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COVID-19 VACCINE *UPDATE*

The road ahead in the U.S. as the U.K. becomes the first country in the West to approve a COVID-19 vaccine.

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BACKGROUND

  • November: AstraZeneca, Moderna & Pfizer all announced promising results from their COVID-19 vaccine clinical trials. Pfizer & Moderna applied for FDA emergency use authorization.
  • December 1: CDC advisory cmte. met to discuss distribution (who should receive priority to get the vaccine first).
  • December 10 & 17: FDA advisory cmte. will meet to discuss Pfizer & Moderna emergency use applications.
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LATEST DEVELOPMENTS

  • A panel of doctors, researchers, and specialists advises the CDC on vaccine recommendations – the FDA ultimately approves a vaccine for use.
  • This CDC advisory panel recommended a plan for potential COVID-19 vaccine distribution based on limited initial supply & weighing who’s at most risk.
  • Those living or working in long-term care facilities and healthcare workers currently would be first in line.
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BY THE NUMBERS

CDC estimates: 

  • Approx. 21M healthcare workers (ex: hospital & long-term care personnel)
  • Approx. 53M adults age 65 and older
  • Approx. 87M non-healthcare essential workers (ex: education, manufacturing, transportation, police & fire employees)
  • More than 100M adults with high-risk medical conditions (ex: cancer, obesity & diabetes)
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IMPORTANT CONTEXT

  • The CDC’s cmte’s recommendations regarding which groups get vaccine priority are not binding on states.
  • Just as each state has their own COVID-related restrictions, each state will establish their own criteria and plan for how vaccines will be allocated.
  • To date, NO vaccines have received FDA emergency use authorization, but the federal gov’t expects to have 40M COVID vaccine doses in coming weeks.
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“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

FDA Commissioner Dr. Stephen Hahn & Center for Biologics Evaluation and Research Director Dr. Peter Marks.
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To date, all the data we have regarding vaccines has come from the companies themselves -- NOT the federal gov't -- or peer-reviewed studies. There's still A LOT we don't know, like how soon after a vaccine dose does immunity protection occur. Vaccine trials are ongoing both in the U.S. and abroad.

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What to know as the U.S. reports more than 1 million COVID-19 cases among the youngest Americans.

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The Latest

Last Week: The *total* number of cases among children surpassed 1 million as America also reported 1 mil *new* cases.

This Week: The country’s largest school district (NYC) reverted back to remote-only learning.

Next Week: At least two states (Kentucky & West Virginia) will temporarily cease all in-person school instruction.

 

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The Latest Data

According to COVID-19 data compiled in a report by the American Academy of Pediatrics and Children’s Hospital Association, as of November 12:

  • 1 mil+ children (0 – 20) have tested positive — that’s 11.5% of all U.S. cases.
  • Last week was the largest one-week increase among cases in children: 112,000 — and a 22% rise over two weeks.
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More Context

  • The data comes from 49 states & D.C., but states differed in the type of data reported (ex: cases vs. hospitalizations vs. deaths) AND definition of “child” (ex: 0 – 14 yrs, 0 – 20 yrs).
  • The hospitalization rate among children was 1.6% based on the 23 states and NYC providing hospitalization data.
  • Of the 42 states providing fatality data, children made up less than 1% of deaths.
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“As a pediatrician who has practiced medicine for over three decades, I find this number staggering and tragic.”

American Academy of Pediatrics President Sally Goza, M.D., FAAP, on the more than 1 million cases among children. She also notes that while severe illness among children with COVID-19 is rare, the secondary effects -- such as school disruptions and family stress -- also weigh heavily on children during the pandemic.
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Based on what we know so far, most children experience milder symptoms of COVID-19 than adults, and some who test positive may not have any symptoms at all but still can spread illness. While some argue schools risk higher infection rates, others say school rules help keep families safe. What do you think?

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Will The Law Stand?

The U.S. Supreme Court tackles the Affordable Care Act… again.

The latest legal challenge to the ACA (aka “Obamacare”).

