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4-year-old mistakenly given adult COVID-19 vaccine instead of flu shot

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A 4-year-old girl in Maryland was given the first dose of the COVID-19 vaccine instead of the seasonal flu shot she was scheduled to receive at her local pharmacy, according to a report by the Baltimore Sun.
Victoria Olivier brought her daughter to get the flu vaccine to a Walgreens in Baltimore, where a pharmacist mistakenly administered her an adult dose of the Pfizer COVID-19 vaccine.
The vaccine has not yet been approved by the Food and Drug Administration for children under 12.
Phil Caruso, a spokesperson for Walgreens, told Fox News in an email that patient safety is the company’s “top priority.”
“Events like this are extremely rare and we take this matter very seriously,” Caruso wrote in a statement. “We are in touch with the patient’s family and we have apologized. Our multi-step vaccination procedure includes several safety checks to minimize the chance of human error. We’ve recently reviewed this process with our pharmacy staff in order to prevent a future occurrence.”
The error comes as children under 12 remain ineligible for the vaccine, though Pfizer-BioNTech has submitted clinical trial data from a COVID-19 vaccine study among kids ages 5-11 to the FDA, the companies announced Tuesday.
A request for emergency approval is anticipated to follow in the coming weeks, Fox News reported. Trial data included findings among 2,268 participants ages 5-11, which suggested the smaller dose shot was safe, well tolerated and resulted in neutralizing antibody responses.
A health care worker administers a dose of a Pfizer-BioNTech Covid-19 vaccine to a child at a pediatrician's office in Bingham Farms, Michigan. (Emily Elconin/Bloomberg via Getty Images)
Olivier told the Baltimore Sun she and her family were “stunned” by the incident. They had apparently dialed a 24/7 nurse’s hotline, Poison Control and contacted Olivier’s network of social media friends for help. So far, the child has had no major side effects, the news outlet reported.
“The vaccines, the way they change between age has a lot more so to do with the dose,” said Panagis Galiatsatos, MD, MHS, assistant professor, of Division of Pulmonary & Critical Care Medicine at John Hopkins.
Galiatsatos told Fox News that when a child is given a higher dose, the result is that the probability of side effects will increase.
“It got our attention, [the] human error, now we investigate how likely the dire outcome is,” Galiatsatos said, adding the probability of harm is low.
“Close monitoring, making sure the child follows up with their health care professional – that is what I would recommend,” he added.
“There's been errors in medicine that have been brought into the spotlight, which makes the next one preventable,” Galiatsatos said.
In a statement to Fox News, the FDA reminded that it has not “evaluated data pertaining to the safety and effectiveness” of the Pfizer vaccine for use in children under 12, nor has it approved or authorized emergency use of the vaccine for that pediatric population.
“We are glad to hear that the child is doing well and hope that she eventually received her flu vaccine,” the spokesperson wrote in an email. “As per the vaccination provider agreement, it is mandatory for vaccination providers to report vaccine administration errors whether or not associated with an adverse event to VAERS [The Vaccine Adverse Event Reporting System].”
The Olivier family is reportedly not planning to file a complaint with the Maryland Board of Pharmacy.
Fox News' Kayla Rivas contributed to this report.

