomiting if they consume spoiled products, according to the company.

Abbott underscores that only a “small percentage, less than 1%” of bottles in these recalled lots have faulty caps, according to a statement. The company says they “internally identified the issue and are addressing it.”

While this is yet another setback for Abbott, industry experts say it is an important part of the oversight system: for companies to rigorously self-monitor their safety and quality control processes and catch problems before they get worse.

Abbott declined to provide an exact number of bottles being recalled now, but said in the statement it “equates to less than one day’s worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply.”

Even so — that still means this recall could temporarily keep millions of bottles off the shelves, in a market still recouping from the months’ long formula crisis this spring.

Between 2 and 3 million babies in the U.S. rely to some degree on formula every day, experts have told ABC. On average, infants drink between four and six 8-ounce bottles’ worth of formula a day. That includes unfinished or spilt bottles, and naturally fluctuating appetites from day to day. Multiplied out — that means American babies need somewhere between 10 and 12 million bottles per day.

The recall from the Columbus facility impacts smaller, 2-ounce bottles, of which more are required for a day’s worth of feeding.

Abbott is still continuing production of these popular Similac products on a different production line at the facility, the company said.

Abbott’s formula industry dominance made their abrupt absence this spring a strain on the U.S. market. When their Sturgis production was shut down amid Cronobacter contamination concerns, it sent the U.S. formula market into a tailspin.

Amid the dire shortage, Abbott ramped up production at their Columbus facility in an attempt to mitigate some of the shortage.

Abbott converted manufacturing lines at their Columbus plant to increase production of Similac and Alimentum liquid ready-to-feed formula — something the company repeatedly touted to the public and in congressional testimony.

Abbott says the products included in the Columbus plant recall were distributed “primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago.”

The company advises parents to check whether formula they have was recalled at similacrecall.com, and if it is, not to use it.

Abbott says their recall includes the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution manufactured at their Columbus facility.

Abbott says this recall does not impact any of their other formula products. They say they will continue to produce Similac formula products “in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network.”

“We take our responsibility to deliver high-quality products very seriously,” Joe Manning, executive vice president of nutritional products at Abbott said in a statement. “We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.”

A Food and Drug Administration spokesperson tells ABC News the agency is “aware” of Abbott’s new recall of Similac products from their Ohio plant, and say they “don’t expect” it to impact overall domestic supply.

The agency spokesperson pointed to how FDA has relaxed their import discretion, allowing foreign formula makers to sell their products on the U.S. market, as the reason they think this latest recall from Abbott shouldn’t have the same kind of drastic impact which the massive one from earlier this year.

“Parents and caregivers have many additional formula options today thanks to FDA’s efforts and those of many of our government partners,” FDA’s spokesperson said, adding they are “more than doubling the number of formula manufacturers” making formula for U.S. infants.

 

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CVS lowers price of period products by 25%, pays ‘tampon tax’ in some areas

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(NEW YORK) — Starting this week, customers shopping for period products like tampons, menstrual pads and liners will pay lower prices in CVS stores.

The national retailer announced it is reducing the cost of CVS Health brand period products by 25% in all CVS Pharmacy locations nationwide.

The retailer will also begin paying the so-called “tampon tax” — the sales tax that states place on feminine hygiene products — on menstrual products in 12 states where such a tax still exists, including Georgia, Louisiana, Tennessee, Texas, Virginia and Utah.

Only 23 states in the U.S. currently exempt period products from taxation, according to the Alliance for Period Supplies, which represents nonprofit organizations that collect and distribute menstrual supplies in local communities, according to its website.

A CVS spokesperson told ABC News the two price-lowering measures are part of the retailer’s Healthier Happens Together, or HERe, initiative, which works to make it easier for women to access services and products that support their “mental and physical well-being.”

In addition to the price changes on menstrual products, CVS said it is also offering new menstrual, menopause and contraception services at its MinuteClinic locations.

“Women experience conditions that are unique to their physiology and life stage, as well as those that are more common in, expressed in and treated differently for women of all ages,” the spokesperson said in a statement. “Women also face serious health care gaps, from systemic barriers created by high health care costs and access issues to health challenges related to a greater risk of chronic conditions.”

