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COVID Hospitalizations Fall Rapidly In US

COVID Hospitalizations Fall Rapidly In US

By RTTNews Staff Writer | Published: 2/2/2021 6:08 AM ET

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The United States is witnessing significant improvement in all three metrics that measure the coronavirus pandemic's severity, with COVID-19 hospitalizations decreasing rapidly after falling below the 100,000 mark at the weekend.

Only 93,536 people are currently admitted in U.S. hospitals with coronavirus infection, which is the fewest since November 29, according to the latest data by COVID Tracking Project. Out of this, 18,572 patients are admitted in Intensive Care Units. The numbers reached a peak of 132,474 on January 6.

Compared to last week, the number of people currently hospitalized with COVID-19 is down by 10 percent or more in 38 states.

The test positivity rate continues to fall regularly. Out of nearly 1.60 million people who were tested for coronavirus on Monday, 9.78 percent were diagnosed with the disease.

With 130,759 additional cases reporting in the last 24 hours, the total U.S. cases rose to 26,317,623, according to the latest data by Johns Hopkins University. 1881 new deaths were reported across the country in the same period, taking the national total to 443,355.

January was the deadliest month in the United States so far with the pandemic, claiming the lives of 95,211 Americans, nearly 20000 more than in December.

On average, more people were hospitalized in the country than in any other month due to COVID-19.

A new projection from the University of Washington says nearly 200,000 more people are likely to die between now and May 1.

Nearly half a billion vaccine doses have been distributed across the country until Monday and at least 32,222,402 shots were administered, according to the US Centers for Disease Control and Prevention.

Anti-Covid vaccine distribution will "get better very quickly" as the Biden administration rolls out a series of measures aimed at ramping up inoculation, according to Dr. Anthony Fauci.

CDC's epidemiological expert Dr. Casey Barton Behravesh told reporters Monday that the risk of animals, including pets, spreading Covid-19 to human beings is considered to be low.

Meanwhile, Tokyo Olympic Games chief vowed that the global sports event will be held this year "no matter how the Covid situation will be."

"We will make sure the Games will be held no matter how the Covid situation will be. We go beyond the discussion of whether we hold (the Games) or not hold. We are to come up with 'new' Olympics," Games organizing committee president Yoshiro Mori said at a news conference Tuesday.

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Johnson amp Johnson’s Covid-19 Vaccine Safe Well-tolerated

Johnson & Johnson's Covid-19 Vaccine Safe, Well-tolerated

By RTTNews Staff Writer | Published: 1/14/2021 5:15 AM ET

Johnson & Johnson announced that its Covid-19 vaccine candidate, JNJ-78436735, being developed by its unit Janssen Pharmaceutical Companies and currently undergoing in a Phase 3 trial, has been found to be safe and well tolerated.

The interim Phase 1/2a data was published on Wednesday in the New England Journal of Medicine. A preview of part of these interim data was posted on medRxiv in September 2020.

As per the data, the single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days. This is the duration of time measured in this study in participants aged 18-55 years.

The ongoing Phase 1/2a multi-center, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, reactogenicity, and immunogenicity of Janssen's COVID-19 vaccine candidate at two dose levels, administered intramuscularly as single-dose or two-dose schedules, eight weeks apart, in healthy adults, aged 18 to 55 years. The study is ongoing at multiple clinical sites in Belgium and the United States.

According to the company, the COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. After a single vaccination, neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57.

These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years.

The study also evaluated a two-dose regimen, in which the data showed that a second dose of the vaccine candidate, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

Johnson & Johnson expects to announce topline Phase 3 data for its single-dose COVID-19 vaccine candidate in late January 2021.

If the single-dose vaccine is shown to be safe and effective, the company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards. Other regulatory applications around the world will be made subsequently.

Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy.

The single-dose regimen in the Phase 3 ENSEMBLE trial completed enrollment on December 17, 2020, while a two-dose regimen in the Phase 3 ENSEMBLE 2 study is ongoing.