COVID-19 vaccine third shot side effects on par with second dose: CDC study

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Most additional doses of mRNA COVID-19 vaccine administered roughly six months after the primary series resulted in mild to moderate side effects, according to an analysis from the Centers for Disease Control and Prevention released Tuesday.
The study was conducted when third-dose eligibility was limited to patients with moderate to severe immunocompromising conditions.
The findings stemmed from data collected between Aug. 12 to Sept. 19 through v-safe, the CDC’s voluntary phone-based surveillance system, and included 22,191 registrants who reported receiving a third dose of the vaccine.
Nearly all registrants under study received a third dose matchingthe primary series, and for 12,591 registrants who completed a check-in survey, 79.4% and 74.1% reported local or systemic reactions, respectively, after the third dose, versus 77.6% and 76.5%, respectively, after the second dose.
“These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate,” the report reads.
Across the board, v-safe data indicated a slight increase in local reactions after the third dose versus dose two, and a slight decrease in systemic reactions after dose three versus dose two. Most reports of pain after the additional dose were characterized as mild-to-moderate reactions (51.4% and 41.9%) compared to 637 registrants (6.7%) who reported severe pain, “defined as pain that makes daily activities difficult or impossible.”
Of the total 22,191 third dose recipients, about 28% said they couldn’t “perform normal daily activities” most frequently the day after vaccination, while 1.8% sought medical care and 0.1% were hospitalized. The survey didn’t capture reasons for medical attention or hospitalization, however the report notes that CDC staff followed up with these registrants.
Dr. Rochelle Walensky, director of the CDC, spoke to the findings during a White House briefing Tuesday, adding that the CDC and FDA reviewed the report in informing the newly released recommendations for booster shots, which awarded expanded eligibility for the Pfizer vaccine booster across several high-risk groups about six months after the primary series. Health authorities are working to review similar data for recipients of other vaccines developed by Moderna and J&J.
“COVID-19 vaccine booster doses so far are well tolerated,” Walensky said of the report, in part, adding, “The frequency and type of side effects were similar to those seen after the second vaccine doses and were mostly mild or moderate and short-lived.”
“We will continue to evaluate data as it becomes available in real-time and with urgency and update our recommendations to make sure that all of those at risk have the protection they need,” Walensky said.
While third dose eligibility was limited to a small fraction of Americans with immunocompromising conditions during the study period, researchers suspected registrants included those with and without such conditions, and the v-safe surveillance system doesn’t include data about immune status.

DEA warns of ‘alarming increase’ in fake prescription pills containing fentanyl

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The Drug Enforcement Administration on Monday issued a rare public safety alert warning Americans of an “alarming increase” in deadly fake prescription pills containing fentanyl flooding the country.
In its first such alert in six years, the agency said the majority of the counterfeit pills found in the U.S. are being manufactured in Mexico with the help of chemicals supplied by China.
Over 9.5 million phony pills have been seized so far this year – more than the last two years combined, the DEA said.
A bag containing 445 fentanyl pills worth an estimated $10,000 inside an Arizona woman's pants, seized by the Yavapai County Sheriff's office. (Yavapai County Sheriff’s Office )
The counterfeit pills are produced to look like real prescription opioid medications.
“DEA laboratory testing reveals a dramatic rise in the number of counterfeit pills containing at least two milligrams of fentanyl, which is considered a lethal dose,” the DEA said in its alert.
Fentanyl is a synthetic opioid that is up to 100 times more potent than heroin.
Methamphetamine has also increasingly been detected in the pills.
The fake pills are commonly peddled on social media, making them easily accessible to minors, the DEA said.
This story first appeared in the New York Post

Steroid nasal sprays reduce COVID-related poor outcomes, study suggests

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Regular use of steroid nasal sprays afforded COVID-19 patients protection against virus-related hospitalization, ICU admission and death, the Cleveland Clinic announced Tuesday. However, the findings don't suggest the sprays as a COVID-19 treatment and further findings are needed to confirm the results, the health system said.
The study, funded by the National Institutes of Health and published in the Journal of Allergy and Clinical Immunology, stemmed from over 70,000 COVID-19 patients ages 18 and older at the Cleveland Clinic health system from April 2020 to March 2021. Of the group, 17.5% were hospitalized, 4.1% were admitted to the ICU and 2.6% died at the hospital. Just over 14% of patients were taking a steroid nasal spray, also known as intranasal corticosteroids (INCS), before infection.
Researchers excluded patients who received INCS prescriptions prior to 2018, as well as pregnant women, those with missing hospitalization data and others.
Patients receiving the spray before COVID-19 illness faced a 22% lower likelihood of virus-related hospitalization, 23% lower odds of ICU admission and 24% reduced risk of COVID-related hospital death, versus patients not taking a steroid nasal spray, according to a release from the Cleveland Clinic.
“While the findings of the study encourage patients who use intranasal corticosteroids chronically to continue to do so as needed, it does not suggest that intranasal corticosteroids should be used to treat or prevent COVID-19 in any way,” the release reads. “The theory behind the study, which was based on reports that intranasal corticosteroid in vitro (in the laboratory) decreased the protein receptor ACE2, allowing the SARS-CoV-2 virus that causes COVID-19 to enter cells and, spread the disease.”
Steroid nasal sprays are meant to relieve irritation, allergies and stuffy nose and can be prescribed or bought over the counter.
“This study shows the importance of the nose in COVID-19 infection,” Dr. Joe Zein, pulmonologist at the Cleveland Clinic, said in a statement. “The nose, in this instance is the gateway to our bodies, allowing the virus to enter and replicate within. The use of intranasal corticosteroids may help disrupt that gateway.”
Dr. Ronald Strauss, allergist-immunologist and director of the Cleveland Allergy and Asthma Center, added: “Our findings are particularly significant, as decreased COVID-19 hospitalizations, ICU admissions, and mortality could alleviate the strain on health care systems with limited resources across the globe, especially in developing countries where there is limited access to vaccines and where mutations in SARS-CoV-2 have emerged.”
The health system noted future studies are needed to confirm the findings, and study authors specifically called for randomized control trials to determine whether steroid nasal sprays cut the risk of severe COVID-related outcomes.