Period poverty, when people cannot afford even the most basic of period supplies like pads and tampons, is an issue that affects women around the world, including in the United States. A lack of access to menstrual products and education affects 1 in 10 college students in the U.S., according to a study released last year.

Advocates for menstrual equity say the taboo around menstruation and the lack of access to menstrual products hurts women economically because it costs them money and may keep them from attending jobs and school. Poor menstrual hygiene also poses health risks for women, including reproductive issues and urinary tract infections.

On average, a woman will spend around seven years in their lifetime on their period, according to UNICEF.

Last year, California Gov. Gavin Newsom signed a bill into law requiring that public schools and colleges provide free menstrual products in classrooms.

In 2020, Scotland made history as the first country in the world to provide period products to all women for free.

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Nearly half of COVID survivors haven’t fully recovered six months later: Study

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(NEW YORK) — Nearly half of COVID-19 survivors may have symptoms of long COVID months after they were first infected, a new study suggests.

Researchers from across Scotland looked at more than 33,000 patients over the age of 16 with a confirmed PCR test for COVID-19 in the past and tracked their symptoms.

Results, published in the journal Nature Communications Wednesday, found that six months later, of the more than 31,000 patients who had had symptomatic COVID, 6% reported not having recovered at all. An additional 42% felt they were only partially recovered.

Patients who reported no recovery were more likely to be women, to have been hospitalized when they had COVID, and to have multiple underlying conditions.

When the team looked at symptoms, they found the most common was tiredness, followed by headache, muscles aches, joint pain and difficulty breathing, respectively.

Patients with an asymptomatic infection were not at increased risk of experiencing symptoms months later.

What’s more, having received at least one dose of a COVID-19 vaccine prior to infection reduced the risk of some symptoms including change in taste and/or smell, poor appetite, confusion and difficulty concentrating.

“Our study is important because it adds to our understanding of long-COVID in the general population, not just in those people who need to be admitted to hospital with COVID-19,” lead author Jill Pell, a professor of public health at the University of Glasgow, said in a statement.

“By comparing symptoms with those uninfected, we were able to distinguish between health problems that are due to COVID-19 and health problems that would have happened anyway,” the statement continued.

Long COVID occurs when patients who have cleared the active infection still have symptoms lasting more than four weeks after recovering. In some cases, these symptoms can persist for months or even years.

Patients can experience a variety of lingering symptoms including fatigue, difficulty breathing, headaches, brain fog, joint and muscle pain, and continued loss of taste and smell, according to the Centers for Disease Control and Prevention.

The authors mentioned some limitations including that most of the participants were white because the study was conducted in Scotland, which has a 96% white population.

“Therefore, it is important that ethnic-specific outcomes are reported by other long-COVID studies with more ethnically diverse populations,” the authors wrote.

Additionally, some of the common symptoms were also reported among a control group who had never tested positive for COVID. The symptoms that were most strongly associated with COVID infection were breathlessness, chest pain, palpitations and loss of taste and smell.

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FDA confirms Adderall shortage in the US

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(NEW YORK) — After weeks of individual reports of frustration with getting Adderall prescriptions filled, the Food and Drug Administration confirmed Wednesday a nationwide shortage of the immediate release formulation of amphetamine mixed salts, commonly referred to by the brand name Adderall.

Adderall is a stimulant medication that can treat attention-deficit/hyperactivity disorder (ADHD). It requires a prescription and as a controlled substance, supply is strictly monitored, and distribution is limited.

Some individuals already knew there was a problem having reported going weeks without medication and calling multiple pharmacies to fill prescriptions. Some patients have had trouble filling Adderall prescriptions since August.

“It’s like the feeling when you first wake up in the morning, and you can’t quite think, except all day long for me without [Adderall]. It really affects my life,” Daryl Linley, a Wheat Ridge resident, told ABC’s Denver affiliate, KMGH-TV.

Teva, the largest maker of generic Adderall in the U.S., told ABC News “the supply that we are manufacturing/distributing right now is on pace to be consistent – or greater than – our supply at this time last year by the end of this year. The demand is not.”

The company said they are experiencing “intermittent backorders” as “there has been a significant rise in national prescription rates, this can cause some constraint to product availability.” Teva says disruptions will only be “temporary” and expects inventory to recover within months.