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BACKSTORY

  • 2010: ACA signed into law.
  • 2012: U.S. Supreme Court upheld the ACA’s “individual mandate” (requires most Americans buy insurance or pay penalty) under Congress’ tax powers, declaring the ACA constitutional.
  • 2018: After Congress eliminated the tax penalty under the GOP’s 2017 tax overhaul, a TX federal judge ruled the ACA can’t stand w/o the tax penalty. This ruling is on hold.
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THE CASE

  • The Court will decide if the individual mandate is unconstitutional and if Congress’ 2017 elimination of the tax penalty means the entire ACA is invalid.
  • 18 states led by TX (& backed by Trump admin) argue the mandate is central to the ACA, and w/o the penalty the ACA is unconstitutional.
  • 20 states + DC led by CA argue the mandate can be separated from the ACA so the law can still stand.
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2012 vs. 2020

  • None of Pres. Trump appointees (Neil Gorsuch, Brett Kavanaugh, Amy Coney Barrett) were members of the Court when it ruled on the ACA previously.
  • The Court now has a 6-3 majority of Republican-appointed justices.
  • Some question if Justice Barrett’s 2017 critique of Chief Justice John Roberts’ 2012 opinion upholding the law means she will vote to strike it down, but she’s said she is “not hostile to the ACA.”
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WHY IT MATTERS

  • Big Picture: The quality, cost & availability of healthcare in America remains a hotly debated issue.
  • Timing: The fate of the ACA is being examined smack in the middle of a global pandemic with unique challenges.
  • Unknowns: While debates continue over the value of the law, roughly 17.5M more Americans have insurance now vs. before the ACA.
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WHAT’S NEXT

We won’t know the results of the case until next spring, and as late as June 2021.

If the law is struck down, the ripple effects are truly TBD.

If the law is upheld, there’s still a possibility of legislative changes as Democrats discuss adding a public option, and Republicans have promised to create a separate plan.

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The incoming Congress could take actions (ex: eliminating the individual mandate or increasing the tax penalty to a nominal amount) which would influence how the Court ultimately rules. This is one of the reasons why the future of the Senate, with two tie-breaking seats in Georgia in a runoff for Senate party majority, matter so much.

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Aspirin
Mouthwash
Baby Shampoo

Are these commonly-found household items part of your defense against COVID-19?

What the studies say…

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Mouthwash & Shampoo

  • Penn State College of Medicine researchers placed samples of a similar human coronavirus – *not COVID-19* – in mouthwashes (ex: Listerine), saline nasal rinses, and a 1% baby shampoo solution (used as nasal rinse) for 30-second, 1-min & 2-min intervals.
  • Next they diluted the results, placed the results in contact with cultivated human cells, and waited a few days to measure how much of the virus was inactivated.
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RESULTS

  • 1% baby shampoo solution nasal rinse: Inactivated more than 99.9% of the human coronavirus tested after 2 min.
  • Mouthwashes: Many inactivated between 90% and  99.9% of the human coronavirus tested after 30 seconds – some took longer than 30 seconds.
  • Saline nasal rinses: No impact.
  • NOTE: Researchers could not use actual COVID-19 due to issues w/availability, safety & expense.
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“While we wait for a vaccine to be developed, methods to reduce transmission are needed… The products we tested are readily available and often already part of people’s daily routines.”

Penn State study leader, distinguished prof. of microbiology and immunology, Craig Meyers. He admits "mouthwash won't cure COVID-19" but says "even if the use of these solutions could reduce transmission by 50%, it would have a major impact" and that more research on nasal and oral rinses is needed.
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FYI: Listerine Says

“Listerine® Antiseptic mouthwash is not clinically proven to kill the coronavirus that causes COVID-19… To date, the available data is not sufficient to support a conclusion that the use of Listerine® Antiseptic or mouthwashes could be helpful against coronavirus as further research is needed.”

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Aspirin

  • Univ. of Maryland researchers reviewed the medical records of 400+ former COVID-19 patients from four East Coast hospitals. About a quarter took daily low-dose aspirin either right before or right after being admitted.
  • RESULTS: Daily low-dose aspirin was *associated* with a 43% lower risk of ICU admission, a 44% lower risk of being put on a ventilator, & a 47% lower risk of death while admitted.
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“If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients.”