‘5 or more’: Higher fruit, vegetable servings linked to kids’ improved mental well-being

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Higher fruit and vegetable intake was linked with greater mental well-being scores among secondary schoolchildren, according to a new study based out of the U.K.
“The relationship of diet and nutrition with mental health and well-being in either children or adults is not fully understood, although the relevance of diet quality to physical health in relation to non-communicable disease morbidity and mortality is well established,” authors affiliated with Norwich Medical School wrote in the study published in BMJ Nutrition, Prevention & Health.
To conduct the study, researchers analyzed the The Norfolk Children and Young People’s Health and Well-being Survey issued in 2017 across more than 50 schools in Norfolk, U.K. including data among 7,570 secondary school children and 1,253 primary school children.
Study authors found a strong association between nutrition and mental well-being among the older secondary schoolchildren, however analyses didn’t reveal such a link among primary schoolchildren, possibly owing to a lesser understanding of portion sizes in self-reported data.
Results from the secondary schoolchildren indicated a linear pattern between fruit and vegetable intake and mental well-being score; five or more portions was associated with a greater mental well-being compared to 3-4 or 1-2 portions. The largest portion size (5 or more) was associated with a 3.73 increased well-being score versus children reporting zero servings.
Study authors found a strong association between nutrition and mental well-being among U.K. secondary school children. Courtesy: Norwich Medical School
What’s more, children who didn’t eat breakfast and kids who only consumed an energy drink scored lower by 2.73 and 3.14 units, respectively. Packed lunches were also associated with improved mental well-being versus not eating lunch at all.
Researchers suggested a potential biological basis behind the link between nutrition and higher mental well-being; nutrition is key in development, growth and hormone metabolism, with “direct effects on a number of biological process including oxidative processes, inflammation and immunity, and brain signaling molecules,” authors wrote in part, adding that unhealthy diets cause inflammation, often higher in patients battling depression, and inadequate intake of “magnesium, folate, and zinc” has been associated with depression and long-chain n-3 fatty acids with anxiety.
“Public health strategies and school policies should be developed to ensure that good quality nutrition is available to all children both before and during school in order to optimise mental well-being and empower children to fulfil their full potential,” study authors concluded.

Fully vaccinated Michigan couple dies from COVID-19 a minute apart while holding hands: report

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A fully vaccinated Michigan couple died one minute apart from COVID-19 on Sunday, weeks after coming down with the virus.
Cal Dunham, 59, and his wife Linda, 66, had preexisting conditions and were very cautious, Fox17Online reported. But they came down with symptoms during a recent camping trip and days later were hospitalized and put on ventilators, the report said.
They did not improve and doctors told the family that they would likely need to come off life support on Monday. Their daughter Sarah Dunham told the outlet that the pair “had other plans.”
“It was Sunday and dad’s like, ‘You know what? This is what we’re going to do today,’” she said.
They were reportedly wheeled into the same room. He died at 11:07 a.m. and she died at 11:08 a.m., the report said. They were holding hands.
VideoThe daughter told the station that her mother would joke around that she would be right behind her husband if something were to ever happen to him.
“And she really was, like she really was right there behind him,” she said.
In studies, the two-dose COVID-19 vaccines by Pfizer and Moderna were around 95% effective at preventing illness, while the one-shot Johnson & Johnson shot was 72% effective, though direct comparisons are difficult. So while the vaccines are very good at protecting us from the virus, it’s still possible to get infected with mild or no symptoms, or even to get very sick.
Still, health experts say the vaccines provide strong protection against serious illness.
The Associated Press contributed to this report.