Johnson & Johnson's phase III study of its COVID-19 vaccine candidate, JNJ-78436735, which was initiated in late September, was temporarily paused in early October due to an unexplained illness in a study participant. However, the trial resumed later after clearance from a regulatory board.

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Parcare Health Network Faces Probe On COVID-19 Vaccine Distribution

Parcare Health Network Faces Probe On COVID-19 Vaccine Distribution

By RTTNews Staff Writer | Published: 12/28/2020 10:14 AM ET

New York State Health officials are joining with State Police to investigate Parcare Community Health Network for allegedly violating state guidelines for distribution of COVID-19 vaccine by obtaining and distributing them illegally.

In a statement, NY State Health Commissioner Howard Zucker stated that the State Department of Health is aware of reports that "Parcare Community Health Network, an Orange County provider, may have fraudulently obtained COVID-19 vaccine, transferred it to facilities in other parts of the state in violation of state guidelines and diverted it to members of the public…"

He added that this is contrary to the state's plan to administer it first to frontline healthcare workers, as well as nursing home residents and staffers.

Meanwhile, Brooklyn-based health care company reportedly insisted that it followed all proper procedures to get the Moderna vaccines. The company said it was approved to administer the shots by both the state Department of Health as well as the Centers for Disease Control and Prevention.

Following the criminal probe, Parcare further said it proactively returned its remaining stash of COVID-19 vaccines, and also provided the documentation regarding the proper receipt of the vaccines to the State Health department.

ParCare reportedly had administered 869 of 2,300 doses it received through an order placed by the DOH.

ParCare's clinic in Orange County faces the investigation. It operates five other clinics located in Brooklyn and Manhattan.

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US Covid-19 Vaccination Begins As CDC Recommends Pfizer Vaccine

US Covid-19 Vaccination Begins As CDC Recommends Pfizer Vaccine

By RTTNews Staff Writer | Published: 12/14/2020 3:23 AM ET

The United States started Covid-19 vaccinations on Monday after Robert Redfield, the director of the Centers for Disease Control and Prevention or CDC, gave the approval for Pfizer- BioNTech's COVID-19 vaccine.

The CDC Director accepted the recommendation by CDC's Advisory Committee on Immunization Practices or ACIP for vaccination with Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older. The recommendation follows the Emergency Use Authorization or EUA issued by the U.S. Food and Drug Administration for the vaccine on last Friday.

Redfield said, "As COVID-19 cases continue to surge throughout the U.S., CDC's recommendation comes at a critical time."

The Pfizer Vaccine is authorized for use under EUA for active immunization to prevent covid-19 caused by severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 in individuals 16 years of age and older.

The ACIP recommendation is based on the scientific evidence supporting the COVID-19 vaccine, including data from a Phase 3 clinical study announced last month, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses.

The ACIP on December 1 had recommended for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.

CNN reported that the first freight trucks carrying around 184,275 vials of the vaccine departed Pfizer's facility in Kalamazoo, Michigan, on Sunday.

The vaccines will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services, including the CDC, to government-designated facilities across the country.

Earlier, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, noted that Pfizer would move vaccine from its manufacturing facility to the UPS and FedEx hubs, and then it would go out to already identified 636 locations nationwide.

According to Perna, the estimate is that 145 sites across all the states would have receive vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday in the initial delivery of the Pfizer orders for vaccine.

Pfizer and Germany's BioNTech earlier said they now gather additional data and prepare to file a planned Biologics License Application or BLA with the FDA for a possible full regulatory approval in 2021.

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Roche’s SARS-CoV-2 Antibody Test Being Used As Part Of Moderna COVID-19 Vaccine Trials

Roche's SARS-CoV-2 Antibody Test Being Used As Part Of Moderna COVID-19 Vaccine Trials

By RTTNews Staff Writer | Published: 12/9/2020 1:22 AM ET

Swiss drug maker Roche Group (RHHBY) announced Wednesday a partnership with Moderna Inc. to utilise the Elecsys Anti-SARS-CoV-2 S antibody test in Moderna's ongoing mRNA-1273 vaccine research trials.

