Евгения Матвеец / Moment / Getty Images
By Alexander Freund
Finally, some good news — soon, frontrunning vaccine developers could submit applications for fast-tracked authorizations of their coronavirus vaccines.
Three companies have reported early Phase III successes in the last several days.
<p>The latest team to release positive interim results is Swedish-British company AstraZeneca, developers of a viral vector vaccine, who published their final report on the <a href="https://bit.ly/3fdOwFn" target="_blank">combined Phase II/ Phase III study on November 18 in The Lancet.</a> </p>
<p>Their trial involved a total of 560 healthy volunteers, with researchers finding that participants more than 56 responded well to the vaccine. Overall, though, a similarly strong immune response was observed in all age groups after the boost vaccination.</p><p>Although there were 13 "serious adverse events" during the study, none of them were "considered to be related to either study vaccine," researchers wrote.</p><p>Even still, further research is needed to confirm the efficacy of the vaccine, the authors stressed. <br><br>BioNTech/Pfizer have edged even further ahead than AstraZeneca with their vaccine trial. </p>
<p>On November 18, the drugmakers reported that they had gathered enough data to effectively end Phase III trials, finding their vaccine had achieved an efficacy of 95%, <a href="https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine" target="_blank" rel="noopener noreferrer">researchers wrote in a press release. </a> </p><p>This news came after BioNTech/Pfizer announced results from their <a href="https://www.dw.com/en/coronavirus-vaccine-90-effective-say-pfizer-and-german-company-biontech/a-55542947" target="_blank" rel="noopener noreferrer">initial Phase III evaluations on November 9,</a> showing their mRNA vaccine was 90% effective against COVID19. <br> <br>Following suit on November 16, pharmaceutical manufacturer <a href="https://www.dw.com/en/us-pharma-firm-moderna-says-its-covid-19-vaccine-is-945-effective/a-55616749" target="_blank" rel="noopener noreferrer">Moderna announced its mRNA vaccine had shown an efficacy of 94.5%</a> in Phase III trials involving more than 30,000 participants. </p><p>While BioNTech and Pfizer, as well as Moderna, are leading the race to develop a COVID-19 vaccine, other pharma companies — such as Sanofi, Sinovac and Johnson & Johnson — <a href="https://www.dw.com/en/australias-coronavirus-vaccine-shows-promise-in-initial-testing/a-55583492" target="_blank">are expected to soon present candidates of their own</a>.<br></p><p>According to the World Health Organization, 47 vaccines candidates are currently in clinical trials, of which 10 are in phase 3 efficacy trials. Russia has already registered two vaccines, one of which — <a href="https://www.dw.com/en/russia-vaccine-sputnik-coronavirus/a-54819322" target="_blank">Sputnik V — became available for public use in August</a>. Experts, however, warn that this vaccine has been insufficiently tested.</p>
Open Questions
<p>Many questions, however, remain unanswered. It is unclear, for instance, how effective these vaccines are, and how they affect individuals of different ages and those with pre-existing medical conditions. Little is known about whether the vaccines lead to long-term immunity, or if they can prevent severe, or indeed asymptomatic COVID-19 infections.</p><p>It is also not known how much the vaccines will cost, <a href="https://www.dw.com/en/germany-to-set-up-hundreds-of-vaccination-centers-from-december-report/a-55605652" target="_blank">who will have access to them</a> and in what quantity and at what time, and how they will be distributed around the globe.</p>How Effective Are These Vaccines?
<p>BioNTech and Pfizer claim their vaccine candidate BNT162b2 is 95% effective in preventing a COVID-19 infection. Moderna claims to have developed a candidate, mRNA-1273, that is 94.5% effective. These are unusually high figures.</p><p>By contrast, the vaccine administered for the 2018/2019 influenza season was only 21% effective, according to Germany's disease control and prevention agency, the Robert Koch Institute. This means only around one in five individuals vaccinated were protected by the influenza shot.</p><p>Achieving a vaccine that is 100% effective is practically impossible, as human bodies differ and because viruses such as the influenza pathogen mutate continuously. This explains why each year, influenza vaccines must be adapted to seasonal and emerging virus strains.</p><p>Nevertheless, vaccines significantly lower the risk of an infection. Elaborate studies ascertain the exact vaccine efficacy. It is determined by studying the antibody concentration developed in patients.</p><p>A typical randomized controlled study consists of two groups of participants. BioNTech and Pfizer assessed the efficacy of their vaccine candidate by testing it on 43,538 participants in different countries. One half of the group was administered the vaccine candidate, while the other half received a placebo. The vaccine was administered twice, with a three-week gap in between shots.</p><p>For obvious ethical reasons, participants were not infected with the SARS-CoV-2 virus during the trial. Still, over the course of the study, 170 individuals contracted the virus in their daily lives. 162 of them belonged to the placebo group.</p><p>The group who had received the vaccine, in contrast, had a 95% chance of protection. This means that 19 out of 20 individuals who statistically speaking could have contracted the virus did not become infected.</p><p>Such efficacy is on par with vaccines administered against measles, mumps and rubella that afford 93% to 99% of individuals with immunity. It is to be expected that as the COVID-19 vaccine trial progresses, efficacy levels will gradually decline. The stage 3 study will be completed once 164 persons have reported a SARS-CoV-2 infection. All participants will be monitored for two full years.</p><p>The Moderna vaccine trial, by comparison, involved over 30,000 participants, half of whom received a placebo. The other half received the vaccine candidate. Over the course of the study, 95 individuals fell ill with COVID-19. Of these, 90 belonged to the placebo group and just five belonged to the vaccinated group.</p>
Are the Vaccines Safe?
<p>Independent monitoring groups registered no serious safety concerns with the vaccines being developed by BioNTech/Pfizer and Moderna. This does not, however, rule out the possibility of serious side effects occurring during large-scale testing, or when vaccines are given to persons with rare pre-existing health issues.</p><p>Intramuscular injections also bear to the risk of causing local reactions. Moreover, immune responses that entail the production of B cells and supportive T cells can lead to fever, chills, muscle aches or headaches.</p><p>In addition, both vaccines — BioNTech/Pfizer's BNT162b2 and Moderna's mRNA-1273 — belong to a new family of vaccines that so far has not been approved for medical use. They contain nucleoside-modified messenger RNA which functions as a blueprint for the virus spike protein. Once administered, the vaccine stimulates the human immune system to produce antibodies against this protein and thus the virus.</p>When Will the Vaccines Be Approved?
