Chief Stipe

Anyone spot the hypocrisy?

Perhaps the first thing the could do is improve the grammar of the person writing for the website!!

Perhaps the first thing the could do is improve the grammar of the person writing for the website!!

Why don't they fix the real problems that they actually have some control over that directly affect the wellbeing of stakeholders!!!! Instead they presumably more money on hiring someone and setting up a new website and facebook page!!!!

Why vaccinate them if they are not at risk from Covid-19? Especially when the medium to long term risk to children is unknown. The latest data shows that for children there is more risk from the vaccination than Covid-19.

So instead of changing the things that are making people leave they are going to help people feel better appreciated and supported. No no no we won't look at programming or apprentice training and retention or improving work conditions for stakeholders........ No no no we'll build 3 new AWT's and they will feel much better and the financial rewards will just come.

In what way? Do you want me to pass your details on?

Racing industry launches wellbeing campaign NZTR, HRNZ, GRNZ 27 September 2021 Coinciding with the start of Mental Health Awareness Week, a personal wellbeing campaign to make racing better for everyone, launches today. The #whenracingwins campaign is about making improvements in the working environment for everyone in Thoroughbred, harness and greyhound racing, whether jockeys, drivers, trainers, stablehands or other employees. “It’s not about rules or sweeping policy changes, this campaign is built around achievable everyday moments that make racing a better environment in which to work” said Greyhound Racing NZ’s Michael Dore. Among the areas of focus are to minimise workplace stress, harassment in various forms, abuse of alcohol or drugs, ensuring the racing community treats everyone with respect, and supporting and encouraging people who need help to speak up. Studies have shown that upwards of two-thirds of participants in racing believe there is a need for change. “Various stresses or negative incidents they face can impact on people’s wellbeing, and we risk losing really good participants from racing to other careers where they feel better appreciated and supported. By being mindful of others and treating people with respect the whole industry can benefit. It’s an important issue, that all three racing Codes recognise and are supporting” said Martin Burns of NZ Thoroughbred Racing. The campaign has the support of a range of participants who have spoken their thoughts in video clips that will be shared in social media and, will have its own website whenracingwins.nz, as well as a presence on Facebook. "That message of harden up might make tough people but it is not sustainable. We aim to raise awareness and discussion of these issues within the racing community – and provide a clear pathway to report and support, for those who need it. The push for better standards, and better wellbeing needs to come from people at all levels within the industry” said Salvation Army's Racing Chaplin Andrew McKerrow who features in the campaign's videos. The campaign starts today and will supported by the Codes and the Salvation Army on an ongoing basis. Social media will raise awareness of issues and allow people to share their stories or find assistance. The website also provides information and avenues for those wanting help. Posters reinforcing the campaign’s messages will also be displayed at racecourses around the country. “It’s appropriate that we are launching during mental Health Awareness Week, but we want this campaign to involve all aspects of wellness – the goal is to make racing a better workplace and industry for everyone, whether you are a big-time owner or a stablehand just starting out”, said Harness Racing NZ’s Natalie Gameson.