University of Maryland study leader, asst. professor of anesthesiology, Jonathan Chow. The study's co-author said aspirin's blood-thinning effects help prevent blood clots and other cardiovascular problems, which can be particularly devastating for COVID-19 patients, but says patients must consult with their doctor before taking aspirin.
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All of the studies' researchers agree that while the results are promising as a starting point, people should continue to follow the preventive measures issued by federal, state, and local health officials, including mask wearing, frequent handwashing, and maintaining social distance.

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“BRAIN FOG”

One mysterious, lingering symptom of COVID-19 catches the attention of top health officials & perplexes doctors, sufferers alike.

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“If you talk to a significant number of people, they will tell you that, for anywhere from weeks to months and possibly longer, that they have symptoms that are characterized by fatigue and a thing that they refer to as brain fog, which really means the difficulty concentrating.”

Dr. Anthony Fauci revealing during an interview with '60 Minutes' one of his concerns over the long-term impact of the virus that causes COVID-19.
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“It’s all related. The fact that people are losing their sense of smell, the fact that people are losing their sense of taste, and the brain fog — all this whole system is neurological.”

Stanford researcher Dr. Kari Nadeau leads an ongoing Stanford study on long-term immunity to SARS-CoV-2. Patients recovering from COVID, across age groups and gender, have described "brain fog" (a lack of mental clarity, confusion) since early in the pandemic.
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“Everything in my brain was white static … I was sitting on the edge of the bed, crying and feeling ‘something’s wrong, I should be asking for help,’ but I couldn’t remember who or what I should be asking. I forgot who I was and where I was.”

31-year-old Erica Taylor who says her "brain fog" after COVID-19 became so debilitating she was forced to take a temporary leave from her job.
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What Do We Know:

“It’s subtle, but it is very real.”

  • The “dysfunction” some have experienced usually won’t surface during a brain scan, according to neurologist Dr. Joanna Hellmuth at University of California, San Francisco.
  • Hellmuth says she sees the impact on cognitive tests, consistent with other viruses that can impact cognitive health.
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Why?

No one knows 100%.

Here’s some early thinking:

  • Brain cells *can* (though rarely) become infected with COVID-19.
  • Inflammation of the body can lead to issues including small, subtle strokes.
  • Low oxygen levels in the blood can have an impact.
  • An exhausted immune system could play a role.
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One encouraging note: Doctors and those recovering from COVID-19 say this fog can "lift" - that it's not permanent. A reminder: This week marks 9 months since the first diagnosed case of COVID-19 in America; research on the impact of COVID - both mentally and physically - remains limited.

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The Sniff Test

A testing method for COVID-19 puts the spotlight squarely on man’s best friend.

Can Dogs Save The World?

 

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BACKSTORY

  • The Theory: Diseases have unique “odorprints.”
  • Past research has shown dogs can “sniff out” diabetes, malaria and different forms of cancer.
  • Early in the pandemic, researchers started studying dogs to see if they can detect COVID. Preliminary research shows promise for detecting cases *before* symptoms emerge.
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“As far as we know, no other airport has attempted to use canine scent detection on such a large scale against COVID-19.”

Director of Helsinki Airport, Ulla Lettijeff, where a recently launched pilot program is using COVID-sniffing dogs. Dogs do not sniff people directly but a wipe given to passengers (to wipe their skin, i.e. neck or wrist) and dropped in a cup. Dogs respond in 10 seconds. Preliminary research from COVID-sniffing dogs used in Dubai's airport shows over 90% accuracy.
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“With covid detection, you are not recognizing the virus. You are recognizing the volatile byproducts of cells dying because they have been infected with the virus.”

Professor of chemistry Kenneth Suslick, University of Illinois, invented an electronic nose to sniff out explosives and diseases. He says research in this area continues to expand. What do dogs actually smell? Chemicals omitted in our sweat, saliva, and breath.
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“Their noses work very differently than ours. We breathe in and out through the same passages. But dogs breathe in one passage and out another so they can separate out the odor that they want to focus on.”