Trick-or-treating amid COVID-19 pandemic: CDC director weighs in

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Looking to partake in Halloween festivities this year? Celebrate outdoors, limit crowds and trick-or-treat in small groups, says Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).
“Oh gosh I certainly hope so,” Walensky told CBS’ Face the Nation, when prompted whether it was safe for kids to trick-or-treat this year. “If you’re able to be outdoors, absolutely. Limit crowds, I wouldn’t necessarily go to a crowded Halloween party but I think that we should be able to let our kids go trick-or-treating in small groups and I hope that we can do that this year.”
Walensky’s comments come as children under 12 remain ineligible for COVID-19 vaccine, though Pfizer CEO Albert Bourla said Sunday the company is “days, not weeks” away from submitting trial data to the FDA in a bid to expand use among kids ages 5-11, and Pfizer board member Dr. Scott Gottlieb has anticipated the age group could become eligible for vaccine by Halloween. Recent findings suggested the shot was safe and effective in elementary school-aged kids at a lower dose, 10 microgram (µg) versus the 30 µg dose for individuals ages 12 and older.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Bourla wrote in part in a release posted on Sept. 20. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Last year, COVID-related precautions and gathering limits resulted in canceled Halloween events across 37 states, USA Today reported, while the CDC had discouraged Americans from participating in traditional trick-or-treating and indoor costume parties. The health agency last year advised trick-or-treaters against wearing a costume mask as a replacement for their virus-related mask or in addition to one.
“Many traditional Halloween activities can be high-risk for spreading viruses,” the CDC said in a previous advisory, adding that anyone who may have COVID-19–or have been exposed to someone with COVID-19–should not partake in any in-person activities during the holiday.
Fox News’ Daniella Genovese contributed to this report.

Salmonella outbreak from unknown source spreads to 29 states

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An ongoing salmonella outbreak from an unknown food source has spread to 29 states, federal health officials warned.
The outbreak has infected nearly 280 people and more than two dozen have been hospitalized, according to the Centers for Disease Control and Prevention's (CDC) latest update, which was issued on Sept. 23.
Still, there have been no deaths associated with the “fast-growing outbreak,” according to the CDC.
The agency created a map showcasing where people impacted by the salmonella outbreak live.
So far, Texas has the most reported illnesses – 81 – followed by Illinois and Virginia, which have 23 and 22 reported cases, respectively.
Minnesota, with 19 illnesses, and Massachusetts, with 10, round out the top five states with the most reported cases.
However, the agency cautioned that the map may not represent all of the cases “because many people recover without medical care and are not tested for salmonella.”
The CDC said officials in several states have been collecting data as part of a multistate investigation into an outbreak of salmonella oranienburg infections.
The agency added that officials have been collecting and testing food items from restaurants “where sick people ate” but have not yet identified a “food linked to illness.”
In its latest update, the CDC said a strain of salmonella oranienburg was found in a takeout condiment cup containing cilantro and lime – although the container had contained onions at one point, making it hard to identify the source.
“Because multiple food items were present in the container and in the sample that was tested, it is not possible to know which food item was contaminated,” the CDC said.
Officials are using the information “in conjunction with other available information to help narrow the list of possible foods linked to illness.”
Each year, the potentially harmful bacteria causes about 1.35 million infections, 26,500 hospitalizations, and 420 deaths across the United States, according to the CDC.
Most people who became infected with the bacteria have diarrhea, fever and stomach cramps with symptoms lasting up to seven days.
However, in some cases, “people’s illness may be so severe that they need to be hospitalized,” the CDC said.