Alysha Collett ready to join the A-grade ranks Alysha Collett is riding in the big smoke on Epsom day. Photo: Trish Dunell. By Clinton Payne 04:59pm • 26 September 2021 0 In-form jockey Alysha Collett is joining up with Sydney’s best jockeys and will ride at Randwick on Epsom Handicap day next Saturday. Collett has been the star quality of the non-Greater Sydney jockey region this season having already booted home 25 winners. Only Australia’s best jockey James McDonald has ridden more winners in NSW this season with 34. Collett, the sister of established Sydney rider Jason, has landed two rides in the Epsom Handicap and The Metropolitan for Chris Waller. The Waller-trained horses Collett will ride in the feature Group 1s remain unknown but will be lightweight chances. “After next Saturday I’m going to have a crack at staying in Sydney,” Collett said. “I can ride light which is a positive at this time of the year. “I might even get lucky and things open back up in the not too distant future. “I’ll just take it week by week and see how things go. “I can ride 52, 53 kilos, week in week out.” Alysha Collett will be aboard Chris Waller-trained gallopers in Group 1 races at Randwick next week. Photo: Mark Evans–Getty Images. Collett has been back in Australia since autumn in 2020 when she left Singapore when the Asian racing centre shut down racing due to Covid. The Group 1-winning Kiwi struggled for winners when she returned to Australia but this year the momentum started to build and in recent times she has become the go-to jockey in her region. Her 25 winners have come at better than 16.5 per cent with 12 of this season’s winners for the powerful Peter and Paul Snowden operation. “It took me a while to settle back into things since I got back from Singapore,” Collett said. “I hadn’t ridden for about a year and a half due to a back injury and the style of racing is very different. “Looking back, it took me longer than I expected to condition my body and it’s much more tactical the racing here. “Over in Singapore they tend to jump and run whereas here every race is run differently so you have to be very switched on. “That’s something I’ve really focused on in the past six months as well as some gym work and it all seems to be paying dividends.” Collett is managed by Shaun Flaherty who can be contacted on 0410 996 817.

The Melbourne and Sydney Cups will be the only 3200-metre Group 1 races in Australasia next year with the New Zealand Pattern Committee downgrading the Auckland Cup. The Auckland Cup was one of three races downgraded upon review of New Zealand's pattern following the 2020/21 season. The Auckland Cup will carry Group 2 status, maintain prizemoney of NZ$500,000 but return to handicap conditions rather than set weights and penalties as per recent years to attract higher quality stayers. Last season's Auckland Cup was won by Ocean Billy ahead of Our Charles Road, Sound and Platinum Invador – the latter trio all boasting experience in Australian stakes company. Other races downgraded were the Easter Handicap (1600m) from Group 2 to Group 3 and the Rotorua Cup (2200m) from Group 3 to Listed. New Zealand held 150 stakes races last season with 56 races not meeting the minimum race rating expectations to retain status. Stakes races that don't achieve the minimum race rating over three consecutive seasons are eligible for downgrade. New Zealand's Group 1 races are a point of concern, with just four of the 21 races not reaching the minimum mark, including all seven two and three-year-old Group 1s. Consequently, first warnings otherwise known as 'Alerts' have been placed against six Group 1s including cherished age-restricted races such as New Zealand Derby, NZ 1000 Guineas, NZ 2000 Guineas, Levin Classic and Manawatu Sires' Produce. Race ratings are gained by averaging the first four placegetters, using their peak performance during the season according to World Best Racehorse Rankings (WBRR). The New Zealand Pattern Committee (NZPC) may also choose to consider the average rating of the four highest rated starters in the race if it considers circumstances appropriate. The NZPC believes the current ratings based assessment is disadvantaging how local two and three-year-old races are treated. "The NZPC continues to have a degree of concern with the WBRR ratings assigned to some New Zealand two-year-old and three-year-old races," read the report of the NZPC. "As a starting point, these ratings tend to be at the bottom end of global norms unless the horses perform well overseas in the same season. Further, many NZ horses are exported following their 3yo season and at times achieve markedly higher ratings as older horses. "This is problematic in that the rating does not carry back through ratings of races that the horses contested in their earlier careers in NZ. Statistical evidence lends some support to this being an issue and it will continue to be pursued." The findings in New Zealand sparks further intrigue on the health of Australia's stakes races with several high prizemoney, non-black type races such as the Everest, Golden Eagle and All-Star Mile introduced in recent years.

