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	<title>Inter Press ServiceSunil J. Wimalawansa - Author - Inter Press Service</title>
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		<title>Are There Clinically Meaningful Differences Between anti-COVID-19 Vaccines?</title>
		<link>https://www.ipsnews.net/2021/05/clinically-meaningful-differences-anti-covid-19-vaccines/</link>
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		<pubDate>Fri, 28 May 2021 06:36:43 +0000</pubDate>
		<dc:creator>Sunil J. Wimalawansa</dc:creator>
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		<description><![CDATA[Despite claims by the industry and some politicians, there are no clinically meaningful differences among the variety of vaccines approved under emergency use authorisation (EUA). There are no significant differences in effectiveness between individual vaccines of different types: mRNA vaccines (e.g., Pfizer and Moderna), adenovirus vector vaccines (e.g., AZN, J&#38;J, and Sputnik V) and inactivated [&#8230;]]]></description>
		
			<content:encoded><![CDATA[<p><font color="#999999"><img width="300" height="136" src="https://www.ipsnews.net/Library/2021/05/health-worker-prepares_-300x136.jpg" class="attachment-medium size-medium wp-post-image" alt="" decoding="async" srcset="https://www.ipsnews.net/Library/2021/05/health-worker-prepares_-300x136.jpg 300w, https://www.ipsnews.net/Library/2021/05/health-worker-prepares_.jpg 624w" sizes="(max-width: 300px) 100vw, 300px" /><p class="wp-caption-text">A health worker prepares to administer the COVID-19 vaccine to her colleague at a hospital in Mogadishu, Somalia.In a video message on May 24  to the World Health Assembly , the decision-making body of UN agency <a href="http://www.who.int/en/" rel="noopener" target="_blank">WHO</a>, UN Secretary-General Antonio Guterres warned against the dangers of “<a href="https://www.un.org/sg/en/content/sg/statement/2021-05-24/secretary-generals-video-message-the-world-health-assembly" rel="noopener" target="_blank">a two-speed global response</a>”, a concern he has frequently expressed. “Sadly, unless we act now, we face a situation in which rich countries vaccinate the majority of their people and open their economies, while the virus continues to cause deep suffering by circling and mutating in the poorest countries,” he said.   Credit: UNICEF/Ismail Taxta</p></font></p><p>By Sunil J. Wimalawansa<br />NEW JERSEY, USA, May 28 2021 (IPS) </p><p>Despite claims by the industry and some politicians, there are no clinically meaningful differences among the variety of vaccines approved under <a href="https://www.theverge.com/22189236/fda-approval-authorization-difference-clearance-vaccines" target="_blank" rel="noopener">emergency use authorisation (EUA)</a>.<br />
<span id="more-171566"></span></p>
<p>There are no significant differences in effectiveness between individual vaccines of different types: mRNA vaccines (e.g., Pfizer and Moderna), <a href="https://www.ebsco.com/blogs/health-notes/adenovirus-vectored-vaccines-covid-19-how-do-they-work" target="_blank" rel="noopener">adenovirus vector vaccines</a> (e.g., AZN, J&amp;J, and Sputnik V) and <a href="https://pubmed.ncbi.nlm.nih.gov/32376603/" target="_blank" rel="noopener">inactivated SARS-CoV-2 virus vaccines</a> (e.g., Sinovac and Valneva) in preventing severe complications and deaths.</p>
<p>If there is no contra-indication or a fundamental reason or belief for not vaccinating, considering the urgency, individuals should take the vaccine provided to them.</p>
<p><strong>Efficacy of COVID vaccines:</strong></p>
<p>As per global data, the COVID-19-related complication among the adult population needing hospitalisation is approximately 14%. As defined by preventing hospitalisation and deaths, the reported efficacy of mRNA vaccines is ~94%.</p>
<p>Therefore, the average efficacy of all COVID vaccines is approximately 90% (0.86/0.94 x 100). Nevertheless, none of these vaccines entirely prevents infection, transmission, lasting harm, or death.</p>
<p>The rate of complications can be significantly reduced by <a href="https://vdmeta.com/" target="_blank" rel="noopener">vitamin D supplementation before infection</a> or <a href="https://www.linkedin.com/posts/sunilwimalawansa_vitamin-d-highly-effective-in-preventing-activity-6801917954717048832-hqGW" target="_blank" rel="noopener">at the time of hospitalisation</a> (<a href="https://www.mdpi.com/2072-6643/12/11/3361" target="_blank" rel="noopener">Mercola 2020</a>; <a href="https://doi.org/10.36811/ojprm.32020.110010" target="_blank" rel="noopener">Wimalawansa, 2020</a>) [<a href="https://vdmeta.com/" target="_blank" rel="noopener">vitamin D3</a> and <a href="https://www.ncbi.nlm.nih.gov/pubmed/33065103" target="_blank" rel="noopener">ivermectin</a>; latter also increases serum 25-hydroxyvitamin D [25(OH)D] concentration].</p>
<p>Most hospitalised COVID-19 patients have 25(OH)D levels less than 20 ng/mL, whilst the vast majority who died from COVID had levels below 10 ng/mL. It is noteworthy that over 50 ng/mL is required for the proper operation of autocrine (inside each cell) and paracrine (nearby cells) signalling and functions of immune cells.</p>
<p>These are required for rapid and well-regulated immune responses to combat pathogens. In the absence, people develop complications.</p>
<p><strong>Types of SARS-CoV-2 vaccines:</strong></p>
<p>mRNA vaccines for other diseases have never deployed for humans outside clinical trials. SARS-CoV-2 produces intense immune responses because the insertions within the micro-lipid particles allow generating large amounts of a portion of the viral spike protein. The human immune system attacks and eliminates these foreign proteins.</p>