The company noted that its Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants. It will help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain or RBD antibodies.

Significantly, Moderna's vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein.

According to the company, measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche's test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions.

Roche recently received Emergency Use Authorization from the U.S. Food and Drug Administration for the Elecsys Anti-SARS-CoV-2 S antibody test.

Thomas Schinecker, CEO Roche Diagnostics, said, "Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies. We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic."

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FDA Authorizes Emergency Use Of Pfizer BioNTech’s COVID-19 Vaccine

FDA Authorizes Emergency Use Of Pfizer, BioNTech's COVID-19 Vaccine

By RTTNews Staff Writer | Published: 12/11/2020 11:05 PM ET

The U.S. Food and Drug Administration on Friday authorized a COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the first COVID-19 vaccine to be approved in the U.S.

The emergency use authorization allows BNT162b2, the Pfizer-BioNTech COVID-19 vaccine, to be distributed in the U.S for people over the age of 16. It was found to be 95 percent effective at preventing symptomatic COVID-19 in clinical trials.

"Today's emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a press release.

An emergency use authorization means that the FDA has given the drug a special authorization to be used during an emergency period. Pfizer would have to file a separate application for its vaccine to be fully approved by the FDA. Meanwhile, researchers will continue to monitor the vaccine's effectiveness in the real world.

FDA's decision to issue an emergency use authorization for the vaccine comes after it faced pressure from the White House to authorize the vaccine. Chief of Staff Mark Meadows told Stephen Hahn, the commissioner of the FDA, to resign if the vaccine was not cleared by Friday, according to the Washington Post. The agency had originally planned to complete the authorization by Saturday.

"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," said Hahn said in a statement. "Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

On Thursday, FDA's vaccine advisory committee had recommended the emergency use of the COVID-19 vaccine. The vaccine has already received a temporary authorization for emergency use in the U.K., Canada, and Bahrain.

Mexico's health agency Cofepris has also approved Pfizer's vaccine for emergency use, Deputy Health Minister Hugo Lopez-Gatell said at a press conference on Friday.

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US COVID Hospitalizations Cross 100K New Deaths And Cases Break Record

US COVID Hospitalizations Cross 100K; New Deaths And Cases Break Record

By RTTNews Staff Writer | Published: 12/3/2020 6:41 AM ET

The number of people hospitalized with coronavirus infection has crossed 100000, and daily COVID deaths and new cases reached all time high on Wednesday.

As per the latest update published by COVID Tracking Project on Thursday, a total of 100,226 patients are currently admitted in U.S. hospitals with coronavirus infection —the first time hospitalizations have exceeded the 100000 mark.

With 3,194 new deaths reporting in the last 24 hours, the country's total number of COVID-19 casualties increased to 273836, as per latest data from the Johns Hopkins University Center for Systems Science and Engineering.

This is the highest daily casualty figure reported in the country, and an increase of about 20 percent from the previous record of 2,603 set on April 15.

It is for the first time that more than 3100 deaths due to the pandemic were reported in a single day in the United States.

In the same period, 2,03,653 new cases were reported nationwide, taking the national total to 13924957. Ten months after the first coronavirus case was reported in the country, daily infections crossed the 2,000,00 mark for the first time on Wednesday.

California reported more than 20000 COVID-19 cases, one tenth of the national total. It is set to overtake Texas as the worst affected state in the country.

As the number of hospitalizations steadily growing since last month, breaking records almost every day, the American Ambulance Association said in a letter to the Department of Health and Human Services that the 911 emergency call system is "at a breaking point".

CDC Director Robert Redfield warned that these next three months will be the most difficult time in U.S. history. "The reality is December and January and February are going to be rough times. I actually believe they're going to be the most difficult time in the public health history of this nation," he said during a U.S. Chamber of Commerce event Wednesday.

Meanwhile, the Centers for Disease Control and Prevention has shortened the recommended length of standard quarantine period for people without symptoms. According to revised guidance issued Wednesday, CDC recommends two additional options for how long quarantine should last. "Based on local availability of viral testing, for people without symptoms quarantine can end on day 10 without testing, and on day 7 after receiving a negative test result".