Major retail pharmacies like CVS and Walgreens have also noted supply chain constraints. A CVS spokesperson told ABC News they are “aware of intermittent shortages of generic amphetamine medication in the supply chain,” adding their pharmacists “will work with patients who are prescribed this medication as needed.”

Another supplier of the drug, Sandoz Pharmaceuticals (a division of Novartis), told ABC News there is no “shortage” of Sandoz amphetamine (generic Adderall) in the market at this time and the company is meeting all current customer orders.

The constraints on the supply have led to many voicing the challenges of getting their prescriptions filled at their regular pharmacy.

In Kentucky, a Fayette County school board member, Stephanie Spires, said the issue was “significantly impacting our classrooms,” at a meeting Monday.

“I talked to a parent today who said she was able to get five pills,” Spires said.

The shortage of this key treatment for so many Americans, especially kids, comes as the new school year kicks into gear. The Centers for Disease Control and Prevention estimates that almost 10% of children have ADHD as of 2019, and these numbers may have increased during the pandemic.

There are many reasons for constrained supply, including tight regulation due to its classification as a schedule II drug which the Drug Enforcement Administration defines as “drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.” In addition, labor shortages, supply chain issues and an increase in the number of people who have been prescribed the drug in recent years may have an effect on supply.

“While stopping Adderall is generally not life-threatening, rebound symptoms, including inattention, hyperactivity and impulsivity, may return and be distressing,” Dr. ​​Anish Dube from the American Psychiatric Association told ABC News.

Doctors and law enforcement officials warn that people should never buy Adderall outside of a pharmacy — including from a friend, as these pills may be counterfeit and/or laced with other lethal substances. The DEA says many fake pills, containing fentanyl, are made to look like prescription stimulants like amphetamines (Adderall) but could be potentially deadly.

If people are struggling to obtain their medication and feel they’ve exhausted all options, they should call their pharmacist or doctor to discuss a plan.

“Those with more severe symptoms should discuss contingency plans with their psychiatrists on how to manage symptoms without medication,” said Dube.

A “classroom of kids who have had to quit their meds cold turkey because they can’t get them – we’ve got some issues going on and brewing here,” Spires, in Kentucky, said. “And it’s not just kids, it’s adults as well. But for us in our purpose here, is children that are not getting what they need, or not coming into the classroom prepared to learn – and it creates a stressful environment for all involved.”

In their announcement, the Food and Drug Administration said they would “continue to use all the tools we have available to help keep supply available for patients.”

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CDC: 11.5M Americans have received updated COVID booster

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(NEW YORK) — About 11.5 million Americans have received the updated bivalent COVID-19 booster, according to data from the Centers for Disease Control and Prevention.

The booster was rolled out at the beginning of September with the Pfizer booster approved for those aged 12 and older and the Moderna booster approved for those aged 18 and older.

This expanded to use among those aged 5 and older for the Pfizer booster and aged 6 and older for the Moderna booster Monday.

Experts told ABC News that while it’s great many Americans have gotten the new booster, they are worried uptake is not as high as it should be ahead of the colder weather months, when COVID-19 typically spreads much more quickly.

“We clearly have had a slowdown in just overall boosting, and that’s driven by a lot of factors,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor. “One being the fact that we’re not in a surge right now. So, there’s not this like immediacy of risk that people are facing, and I think that may change as we head into the winter months and potentially new variants emerge.”

Brownstein also said there is evidence of COVID fatigue and vaccine fatigue, with people wanting to move on from the pandemic and not thinking of the virus as a major threat.

Another factor may be confusion over who can get the booster.

A new Kaiser Family Foundation poll found half of participants had either heard little or nothing about the new bivalent COVID-19 booster, which targets the omicron subvariants BA.4 and BA.5. Additionally, some Americans don’t know if the updated booster is recommended for them.

“There has been challenges in the communication strategy around the booster,” Brownstein said. “Is it a booster? Is it an annual shot? There’s a lack of awareness that even the vaccine was reformulated. So, I think generally, there’s some confusion and lack of awareness that are also slowing down uptake.”

The updated bivalent booster targets the omicron subvariants BA.4 and BA.5, which currently make up most COVID-19 cases in the U.S.

That’s not to say that some Americans haven’t rushed to get the booster.

On Sept. 23, there were 4.4 million people who had received the new booster, meaning more than twice as many have received the booster since.