<p>The approval process differs in the United States and European Union. Intermediate tests are designed to speed up the procedure.</p><p>BioNTech and Pfizer have announced that they will request emergency use authorization (EUA) for their vaccine from the US Food and Drug Administration (FDA) in the coming weeks. By this time, a minimum two-month observation period after the second vaccine shot will have passed. This is an FDA requirement. Moderna similarly plans to request a EUA from the FDA in coming weeks.</p><p>It is unclear when BioNTech will request the stricter European Medicines Agency (EMA) to approve its vaccine. In Germany, the Paul Ehrlich Institute tests and approves vaccines for public use.</p><p>It looks likely that a coronavirus vaccine will become available in Europe later this year, or in early 2021, thanks to the EU's fast-tracked approval process.</p>Challenges Ahead
<p>For months, the EU <a href="https://www.dw.com/en/coronavirus-vaccine-eu-seals-deal-with-biontech-pfizer-to-secure-doses/a-55551329" target="_blank" rel="noopener noreferrer">has been in talks with BioNTech and Pfizer</a>. Initially, the bloc aimed to secure up to 300 million vaccine doses. A contract drawn up between the parties now places an order for 200 million doses, with the option of a further 100 million.</p><p>The Commission is reportedly also negotiating with Moderna to secure up to 160 million doses of its vaccine. So far, however, no contract has been finalized.</p><p>In addition, the EU has struck a deal to buy 300 million vaccine doses from AstraZeneca. It has also reached deals with Sanofi-GSK and Johnson & Johnson.</p><p>In early June, Germany, France, Italy and the Netherlands joined forces <a href="https://www.dw.com/en/eu-joins-whos-coronavirus-vaccine-alliance-offers-400-million-investment/a-54774743" target="_blank" rel="noopener noreferrer">to create the so-called Inclusive Vaccine Alliance</a>, which will aim to boost vaccine production in as many locations across the EU as possible as soon as possible.</p><p>This way, the EU plans not only to <a href="https://www.dw.com/en/paris-peace-forum-to-raise-more-than-500-million-for-global-coronavirus-vaccine-access/a-55577629" target="_blank" rel="noopener noreferrer">make affordable vaccines available</a> to member states but also to poorer nations, for example in Africa.</p><p>Yet big questions still remain over <a href="https://www.dw.com/en/coronavirus-germany-debates-how-to-distribute-a-vaccine/a-55554314" target="_blank">how the vaccines will be distributed</a> and administered across the globe. Most will presumably need to be permanently stored at minus 80 degrees Celsius, which poses a major logistical challenge.<br></p><p><em>This article was translated from German. It has been updated on November 19, 2020 to include the publication of the study on the Oxford-vaccine.</em></p><p><em>Reposted with permission from <a href="https://www.dw.com/en/coronavirus-can-we-trust-recent-covid-vaccine-successes/a-55623111" target="_blank">Deutsche Well</a>.</em><a href="https://www.ecowatch.com/r/entryeditor/2648980453#/" target="_self"></a></p>
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Johnson & Johnson Pauses COVID-19 Vaccine Trial After Mystery Illness
13 October 2020
Health + Wellness
Pharmaceutical giant Johnson & Johnson is pausing its COVID-19 vaccine trials after a study participant fell ill. Lubo Ivanko / Getty Images
Pharmaceutical giant Johnson & Johnson (J&J) announced that it is pausing COVID-19 vaccine trials after a study participant fell ill. The announcement comes just weeks after the company said trials were in the final stages, NBC News reported.
<p>J&J told <a href="https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/" target="_blank">STAT</a> that the pause was due to "an unexplained illness in a study participant," but would not provide more details citing the patient's privacy. The company added that it needs to gather more information before sharing any details. J&J does not yet know if the participant received the vaccine-candidate or the placebo.</p><p>"Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians," the company <a href="https://www.jnj.com/our-company/johnson-johnson-temporarily-pauses-all-dosing-in-our-janssen-covid-19-vaccine-candidate-clinical-trials" target="_blank">said in a statement</a>. "Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies."</p><p>Pauses are not uncommon, NBC News reported, but rather a testament to upholding regulatory standards. <a href="https://www.ecowatch.com/covid-vaccine-trial-stopped-2647532475.html" target="_self">AstraZeneca paused its vaccine trial</a> last month when a study participant in the UK also fell ill with an unexplained illness.</p>
<p>While the 60,000-patient trial is paused, it's different from a clinical hold, which is a longer regulatory procedure. In fact, it is rare for J&J to disclose study pauses to the public, STAT reported.</p><p>"A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol," J&J said in the statement. "A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration. As outlined in our transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial."</p><p>J&J CFO Joseph Wolk told <a href="https://www.cnbc.com/2020/10/13/jnjs-coronavirus-vaccine-trial-paused-after-adverse-event-reported-36-hours-ago.html" target="_blank">CNBC</a> that the company was acting responsibly. "We're letting safety protocol follow proper procedure here," he said. "What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here."</p>
<p>Experts also pointed out the importance of study pauses.</p><p>"This is completely expected, and it's just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3," Ashish Jha, dean of the Brown University School of Public Health, told <a href="https://www.cnn.com/2020/10/12/health/johnson-coronavirus-vaccine-pause-bn/index.html" target="_blank">CNN</a>.<br></p><p>J&J is the fourth pharmaceutical company receiving funding under Operation Warp Speed to enter late-stage testing of its vaccine candidate. Moderna, AstraZeneca and Pfizer are all in the process of evaluating safety and efficacy data of their clinical trials, <a href="https://www.cnbc.com/2020/09/23/coronavirus-vaccine-johnson-johnson-begins-late-stage-covid-19-trial-.html" target="_blank" rel="noopener noreferrer">CNBC </a>reported.</p>
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Like many other plant-based foods and products, CBD oil is one dietary supplement where "organic" labels are very important to consumers. However, there are little to no regulations within the hemp industry when it comes to deeming a product as organic, which makes it increasingly difficult for shoppers to find the best CBD oil products available on the market.
<p>Here you can learn about the importance of organic hemp oil, why it's better for the environment, and which CBD companies actually make trustworthy products with sustainable farming processes. origins which weigh heavily on many consumers who want to buy a product that's produced in the best way possible for not only themselves to ingest, but for the environment as well through sustainable farming methods. </p><h2>What Is CBD Oil?</h2><p>First things first, CBD stands for cannabidiol, and it's a cannabinoid found within cannabis sativa plants. This plant compound is believed to have many potential benefits, and it is primarily derived from hemp plants via a CO2 extraction process. </p><p>Since CBD is extracted from industrial hemp, which contains only trace amounts of THC (the psychoactive component in cannabis plants), this means that CBD won't make you feel high like marijuana, which has much higher levels of THC that causes psychoactive effects. Instead, the effects of CBD are much more subtle and promote a general sense of calm and relaxation in most users.</p><h2>What Makes a CBD Oil Organic?</h2><p>In terms of organic labels, perhaps the most important (and prominent) certification comes from the United States Department of Agriculture (USDA). This government organization has been labeling foods as "organic" for many years, but what exactly does this certification entail? Essentially, a label indicating that a product is "USDA Organic" or "Certified Organic" means that at least 95% of the ingredients are obtained from organic sources.</p><p>For a crop to be considered organic by the USDA, it must be grown without the use of industrial solvents, irradiation, genetic engineering (GMOs), synthetic pesticides, or chemical fertilizer. Instead, farmers rely on natural substances and <a href="https://www.usda.gov/media/blog/2012/03/22/organic-101-what-usda-organic-label-means" rel="noopener noreferrer" target="_blank">mechanical, physical, or biologically based farming</a> techniques to cultivate healthy and organic crops.</p><p>Before the passage of the 2018 Farm Bill, no hemp-derived products could be dubbed as "certified organic" since the hemp plant and its extracts were still categorized as a Schedule I Controlled Substance. However, it's still difficult for CBD companies to obtain a USDA certified organic label for their products due to the legal grey area that still surrounds CBD extracts. </p><p>Because of these challenges, and due to the fact that industrial hemp has only recently become an agricultural crop, very few CBD oils are USDA certified organic. Rather, many CBD products contain hemp extracts from plants that were grown in organic conditions but may not be federally certified.</p><h2>What are the Best Organic CBD Oil Brands?</h2><p><em>Each product featured here has been independently selected by the writer. If you make a purchase using the links included, we may earn commission.</em></p><em><br></em>