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in an interview that the United Kingdom's health regulators who authorized Pfizer's Covid-19 vaccine did not scrutinize the trial data as carefully as the US Food and Drug Administration is doing in its review.

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Pernicious Anemia – Caused by Vitamin B12 Deficiency

Pernicious Anemia – Caused by Vitamin B12 Deficiency

There are many articles found on the Internet regarding the importance of vitamin b12. Articles on the affects of vitamin b12 deficiency are even more readily found. I’ve compiled a few of the articles I’ve found while searching Google for "vitamin b12 deficiency." Some of these articles are listed below.

During my search, I’ve yet to find an article that says vitamin b12 is not an important vitamin. All of the articles I’ve read during my searches have stated the seriousness of a deficiency of vitamin b12. Before we get into the articles lets take a look at some of the vitamin b12 deficiency symptoms.

Vitamin B12 deficiency symptoms, like those of many other treatable health conditions, can be virtually identical to age dementia symptoms, senile dementia symptoms and Alzheimer symptoms. As many as 20% of people over age 65 have low Vitamin B12 levels. Correcting the deficiency can help older people resume a full and normal lives.

Vitamin B12 deficiency symptoms include:

  • Loss of appetite
  • Diarrhea
  • Numbness and tingling of hands and feet
  • Paleness
  • Shortness of breath
  • Fatigue
  • Weakness
  • Sore mouth and tongue
  • Confusion or change in mental status in severe or advanced cases. This is sometimes confused with dementia. More importantly, even a moderate deficiency of this important vitamin and its counterpart, folic acid, may ultimate contribute to the onset of Alzheimer disease or other related dementia.

The absorption of dietary vitamin B12 occurs in the small intestine and requires a secretion from the stomach known as intrinsic factor. If intrinsic factor is deficient, absorption of vitamin B12 is severely diminished. Vitamin B12 deficiency impairs the body’s ability to make blood, accelerates blood cell destruction, and damages the nervous system. The result is pernicious anemia (PA).[1]

Pernicious anemia (per-NISH-us uh-NEE-me-uh) is a condition in which the body does not make enough red blood cells due to a lack of vitamin B12 in the body. It usually occurs in people whose bodies have lost the ability to absorb vitamin B12 from food.[2]

Low stomach acid, known as hypochlorhydria, interferes with the absorption of B12 from food but not from supplements. Aging is associated with a decrease in the normal secretion of stomach acid. As a result, some older people with normal levels of intrinsic factor and with no clear cause for malabsorption will become vitamin B12-deficient unless they take at least a few micrograms per day of vitamin B12 from supplements.

From U.S. Army Health Clinic, Darmstadt, Germany.

Vitamin B12 (cobalamin) deficiency is a common cause of macrocytic anemia and has been implicated in a spectrum of neuropsychiatric disorders. The role of B12 deficiency in hyperhomocysteinemia and the promotion of atherosclerosis is only now being explored. Diagnosis of vitamin B12 deficiency is typically based on measurement of serum vitamin B12 levels; however, about 50 percent of patients with subclinical disease have normal B12 levels. A more sensitive method of screening for vitamin B12 deficiency is measurement of serum methylmalonic acid and homocysteine levels, which are increased early in vitamin B12 deficiency. Use of the Schilling test for detection of pernicious anemia has been supplanted for the most part by serologic testing for parietal cell and intrinsic factor antibodies. Contrary to prevailing medical practice, studies show that supplementation with oral vitamin B12 is a safe and effective treatment for the B12 deficiency state. Even when intrinsic factor is not present to aid in the absorption of vitamin B12 (pernicious anemia) or in other diseases that affect the usual absorption sites in the terminal ileum, oral therapy remains effective.[3]

From the Department of Internal Medicine, New York University School of Medicine.