Additionally, the seven-day average of total vaccine doses being administered rose from an average of 118,000 as of Sept. 7 to 549,000 as of Sept. 28, CDC data shows.

“It does tell you people are still going out and getting that booster,” Brownstein said. “There may not have been that immediate sort of rush on vaccines because they’re widely available and there wasn’t a looming threat.”

He continued, “So, we are seeing a steady rise of people still going and getting immunized, which is great. But it would be great to see if we could pick up that pace.”

Brownstein said to increase uptake, he recommends continuing to educate the public and spread awareness of the boosters and improving access by making the shot available at community vaccination sites or hubs as opposed to just pharmacies or doctors’ offices.

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Guidelines say kids 8 and older should be screened for anxiety: What parents should know

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(NEW YORK) — Children ages 8 and older should be screened by physicians for anxiety, according to new guidelines published Tuesday.

The new recommendations from the U.S. Preventive Services Task Force apply to children who are not showing recognized symptoms of anxiety or depression and who do not have a diagnosed mental health condition.

The call for screenings marks a first for the task force, an independent group of medical experts whose views carry enormous weight in the medical community. Its recommendations often change the way doctors practice medicine.

The task force also re-emphasized in its recommendations that children ages 12 and older should also be screened for depression.

“For something to be recommended as a screening test, the condition needs to be common, it needs to be treatable, and the screening test needs to be inexpensive and easy to implement,” said ABC News chief medical correspondent Dr. Jennifer Ashton, who is not a task force member. “This checks all those boxes.”

In its recommendation, the task force noted that nearly 8% of children ages 3 to 17 had a current anxiety disorder, and that kids under age 18 who have anxiety disorders have an “increased likelihood of a future anxiety disorder or depression.”

According to the Centers for Disease Control and Prevention, the number of children over age 6 ever having been diagnosed with anxiety or depression increased from 5.4% in 2003 to 8.4% in 2012.

“Mental health illnesses are on the rise, particularly in teens and younger children, and we have heard and talked about it so many times, it deserves attention,” said Ashton. “There is a growing mental health crisis in this age group.”

The task force said it was not recommending anxiety or depression screenings for kids ages 7 and under because there is not enough evidence to demonstrate the benefits and harms of screenings for that age group.

Anxiety is the feeling evoked when someone experiences fear of something bad happening. It can lead to avoidance, panic attacks, excessive worrying or other symptoms. Anyone can have anxiety at times, but when anxiety symptoms become overwhelming to the point that they consistently interfere with daily life, it can be an anxiety disorder, according to the National Institute of Mental Health.

Like most mental health conditions, anxiety falls on a spectrum, with differing degrees of severity.

In children, symptoms of anxiety may include interruptions in sleeping patterns or difficulty sleeping and excessive emotions in terms of anger, irritability and clingy behaviors. Kids may also demonstrate physical symptoms like an upset stomach or a headache, according to Ashton.

Treatment for anxiety is available and may include things like child therapy and family therapy. Maintaining a healthy lifestyle by eating well, being physically active and getting adequate sleep can also help the symptoms of anxiety, according to the CDC.

Ashton said the most important thing for parents is to be in touch with their child’s health care provider so they can get help as needed.

“It’s not your job to be a doctor and diagnose your child,” she said. “Talk to your child’s pediatrician or health care provider.”

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More polio detected in New York City wastewater, data shows

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(NEW YORK) — More evidence of polio has been detected in New York City wastewater, according to the state Department of Health.

So far, only one case of polio has been identified, in a previously healthy 20-year-old man from Rockland County who developed paralysis in his legs, local officials said.

As of Oct. 7, 70 wastewater samples have detected, including 63 samples genetically linked to the Rockland County patient, according to health department data.

Of the 63 samples, 37 were collected in Rockland County, 16 in Orange County, eight in Sullivan County, one in Nassau County, and one in New York City from Brooklyn “and a small, adjacent part of Queens County.”

The New York City sample was collected in August, the health department said.

State health officials said most adults do not need the polio vaccine or a booster because they were already fully vaccinated as children.

However, they have stressed the importance of getting vaccinated against or staying up to date with the immunization schedule. Among unvaccinated people, polio can lead to permanent paralysis in the arms and/or legs and even death.