Founder of BioScent K9, Heather Junqueira, a U.S. nonprofit training beagles and beagle-basset hound mixes to sniff out COVID-19. She says ideally a "positive" detection by a dog will be followed with an instant saliva test.
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Those optimistic think dogs may be more accurate than current testing, offering a powerful surveillance tool for returning communities back to "normal" by working at schools, stadiums and airports. Critics say training dogs is too expensive and time consuming to scale effectively.

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A new study sheds light on the increased frequency of alcohol consumption amid the COVID-19 pandemic.

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″We’ve had anecdotal information about people buying and consuming more alcohol, but this is some of the first survey-based information that shows how much alcohol consumption has increased during the pandemic.”

RAND Corporation's Michael S. Pollard, PhD, one of the authors of a new study showing Americans' alcohol intake frequency increased by 14% during the COVID-19 pandemic.
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ABOUT THE STUDY

  • Published as a research letter in the journal JAMA Network Open.
  • 1,500+ U.S. adult participants, aged 30 – 80, were asked about their drinking habits during the spring of 2020 compared to the spring of 2019.
  • On average, the 14% increase reported translates to 75% of adults consuming alcohol 1 day more per month.
  • Study’s authors note that results are based on participants’ self-reporting.
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The alcohol consumption increase was most notable among two groups:

  • Females, with 17% reporting drinking alcohol more frequently
  • Those aged 30 to 59, with 19% reporting drinking alcohol more frequently

Additionally, women reported a 41% increase in heavy drinking (i.e., drinking 4 or more drinks within 2 hours).

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WHY IT MATTERS

  • In April, the World Health Org. recommended that people currently restrict their alcohol consumption b/c of its negative impacts, incl. on mental health & potential to compromise people’s immune systems.
  • The study’s author echoed similar concerns, noting the results suggest “another way that the pandemic may be affecting the physical and mental health of Americans.”
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Why are women drinking more frequently? This study doesn't say. Separately, a UK study found those with the greatest increase in mental distress during the pandemic included young adults (18-24), women, and those with small children.

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COVID-19 &
Your Workout

New research on COVID-19 infections from exercise classes as states weigh whether to reopen gyms.

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KEEP IN MIND

  • CDC: COVID-19 spreads “mainly” person-to-person via respiratory droplets released when someone talks, sneezes, or coughs.
  • CDC: Questions remain about how effectively the virus spreads on surfaces. Hard, non-porous materials – like metal – in high traffic areas pose a risk for transmission (ex. touching an infected handle on an exercise bike and then wiping sweat from your eyes).
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The Latest Science

  • New study on COVID-19 spread among fitness class attendees in South Korea.
  • 27 instructors attended a February 15 workshop before returning to 12 different gyms; unknowingly 8 instructors were infected w/ COVID-19.
  • In the following weeks, 57 of the 217 class attendees developed COVID-19.
  • Additionally, 38 family members and 17 co-workers / friends developed COVID-19. Total infections: 112.
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“Because of the increased possibility of infection through droplets, vigorous exercise in closely confined spaces should be avoided during the current outbreak, as should public gatherings, even in small groups.”

The study's authors hypothesized high-intensity workout classes held in small spaces with moist, warm air and many participants can lead to COVID-19 transmission. They noted infected instructors *appear* to not have spread the virus in yoga or pilates classes.
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THE LATEST: USA

  • Gyms are open in 25+ states under new rules requiring precautions like social distancing, masks & reduced capacities.
  • Ohio: judge ruled state’s health dept “criminalized lawful businesses” by closing gyms & health clubs, allowing them to reopen as long as they comply w/ safety requirements.
  • Maine: delayed reopening of gyms after seeing the new study out of South Korea highlighted by CDC.
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Unlike other industries (ex: schools, restaurants, places of worship), the CDC has not issued specific reopening guidance for gyms. Check out the CDC's guidance for other industries on our source page.