This is from the TGA in Australia!! What the hell is "generally" and "limited" doing in a safety assessment document? TGA-Australia-Safety-Assessment-Pzifer-vaccine-foi-2389-06.pdf

I can't find any study or trial data on the two lipids included in the vaccine namely ALC-0315 and ALC-0159. The UK refers to a study which doesn't seem to exist. The study number it references is actually the main Pzifer trial of the complete vaccine. There is no mention in the latter of the two lipids. https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

The EMA covid-19 data leak, and what it tells us about mRNA instability BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n627 (Published 10 March 2021)Cite this as: BMJ 2021;372:n627 Read our latest coverage of the coronavirus outbreak Article Related content Metrics Responses Serena Tinari, journalist Author affiliations serena.tinari@re-check.ch Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.1 More than 40 megabytes of classified information from the agency’s review were published on the dark web, and several journalists—including from The BMJ—and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed. The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said. Ultimately, on 21 December, EMA authorised Pfizer-BioNTech’s vaccine. The agency’s public assessment report, a technical document published on its website, noted, “the quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”2 It’s unclear how the agency’s concerns were satisfied. According to one of the leaked emails dated 25 November, positive news had come from an undisclosed source in the US: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue,” the email said. A near miss? It’s also unclear whether the events in November constitute a near miss in the commercial manufacturing of mRNA vaccines. EMA says the leaked information was partially doctored, explaining in a statement that “whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created, and additional titles were added by the perpetrators.”3 But the documents offer the broader medical community a chance to reflect on the complexities of quality assurance for novel mRNA vaccines, which include everything from the quantification and integrity of mRNA and carrier lipids to measuring the distribution of particle sizes and encapsulation efficiency. Of particular concern is RNA instability, one of the most important variables relevant to all mRNA vaccines that has thus far received scant attention in the clinical community. It is an issue relevant not just to Pfizer-BioNTech’s vaccine but also to those produced by Moderna, CureVac, and others,4 as well as a “second generation” mRNA vaccine being pursued by Imperial College London.5 RNA instability is one of the biggest hurdles for researchers developing nucleic acid based vaccines. It is the primary reason for the technology’s stringent cold chain requirements and has been addressed by encapsulating the mRNA in lipid nanoparticles (box). “The complete, intact mRNA molecule is essential to its potency as a vaccine,” professor of biopharmaceutics Daan J.A. Crommelin and colleagues wrote in a review article in The Journal of Pharmaceutical Sciences late last year. “Even a minor degradation reaction, anywhere along a mRNA strand, can severely slow or stop proper translation performance of that strand and thus result in the incomplete expression of the target antigen.”6 Crommelin and colleagues note that specific regulatory guidance for mRNA based vaccines has yet to be developed, and The BMJ’s attempts to clarify current standards were unsuccessful. Transparency and confidentiality The BMJ asked Pfizer, Moderna, and CureVac, as well as several regulators, what percentage mRNA integrity they consider acceptable for vaccines against covid-19. None offered any specifics. The Medicines and Healthcare products Regulatory Agency, the UK’s medicines regulator, acknowledged the lack of a specified percentage RNA integrity, but declined to provide further detail. “The specification limit acceptance criteria are commercially confidential,” the agency said in an email. The US Food and Drug Administration (FDA) directed The BMJ to read its guidance documents78 and its review of Pfizer’s vaccine,9 but none of these specify the percentage RNA the agency is requiring. Asked to comment, the regulator pointed to Pfizer: “information that you seek that is not addressed in the FDA Review Memorandum should be directed to Pfizer.” In subsequent correspondence, FDA, EMA, and Canadian government department Health Canada all stated that specific information related to the acceptability criteria is confidential. EMA did acknowledge, however, that vaccine efficacy depends on the presence of suitable amounts of intact mRNA. In the case of the commercial batches that first raised alarm bells, the agency told The BMJ that the levels of truncated mRNA “and the amounts of a potential protein produced by the truncated mRNA would be too low to constitute a safety risk.” EMA did not comment on how truncated mRNA might affect efficacy. The issue was satisfactorily addressed, the agency underlined, when further information was supplied by the manufacturer. Health Canada told The BMJ that Pfizer had conducted investigations into the root cause of reduced integrity in the commercial vaccine batches, and “changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches.” Health Canada said the three agencies subsequently determined that “there was no concern with the RNA integrity or any other product specifications.” Correspondence in the leaked documents suggests that FDA, Health Canada, and EMA were aligned on clinically qualified specifications of percentage mRNA integrity. Health Canada has confirmed to The BMJ that regulators “have worked together to align those requirements,” but all agencies declined to share with The BMJ any specifics on grounds that such information was commercially sensitive. Pfizer also declined to comment on what percentage