<p>Spike proteins have a high affinity for <a href="https://www.asbmb.org/asbmb-today/science/051620/what-is-the-ace2-receptor" target="_blank" rel="noopener">ACE2 receptor protein</a> located on human epithelial cell membranes in the lungs, gastrointestinal tract, blood vessels, etc. Due to sequence similarities of ACE2 and <a href="https://www.rndsystems.com/ace2/protein" target="_blank" rel="noopener">ACE2-SARS.CoV-2</a> complexes, antibodies generated against spike proteins could harm normal cells in the presence of an incompetent immune system.</p>
<p><strong>Why are some developing complications, others are not?</strong></p>
<p>Following natural infection and vaccination, different types of antibodies produced by immune cells. Some of these could cross-react with the ACE2 receptor protein. Vitamin D is critical for the proper functioning of the immune system. Vitamin D deficiency weakens innate and adaptive responses and allows harmful hyper-inflammatory (<a href="https://www.verywellhealth.com/cytokine-storm-syndrome-4842383" target="_blank" rel="noopener">cytokine-storm</a>) responses.</p>
<p>Therefore, people with weakened immune systems have a higher risk of antigenic cross-reactivity, generating autoimmune reactions, and auto-antibodies formation, increasing the risks of complications from SARS.CoV-2 (e.g., cytokine-storm and deaths).</p>
<p>Inactivated viral vaccines are used less in Western nations, despite the advantages of generating broader immune responses against the nucleocapsid protein and the spike protein. In contrast, the mRNA and adenoviral vector vaccines present only a portion of the spike proteins antigen to the immune system.</p>
<p>Therefore, antibodies generated by mRNA vaccines have a narrow specificity, which could be a disadvantage in the long run.</p>
<p><strong>The efficacy of the groups of vaccines cannot be compared:</strong></p>
<p>The conditions and the timing of the vaccine trials conducted were vastly different. No head-to-head comparative RCTs performed to compare mRNA or adenovirus vector vaccines against traditional inactivated viral vaccines, whose safety is better understood.</p>
<p>Heavy promotion, particularly by big investors and governments, of mRNA and viral vector vaccines companies are driven by the patents-based, higher profits of novel mechanisms. Despite claims by companies, pundits, and mass media, the efficacy of mRNA and viral vector vaccines cannot be assumed to be superior to those of traditional inactivated virus vaccines.</p>
<p><strong>Vaccine RCTs conducted under differing conditions:</strong></p>
<p>Obtaining approval for the mRNA vaccines for RCTs and EUA were straightforward. These RCTs were conducted in the USA during the summer and fall of 2020, before the emergence of COVID-19 variants. A few of these variants evolved mutant spike proteins with much greater affinity for the ACE2 receptor to facilitate their entrance into our cells.</p>
<p>As the vaccination program expands, variants continue to evolve, including double (e.g., Indian variant) and multi-mutants to evade immunity. Mutations generate differing spike-proteins sequences (A) to overcome recognition by antibodies and killer cells, and (B) to increase the infectiousness. The risks of such mutations are higher following mRNA and viral vector vaccines.</p>
<p>mRNA vaccine trials during summer and fall involved people having higher average vitamin D concentrations with fewer severe symptoms. In contrast, the viral vector vaccines and inactivated viral vaccines took longer to obtain EUAs due to complexities requiring multiple approvals.</p>
<p>These RCTs mainly were conducted outside the USA during fall and winter, after the emergence of multiple variants and when COVID-19 prevalence rose again.</p>
<p><strong>Efficacy vs. adverse effects of vaccines:</strong></p>
<p>There is no question about the benefits of COVID-vaccines in adults. Given the different nature of the RCTs and rushed deployments, there is insufficient comparable data to conclude that one vaccine is more effective than another.</p>
<p>Besides, incomplete reports and analysis of adverse reactions are a concern, especially potential longer-term adverse effects. For those who have mild to moderate risk of harm from COVID-19, such as children, these poorly characterised risks must be considered more carefully in the context of limited individual benefits of vaccination.</p>
<p>Ill-effects of vaccines are the subject of ongoing research and controversy, and therefore, dialogue should be allowed with the freedom of speech. Instead, such discussions are suppressed and maligned: administrators remove posts from social media sites on the pretext of reducing public confidence in COVID-19 vaccines.</p>
<p>People should be provided facts: they have the right to know the pros and cons and make their own decision. In addition to <a href="https://ceylontoday.lk/print-more/56879" target="_blank" rel="noopener">vitamin D deficiency</a>, emerging data suggest ill-effects are specific to a particular vaccine group and, perhaps, underlying vulnerability and individual characteristics, such as sex and age.</p>
<p><strong>Uncertainties of vaccines and duration of effectiveness:</strong></p>
<p>Despite unfounded assertions by vaccine manufacturers and certain administrators in higher positions, claims of up to five-year duration of immunity after vaccination, are sheer speculation.</p>
<p>The duration of immunity from natural infection and COVID vaccines is uncertain. However, by extrapolating from the <a href="https://pubmed.ncbi.nlm.nih.gov/22536382/" target="_blank" rel="noopener">SARS experience, post-vaccination immunity</a> may last no more than 18 months, which will impede developing global herd immunity.</p>