<h2>Why Organic Hemp Oil Matters</h2><p>Hemp is a unique plant, not only for its rich cannabinoid content, but also for its ability to absorb a wide variety of components in soil. But this trait poses great risks when it comes to the creation of CBD products derived from hemp.</p><p>Because hemp has a high capacity for compound uptake, this means that the plants can retain <a href="https://www.remedyreview.com/industry/lab-test-results/" target="_blank">harmful chemicals like pesticides</a>, heavy metals, and other residual solvents. This is especially true when it comes to synthetic chemicals that are more toxic to humans, and difficult to remove once they have been absorbed by the hemp plant.</p><p>Organic farming practices help reduce the risk of hemp crops absorbing harsh chemicals that may later end up in CBD oil after extraction. When you're taking CBD as a wellness supplement to help alleviate your symptoms or improve your overall well-being, the last thing you want is to ingest compounds that might negatively outweigh the benefits of CBD. This is an important reason to look for third party lab test results when shopping for CBD products since these certificates of analysis can show the full cannabinoid and terpene profile of a hemp extract, as well as test results that search for the presence of any residual solvents.</p><p>In addition to creating a better end product, organic farming practices are also better for the environment. Sustainable and organic farming methods may <a href="https://www.helpguide.org/articles/healthy-eating/organic-foods.htm" rel="noopener noreferrer" target="_blank">reduce pollution, conserve water, reduce soil erosion, increase soil fertility, and use less energy</a>. The use of natural pest deterrents as opposed to chemical pesticides is also better for nearby animal populations and ecosystems.</p><h3>Organic vs. Natural</h3><p>While there are only a select few companies offering certified organic ingredients in their products, almost every brand in the CBD market creates "natural" products. The term "all-natural" or "plant-based" does not mean that a product is organic, and since hemp oil is a natural derivative of hemp plants, these products are often referred to as all-natural. However, there are some synthetic CBD oils that should be avoided because they are chemically constructed and may produce unwanted side effects that are not caused by naturally derived CBD extracts.</p><h2>What are the Benefits of Organic CBD Oil?</h2><p>There's a long list of potential CBD oil health benefits, and some of the most common wellness advantages include:</p><ul class="ee-ul"><li><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2503660/" target="_blank">Chronic pain relief</a></li><li><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604171/" target="_blank">Anti-anxiety effects</a></li><li>Better sleep</li><li><a href="https://www.psychologytoday.com/us/blog/inner-source/201901/cbd-oil-mental-health-should-you-take-it-too" rel="noopener noreferrer" target="_blank">Improvements in mood</a></li><li>Internal balance and regulation</li></ul><p>When dealing with pain, inflammation, sleep issues, and mental health struggles, it can be hard to find sufficient treatment options. The use of certain prescriptions can cause unwanted side effects, yet they are often the only solution for patients with these medical conditions. In search of other therapies, people have started to flock towards CBD oil as an alternative remedy for a variety of conditions. However, it should be noted that CBD products are not approved by the Food and Drug Administration (FDA), and you should seek your doctor's advice before using CBD if you have a serious medical condition.</p><h2>Look at the Labels Before You Buy CBD Oil</h2><p>When you go online to buy CBD oil, you'll quickly realize there is an overwhelming number of brands that are saturating the market. It can be difficult to determine which products are truly as good as they make themselves out to be. Always look for up-to-date third-party lab tests so you know you are getting a great product, and don't hesitate to contact the brand if you have any additional questions. And if you're intent on purchasing 100% organic CBD oil, it's best to look for certified products or brands that are held to strict regulatory standards.</p><p><strong>Melena Gurganus </strong>is the Reviews Editor at EcoWatch. She is passionate health and wellness and her writing aims to help others find products they can trust. Her work has been featured in publications such as Health, Shape, Huffington Post, Cannabis Business Times, and Bustle.<br></p>
Spruce
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDY4NjI3OC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyOTM2NzgzOX0.axY0HjeqRctJsR_KmDLctzDpUBLBN-oNIdqaXDb4caQ/img.jpg?width=980" id="774be" class="rm-shortcode" data-rm-shortcode-id="8379f35b1ca8a86d0e61b7d4bfc8b46e" data-rm-shortcode-name="rebelmouse-image" alt="spruce organic cbd oil" data-width="710" data-height="959" /><p>As one of the best brands in the business, Spruce CBD is well-known for its potent CBD oils that feature many additional beneficial phytocannabinoids. This brand works with two family-owned, sustainably focused farms in the USA (one located in Kentucky and one in North Carolina) to create its organic, small product batches. The max potency Spruce CBD oil contains 2400mg of full-spectrum CBD extract, but the brand also offers a lower strength tincture with 750mg of CBD in total.</p>
$89
CBDistillery
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDcwMjkzNC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyMTU4OTM4Nn0.ypRdeDSBcE87slYrFfVrRwtJ2qGIK6FD5jBB4pndTMo/img.jpg?width=980" id="b473b" class="rm-shortcode" data-rm-shortcode-id="9930b53c9d58cb49774640a61c3e3e75" data-rm-shortcode-name="rebelmouse-image" alt="cbdistillery cbd oil" data-width="1244" data-height="1244" /><p>All of the products from CBDistillery are <a href="https://ushempauthority.org/" target="_blank" rel="noopener noreferrer">U.S. Hemp Authority Certified</a>, and for good reason. The company only uses non-GMO and pesticide-free industrial hemp that's grown organically on Colorado farms. Its hemp oils are some of the most affordable CBD products on the market, yet they still maintain a high standard of quality. CBDistillery has a wide variety of CBD potencies across its product line (ranging from 500mg to 5000mg per bottle) and offers both full-spectrum and broad-spectrum CBD oils to give customers a completely thc-free option.</p>
$35
FAB CBD
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDY4NjIyNS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NDIwOTEyMn0.MlTjz096FJ0ev_-soK7_Z-FeQeJczWoeh9Qi9SSkHsY/img.jpg?width=980" id="04b26" class="rm-shortcode" data-rm-shortcode-id="76aa4862f44603242e318982acea6646" data-rm-shortcode-name="rebelmouse-image" alt="fab cbd oil" data-width="800" data-height="800" /><p>For an organic CBD oil that has it all, FAB CBD offers plenty of variety for any type of consumer. All of its products are made with zero pesticides and extracted from organically grown Colorado industrial hemp. FAB CBD oil comes in five all-natural flavors (mint, vanilla, berry, citrus, and natural) and is also available in four strengths (300, 600, 1200, and 2400mg per bottle).</p>
$39
NuLeaf Naturals
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDY4NjIxOS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY1NzExNTgyMX0.D6qMGYllKTsVhEkQ-L_GzpDHVu60a-tJKcio7M1Ssmc/img.jpg?width=980" id="94e4a" class="rm-shortcode" data-rm-shortcode-id="3609a52479675730893a45a82a03c71d" data-rm-shortcode-name="rebelmouse-image" alt="nuleaf naturals organic cbd oil" data-width="600" data-height="600" /><p>As an industry-leading brand, it comes as no surprise that NuLeaf Naturals sources its CBD extract from organic hemp plants grown on licensed farms in Colorado. The comany's CBD oils only contain two ingredients: USDA certified organic hemp seed oil and full spectrum hemp extract.</p><p>NuLeaf Naturals uses one proprietary CBD oil formula for all of its products, so you will get the same CBD potency in each tincture (60mg per mL), but can purchase different bottle sizes depending on how much you intend to use.</p>
$38.50
Charlotte's Web
<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDcwMjk3NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0MzQ0NjM4N30.SaQ85SK10-MWjN3PwHo2RqpiUBdjhD0IRnHKTqKaU7Q/img.jpg?width=980" id="84700" class="rm-shortcode" data-rm-shortcode-id="a2174067dcc0c4094be25b3472ce08c8" data-rm-shortcode-name="rebelmouse-image" alt="charlottes web cbd oil" data-width="1244" data-height="1244" /><p>Perhaps one of the most well-known brands in the CBD landscape, Charlotte's Web has been growing sustainable hemp plants for several years. The company is currently in the process of achieving official USDA Organic Certification, but it already practices organic and sustainable cultivation techniques to enhance the overall health of the soil and the hemp plants themselves, which creates some of the highest quality CBD extracts. Charlotte's Web offers CBD oils in a range of different concentration options, and some even come in a few flavor options such as chocolate mint, orange blossom, and lemon twist.</p>
$60
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FDA Director Stephen Hahn looks on as Donald Trump leaves the lectern during the daily coronavirus task force briefing at the White House on April 24, 2020 in Washington, DC. Drew Angerer / Getty Images
New guidelines produced by the Food and Drug Administration (FDA) to ensure the safety of a vaccine to protect against the novel coronavirus are being blocked by White House officials. The new guidelines would almost certainly guarantee that a vaccine would not be ready and approved by Election Day, according to The New York Times.