Recent evidence suggests that vitamin B12 deficiency in the elderly is more than classic pernicious anemia. Instead, it is a continuum from negative B12 balance to frank deficiency, which can be detected by low serum B12 levels long before changes occur in hemoglobin levels. Current findings in the literature suggest that subtle B12 deficiency is indeed clinically significant. Treatment may prevent significant neurologic and/or hematologic disease.[4]

From the University of Illinois College of Medicine, Peoria.

Low serum vitamin B12 levels are not uncommon in the elderly. Patients with vitamin B12 deficiency manifest a spectrum of clinical findings. Pernicious anemia and malabsorption syndrome are the usual causes of vitamin B12 deficiency. Pernicious anemia is confirmed by the presence of intrinsic factor blocking antibody or abnormal results on the Schilling test. Patients with neuropsychiatric symptoms of vitamin B12 deficiency may have a normal Schilling test and no evidence of macrocytic anemia. In such patients, vitamin B12 deficiency is confirmed by determining serum levels of homocysteine and methylmalonic acid.[5]

From all of my research, pernicious anemia is usually easy to treat with vitamin B12 supplements or shots, although some people develop permanent nerve damage before they find out they have the disease and get treatment. Since pernicious anemia does increase the risk of developing stomach cancer, doctors may do periodic cancer tests to check for it. Overall, however, people with pernicious anemia who get proper lifelong treatment can have a normal life span.

I’m not a doctor or even a healthcare professional, but I am a thinker and I do a lot of research. Because of my age, I’m trying to prevent issues that may arise as a result of the aging process. With that in mind, I’ve taken the initiative to research pernicious anemia, a fairly common condition in the aging process.

If you or someone you know is affected by this condition, spend some time doing the research on your own. There are many b12 supplements, but not many have the same patented delivery system as TriVita’s® Sublingual Vitamin B12, a safe and effective means of getting vitamin b12 into your body. You can learn more about Vitamin B12 Deficiency by clicking on the previous link.

REFERENCES:

[1] https://www.publix.com/wellness/notes/Display.do?id=Concern&childId=Vitamin_B12_Deficiency

[2] https://www.medicinenet.com/pernicious_anemia/article.htm

[3] PMID: 12643357 [PubMed – indexed for MEDLINE], https://www.ncbi.nlm.nih.gov/pubmed/12643357?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedreviews&logdbfrom=pubmed

[4] PMID: 2680773 [PubMed – indexed for MEDLINE], https://www.ncbi.nlm.nih.gov/pubmed/2680773?ordinalpos=16&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

[5]PMID: 2278533 [PubMed – indexed for MEDLINE], https://www.ncbi.nlm.nih.gov/pubmed/2278533?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

pernicious anemia

After further review and research, vitamin b12 is an important nutrient to help in the prevention of several diseases.

Pernicious anemia is a decrease in red blood cells that occurs when the body cannot properly absorb vitamin B12 from the gastrointestinal tract. Vitamin B12 is necessary for the formation of red blood cells.

Pernicious anemia is caused by a lack of intrinsic factor. Intrinsic factor is a protein produced by the stomach that helps the body absorb vitamin B12. When stomach does not have enough intrinsic factor, it cannot properly absorb the vitamin. Nerve and blood cells need vitamin B12 to function properly.

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Breastfeeding Supports Healthy Brains for Babies – and Moms

Breastfeeding Supports Healthy Brains for Babies – and Moms

The key is seafood for Mom, to replenish vital stores of DHA and other nutrients for her and her new child.

10/12/2020       By Eliza Leggatt

In 2008, I was nursing a broken heart – and a newborn baby. The joy of my firstborn’s arrival was overshadowed by the abrupt hormonal postpartum crash and some challenging personal issues in my life. It felt almost unbearable at times. We made it through that tough time together, thanks to supportive parents, a great pediatrician, and especially, breastfeeding.

Breastfeeding is the single most beneficial gift any mother can give her child to impact their health, but amazingly, research shows the benefits for moms who are able to breastfeed are both immediate and long-lasting.