<p><strong>Vitamin D sufficiency synergises vaccines benefits: </strong></p>
<p>The most beneficial aspect of vaccines and <a href="https://www.ipsnews.net/2021/05/high-dose-vitamin-d-supplements-significantly-reduce-icu-admissions-covid-19-deaths/" target="_blank" rel="noopener">vitamin D sufficiency</a> is preventing hospitalisation, complications needing oxygen and ICU use, and deaths. Therefore, as with vitamin D sufficiency, vaccinations should also prevent the post-COVID syndrome, also known as ‘long COVID,’ which is a misnomer.</p>
<p>Post-COVID-19 syndrome primarily arises in the central nervous system or other locations where the SARS-CoV-2 virus can escape from incomplete immune responses, especially in those <a href="http://C:\Users\Owner\OneDrive\Desktop\A lifeline to reduce COVID complications (msn.com)" target="_blank" rel="noopener">with severe vitamin D deficiency</a> and, thus, having a less robust immune system.</p>
<p>Vitamin D sufficiency prevents post-COVID syndrome. Whether vaccines prevent post-COVID-19 syndrome remains to be seen, but it is optimistic.</p>
<p><strong>*Sunil J. Wimalawansa, MD, PhD, MBA, DSc, <em>is Professor of Medicine, Endocrinology &amp; Nutrition, Director CardioMetabolic Institute, USA</em> <a href="mailto:suniljw@hotmail.com" target="_blank" rel="noopener">suniljw@hotmail.com</a> </strong></p>
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		<title>COVID-19 Vaccination: The Barriers to Achieving Global Herd Immunity</title>
		<link>https://www.ipsnews.net/2021/05/covid-19-vaccination-barriers-achieving-global-herd-immunity/</link>
		<comments>https://www.ipsnews.net/2021/05/covid-19-vaccination-barriers-achieving-global-herd-immunity/#comments</comments>
		<pubDate>Mon, 17 May 2021 07:12:58 +0000</pubDate>
		<dc:creator>Sunil J. Wimalawansa</dc:creator>
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		<description><![CDATA[<em>The writer is Professor of Medicine, Endocrinology &#038; Nutrition, Director CardioMetabolic Institute, USA</em>]]></description>
		
			<content:encoded><![CDATA[<p><font color="#999999"><img width="300" height="136" src="https://www.ipsnews.net/Library/2021/05/COVID-19-vaccinations_-300x136.jpg" class="attachment-medium size-medium wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.ipsnews.net/Library/2021/05/COVID-19-vaccinations_-300x136.jpg 300w, https://www.ipsnews.net/Library/2021/05/COVID-19-vaccinations_.jpg 624w" sizes="auto, (max-width: 300px) 100vw, 300px" /><p class="wp-caption-text">COVID-19 vaccinations are key to overcoming the pandemic, says the World Health Organizations (WHO). The UN agency has approved the Chinese Sinopharm vaccine for emergency use, which is a prerequisite for inclusion in the global vaccine solidarity initiative, <a href="https://www.who.int/initiatives/act-accelerator/covax" rel="noopener" target="_blank">COVAX</a>. Credit: Unsplash/Ivan Diaz via UN News</p></font></p><p>By Sunil J. Wimalawansa<br />NEW JERSEY, USA, May 17 2021 (IPS) </p><p>The global community is conducting a rapid vaccination program against the SARS.Cov-2 virus, using several vaccines, authorised for emergency use.  To date, the percentages of adults vaccinated <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html?s_cid=10504:when%20can%20i%20get%20covid%20vaccine:sem.ga:p:RG:GM:gen:PTN:FY21" rel="noopener" target="_blank">vary between less than 2% to over 90% in different countries</a>.<br />
<span id="more-171392"></span></p>
<p>Vast socio-economic variation is primarily responsible for this disparity.  Moreover, while the industrialised countries have secured more than adequate COVID vaccines, the middle- and low-income countries (MLIC) are significantly lagging.  </p>
<p>Globally, the vaccination rate is slowing down, scarcity in some countries and refusal in others.  At the current rate of vaccination, less than half of adults in MLIC countries will be vaccinated by the end of 2021.  </p>
<p>Therefore, the focus of WHO and MLIC countries must be directed to improving this grim situation.</p>
<p><strong>Concerns about achieving herd immunity </strong></p>
<p>The increasing virulence of new mutations (i.e., variants) of SARS-CoV-2 [i.e., <a href="https://www.researchgate.net/publication/343281558_What_Modelling_and_Reproduction_Numbers_are_Useful_in_Predicting_COVID-19_Spread" rel="noopener" target="_blank">increasing reproductive number</a> (R0)] increased R0 from original SARS.Cov-2higher infectivity, and the human behaviour, achieving a global herd immunity needs vaccinating approximately 85% of adults, in the absence of vaccinating children under 12 years.  </p>
<p>Considering that between <a href="https://www.npr.org/sections/health-shots/2021/04/07/984697573/vaccine-refusal-may-put-herd-immunity-at-risk-researchers-warn" rel="noopener" target="_blank">15 and 30% of adults and adolescents (and parents of younger children) are reluctant to be vaccinated</a>, and children up to 16 years are not approved for COVID vaccination in most countries, achieving herd immunity is impossible soon.   </p>
<p>On May 5th, the FDA and the CDC approved vaccination of children between 12 and 15 years in the USA.  However, vaccination of even 70% of children between 12 and 18 is insufficient for achieving herd immunity.  </p>
<p>Although millions of people have recovered from COVID infection, at the current rate, accomplishing herd immunity collectively from immunisation and post-infection immunity) is hard.</p>
