a healthy choice for a healthier lifestyle
By RTTNews Staff Writer | Published: 10/16/2020 9:48 AM ET
Pfizer Inc (PFE) said Friday that it will apply for emergency authorization use of its COVID-19 vaccine in the U.S. in the third week of November, once safety milestone is achieved.
The U.S. Food and Drug Administration wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.
Pfizer, which is developing vaccine candidate BNT162b2 with German BioNTech SE (BNTX), said it will continue running its trial through its final analysis point, even if it is declared effective at an earlier stage. The company expects to reach safety milestone in the third week of November.
"As I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," CEO Albert Bourla wrote in an open letter.
BNT162b2 vaccine candidate is based on BioNTech's mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase 3 study.
Earlier this month, Pfizer and BioNTech said that they have initiated a rolling submission to the European Medicines Agency for the COVID-19 vaccine.
Last month, the companies said they are on track to seek regulatory review for BNT162b2 as early as October 2020. If regulatory authorization or approval is obtained, the companies plan to supply up to 100 million doses worldwide by the end of 2020, and about 1.3 billion doses by the end of 2021.
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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.
Article reposted on Markethive by Jeffrey Sloe
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:
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).
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.
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.
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.
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.
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.
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.
 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
 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
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
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.
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.
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.
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.