<p>An administration official told <a href="https://www.reuters.com/article/health-coronavirus-usa-vaccine/update-1-white-house-blocking-strict-guidelines-for-emergency-release-of-coronavirus-vaccine-nyt-idUSL1N2GW27S" target="_blank">Reuters</a> that the approval process was pending and there was no connection to Election Day.</p><p>The thorniest issue seems to be that the FDA guidelines mandate that vaccine developers follow patients enrolled in their trials for a minimum of two months before seeking approval for the vaccine under an Emergency Use Authorization license, according to the <a href="https://apnews.com/article/virus-outbreak-archive-efdb363953cc5e2d64028b60baabdc90" target="_blank">AP</a>.</p><p>The recommendation from the FDA about the follow-up period is designed to make sure the vaccine is safe. A senior administration official confirmed that the White House was blocking the guideline, arguing there was "no clinical or medical reason" to wait two months, as the AP reported.</p>
<p>Two weeks ago, when the <a href="https://www.washingtonpost.com/health/2020/09/22/fda-covid-vaccine-approval-standard/" target="_blank">FDA signaled</a> that it would issue tougher standards to increase transparency and increase public trust in the safety and efficacy of a vaccine, Trump signaled he may not be open to the tougher standards, dismissing it as a political move, according to <a href="https://thehill.com/homenews/administration/517907-trump-questions-need-for-tougher-fda-standards-on-coronavirus-vaccine" target="_blank">The Hill</a>.</p><p>During the weeks that the FDA has tried to implement stricter guidelines to ensure safety and efficacy, FDA Administrator Stephen Hahn has vowed that any and all decisions about approving a potential vaccine would be made by career scientists, not politicians, according to the AP.</p>
<p>White House Chief of Staff Mark Meadows has blocked the guidelines from moving forward, arguing the two-month follow up of patients would alter the rules in the midst of clinical trials. He also suggested that Hahn was bowing to pressure from career scientists, according to The New York Times.</p><p>In the face of White House resistance, the FDA is looking for a workaround, which includes handing off the standards to an advisory committee that must meet publicly before an emergency authorization license is granted. The idea behind the maneuver would be to have the committee adhere to the guidelines, even when confronted by the Trump administration's resistance to them, as The New York Times reported.</p>
<p>The administration's move to block the guidelines is undermining the public's trust that a vaccine is safe and effective. If one is released without public trust, that may make people resistant to receiving it, which would derail an immunization campaign.</p><p>"We cannot allow a lack of transparency to undermine confidence in the vaccine development process," Michelle McMurry-Heath, the president and chief executive officer of the trade group BIO, wrote in <a href="https://int.nyt.com/data/documenttools/letter-to-the-health-secretary-about-emergency-use-authorization-for-coronavirus-vaccines/d67f86d1ee10a6f0/full.pdf" target="_blank" title="">a letter</a> sent Thursday evening to Trump's health secretary, Alex M. Azar II, as <a href="https://www.nytimes.com/2020/10/02/us/politics/covid-vaccine-guidelines.html" target="_blank" rel="noopener noreferrer">The New York Times</a> reported. "The public must have full faith in the scientific process and the rigor of FDA's regulatory oversight if we are to end the pandemic."</p>
<p>Dr. Peter Marks, the head of FDA's vaccine division, in an online interview last week with the nonprofit Friends of Cancer Research, said the guidelines are simply an effort to educate the public on what the FDA is requiring of the drug manufacturers, according to the AP. "The companies know what we're expecting," he said.</p><p>Of the companies working on a vaccine, only Pfizer has said it may have a vaccine's safety and efficacy data complete before Election Day. Other vaccine candidates produced by Moderna, AstraZeneca, and Johnson and Johnson are under development under longer timelines, as the AP reported.</p><p>Additionally, FDA scientists have been discussing the contents of the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.</p>
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A woman swims at night with a shark in the Indian Ocean, Maldives on March 23, 2017. Andrey Nekrasov / Barcroft Media via Getty Images
Scientists are racing to create a cure for COVID-19, but the toll on sharks might be irreparable. Conservationists estimate that half a million of the predators may be killed to supply the world with a coronavirus vaccine when one is developed.
<p>Shark liver oil is primarily made of squalene, which helps regulate a shark's buoyancy in deep water. The compound is also found in plants, humans and other animals. Used as a moisturizing agent in cosmetics, squalene also creates a stronger immune response in vaccines, making them more effective, reported <a href="https://www.sciencetimes.com/articles/27486/20200928/developing-coronavirus-vaccines-harming-shark-species.htm" rel="noopener noreferrer" target="_blank">Science Times</a>.</p><p>Squalene has been used in flu vaccines since 1997, <a href="https://www.boston25news.com/news/health/advocates-worry-about-covid-19-culling-sharks/D35KAG7H5BHOJAV5KC7RAVWF3A/" target="_blank">Boston 25 News</a> reported, and has an "excellent safety record" according to the CDC, <a href="https://www.miamiherald.com/news/coronavirus/article246069130.html" target="_blank">Miami Herald</a> reported. It could also help reduce the amount of vaccine needed per person, the Boston news report said.</p>
<p><a href="https://www.sharkallies.com/" rel="noopener noreferrer" target="_blank">Shark Allies</a>, an advocacy group fighting against shark overfishing, claims that five COVID-19 vaccine candidates use shark squalene; the California-based non-profit is <a href="https://www.change.org/p/us-fda-food-and-drug-administration-of-the-united-states-of-america-stop-using-sharks-in-covid-19-vaccine-use-existing-sustainable-options?utm_source=share_petition&utm_medium=custom_url&recruited_by_id=923ecf50-6a7c-0130-2a28-3c764e0455b2" target="_blank">petitioning</a> the U.S. Food and Drug Administration, Europe, China and all vaccine developers to omit the compound or find an alternative that doesn't require sharks.</p><p>One British pharmaceutical that currently uses shark squalene in flu vaccines plans to manufacture a billion doses of the compound for potential use in coronavirus vaccines by May 2021, <a href="https://news.sky.com/story/coronavirus-half-a-million-sharks-could-be-killed-for-vaccine-experts-warn-12083167" target="_blank">Sky News</a> reported. <a href="https://www.vice.com/en/article/k7qdym/half-a-million-sharks-could-be-killed-to-make-a-global-covid-vaccine" rel="noopener noreferrer" target="_blank">VICE</a> reported that roughly 3,000 sharks have to die to extract a single tonne of squalene.</p><p>"It's called harvesting, but really you're not growing it, you're taking it from the wild," Stefanie Brendl, executive director of Shark Allies, told Boston 25 News. "It's a limited resource."</p><p>Shark Allies worries that the development and production of enough vaccines to create worldwide immunization to the novel coronavirus and future coronaviruses that are identified could carry "an immense ecological cost," VICE reported.</p>
<p>"It's something we need to get ahead of ASAP, because we are facing many years of vaccine production, for a global population, for many more coronavirus vaccines to come," Brendl told VICE. "The real danger is in what this can turn into in the future. A reliance on shark oil for a global vaccine — it's truly insane. A wild animal is not a reliable source and cannot sustain ongoing commercial pressure. [And] the <a href="https://www.ecowatch.com/reef-shark-2646585350.html?rebelltitem=1#rebelltitem1" target="_self">overfishing of sharks globally</a> is already at critical levels."</p><p>The conservationists fear that a global vaccine using shark squalene will endanger most shark species and could potentially wipe out some more threatened species, Miami Herald reported. <a href="https://www.ecowatch.com/sharks-imperiled-2646931482.html?rebelltitem=4#rebelltitem4" target="_self">Shark populations are vulnerable</a> because they reproduce in low numbers and are slow to mature. According to VICE, great whites, hammerheads and whale sharks are among those most often targeted for their livers. According to Oceana, deep-sea sharks are especially vulnerable because their livers contain more squalene than other species as it helps them adapt to their environment, reported Miami Herald.</p>
<p>"We're not trying to take anything away from humanity and say don't cure yourself, don't create a vaccine," Brendl told Boston 25 News. "What we're saying is the alternative is already there."</p><p>In a popular <a href="https://www.sharkallies.com/shark-free-products/could-squalene-end-up-in-a-covid-19-vaccine" target="_blank">online campaign</a>, Shark Allies outlined the non-shark alternatives for squalene already in existence. Plant-based oils can be harvested from things like yeast, wheat germ, sugarcane and olive oil, VICE and Miami Herald reported. Bacteria-created squalene has also been researched, the petition noted. The problem with these alternatives is that they are about 30% more expensive and harder to extract than shark-based squalene, Miami Herald reported.</p><p>A team of researchers in Poland who were working on a plant-based squalene alternative in 2013 <a href="https://pubmed.ncbi.nlm.nih.gov/23449131/" rel="noopener noreferrer" target="_blank">stressed in their report </a>that "in the interest of protecting biodiversity, raw materials of animal origin must be replaced by alternative sources that respect our environment."</p><p>Shark Allies also noted that there are coronavirus vaccines in development that do not require squalene at all and encouraged the development of those alternatives.</p>
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Fall is with us and winter is around the corner, so the season for colds and flu has begun — joining COVID-19. monstArrr / Getty Images
By Gudrun Heise
Just as scientists are scoring successes in coronavirus research, new problems are on their way. Fall is with us and winter is around the corner, so the season for colds and flu has begun — joining COVID-19.