<p>In addition, there are concerns about short-term and long-term ill-effects, known and unknown, and to what degree is vaccinating children justified given their generally low (in the absence of obesity and deficient vitamin D) probability of being seriously harmed or killed by COVID-19.  </p>
<p>Based on the availability of vaccines and the reasonable immune responses to defend against current and likely future variants, vaccination of adults and adolescents has become an ongoing process. </p>
<p><strong>Barriers to achieving herd immunity</strong></p>
<p>The collective effects of those mentioned above likely to prevent a sufficient percentage of people fully immunised within a given period to achieve and maintain herd immunity.  Failure will allow the virus to spread within and from country to country for years to come, as it disseminated across the world during the early part of the pandemic.  </p>
<p>It demonstrates the importance of honest and open collaborations of all counties, working coherently to achieve global herd immunity, enabling the elimination of SARS.Cov-2 from the world.  </p>
<p>Herd immunity cannot be achieved through vaccination and actual infection unless (A) pharmaceutical (vaccine) companies eliminate their greed, (B) revoke or share restrictive patents related to COVID vaccines and their production for a greater good, (C) provide adequate doses of <em>effective</em> vaccines free or at a discount for the MLICs, (D) motivate and incentivise those who are reluctant to get vaccinated, and (E) maintain wearing facemasks and avoiding mass gatherings for months to come.  </p>
<p>Even if the mentioned barriers are overcome, the inability to access, secure or purchase COVID-vaccines by most MLICs will prevent achieving herd immunity.  Despite vast propaganda, the World Health Organization (WHO), GAVI institute, and industrialised (G-20) countries seem not to pay attention to overcome these critical barriers promptly.  </p>
<p><strong>Vaccination of children</strong></p>
<p>The recently started <a href="https://www.cnbc.com/2021/04/30/biontech-expects-covid-vaccine-data-on-kids-ages-5-to-11-as-early-as-end-of-summer.html" rel="noopener" target="_blank">vaccine clinical trials in children between age 5 and 16 years</a> is expected to be completed <a href="https://www.cincinnati.com/story/news/2021/04/12/covid-19-vaccine-kids-young-5-possibly-late-summer-cincinnati-childrens/7187714002/" rel="noopener" target="_blank">by the end of summer/fall 2021</a>.  Assuming there are no complications or unexpected developments, COVID vaccines for children ages five upwards are likely to be approved towards the end of the year.  </p>
<p>Despite rhetoric by vaccine companies and certain administrators, the scenario could worsen because both the natural and vaccine-induced immunity fail to sustain for more than one year.  </p>
<p>Still, concerns remain about currently unknown longer-term ill-effects of vaccine and the degree to which these uncertainties can be justified, depending on the near-term likelihood of COVID-19 infection versus harm to a child.  </p>
<p>While clinical trials are ongoing in children, the wealthy countries should consider (A) waiving patents related to the COVID vaccine, (B ) postponing vaccination of children under 16 years, and (C) divert millions of doses of surplus vaccines and those ear-marked for younger children to MLIC countries immediately.</p>
<p><strong>The approval status of COVID vaccines</strong></p>
<p>COVID vaccines are currently using, via “emergency use authorisation” (EUA) by regulatory authorities, including the FDA.  EUA is required by federal law when the intended agent is not licensed and there is no effective treatment.  </p>
<p>However, this temporary approval status under the EUA for COVID-vaccines will be- or arguably should be-rescinded when alternative agents, such as <a href="https://vdmeta.com/" rel="noopener" target="_blank">vitamin D3</a>, <a href="https://www.ncbi.nlm.nih.gov/pubmed/33065103" rel="noopener" target="_blank">ivermectin</a>, etc., are approved for prevention or treatment of COVID.  </p>
<p>It is noteworthy that none of the COVID vaccines is licensed for the prevention or treatment of COVID.  Consequently, COVID-19 vaccine consent forms and promotional material mandated to indicate that <strong>vaccine has not been approved or licensed by the</strong> Federal Drug Administration (FDA) but authorised only for emergency use (see below).  </p>
<p>Moreover, <a href="https://www.americasfrontlinedoctors.org/legal-articles/federal-law-prohibits-mandating-investigational-vaccine" rel="noopener" target="_blank">federal law prohibits mandating investigational agents</a> (i.e., COVID vaccines) by states, employers, school administrators, etc.: i.e., <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" rel="noopener" target="_blank">medicines authorised under the EUA rule cannot be legally mandated</a>.  Thus, people have the right to refuse.  </p>
<p>While organisations and entities are encouraged to facilitate and provide vaccination to employees and students, the law prevents them from making vaccination compulsory.  While vaccination is likely to prevent complications and deaths, employee and students have the right to decline.  If the regulators, such as the FDA, eventually licensed vaccines, guidelines will change. </p>
<p><strong>Industry disclaimers associated with COVID vaccine</strong></p>
<p>The <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines" rel="noopener" target="_blank">US Federal government and the FDA have mandated</a> the inclusion of specific disclaimers by manufacturers and state governments on COVID-19 vaccines.  The following <a href="https://www.gov.uk/government/publications/covid-19-vaccination-consent-form-and-letter-for-adults" rel="noopener" target="_blank">statements appear in the consent forms informing the recipients prior to getting the vaccine</a> and advertisements.  </p>
