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.
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>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>EcoWatch Daily Newsletter
Johnson & Johnson Pauses COVID-19 Vaccine Trial After Mystery Illness
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.
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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.
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>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>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>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>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>- Best CBD Oils of 2020: Reviews & Buying Guide - EcoWatch ›
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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.
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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.
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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.
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>- Fauci Warns Bad Second Wave of Coronavirus Could Hit U.S. ... ›
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WHO Releases Plans for COVID-19 Vaccine Distribution as U.S., China and Russia Opt Out
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.
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Moderna, Pfizer Release Study Designs as Vaccine Distrust Grows Among Americans
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.
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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.
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Fauci Warns Pre-Pandemic Normalcy May Not Be Likely Until Late 2021
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.
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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.
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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.
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