<p>The coronavirus is already new territory for science, and the effects of its combination with influenza are equally unknown. There is much speculation about what is to be expected and what will or could happen when these two dangerous infectious diseases come together. This is what is making it so difficult to prepare adequately for the cold time of year.</p><p>Coughing, sniffles and hoarseness in fall and winter are nothing new, and flu is also a regular feature of these seasons. But we can be vaccinated against it, and that is of advantage in diagnosing cases of coronavirus as well.</p><p>"If people who have been vaccinated against influenza still have flu symptoms, it is more likely that it is not influenza," says <a href="https://www.helmholtz-hzi.de/de/forschung/forschungsschwraund-virale-krankheitserreger/epidemiologie/gerard-krause/" target="_blank">Gerárd Krause from the Helmholtz Centre for Infection Research in the northern German city of Braunschweig</a>. "This, in turn, makes it easier to decide matters regarding home quarantine and getting a clear diagnosis."</p>
Influenza Vaccination
<p>A flu vaccination may thus be able to narrow down the diagnostic options when flu-like symptoms occur, but whether such a vaccination also has an influence on the behavior of the dangerous new virus is — like so much else — not clear. "It is conceivable that there is an indirect effect. But it is, I believe, a matter of speculation whether it has an immunological effect in the narrower sense," says Krause.</p><p>Every winter, doctors' waiting rooms are full of people who are coughing and sniffing but who mostly turn out to have only a severe respiratory infection. According to current knowledge, the virus that causes COVID-19, SARS-CoV-2, is also likely to be subject to seasonal fluctuations. </p><p>In winter, cold viruses, at least, flourish because cold and dry air offers ideal conditions for their spread. In addition, it becomes more difficult to air rooms regularly and intensively — an important further measure to counteract the coronavirus and contain to some extent the danger posed by aerosols.</p><p>According to the <a href="https://www.rki.de/DE/Home/homepage_node.html" target="_blank">Robert Koch Institute, Germany's public health agency</a>, between 5% and 20% of people in Germany become infected with flu viruses every year. These viruses are also dangerous and can be fatal. The flu vaccination must be adapted to the influenza viruses every year, because they mutate. But at least there is a vaccination.</p><p>Most experts agree that there is unlikely to be a vaccine against the coronavirus by the time the next wave of influenza comes around. And even if a vaccine were to be approved, many unknowns remain.</p>COVID-19 and Flu Simultaneously
<p>For example, there is a lack of practical experience in dealing simultaneously with SARS-CoV-2 and influenza. It is possible to speculate that having influenza could facilitate the entry of the coronavirus into the human body. "The general weakening of the immune system during an influenza infection could increase the susceptibility of a patient to a SARS-CoV-2 infection," Krause says.</p><p>However, it is uncertain how dangerous this double infection could ultimately be and what can be done about it. Krause is of the opinion that we must arm ourselves against all three diseases — colds, flu and COVID-19. If we have a cold, bed rest, hot tea and cough medicine usually help. We can get vaccinated against flu. But how do we deal with COVID-19?</p><p><span></span>Probably people can only hope that if they get the illness, they will have a mild form with as few after-effects as possible. Here, it will certainly help to stick to suggested rules on hygiene to reduce or prevent our exposure to the virus. In an interview with DW, Bonn-based virology professor Hendrik Streeck made it clear that COVID-19 usually takes a more severe course when there is a high viral load at infection.</p>Hygiene, Hygiene, Hygiene
<p>The same hygiene measures with which we are trying to get at least some kind of grip on COVID-19 also apply to influenza. The less we come into contact with viruses, the greater the chance that we will be spared an infection or that it will be mild.</p><p>These measures include general hygiene precautions such as frequent hand washing and the wearing of protective face masks. "The various hygienic measures against COVID-19 will also reduce the spread of influenza," says Krause. "Possibly, further connections of a more immunological nature will be discovered."</p><p>Let us hope that is the case, because the flu season hasn't even started.</p>From Your Site Articles
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WHO Releases Plans for COVID-19 Vaccine Distribution as U.S., China and Russia Opt Out
22 September 2020
Health + Wellness
Headquarters of the World Health Organization in Geneva amid the COVID-19 outbreak on Aug. 17, 2020. FABRICE COFFRINI / AFP via Getty Images
The World Health Organization (WHO) announced Monday that 64 high-income nations have joined an effort to distribute a COVID-19 vaccine fairly, prioritizing the most vulnerable citizens, as Science reported. The program is called the COVID-19 Vaccines Global Access Facility, or Covax, and it is a joint effort led by the WHO, the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance.
<p>The 64 high-income countries bring the total number of participating countries up to 156, but their participation is crucial to financing the 2 billion doses that the WHO hopes to purchase and distribute before the end of 2021, according to <a href="https://www.statnews.com/2020/09/21/64-high-income-nations-join-effort-to-expand-global-access-to-covid-19-vaccines-but-u-s-and-china-do-not/" target="_blank" rel="noopener noreferrer">STAT News</a>.</p><p>The 156 economies participating in Covax make up 64 percent of the global population.</p><p>"COVAX is now in business: governments from every continent have chosen to work together, not only to secure <a href="http://www.ecowatch.com/tag/vaccines">vaccines</a> for their own populations, but also to help ensure that vaccines are available to the most vulnerable everywhere," said Dr. Seth Berkley, CEO of Gavi, in a WHO <a href="https://www.who.int/news-room/detail/21-09-2020-boost-for-global-response-to-covid-19-as-economies-worldwide-formally-sign-up-to-covax-facility" target="_blank">statement</a>. "With the commitments we're announcing today for the COVAX Facility, as well as the historic partnership we are forging with industry, we now stand a far better chance of ending the acute phase of this pandemic once safe, effective vaccines become available."</p>
<p>The United States, Russia and China have not agreed to join Covax. The <a href="http://www.ecowatch.com/trump-watch/">Trump</a> administration plans to withdraw from the WHO by next July so it refuses to participate in a WHO-led campaign, as STAT News reported. China has not said if it will participate or not, according to <a href="https://www.washingtonpost.com/world/coronavirus-vaccine-covax-who/2020/09/21/d21c7b4a-f9d3-11ea-a510-f57d8ce76e11_story.html" target="_blank">The Washington Post</a>.</p><p>"COVID-19 is an unprecedented global crisis that demands an unprecedented global response," said WHO Director-General Dr. Tedros Adhanom Ghebreyesus in a statement. "Vaccine nationalism will only perpetuate the disease and prolong the global recovery. Working together through the COVAX Facility is not charity, it's in every country's own best interests to control the pandemic and accelerate the global economic recovery."</p>
<p>At a briefing on Monday, Ghebreyesus denounced vaccine nationalism again, according to The Washington Post. "The race for vaccines is a collaboration, not a contest," he said to a gathering of reporters. "This is not charity. It's in every country's best interest. We sink or swim together."</p><p>Once a vaccine candidate reaches all of its endpoints for safety and efficacy, the WHO's plan will be implemented in two phases under a "fair allocation mechanism." The first phase has two discrete parts. After enough doses of a successful candidate are produced, each participating country will receive enough doses for 3 percent of their population. That first batch would go to health care and social care workers on the frontlines of the pandemic. After that first batch is distributed, a second set of doses will be distributed equally so 20 percent of the population can be inoculated. The second set of doses will be for vulnerable populations like the elderly and people with complicating health conditions, according to Science.</p>
<p>The second phase will distribute vaccine doses by need rather than by equal distribution. Countries that take part in Covax will receive vaccines based on how desperately they are needed. To determine urgency, Covax will look at the transmission rate, whether other diseases like flu are spreading rapidly, and if a healthcare system is seeing its hospitals and intensive care units overwhelmed, as Science reported.</p><p>"Providing each country with enough doses to start protecting the health system and those at higher risk of dying is the best approach to maximize the impact of the small quantities of vaccines," said Mariângela Batista Galvão Simão, the WHO's assistant director general for access to medicines and health products, as The Washington Post reported.</p><p>While the first phase of the plan may not address the most dire and urgent situations, the equal distribution of the vaccine in proportion to population is meant to encourage more countries to participate in Covax, according to The Washington Post.</p><p>"It's a very pragmatic and expedient way of trying to put forward a simple plan and will not ignite a food fight among different member states in the first phase," said J. Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, as The Washington Post reported.</p>
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Moderna, Pfizer Release Study Designs as Vaccine Distrust Grows Among Americans
18 September 2020
Health + Wellness
Rabbi Shmuel Herzfeld has his arm disinfected by Dr. Chao Wang during a Moderna clinical trial for a coronavirus vaccine at Meridian Clinical Research in Rockville, Maryland on July 27, 2020. Amanda Andrade-Rhoades for The Washington Post via Getty Images
The secretive blueprints for two of the leading vaccine candidates for the coronavirus were released Thursday. Pfizer and Moderna became the first two companies among the nine leading vaccine candidates to share their study designs, hoping that the disclosures will create trust and clarity for the public, as The New York Times reported.