<p>The disclaimer states, “I have informed that this COVID-19 vaccine is an unapproved drug permitted under an Emergency Use Authorisation from the FDA.  I have been informed of alternatives to receiving the COVID-19 vaccine and the risks and benefits of alternatives.  I have also been informed of the significant known and potential risks and benefits of this COVID-19 vaccine and the extent to which such risks and benefits are unknown.”  </p>
<p>Nevertheless, no one reads these small-print consent forms in detail since they are eager to get vaccinated.  The second half of the above disclaimer is not adhered to by the vast majority of vaccination staff, and most have no clue about it.  </p>
<p>Consequently, vaccination teams neither inform recipients of alternative options nor potential risks, benefits, or available alternatives to recipients to make an informed choice. </p>
<p><em>Contact information: Sunil J. Wimalawansa, MD, PhD, MBA, DSc:  s<a href="http://suniljw@hotmail.com"></a>uniljw@hotmail.com</em></p>
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		<p>Excerpt: </p><em>The writer is Professor of Medicine, Endocrinology &#038; Nutrition, Director CardioMetabolic Institute, USA</em>]]></content:encoded>
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		<title>High-Dose Vitamin D Supplements Significantly Reduce ICU Admissions &#038; COVID-19 Deaths</title>
		<link>https://www.ipsnews.net/2021/05/high-dose-vitamin-d-supplements-significantly-reduce-icu-admissions-covid-19-deaths/</link>
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		<pubDate>Thu, 06 May 2021 05:59:11 +0000</pubDate>
		<dc:creator>Sunil J. Wimalawansa</dc:creator>
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		<description><![CDATA[<em>The writer* is Professor of Medicine, Endocrinology &#038; Nutrition, Director CardioMetabolic Institute, USA</em>]]></description>
		
			<content:encoded><![CDATA[<p><font color="#999999"><img width="300" height="169" src="https://www.ipsnews.net/Library/2021/05/High-Dose-Vitamin_-300x169.jpg" class="attachment-medium size-medium wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.ipsnews.net/Library/2021/05/High-Dose-Vitamin_-300x169.jpg 300w, https://www.ipsnews.net/Library/2021/05/High-Dose-Vitamin_.jpg 624w" sizes="auto, (max-width: 300px) 100vw, 300px" /><p class="wp-caption-text">UN Secretary-General António Guterres (right) speaks with Yeashea Braddock, Operations Manager at the Morris High School vaccination site, after getting his second vaccine shot against COVID-19 at that High School in the Bronx, New York. Credit: UN Photo/Eskinder Debebe</p></font></p><p>By Sunil J. Wimalawansa<br />NEW JERSEY, USA, May 6 2021 (IPS) </p><p>There is considerable evidence that vitamin D reduces the risk and severity of COVID-19 (<a href="https://www.mdpi.com/2072-6643/12/11/3361" target="_blank" rel="noopener">Mercola 2020</a> ; <a href="https://doi.org/10.36811/ojprm.32020.110010" target="_blank" rel="noopener">Wimalawansa, 2020</a>). More than 50 clinical studies have published confirming that high doses of vitamin D administered early in persons with COVID-19 significantly reduce complications and the need for ICU admissions.<br />
<span id="more-171276"></span></p>
<p>Additionally, five randomised controlled clinical trials (RCTs) were published using high-dose vitamin D in COVID-19 patients, and over 20 other large RCTs are ongoing. To obtain benefits, however, doses high enough must be administered early in the disease.</p>
<p>Among others, few examples of countries where these RCTs conducted were Brazil (<a href="https://jamanetwork.com/journals/jama/article-abstract/2776738" target="_blank" rel="noopener">Murai et al, 2021</a>), India (<a href="https://pmj.bmj.com/content/early/2020/11/12/postgradmedj-2020-139065" target="_blank" rel="noopener">Rastogi, et al, 2020</a> ; <a href="https://www.researchsquare.com/article/rs-152494/latest.pdf" target="_blank" rel="noopener">Lakkireddy, 2021</a>), and Spain (<a href="https://www.sciencedirect.com/science/article/abs/pii/S0960076020302764/" target="_blank" rel="noopener">Castillo, et al, 2020</a> ; <a href="http://dx.doi.org/10.2139/ssrn.3771318" target="_blank" rel="noopener">Nogués et al, 2021</a>). The vitamin D3 doses used were between 130,000 IU to 300,000 IU or the equivalent of 25-hydroxyvitamin D [25(OH)D, also known as calcifediol] as used by <a href="https://www.sciencedirect.com/science/article/abs/pii/S0960076020302764/" target="_blank" rel="noopener">Castillo et al</a>. in Spain.</p>
<p>As shown in the meta-analysis, figures 1 and 2, at <a href="https://vdmeta.com" target="_blank" rel="noopener">https://vdmeta.com</a>, even with slightly less optimal doses of calcifediol resulted in over 50% (95% confidence interval, 14 to 71%) reduction in severe adverse outcomes by preventing the development of cytokine storm and death.</p>
<p>The effect of early treatment with high-dose vitamin D in persons with COVID-19 illustrated in Figure 1 (adapted from <a href="https://vdmeta.com" target="_blank" rel="noopener">https://vdmeta.com</a>).</p>
<p><img loading="lazy" decoding="async" class="alignleft size-full wp-image-171277" src="https://www.ipsnews.net/Library/2021/05/vitamin-D.jpg" alt="" width="624" height="221" srcset="https://www.ipsnews.net/Library/2021/05/vitamin-D.jpg 624w, https://www.ipsnews.net/Library/2021/05/vitamin-D-300x106.jpg 300w" sizes="auto, (max-width: 624px) 100vw, 624px" /></p>