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One of America’s oldest companies will stop selling one of its most iconic products.

WHY?

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WHAT TO KNOW

  • Johnson & Johnson (J&J) will stop selling its talc-based baby powder in the US and Canada.
  • Thousands of lawsuits challenging its safety have led to mixed outcomes. J&J currently faces approx. 19,400 lawsuits over the product.
  • J&J has lost more lawsuits than it won, but the appealed losses have been reduced, overturned or are working their way through the system.
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Talc-Based Baby Powder

  • Talc is a naturally-occurring mineral.
  • Asbestos, also a naturally-occurring mineral, is often found near & can contaminate talc mining sites.
  • Crushed talc is in many personal care products, like makeup, deodorant, and one formula of Johnson’s Baby Powder.
  • Concerns about talc & asbestos cross-contamination began in the 1930s.
  • Questions about links between talc and ovarian cancer date back to the 1960s.
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Is Talc Dangerous?

  • A World Health Org. agency: talc containing asbestos is “carcinogenic” (potential to cause cancer) when inhaled.
  • American Cancer Society: studies have been mixed, but notes “some suggestion of a possible increase in ovarian cancer risk.”
  • FDA: no studies have proven a conclusive link between talc and ovarian cancer.
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“Demand for talc-based Johnson’s Baby Powder in North America has been declining due in large part to changes in consumer habits and fueled by misinformation around the safety of the product and a constant barrage of litigation advertising.”

J&J in a statement, noting it remains "remains steadfastly confident" in the safety of its product, citing "decades of scientific studies by medical experts around the world."
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“Today’s victory means that children and families no longer will be endangered by this baby powder.”

Rep. Raja Krishnamoorthi (D-IL), the Chair of the Subcommittee on Economic and Consumer Policy, led a 14-month investigation into the health risks of asbestos in talc-containing products & said J&J "knew for decades that its product contains asbestos, and the company fought to keep using a testing method that never would have allowed it to be detected."
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Not Just The Powder: Johnson & Johnson says it decided to cut 100 products, including talc-based baby powder, after assessing its product line in light of COVID-19. J&J will continue to sell its cornstarch-based powder, but will keep the talc-based product on market shelves until it is sold out. Will you continue using it?

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New Questions About
COVID-19 & Children As a Rare Set of Symptoms Surface

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The Backstory

Monday: NYC Health Dept. issued alert after flagging 15 children with similar symptoms hospitalized since mid-April.

Patients: Aged 2-15 years old; some tested positive for COVID-19 (or antibodies) while others tested negative.

Symptoms: Similar to toxic shock and/or “Kawasaki disease” (an illness that causes inflammation), persistent fever.

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“We want to reassure parents – this appears to be uncommon.”

Dr. Jane Newburger, Dir of the Kawasaki Program at Boston Children’s Hospital, in a statement released by the American Heart Association on Wednesday. The group says, though rare, "some children are becoming very ill extremely quickly" and list symptoms as "persistent fever, inflammation & evidence of single or multi-organ dysfunction" and "may or may not test positive for COVID-19."
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Why It Matters:

This bulletin from NYC is corroborated by reports from doctors in Europe and the U.S, (mainly on the East Coast) and notably in areas with high COVID-19 infection rates.

Health officials have been baffled at the low rates of COVID-19 among children — this raises questions about a more nuanced, rare response in otherwise healthy children.

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Something To Consider

The number of confirmed COVID-19 cases among U.S. children remains low. However, children are not extensively tested.

According to the most recent CDC data, about 21,000 Americans under 18 tested positive for COVID-19, a small percentage of the 1M+ cases.

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For context - the 2019-2020 flu season was particularly deadly for children under the age of 4 (CDC reported 170 deaths), and had historically-high hospitalization rates for those under 18 years old.

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“HIGHLY POWERED”

The results of a drug trial provide an important clue to treating COVID-19.

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What To Know:

Nat’l Inst. of Health’s Dr. Fauci shared the results today of “the first truly high-powered randomized placebo control trial” on a drug used to treat COVID-19.