<p>The details that the two companies shared are usually kept secret until after a study is complete, yet the companies decided to publish the size of their trials, the selection criteria for patients, and the adverse reactions that would cause the trials to stop prematurely. The Moderna trial will include 30,000 participants, while the Pfizer trial will have 44,000 participants, according to The New York Times.</p><p>The information released shows that the two companies and their executives still do not know if the vaccines are safe and effective. Furthermore, the disclosure shows that the ambitious time frame that President <a href="http://www.ecowatch.com/trump-watch/">Trump</a> touts to have a vaccine available in a few weeks is all but impossible, according to <a href="https://www.washingtonpost.com/health/2020/09/17/vaccine-companies-reveal-their-study-designs-even-trump-sows-confusion/" target="_blank">The Washington Post</a>.</p>
<p>Trump's frequent comments about the availability of a vaccine to the general population by election day contradict the word of scientists, health officials and the companies manufacturing and testing the vaccine candidates. That mixed-messaging has sown confusion with the public and created the appearance that a vaccine candidate will be rushed to market prior to proving its safety and efficacy, according to The Washington Post.</p><p>"We need trust as much as we need efficacy," said Andrew Pavia, an infectious-diseases specialist at the University of Utah School of Medicine, to The Washington Post. "We can't afford to do anything that reduces the trust. It's not just the trust of the public. Experts in the field have to see enough of the data to feel comfortable to recommend it."</p><p>New poll number show that trust is eroding. Data released Thursday by the <a href="https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/" target="_blank">Pew Research Center</a> show that the number of Americans who are willing to get a vaccine for the coronavirus has dropped precipitously since the beginning of the pandemic.</p><p>According to the new poll, about 51 percent of the population is likely to get the vaccine, while 49 percent said they are unwilling or unlikely to get it. Only 21 percent said they would definitely get the vaccine.</p>
<p>The percentage of people who were likely to get the vaccine is down from 72 percent in May, marking a 21 percent drop over the summer. The thorniest issue for study participants was their growing concern that a vaccine was being developed too fast and it would be widely distributed before it was proven to be safe and effective.</p><p>"Over the past month alone — a period in which President Donald Trump has repeatedly promised a vaccine will be delivered by the end of 2020 and possibly before the Nov. 3 election — the share of adults who say they would get vaccinated has fallen 8 points after public opinion on the matter generally remained steady over the summer," the researchers wrote, as <a href="https://thehill.com/changing-america/well-being/prevention-cures/516952-americans-willingness-to-take-covid-19-vaccine" target="_blank">The Hill</a> reported.</p><p>That growing unease about a vaccine is what prompted the nine companies with the leading vaccine candidates to take the unusual step of banding together to pledge that a vaccine would not be released prematurely, according to The Hill. For a vaccine to be effective, confidence has to grow so enough people will receive the vaccine to raise immunity levels high enough to stop transmission of the virus.</p><p>As for a realistic timeframe, Thursday's disclosures by Moderna and Pfizer showed that there would not be a vaccine from either company by election day. Moderna's estimated timetable showed it would not likely know if its candidate works until 2021. Pfizer did not release an estimated timetable in its disclosure, according to The New York Times.</p>
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Dr. Robert Redfield, director of the CDC and Trump participate in the daily briefing of the coronavirus task force at the White House on April 22, 2020 in Washington, DC. Drew Angerer / Getty Images
Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention (CDC), testified before the Senate health panel Wednesday and discussed a realistic timeline for a vaccine. While he said an initial vaccine for the novel coronavirus may be ready by November or December, the first batch will have an extremely limited supply that will go to the most vulnerable populations, as The Washington Post reported.
<p>Redfield then said that widespread distribution of the vaccine would happen gradually, with those least at risk likely not receiving the vaccine until the summer of 2021. For it to be "fully available to the American public, so we begin to take advantage of vaccine to get back to our regular life," he said, as The Washington Post reported. "I think we are probably looking at late second quarter, third quarter 2021."</p><p>In his testimony, Redfield also acknowledged that a vaccine is not 100 percent effective and works best when most people in a population have it. In contrast to the vaccine, he said, a mask is a reliable and scientifically proven tool to stop the spread of the virus.</p>
<p>"I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine, because the immunogenicity may be 70 percent," he said to lawmakers, as CNN reported. "And if I don't get an immune response, the vaccine is not going to protect me. This face mask will."</p><p>He added that the American public has not yet adapted to the widespread use of masks that could stop the transmission of the coronavirus outbreak.</p><p>The remarks under oath from Redfield clashed with President Trump's insistence that a vaccine will be ready in a few weeks. Redfield's championing of mask-wearing also contrasted with Trump's reluctance to wear one in public.</p>
<p>In a press conference Wednesday, Trump publicly undermined Redfield's testimony, continuing to say that a vaccine will be ready shortly, and expressing skepticism about the efficacy of masks, according to <a href="https://www.nytimes.com/2020/09/16/world/covid-coronavirus.html" target="_blank">The New York Times</a>.</p><p>In response to Redfield's testimony about a timeline for a vaccine, Trump said, according to <a href="https://www.theguardian.com/world/2020/sep/16/cdc-director-coronavirus-vaccine-late-2021-trump" target="_blank">The Guardian</a>, "I think he made a mistake with that statement. When he said it, I believe he was confused. I'm just telling you we're ready to go."</p><p>Trump then added that a vaccine would go "to the general public immediately," and "under no circumstance will it be as late as the doctor said," as The New York Times reported.</p>
<p>On the point of masks, Trump cast doubt on Redfield's testimony, saying that Redfield made a mistake and that he was confused by the question.</p><p>"Maybe he misunderstood it," Trump said, as CNN reported. He then added, "As far as the masks are concerned, I hope that the vaccine is going to be a lot more beneficial than the masks."</p><p>He also expressed doubt that they were effective.</p><p>"Masks have problems too ... A lot of people did not like the concept of mask initially, Dr. Fauci didn't like it initially," Trump said, as The Guardian reported. However, he did not add that Dr. Fauci later clarified his comments that he did not want to see panic that would create a run on N95 masks and leave a shortage for health care workers.</p>
<p>After Trump publicly rebuked the head of the world's preeminent health agency, Redfield released a statement that reiterated the importance of a vaccine and masks, but did not address the idea that he was mistaken.</p><p>"A COVID-19 vaccine is the thing that will get Americans back to normal everyday life. The best defense we currently have against this virus are the important mitigation efforts of wearing a mask, washing your hands, social distancing and being careful about crowds," he said in the statement, as CNN reported.</p>
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Fauci Warns Pre-Pandemic Normalcy May Not Be Likely Until Late 2021
14 September 2020
Health + Wellness
Dr. Anthony Fauci says that it may not be safe to attend movie theaters or indoor events until a year after the U.S. has a safe, effective vaccine. Pxfuel
By Jessica Corbett
As the number of confirmed Covid-19 cases in the United States surpassed 6.43 million and the nation's death toll topped 192,600, the federal government's top infectious disease expert warned Friday that life likely won't return to normal until sometime—perhaps late—in 2021.