“These findings put an alarming exclamation point on what we have already observed: unvaccinated people are at a real and unnecessary risk” State Health Commissioner Dr. Mary T. Bassett and City Health Commissioner Dr. Ashwin Vasan said in a joint statement. “We have seen more New Yorkers getting vaccinated.”

The statement continued, “But these latest results are a searing reminder that there is no time to waste, especially for young children, who must be brought up to date with vaccinations right away. Paralysis changes life forever. Fortunately, the response is simple: get vaccinated against polio.”

According to the Centers for Disease Control and Prevention, the polio vaccine protects 99% of children who get all recommended doses from severe disease from poliovirus.

The NYSDOH said between July 21 — when the case of polio was announced — and Oct. 2, more than 28,000 polio vaccine doses have been administered to children aged 18 and younger, in Nassau, Orange, Rockland and Sullivan counties.

New York Gov. Kathy Hochul extended the state of emergency declared in response to the polio case and said it will remain until at least Nov. 8 as health officials continue to try and boost polio vaccination rates.

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Maternity care is getting harder and harder to access in the US, new report finds

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(NEW YORK) — Maternal care is becoming increasingly difficult to access in the United States, according to a report released Tuesday by the March of Dimes, a nonprofit organization focused on improving the health of pregnant people and babies.

More than a quarter of counties in the U.S., 36%, have no obstetric hospitals or birth centers and no obstetric providers, such as obstetricians, gynecologists and certified midwives or nurse midwives, according to the report, which describes those areas as “maternity care deserts.”

That figure is an increase from 2020, and means that more than 2 million women of childbearing age — ages 15 to 44 — in the U.S. live in maternity care deserts, the report found.

Nearly 7 million women live in areas with little to no access to maternity care, mostly in the South and Midwest, according to the report.

“We know that lack of access to crucial maternal care is a driving factor for the poor outcomes that we see for moms in this country, for high mortality rates,” Dr. Zsakeba Henderson, March of Dimes’ interim chief medical and health officer, told “Good Morning America.” “And we know that the United States continues to be one of the most dangerous industrialized nations to give birth in.”

Describing the increase in so-called maternity care deserts in the U.S., Henderson added, “This problem is worsening. It’s not getting better.”

Around 700 women die each year in the U.S. due to complications of pregnancy or delivery, according to the Centers for Disease Control and Prevention.

During the coronavirus pandemic, maternal mortality rates in the U.S. climbed 33%, with Black and Hispanic women dying at much higher rates than white women, according to research published by the University of Maryland and Boston University .

Black, Hispanic and Native American women are also disproportionately impacted by the lack of access to maternal care, March of Dimes researchers found.

According to the report, in 2020, 1 in 4 Native American babies and 1 in 6 Black babies are born in areas with no or limited access to maternity care services.

“Communities of color are disproportionately impacted by this crisis,” said Henderson. “And we know that it’s not just an issue of access but an issue of quality.”

The reason why more women have less access to maternity care in 2022 stems from a variety of factors, including hospital closures and COVID-19, according to the report.

Hospital closures can be attributed to everything from staffing difficulties to low birth volumes that make maternal care not profitable enough to remain open to higher proportions of patients on Medicaid, which can lead to greater financial vulnerability for hospitals, according to Henderson.

The impact of a lack of maternity care is felt most in rural areas, where more than 60% of the nation’s maternity care deserts exist and where it’s estimated that only 7% of obstetric providers practice, according to the report.

The data on maternal care was collected prior to the U.S. Supreme Court’s decision in June that overturned Roe v. Wade and the constitutional right to abortion in the U.S.

Henderson said she is concerned that new state restrictions on abortion care could lead to an even larger gap of maternal care access in rural areas.

“Research has shown that there’s a high likelihood that these restrictions may not only increase the rate of unsafe abortions that may impact maternal and infant death rates but may also impact the number and quality of providers that are available to provide other maternity services,” she said. “We are definitely particularly sensitive to the impact that it will have on the populations that we know are already vulnerable and have been underserved and are already impacted by poor outcomes.”

Henderson said that while the problem of lack of access to maternity care in the U.S. is daunting, it’s not unsolvable.

For the past two years, the March of Dimes has operated mobile health units in different states to bring care to people in low-access areas and has started a venture philanthropy initiative to invest money in early-stage companies working to bring maternal care to more people.