  • Drug: remdesivir (rem-des-a-veer)
  • NIH sponsored the trial that began in February and included 1,000+ hospitalized patients across the globe
  • Reduced recovery time of patients from 15 days to 11 days, or roughly 30%
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Why It Matters:

There are no *proven* therapeutics to specifically treat COVID-19.

Dr. Fauci: “What it’s proven is that a drug can block this virus…We think it’s really opening the door to the fact that we now have the capability of treating.”

This will encourage further research, testing, and innovation on remdesivir and other therapeutics.

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How It Works:

Remdesivir blocks an enzyme used by the virus to gain strength or replicate.

Administered through an IV.

Interesting to Note: Though tested for treating SARS & MERS (coronaviruses), leading to positive results for shortening disease and symptoms in animals, remdesivir has NOT been approved anywhere in the world.

 

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“It’s active against every coronavirus that we’ve ever tested. It was very hard for the virus to develop resistance to remdesivir. That means the drug would likely be effective over longer term use.”

Vanderbilt University’s Dr. Mark Denison who has studied the drug's impact on different coronaviruses dating back to 2013. Additional information is needed about its use on COVID-19, including whether or not it can be safe & effective treating less severe cases of COVID-19.
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Something To Consider

In a separate study on remdesivir in China, the drug did not lead to shorter recovery times. Patients receiving the drug vs. placebo did not experience any significant benefit.

The study was smaller and ended early. Researchers wanted more than 450 people enrolled, but ended up with just over half of that, due to decreasing number of COVID cases.

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Dr. Fauci says the drug's impact on COVID-19 mortality is TBD. Initial data reflects a trend that those treated with remdesivir have lower mortality rates but a lot more information is needed. That said, the FDA says its already working with the drug-maker to secure availability of the treatment *if* approved.

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How COVID-19 impacts what you and your family are able to buy, cook & eat.

 

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THE STAKES (& STEAKS)

  • The U.S. is the world’s largest food exporter.
  • The U.S. is the world’s largest beef producer & consumer in the world.
  • The U.S. is the world’s largest poultry producer. It’s also a major egg producer & the second largest poultry exporter.
  • Meat byproducts (ex: gelatin, wool, lanolin) also contribute to many commonly used household products.
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What’s the Problem?

The U.S. food supply chain is impacted by COVID-19 in these two ways:

  • Distribution: Restaurants, cafeterias, closed, immediately halting demand.
  • Human Power: When plants shut down due to illness/sick leave, fewer workers can process food.

Why It Matters: Livestock farmers have too much product & nowhere to send it.

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THE LATEST

  • The U.S. gov’t considers livestock, agriculture workers “critical.”
  • Large processing plants employ a lot of people working in close quarters.
  • Outbreaks have halted production. U.S. meat industry workers have reportedly died from COVID-19.
  • This has led to the closure of major U.S. meat processing plants, potentially impacting meat supply nationwide (and beyond).
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“As pork, beef and chicken plants are being forced to close, even for short periods of time, millions of pounds of meat will disappear from the supply chain… Farmers across the country will not have anywhere to sell their livestock to be processed, when they could have fed the nation… The food supply chain is breaking.”

Tyson Foods chairman John Tyson in a full-page ad published in various newspapers over the weekend.
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“They say, ‘How dare you throw away food when so many people are hungry?.’ They don’t know how farming works. This makes me sick, too.”

A U.S. farmer, speaking on the condition of anonymity, about disposing of their product. Some farmers have been forced to euthanize livestock because they have nowhere to keep or sell the animals.
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What This Means For You

Even if individual families buy more at the grocery store, we can’t make up for the large, bulk purchasing power of restaurants, corporate cafeterias, event catering and beyond.

Some economists believe the disruption in the supply chain (lower supply due to closed processing plants) will lead to higher prices for all in the weeks and months ahead.

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Currently, meat produced for food-service (like restaurants) cannot be repackaged and sold in grocery stores, or donated easily. The USDA has set up an emergency network to try to coordinate oversupply, funneling it to places of need.

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