<p>During a televised interview, <em>MSNBC</em>'s Andrea Mitchell asked Dr. Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, about his comments earlier this week that it may not be safe to attend movie theaters or indoor events until a year after the U.S. has a safe, effective vaccine.</p><p>Fauci said that he remains confident the U.S. could have a vaccine for Covid-19 by the end of this year or early next year, "but by the time you mobilize the distribution of the vaccinations and you get the majority or more of the population vaccinated and protected, that's likely not gonna happen till the mid or end of 2021."</p><p>"If you're talking about getting back to a degree of normality which resembles where we were prior to Covid, it's gonna be well into 2021, maybe even towards the end of 2021," Fauci added, referencing the local and state level lockdowns and social distancing practices that have been implemented throughout this year.</p>
<div id="38899" class="rm-shortcode" data-rm-shortcode-id="c876b6251b5bd2514394cc7fcffb6486"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1304450398883807232" data-partner="rebelmouse"><div style="margin:1em 0">Live now on @MSNBC: @mitchellreports interviews Dr. Fauci.
https://t.co/MPjgQRmzjX https://t.co/qrS4zxbvqZ</div> — MSNBC (@MSNBC)<a href="https://twitter.com/MSNBC/statuses/1304450398883807232">1599840185.0</a></blockquote></div>
<p>A White House adviser, Fauci also disagreed with President Donald Trump's <a href="https://www.whitehouse.gov/briefings-statements/remarks-president-trump-press-briefing-091020/" target="_blank">claim</a> during a Thursday press briefing that the United States has "rounded the final turn" in the pandemic. Looking at the statistics, "they're disturbing," Fauci told Mitchell. "We're plateauing at around 40,000 cases a day and the deaths are around 1,000."</p><p>The expert expressed hope that the U.S. won't see a post-Labor Day Weekend surge in cases like what occurred after July 4 and Memorial Day, and stressed the importance of driving down infection numbers heading into the fall and winter months.</p><p>"What we don't want to see is going into the fall season, when people will be spending more time indoors—and that's not good for a respiratory borne virus—you don't want to start off already with a baseline that's so high," he said.</p>
<p>Fauci also <a href="https://twitter.com/MSNBCPR/status/1304458897353211904" target="_blank">denied</a> that he has been influenced by the <a href="https://www.commondreams.org/news/2020/09/09/emails-show-how-trump-official-hhs-tried-get-fauci-downplay-covid-19-threat-school" target="_blank">reported</a> efforts of a Trump-allied official within the Department of Health and Human Services to muzzle him or otherwise guide what the expert says publicly about the pandemic.</p><p>Regarding AstraZeneca's <a href="https://www.statnews.com//09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/" target="_blank">decision</a> earlier this week to halt human trials for a potential vaccine after a participant in the U.K. showed signs of a suspected adverse reaction, Fauci said the development was unfortunate but should also reassure the public that safety concerns are being taken seriously.</p><p>The trial delay came as AstraZeneca joined eight other pharmaceutical companies in pledging to "stand with science" amid alarm that Trump may pressure the industry and the Food and Drug Administration to approve a vaccine ahead of the general election. As <em>Common Dreams</em> <a href="https://www.commondreams.org/news/2020/09/08/what-it-has-come-amid-fears-politicization-fda-big-pharma-pledge-stand-science-met" target="_blank" rel="noopener noreferrer">reported</a> Tuesday, public health experts responded to Big Pharma's promise with cautious optimism.</p>
<p><em>Reposted with permission from <a href="https://www.commondreams.org/news/2020/09/11/fauci-warns-pre-pandemic-normalcy-not-likely-until-well-or-towards-end-2021?cd-origin=rss" target="_blank">Common Dreams</a>.</em></p>From Your Site Articles
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27 June 2016
The offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire on July 21, 2020. PAUL ELLIS / AFP via Getty Images
One of the leading candidates for a COVID-19 vaccine has been stopped after a study participant had a serious adverse reaction that is suspected to have been caused by the vaccine, as STAT News reported. The vaccine from the pharmaceutical giant AstraZeneca and the University of Oxford was in the late stages of a phase 3 trial, meaning it was being tested for safety at several sites around the country and in Europe.
<p><br/></p>
<p>After a study participant in the United Kingdom fell ill, AstraZeneca said in a <a href="https://twitter.com/RebeccaDRobbins/status/1303452507641839616" target="_blank">statement</a> that it would review safety and efficacy data. Then the company released a <a href="https://twitter.com/RebeccaDRobbins/status/1303491310968479745" target="_blank">second statement</a>, saying it initiated the pause even though the study participant is expected to make a full recovery, according to STAT News.</p><p>Despite the pause, adverse reactions are very common in clinical trials as is pausing for a safety and efficacy review. It also does not mean the vaccine candidate is a failure. However, it does make it increasingly unlikely that the vaccine will be approved and ready for distribution by Election Day, as President <a href="http://www.ecowatch.com/trump-watch/">Trump</a> has often said a vaccine would be.</p>
<p>In a statement, according to <a href="https://www.nytimes.com/2020/09/08/health/coronavirus-astrazeneca-vaccine-safety.html" target="_blank">The New York Times</a>, AstraZeneca described the pause as a "routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."</p><p>AstraZeneca was not clear about how long the pause in the vaccine trial will last. The late-stage vaccine trial so far has included 17,000 people in Europe, the U.S., Brazil and South Africa, according to <a href="https://www.theguardian.com/world/2020/sep/09/the-oxford-university-astrazeneca-covid-19-vaccine-trial-has-been-paused-should-we-be-worried" target="_blank">The Guardian</a>. Phase 3 trials include a large number of study participants for exactly this reason; only by testing a large number of people do rare side-effects emerge.</p><p>"This is the whole point of doing these Phase 2, Phase 3 trials," said Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, as The New York Times reported. "We need to assess safety, and we won't know the efficacy part until much later. I think halting the trial until the safety board can figure out whether or not this was directly related to the vaccine is a good idea."</p>
<p>While the exact condition that the study participant suffered has not been released, The New York Times is reporting that sources are saying the person received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. It's unclear if the diagnosis is directly related to the vaccine candidate or not.</p><p>Robert Booy, a University of Sydney professor of vaccinology, told The Guardian that if the sickness is unrelated to the vaccine candidate then the trial might be paused for just one week, but it may extend to one month. He said that the pause "is more likely the product of being super careful" rather than a problem with the vaccine.</p><p>"This could have just been a high fever and it turns out they've got appendicitis," he said. "My bet would be that they find something in this participant that is not causal [from the vaccine]. It'll take them about one to two weeks to ascertain this, and then they will probably restart the trial in a month."</p>
<p>AstraZeneca said in a statement that it was "working to expedite the review of the single event to minimize any potential impact on the trial timeline," and did not waver from its commitment "to the safety of our participants and the highest standards of conduct in our trials," as The New York Times reported.</p><p>AstraZeneca was one of nine companies that signed a pledge Tuesday to assure the public that a vaccine would not be rushed due to politics. In a rare move, nine companies working on a vaccine made a joint pledge to "stand with <a href="http://www.ecowatch.com/science/">science</a>" and insisted that they would not be rolled out prematurely without proving beyond a doubt that they are safe and effective, according to The New York Times.</p>
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Trump takes questions after delivering remarks during a news conference at the North Portico at the White House on Sept. 7, 2020 in Washington, DC. Tasos Katopodis / Getty Images
By Jake Johnson
After President Donald Trump on Monday suggested a COVID-19 vaccine could be fully developed and put to market "before a very special day" — apparently referring to the Nov. 3 presidential election — Sen. Bernie Sanders warned that Trump's ongoing politicization of the vaccine process threatens to undermine public trust and safety.