<p>There are no adverse effects of high-dose vitamin D3 supplementation of up to 600,000 IU administered as single or divided doses. Also, long-term supplementation of 50,000 IU/day vitamin D3 have not reported adverse effects (<a href="https://www.sciencedirect.com/science/article/abs/pii/S0960076018306228" target="_blank" rel="noopener">McCullough, et al, 2019</a>).</p>
<p>An example of cost-effectiveness of treating persons with “Symptomatic” COVID-19, using high dose vitamin D.</p>
<div id="attachment_171278" style="width: 634px" class="wp-caption alignleft"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-171278" class="size-full wp-image-171278" src="https://www.ipsnews.net/Library/2021/05/who_.jpg" alt="" width="624" height="247" srcset="https://www.ipsnews.net/Library/2021/05/who_.jpg 624w, https://www.ipsnews.net/Library/2021/05/who_-300x119.jpg 300w" sizes="auto, (max-width: 624px) 100vw, 624px" /><p id="caption-attachment-171278" class="wp-caption-text">Credit: World Health Organization (WHO)</p></div>
<p>In examples below, the expected death rates is adjustable with 75% reduction following vitamin D; so as the cost of vitamin D per patient:</p>
<ul>&#8211; Admissions or transfers of symptomatic COVID patients to a hospital: n=2,000<br />
&#8211; Administer 200,000 IU dose to 1,000 and a placebo to 1,000 (i.e., every other person)<br />
&#8211; Expected death rate without vitamin D: 8%; i.e., 80 people die out of 1,000<br />
&#8211; Expected death rate with vitamin D, “4-times” less, 2%; 20 people die out of 1,000<br />
&#8211; 60 fewer deaths for 1,000 symptomatic COVID persons treated with vitamin D<br />
&#8211; Assume, one dose cost, $1.00: So, 1,000 persons cost, $1,000<br />
&#8211; So, 60 fewer deaths in 1,000 patients: to save 60 lives, cost $1,000<br />
&#8211; Approximate cost per life saved = $16.60</ul>
<p><strong>Conclusion</strong></p>
<p>Vitamin D, 200,000 IU dose in single or divided doses is safe and highly cost-effective in reducing complications and deaths in persons with SARS-CoV-2 infection. Early use of vitamin D (100,000 to 600,000 IU) can reduce ICU admissions by ~80%. Therefore, vitamin D can greatly reduce the need for expanding ICU beds AND cost less than 0.001% of using an ICU bed/day.</p>
<p><strong>Additional information regarding bolus D3 and oral calcifediol:</strong></p>
<p>There is little vitamin D3 (cholecalciferol) in food and multivitamins, including fortified food. Without passing through glass or sunscreen, skin exposure to ultraviolet-B from high-elevation sunlight can produce sufficient D3 for bone and immune system health.</p>
<p>However, low elevation sunlight in winter, clouds, pollution, clothing cover, melanin-rich skin and concerns about skin cancer mean that most people are vitamin D deficient <a href="https://vitamindwiki.com/" target="_blank" rel="noopener">unless they take vitamin D supplements</a>.</p>
<p>Conversion of D3 in the liver to the circulating form, 25(OH)D, and for the immune cells to function takes two to five days. 25(OH)D is measured in the blood test and has a half-life of ~three weeks. Recent research shows that the immune system requires at least 40 ng/ml (100 nmol/L) circulating 25(OH)D to support autocrine (inside each cell) and paracrine (to nearby cells) signalling. Please refer to the research articles at: <a href="https://vitamindstopscovid.info/02-autocrine/" target="_blank" rel="noopener">https://vitamindstopscovid.info/02-autocrine/</a>.</p>
<p>In the long term, such levels can be attained, on average for 70 kg adults, with 0.125 mg (5,000 IU) D3 per day. This is 72 IU per kg body weight per day and 100 IU/kg for people suffering from obesity due to fat absorption of 25(OH)D.</p>
<p>The link to research articles cited follows: <a href="https://vitamindstopscovid.info/01-supp/" target="_blank" rel="noopener">https://vitamindstopscovid.info/01-supp/</a>.</p>
<p>Since most people-and almost all who are at risk of severe COVID-19 symptoms-have circulating 25(OH)D levels much lower than 40 ng/mL, such as between 5 and 25 ng/mL, their D3 supplementation should begin at 5 to 10 times the <a href="https://vitamind4all.org/letter.html" target="_blank" rel="noopener">long-term quantity of 4,000 IU/day</a> needed, in order to attain and maintain the required blood 25(OH)D levels rapidly.</p>
<p>While vaccines markedly reduce the severity of and deaths from COVID-19, <a href="https://vitamind4all.org/letter.html" target="_blank" rel="noopener">vitamin D cost less than 1% of a COVID vaccine</a>.</p>
<p>As reported in several studies, most hospitalised patients with COVID-19 can be assumed to be vitamin D deficient. Their health and survival depend mainly on raising their 25(OH)D levels to at least 40 ng/ml, ideally within hours, rather than days or weeks.</p>
<p>Some of the trials mentioned above attempted to do this with bolus D3 doses, except that in the <a href="https://jamanetwork.com/journals/jama/article-abstract/2776738" target="_blank" rel="noopener">Murai et al</a>. trial, given too little treatment, too late (i.e., faulty study design).</p>
<p>The urgency of 25(OH) D repletion is acute for all those suffering from, or at risk of, hyper-inflammatory immune dysregulation (i.e., cytokine storm), which causes severe COVID-19 and death.</p>
<p>The primary mechanism of this recently elucidated by <a href="https://www.biorxiv.org/content/10.1101/2020.07.18.210161v1" target="_blank" rel="noopener">McGregor, et al, 2020</a>-Th1 regulatory lymphocytes remain stuck in their initial pro-inflammatory program and fail to switch to their anti-inflammatory shutdown program due solely to lack of 25(OH)D.</p>