mRNA integrity it is aiming for, nor would it address questions about the cause of the unexpectedly low percentage mRNA integrity in certain batches, leaving open the question of whether it could happen again. Pfizer stressed: “Each batch of vaccines is tested by the official medicinal control laboratory—the Paul Ehrlich Institute in Germany—before final product release. As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities.” Moderna’s chief corporate affairs officer Ray Jordan declined to respond to any of The BMJ’s questions, stating: “At this point, Moderna will not be offering additional commentary on these topics.” CureVac, whose mRNA vaccine was submitted for EMA’s “rolling review” in February,10 told The BMJ that “it is too soon to give details.” The shortage of information may reflect the lack of certainty, even among regulators, about how to assess the evidence fully for this novel technology. Professor Crommelin told The BMJ that, “For small, low molecular weight products, the active pharmaceutical ingredient integrity is typically close to 100%.” But for mRNA vaccines? “Experience with mRNA integrity is limited.” Lipid nanoparticles—where do they go and what do they do? Conceived three decades ago, RNA based therapeutics11 have long inspired imaginations for their theoretical potential to transform cells of the body into “an on-demand drug factory.”12 But despite heavy investment by the biotech industry, bench-to-bedside translation was constantly hindered by the fragility of mRNA. Over the years, researchers attempted to resolve intrinsic instability by encapsulating mRNA in nanocarriers made of polymers, lipids, or inorganic materials. Lipid nanoparticles (LNPs) were chosen by Moderna, Pfizer-BioNTech, CureVac, and Imperial College London for their covid-19 vaccines. This has attracted the attention of specialists in the field of pharmaceutical biotechnology, some of whom have raised concerns about further unknowns. In a rapid response posted on bmj.com, JW Ulm, a gene therapy specialist who has published on tissue targeting of therapeutic vectors,13 raised concerns about the biodistribution of LNPs: “At present, relatively little has been reported on the tissue localisation of the LNPs used to encase the SARS-CoV-2 spike protein-encoding messenger RNA, and it is vital to have more specific information on precisely where the liposomal nanoparticles are going after injection.”14 It is an unknown that Ulm worries could have implications for vaccine safety. Ulm told The BMJ: “Pfizer-BioNTech and Moderna did a remarkable job of rapidly scaling up manufacturing of such a novel system in swift fashion, which is genuinely a landmark technological achievement. However, pharmacokinetic studies, with independent laboratory confirmation, are essential to ascertain potential cytotoxicity and macroscopic toxicity, especially given the likelihood of booster injections over months or years, since the tissue trafficking patterns of the mRNA vaccine payload will determine which cells and tissues are killed by cytotoxic T-cells in each round.” Given the variation in LNP formulations, it is unclear how relevant previous animal experiments are to answering this question. Regulators and manufacturers contacted by The BMJ for this article did not wish to address any of the questions raised by Ulm’s rapid response. Footnotes Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare. Provenance and peer review: commissioned; externally peer reviewed This article is made freely available for use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. https://bmj.com/coronavirus/usage References ↵ European Medicines Agency. Cyberattack on the European Medicines Agency (press release). 2020. https://www.ema.europa.eu/en/news/cyberattack-european-medicines-agency ↵ European Medicines Agency. European public assessment report (EPAR) 2020. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf ↵ European Medicines Agency. Cyberattack on EMA—update 6. (press release). 2021. https://www.ema.europa.eu/en/news/cyberattack-ema-update-6 ↵ World Health Organization. The covid-19 candidate vaccine landscape. 2021. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines ↵ Cormier Z. The second-generation covid vaccines are coming. Scientific American 2021. https://www.scientificamerican.com/article/the-second-generation-covid-vaccines-are-coming/ ↵ Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E . Addressing the cold reality of mRNA vaccine stability. J Pharm Sci2021;110:997-1001. doi:10.1016/j.xphs.2020.12.006 pmid:33321139 CrossRefPubMedGoogle Scholar ↵ US Food and Drug Administration. Development and licensure of vaccines to prevent covid-19/Guidance for industry. 2020. https://www.fda.gov/media/139638/download ↵ US Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19/Guidance for Industry. 2021. https://www.fda.gov/media/142749/download ↵ US Food and Drug Administration. Emergency use authorization (EUA) for an unapproved product review memorandum. 2020. https://www.fda.gov/media/144416/download ↵ European Medicines Agency. EMA starts rolling review of CureVac’s covid-19 vaccine (CVnCoV) (press release). 2021. https://www.ema.europa.eu/en/news/ema-starts-rolling-review-curevacs-covid-19-vaccine-cvncov ↵ Sahin U, Karikó K, Türeci Ö . mRNA-based therapeutics--developing a new class of drugs. Nat Rev Drug Discov2014;13:759-80. doi:10.1038/nrd4278 pmid:25233993 CrossRefPubMedGoogle Scholar ↵ Garde D. The story of mRNA: how a once-dismissed idea became a leading technology in the covid vaccine race. STAT News 2020. https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ ↵ Ulm JW, Perron M, Sodroski J, Mulligan RC . Complex determinants within the Moloney murine leukemia virus capsid modulate susceptibility of the virus to Fv1 and Ref1-mediated restriction. Virology2007;363:245-55. CrossRefPubMedGoogle Scholar ↵ Ulm JW. Rapid response. Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ 2020. https://www.bmj.com/content/371/bmj.m4037/rr-19