The organization is also focusing on policy through its so-called Mamagenda that calls on lawmakers to pass legislation to improve maternal care, according to Henderson.

“We are supporting making sure that all women have quality, affordable health insurance and health care,” she said. “Providing preventive and supportive care for women during and after pregnancy, which includes extending Medicaid postpartum coverage to 12 months and expanding access to midwifery and doula care, these are proven solutions that we know will help address this crisis.”

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Scientists pan analysis Florida’s surgeon general posted on COVID-19 vaccines

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(NEW YORK) — Vaccine experts are pushing back on an analysis published by Florida’s surgeon general that warns COVID-19 vaccines increase the risk of cardiac-related deaths in young men, calling the study poorly designed and dangerously misleading.

The warning against vaccines from Dr. Joseph Ladapo is the latest move by the state surgeon general and his boss — Republican Gov. Ron DeSantis — that casts doubt on scientific consensus as they tap into voter frustration still lingering from the pandemic.

“I love the discussion that we’ve stimulated,” tweeted Ladapo on Monday after being accused by immunologists and doctors of spreading misinformation.

“Isn’t it great when we discuss science transparently instead of trying to cancel one another?” he added.

But if Ladapo wanted to spark a scientific discussion, he would have submitted the health department’s work for peer review instead of posting it on the Florida government website, said Dr. Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine.

Hotez called it another “phony-baloney” advisory by the DeSantis administration intended to raise the Republican governor’s national profile ahead of an election.

“This is much more of a political stunt than it has anything to do with science or protecting the population of the people of Florida … They cherry pick the risks, and they cherry pick the benefits,” said Hotez.

Ladapo did not immediately respond to requests for comment.

Bryan Griffin, press secretary for DeSantis, said: “We have no interest in responding to this.”

At issue is a paper Ladapo cites as his rationale for no longer recommending vaccines for young men ages 18-39. The recommendation bucked the consensus of every major government scientific organization, including the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health.

Those government agencies and the American Heart Association cite larger studies that found the benefits of COVID vaccination far outweigh the risks.

Ladapo’s recommendation was so far outside mainstream scientific consensus that it prompted immediate online pushback. At one point, Twitter removed the surgeon general’s announcement from its platform.

When asked why, a Twitter spokesperson only said the “enforcement action” was done “in error” and later reversed.

Vaccine experts said the Florida paper raised several red flags: Written anonymously before being released by the Florida Department of Health, the analysis omitted key details on methodology and didn’t examine medical records, only deaths.

“There’s just issue after issue piled up when you look at how this study was conducted and the interpretation of the findings,” said John Brownstein, chief innovation officer at Boston Children’s Hospital and an ABC contributor.

Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins School of Public Health, said among those concerns was that Florida looked at deaths up to 25 weeks after vaccination. He called that a “huge problem” because it’s too long and likely impacted by the “seasonality” of outcomes.

“No experienced vaccine safety researcher would have a 20- or 25-week control period,” he said.

“If you submitted that to peer review, any decent journal would reject it,” he added.

The Florida analysis also didn’t mention what medical experts and scientists agree has become evident in the past year: The virus is more likely than the vaccine to cause health problems in young men.

When the vaccine does induce myocarditis, most cases appear to be relatively mild and resolve on their own.

“COVID can cause all sorts of cardiovascular problems,” said Salmon, who said he personally opted to vaccinate his own sons. “So at the end of the day, the benefits (of the vaccine) outweigh the risks and that’s what really matters.”

Hotez and Brownstein agreed, both pointing to larger studies that show the COVID virus can put young men at risk in ways the vaccine does not.

“We know that there’s some concern about myocarditis. But overall, the evidence actually suggests there’s much greater risk of cardiac-related events when you’re unvaccinated,” Brownstein said.

A significantly larger global study is underway to examine the risk of myocarditis by combing through the data collected by more than a dozen of countries. Those results are expected next spring.

When asked about Florida’s position in a CNN interview, Dr. Anthony Fauci, the nation’s top infectious disease expert, warned the primary problem was that misinformation was still spreading too easily.

“The enemy of public health, when you’re dealing with a pandemic, is misinformation and disinformation. And unfortunately we have plenty of that,” he said.

ABC News reporter Cheyenne Haslett and Dr. Tiffany Russ contributed to this report.

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