<p>This explains the extraordinary success of trial by <a href="https://www.sciencedirect.com/science/article/abs/pii/S0960076020302764/" target="_blank" rel="noopener">Castillo et al</a>., in which patients were given 0.532 mg oral calcifediol, which raises circulating 25(OH)D levels to about 50 ng/ml in four hours (<a href="https://patents.google.com/patent/WO2016124724A1" target="_blank" rel="noopener">Sune Negre, 2016</a>).</p>
<p>This resulted in the reduction of ICU admissions by 90% (from 50% to 2%) and deaths from 8% to zero. The earlier the treatment is given, the better the clinical outcomes are.</p>
<p>Calcifediol has been hard to obtain but is now available in the USA and Canada without prescription: <a href="https://dvelopimmunity.com" target="_blank" rel="noopener">https://dvelopimmunity.com</a>. Sixty 20 microgram tablets for $30 contain 1.2 mg calcifediol-more than twice the single initial dose used by Castillo et al.</p>
<p>In that trial, 0.266 mg calcifediol was also given on days 3, 7, 14, etc. However, maintenance of the initial boost to 25(OH)D can most easily be achieved with 5,000 to 10,000 IU D3 per day.</p>
<p>We have urged governments of Sri Lanka and India, in particular, to seriously consider obtaining calcifediol tablets to prevent severe complications, ICU admissions, and deaths from COVID-19, which is highly cost-effective.</p>
<p><em>Contact information: *Sunil J. Wimalawansa, MD, PhD, MBA, DSc<br />
<a href="mailto:suniljw@hotmail.com" target="_blank" rel="noopener">suniljw@hotmail.com</a></em></p>
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		<p>Excerpt: </p><em>The writer* is Professor of Medicine, Endocrinology &#038; Nutrition, Director CardioMetabolic Institute, USA</em>]]></content:encoded>
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		<title>State of COVID-19 in Sri Lanka: Are Government Policies Effective in Controlling it?</title>
		<link>https://www.ipsnews.net/2021/04/state-covid-19-sri-lanka-government-policies-effective-controlling/</link>
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		<pubDate>Wed, 28 Apr 2021 07:02:46 +0000</pubDate>
		<dc:creator>Sunil J. Wimalawansa</dc:creator>
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		<description><![CDATA[<em>The writer is Professor of Medicine, Director, Cardio-Metabolic Institute, New Jersey, U.S.A. </em>]]></description>
		
			<content:encoded><![CDATA[<p><font color="#999999"><img width="300" height="223" src="https://www.ipsnews.net/Library/2021/04/COVID-19-in-Sri-Lanka_-300x223.jpg" class="attachment-medium size-medium wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.ipsnews.net/Library/2021/04/COVID-19-in-Sri-Lanka_-300x223.jpg 300w, https://www.ipsnews.net/Library/2021/04/COVID-19-in-Sri-Lanka_-200x149.jpg 200w, https://www.ipsnews.net/Library/2021/04/COVID-19-in-Sri-Lanka_.jpg 424w" sizes="auto, (max-width: 300px) 100vw, 300px" /></font></p><p>By Sunil J. Wimalawansa<br />NEW JERSEY, Apr 28 2021 (IPS) </p><p>The SARS-CoV-2 infection (COVID-19) affected the entire world; many died, millions got sick, and the misery continues. Second and third waves of SARS.Cov-2 infection are devastating most countries.<br />
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<p>Non-strategic lockdowns and curfews (as in Sri Lanka) further aggravated the peoples’ misery, sufferings, daily lives, and economies, more than that from the virus. The toxic combination of COVID-19 and curfews devastated local productions and supply chains, livelihoods, people welfare, food security, and the county’s economy.</p>
<p>Many viral diseases can control using natural and non-pharmacological approaches, adhering to public health standards, personal hygiene, and maintaining health: COVID-19 is not an exemption.</p>
<p>SARS.Cov-2 viruses enter humans mainly through the respiratory tract epithelial, causing predominantly immunological (cytokine storm), cardiovascular (clots), and multiple endocrinological abnormalities.</p>
<p>In some, the combined effects can be deadly. In addition to supportive therapies, preventing clots, cytokine storms, and providing oxygen, treatments should be geared to prevent complications in the mentioned systems.</p>
<p>Approximately a quarter of persons who develop complications develop an intractable “post-COVID syndrome.” This protracted disease mainly arises from the longer-term adverse effects in the central nervous system (mainly the brain) and must be prevented.</p>
<p>The combination of strengthening the innate immune system with nutrient vitamin D and vaccination significantly reduces this serious complication following COVID-19.</p>
<p><strong>Governmental actions to control COVID-19 </strong></p>
<p>Sri Lanka’s President delegated full responsibility of COVID control to a handful of people and made government funds available. Nevertheless, the lack of systems thinking, focus, practical strategies, and misinterpretations of data preclude proper control of COVID-19 that led to a countrywide community spread, from May 2020.</p>
<p>Moreover, weak leadership and egotism led to improper and vague policies jeopardising the economy, people, and the country. Ineffective and harmful policies (some originated from WHO and CDC) led to contradictions, confusion and collectively eroded public trust. The lack of transparency and accountability of the government and its administrators further compromised COVID control.</p>