I didn’t fully understand it at the time, but breastfeeding my new baby was helping me as much as it was helping her. Studies indicate not only that breastfeeding mothers typically experience lower levels of depressive symptoms (Hahn-Holbrook, 2013) but oxytocin release during lactation can help regulate blood pressure, lower stress, and decrease levels of cortisol, sometimes called the “stress hormone” (Handlin, 2009).

Human breast milk is a marvel; a dynamic, medicinal food that is created and distinctly “personalized” for their infants by mothers at the most intimate and individual level. Its composition varies almost constantly, changing from feed to feed and even within feedings, according to and perhaps even influencing circadian rhythms of both mother and child (Sánchez et al., 2013).

Teeming with thousands of diverse bioactive molecules that offer protection against infection and inflammation, mother’s milk begins laying the foundation for a baby’s lifelong immune response. It starts and begins to form the immune system, develops internal organs, and jump-starts healthy microbial colonization of the newborn baby’s mostly sterile gut (Yu et al., 2018).

In recent years, the indispensable role of DHA, the brain’s main structural fat, has been increasingly understood to not only impact infant brain growth, but a new mother’s mental state as well. And while I was nursing that little baby, I was giving away that “superfat” and in desperate need of replenishment. My baby, like all babies, was completely dependent on me for the DHA that would help to grow her amazing brain.

Brain Growth Spurt

The growth of the new baby’s brain is occurring at an astonishing rate of one percent a day; the cerebellum has doubled by the time the baby is 90 days old (Holland, 2014). At birth, the newborn brain is already 25 percent of its adult weight. By age 2, it will reach over 75 percent of its adult weight (Dekaban, 1978).

During this short window of unparalleled cerebral growth, nourishing a baby’s brain is perhaps the most important work of breastfeeding. Babies are entirely dependent upon their mothers for omega-3 DHA, the primary structural fat of the brain whose critical role facilitates every neuronal function.

Lifelong benefits that breastfeeding also confers to mothers, such as a reduction in breast cancer risk (Bernier, 2000) are often noted, yet the needs of mothers during this pivotal time do not receive nearly enough attention. An abrupt shift occurs almost immediately after birth – just as the focus of the mother has shifted to her newly arrived child, so has everyone else’s.

Read the complete article, and see all the informational sources on the VitalChoice website.

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AstraZeneca’s COVID-19 AZD7442 Antibodies Advance Into 2 Phase III Trials Gets 486 Mln US Fund

AstraZeneca’s COVID-19 AZD7442 Antibodies Advance Into 2 Phase III Trials; Gets $486 Mln U.S. Fund

By RTTNews Staff Writer | Published: 10/12/2020 2:40 AM ET

AstraZeneca Plc. (AZN.L,AZN) announced Monday that its long-acting antibody or LAAB combination, AZD7442, will advance into two Phase III clinical trials for the prevention of COVID-19.

Further, the company said it has received support of around $486 million from the US Government for the development and supply of AZD7442. The US Government funding is for the development and supply of up to 100,000 doses starting towards the end of 2020. The US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

The funding is received under an agreement with the Biomedical Advanced Research and Development Authority or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

AZD7442 is a combination of two LAABs derived from convalescent patients after SARS-CoV-2 infection. It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.

The LAABs have been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.

The company noted that the two trials will enrol over 6,000 adults for the prevention of COVID-19 at sites in and outside the US that are due to begin in the next weeks.

one trial will evaluate the safety and efficacy of AZD7442 to prevent infection for up to 12 months, in approximately 5,000 participants. The second trial will evaluate post-exposure prophylaxis and pre-emptive treatment in approximately 1,100 participants.

AstraZeneca is planning additional trials to evaluate AZD7442 in approximately 4,000 patients for the treatment of COVID-19. The additional trials will enroll around 4,000 adults for the treatment of SARS-CoV-2 infections.

AstraZeneca said the agreement is not anticipated to impact its financial guidance for 2020 as the US Government funding is being offset by expenses to progress the clinical trials of AZD7442 as well as manufacturing process and upscaling costs.

Should the Phase III trials prove successful and AZD7442 become an approved medicine, the Company anticipates providing the medicine at commercial terms during and after the current coronavirus pandemic.

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