COVID-19 vaccine boosters: Who is eligible?

close Video Dr. Siegel: COVID booster shot will decrease risk of spread, severe illness Fox News medical contributor Dr. Marc Siegel joins ‘America’s Newsroom’ to weigh in on coronavirus vaccine booster guidance.
U.S. health authorities’ move last week to authorize and recommend the Pfizer-BioNTech COVID-19 vaccine to certain populations who received a second dose six months ago has left about 20 million Americans eligible, according to Jeff Zients, White House COVID-19 response coordinator.
Booster shots are aimed to extend and enhance protection against severe COVID-19 disease and related complications among vulnerable populations, U.S. Surgeon General Dr. Vivek Murthy said during a White House briefing Friday. But who can receive a booster dose at this time?
“If you are six months out from your last dose of Pfizer vaccine, you are eligible for a booster if you fall into one of three high risk groups,” Murthy said, noting the following eligible groups:
People ages 65 or older and residents in long term care facilitiesPeople ages 50-64 with medical conditions and at high risk for severe COVID-19 illness (such as obesity, diabetes, high blood pressure, chronic kidney disease). People ages 18-49 with underlying conditions may receive a shot and should consider individual benefits and risksPeople ages 18-64 who live or work in a setting with increased risk of COVID-19 exposure (including healthcare workers, teachers, individuals in shelters or prisons and grocery store workers)A small fraction of Americans with moderate-to-severe immunocompromise were previously made eligible for a third dose as well. Murthy advised visiting for thousands of locations nationwide offering COVID-19 booster doses.
Video”CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations to keep all Americans safe,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), said in a statement. “We will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations or people who got the Moderna or Johnson & Johnson vaccines.”
“Your health matters just as much as other vaccine recipients and we want to make sure that your protection against COVID is strong and reliable as well,” Murthy added.
According to Zients, the U.S. has secured enough booster supply for every American, and doses are free with no I.D. or insurance required. Officials worked with governors, pharmacies, doctors, long term care facilities and other providers to make doses available to eligible Americans, he said, noting that 80,000 locations are offering a booster shot nationwide, including over 40,000 local pharmacies.
More specifically, Pfizer-BioNTech booster shots are available at nearly 6,000 CVS Pharmacy and MinuteClinic locations, and patients will be prompted to self-attest to their eligibility by the defined guidelines; Walgreens, Walmart and Sam's Club, Kroger and other pharmacies are offering doses as well.
Nevertheless, more than 70 million Americans remain unvaccinated, and federal health officials emphasized that vaccinating the unvaccinated remains a top priority in an effort to suppress the pandemic. As of Sept. 24, the U.S. recorded over 130,000 new daily cases, with a seven-day average of deaths exceeding 1,500 and weekly average for hospital admissions at 8,906.

Life expectancy of American men fell by 2 years amid COVID pandemic: study

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The life expectancy of American men dropped by more than two years during the COVID-19 pandemic, a new study has found.
Oxford University said in the study published Monday that the life expectancy among men fell by 2.2 years in 2020, the largest drop since World War II, according to Reuters.
Life expectancy fell by more than six months compared to 2019 for 22 of the 29 countries analyzed for the study, which included the U.S. and European nations.
Overall, there were reductions in life expectancy in 27 of the 29 countries, the news outlet said.
Nov. 19, 2020: Ventilator tubes are attached to a COVID-19 patient at Providence Holy Cross Medical Center in the Mission Hills section of Los Angeles. (AP Photo/Jae C. Hong, File)
Most life expectancy reductions could be linked to official COVID-19 deaths. The pandemic has so far claimed about 4.7 million lives across the globe and infected almost 232 million people, according to the latest numbers by Johns Hopkins University.
In the U.S., more than 688,000 people have died and almost 43 million cases have been confirmed.
“The fact that our results highlight such a large impact that is directly attributable to COVID-19 shows how devastating a shock it has been for many countries,” said Dr. Ridhi Kashyap, co-lead author of the study, which was published in the International Journal of Epidemiology.
Most countries saw greater drops in life expectancy for men than women. Overall, men’s life expectancy fell by more than a year in 15 countries, compared to women in 11 countries.
In the U.S., the increased mortality was mainly among people of working age and those under 60. In Europe, meanwhile, deaths among those over 60 contributed more significantly to the spike in mortality.