<div id="attachment_171173" style="width: 634px" class="wp-caption alignleft"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-171173" class="size-full wp-image-171173" src="https://www.ipsnews.net/Library/2021/04/World-Health-Organization_22.jpg" alt="" width="624" height="247" srcset="https://www.ipsnews.net/Library/2021/04/World-Health-Organization_22.jpg 624w, https://www.ipsnews.net/Library/2021/04/World-Health-Organization_22-300x119.jpg 300w" sizes="auto, (max-width: 624px) 100vw, 624px" /><p id="caption-attachment-171173" class="wp-caption-text">The World Health Organization (WHO) is working closely with global experts, governments and partners to rapidly expand scientific knowledge on this new virus, to track the spread and virulence of the virus, and to provide advice to countries and individuals on measures to protect health and prevent the spread of this outbreak.</p></div>
<p>The lack of vision and practical strategies, inexperience in managing epidemics, and the refusal to consult experts with managing epidemics led to creating flawed policies that hurt the economy.</p>
<p>Despite the hard work of healthcare workers and other frontline personnel, the second wave of COVID began in August 2020; within weeks, it got out of control. In June 2020, the author predicted the impending second wave in August and the third wave in April 2021.</p>
<p>The inability to comprehend the viruses’ biology, failure to adjust an effective (living)strategy to control the spread, and failure to use acceptable means to enhance natural immunity, prevented successful control of the epidemic.</p>
<p>Besides misinterpreting statistics and consequently enforcing island-wide curfew inappropriately, refusing community PCR testing, and preventing conducting crucial prevention and treatment randomised controlled clinical studies, and the failure to incorporate emerging scientific data for better management of COVID-19 were few lost opportunities for Sri Lanka.</p>
<p><strong>What should have been done</strong></p>
<p>Conducting broader preventative actions, including prioritising humane “home” quarantining and local production of high-quality, reliable PCR kits, would have markedly reduced the government’s economic burden and peoples suffering.</p>
<p>The government had plenty of time to prevent hospitals and the healthcare sector burden. For example, increasing the populations’ innate immunity could have achieved through safe sun exposure advice and vitamin D supplementation. These would have prevented COVID-19-associated complications and deaths.</p>
<p>There was no rationale for military-style, forced quarantining of people. Those exposed to a person infected with COVID-19 and PCR positive asymptomatic persons could have better and cost-effectively managed in their homes, with oversights from the medical officer of health and public health inspectors.</p>
<p>Such simple measures would have improved the safety and well-being of people and markedly reduce government costs. Collectively, these approaches would have cost less than 10% of what the government spent (and continue to spend) on COVID-19 and associated significant opportunity costs.</p>
<p>Community spreads could have prevented through geographically limited lockdowns not exceeding two weeks while supplying essentials to the local community. Shutting down entire districts or the country was a colossal mistake. Consequently, small businesses and self-employed and daily wage-earners accounting for two-thirds of adults in Sri Lanka were worst affected.</p>
<p><strong>Pitfalls of managing COVID-19 in Sri Lanka</strong></p>
<p>Public trust and cooperation are essential in successfully managing an epidemic or any severe crisis. The loss of trust was detrimental for the governance, especially the belief that neither the administration nor law enforcement has genuine interests or intentions to control the COVID-19 epidemic and protect the public. These concepts entrenched following turning the COVID misery into a profitable business.</p>
<p>Ironically, the decision-makers who enforced draconian restrictions had all supplies for themselves and full salaries. Simultaneously, the lower-middle-class and the poor, two-thirds of the country, suffered the most.</p>
<p>Besides, inappropriate curfew also interrupted local travel and businesses, tourism, air travel, hotel industry, import and export trade, and all supply chains, causing significant food insecurity and financial burdens on over 80% of the population. It will take years to recover from the harmful effects of COVID, amplified by poor administrative decisions.</p>
<p>The lack of candour and commercialisation of COVID-19 is understandably worrisome for the local public, expatriates, and the international community. Boosting the supply-chain-related businesses by respective administrations during the LTTE war and COVID-19 are remarkably similar: achieved at the public expense. In both cases, a handful of the same set of companies allied with the government became rich.</p>
<p>Moreover, faulty actions in 2020 significantly increased poverty and malnutrition, worsen existing medical disorders, the disease burden, suicides and excess premature deaths, and increase healthcare costs.</p>
<p>Instead of strengthening the power base, militarisation, and environmental destruction, the government should focus on disease prevention, improving education and health, supply chain, exports, national security, re-establish law and order and freedom of speech, increase food security, and lower the cost of living. These would facilitate getting the country back on track for prosperity.</p>
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		<p>Excerpt: </p><em>The writer is Professor of Medicine, Director, Cardio-Metabolic Institute, New Jersey, U.S.A. </em>]]></content:encoded>
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