<p>"I think you got a president who's losing it, and I think most people are sick and tired of the ranting and the ravings of Donald Trump," the Vermont senator said in an appearance on CNN late Monday. "Look, everybody wants a vaccine, but we want to make sure that that vaccine is safe. We don't want to see that vaccine put on the market for political reasons."</p><p>Sanders went on to urge doctors, scientists, and <a href="https://www.commondreams.org/news/2020/09/01/wolf-saying-hell-guard-henhouse-big-pharma-ceo-insists-industry-can-police-itself" target="_blank">pharmaceutical companies</a> to "do the right thing and get it onto the market, get it into people's arms when it is ready, not when it suits the political purposes of this increasingly irrational president."</p><p>"Let's not politicize this thing. We have developed vaccines for decade after decade after decade. We have to give the resources to the doctors and the scientists to do their work," Sanders said. "We've got to make sure that vaccine undergoes the clinical trials that [are] necessary to make sure that it is safe."</p>
<blockquote class="twitter-tweet"><p lang="en" dir="ltr">“Let's not politicize this thing,” Sen. Bernie Sanders says about the coronavirus vaccine. “We have developed vaccines for decade after decade after decade. We have to give the resources to the doctors and the scientists to do their work." <a href="https://t.co/GqSF5xfRbd">https://t.co/GqSF5xfRbd</a> <a href="https://t.co/jwJVMQo12i">pic.twitter.com/jwJVMQo12i</a></p>— The Situation Room (@CNNSitRoom) <a href="https://twitter.com/CNNSitRoom/status/1303114086083964928?ref_src=twsrc%5Etfw">September 7, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
<p>The Vermont senator's remarks came hours after Trump <a href="https://twitter.com/CNNPolitics/status/1303040452577374208" target="_blank" rel="noopener noreferrer">claimed</a> during a Labor Day press conference Monday that "we're going to have a vaccine very soon, maybe even before a very special day."</p><p>Asked whether he's pushing for speedy approval of a coronavirus vaccine for political gain, Trump said: "No, I'm saying that because we want to save a lot of lives. With me, it's the faster the better. With somebody else, maybe they would say it politically but I'm saying it in terms of this is what we need."</p><p>"Now," Trump continued, "do benefits inure if you're able to get something years ahead of schedule? I guess maybe they do."</p>
<blockquote class="twitter-tweet" data-conversation="none"><p lang="en" dir="ltr">"The faster, the better" -- Trump on a coronavirus vaccine <a href="https://t.co/Lc83qixbp3">pic.twitter.com/Lc83qixbp3</a></p>— Aaron Rupar (@atrupar) <a href="https://twitter.com/atrupar/status/1303033886163849217?ref_src=twsrc%5Etfw">September 7, 2020</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
<p>Federal officials have repeatedly cast doubt on the president's suggested timeline, saying there's little chance that a sufficiently tested vaccine will be ready ahead of the November election.</p><p>"I don't know any scientist involved in this effort who thinks we will be getting shots into arms any time before Election Day," one anonymous federal official familiar with Operation Warp Speed <a href="https://www.cnn.com/2020/09/07/health/trump-vaccine-timeline/index.html" target="_blank">told</a> CNN Monday, echoing the public statements of other officials involved with the vaccine development effort.</p>
<p><em>Reposted with permission from <a href="https://www.commondreams.org/news/2020/09/08/people-are-sick-and-tired-ranting-and-ravings-sanders-rips-trump-effort-rush-covid?cd-origin=rss" target="_blank">Common Dreams</a>.</em></p>From Your Site Articles
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Director of the Centers for Disease Control Robert Redfield arrives for Trump's speech on vaccine development on May 15, 2020 in the Rose Garden of the White House in Washington, DC. MANDEL NGAN / AFP via Getty Images
The appearance that the Centers for Disease Control and Prevention (CDC) is taking orders from political leaders grew stronger this week as the organization told states to prepare facilities for a coronavirus vaccine before November's general election. The issue raised alarm for health experts who worry that a vaccine will be rolled out before its safety and efficacy are well established, according to The New York Times.
<p>The letter, written by Director of the CDC Dr. Robert Redfield, is dated August 27 — the same day that President Trump gave his speech at the Republican National Convention claiming that a vaccine would be available before the end of the year. The letter says that the CDC had entered a contract with McKesson Corp. to distribute hundreds of millions of vaccine doses to state and local health departments nationwide in less than two months, according to <a href="https://www.nbcnews.com/news/us-news/cdc-tells-states-prepare-large-scale-distribution-covid-19-vaccine-n1239149" target="_blank">NBC News</a>.</p><p>The New York Times obtained a <a href="https://int.nyt.com/data/documenttools/phase-1-vaccination-planning-scenarios-8-27/e0b519d686f4dda5/full.pdf" target="_blank">planning document</a> that the CDC sent out. It described an evolving vaccine landscape, but touted the promise of two different vaccine candidates, and laid out a scenario where 2 million doses could be distributed before November and another 10 to 20 million doses distributed by the end of that month.</p>
<p>Both vaccine candidates would require two injections taken a couple of weeks apart and it identified at-risk populations and frontline workers as the people to receive the vaccine first.</p><p>"These scenarios are designed to support jurisdictional, federal, and partner planning, but they are still considered hypothetical," one document reads, as <a href="https://www.cnn.com/2020/09/02/health/cdc-covid-19-vaccine-distribution/index.html" target="_blank">CNN</a> reported.</p><p>In the documents, Redfield asks governors to expedite applications for the vaccine distribution facilities that McKesson would run, according to NBC News.</p><p>"If necessary," Redfield wrote, the agency "asks you to consider waiving requirements that would prevent these facilities from being fully operational by November 1, 2020," as NBC News reported.</p>
<p>Public health officials worry that the Trump administration is looking to roll out a vaccine prematurely, or at least to hype one, before the election as a way to score political points, as The New York Times noted. There are Herculean logistical challenges involved in distributing and storing a vaccine in sub-zero temperatures to a messy and disjointed healthcare system.</p><p>"This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications," said Saskia Popescu, an infection prevention epidemiologist based in Arizona, to The New York Times. "It's hard not to see this as a push for a pre-election vaccine."</p>
<p>Director of the National Institutes of Health Dr. Francis Collins, however, told CNN that he doesn't see it as a premature rush to distribute a vaccine. He said it's proper planning should one of the two vaccine candidates tested show fast, clear evidence that it is protecting people.</p><p>"Now, keep in mind that the likelihood of that is pretty low," Collins told CNN. "This is like the Boy Scout motto, 'Be Prepared.'"</p><p>"Even if it's very low likelihood, if everything happened to come together really beautifully and we had an answer by then and we knew we had a vaccine that was safe and effective, wouldn't you want people to be ready to figure out how to do the distribution? That's all that CDC is saying," he added.</p><p>Medical experts did appreciate that the CDC earmarked the first vaccines for healthcare workers, essential workers and people who work in national security, according to The New York Times. The guidelines also said early vaccines should go to older people, indigenous people, minority groups and to prison populations — all communities that have been most affected by the novel coronavirus.</p><p>That specific direction is beneficial for public health, "so it doesn't just all wind up in high-income, affluent suburbs," said Dr. Cedric Dark, an emergency medicine physician at Baylor College of Medicine in Texas, to The New York Times.</p>
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