The two key nano-particle lipids haven't been fully tested ever. Certainly no published pharmcokinectic studies. ALC-3015 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis ALC-0159 (2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide -------------------------- https://www.bmj.com/content/372/bmj.n627/rr-1 Rapid Response: Re: The EMA covid-19 data leak, and what it tells us about mRNA instability Dear Editor Reading this important article has reminded me of a concern I had when reading what the MHRA's Public Assessment Report [1] on the Pfizer/BioNtech vaccine said about the lipid nanoparticles used as excipients - ALC-0315 and ALC-0159. They are novel excipients (at least in UK-authorised medicinal products) and the justification for not having conducted pharmacokinetic (PK) studies is that they “are generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005; WHO, 2014)”. But on reading WHO, 2005 - which is a reference to WHO Guidelines on nonclinical evaluation of vaccines [2]- I see that PK studies are not normally needed but should be considered on a case-by-case basis (para 4.2.6) ), and toxicity studies should be performed where new excipients (and preservatives) are used for which no toxicological data exist (para 5.2). I also note that the still extant EMA 2006 guidance [3] states “Pharmacokinetic studies are usually not required for vaccines. However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients. The need for PK studies and their design should be considered on a case by case basis and it is recommended that applicants should obtain scientific advice from EU Competent Authorities” (para 4.1). The 2006 guidance is being revised, and this text is missing from the current draft revised version [3]. I would have expected therefore at least an explanation as to why PK studies were not considered necessary. I also see that the EMA's Public Assessment Report [4] states that in January 2021 (and April 2021) “additional information about the synthetic process and control strategy for” ALC-0315 and ALC-0159 “should” be provided by BioNTech, with final reports in July 2021, in order to “confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product”. I have no pharmacological expertise, but it seems to me that an explanation should be given as to why PK studies were not considered necessary, and the additional information that was due to be provided in January 2021 should be disclosed, along with the April and July updates when provided. The EMA should also explain why paragraph 4.1 of its 2006 guidance has been dropped from its draft revised guidance. Yours sincerely, Peter Roderick 1. https://assets.publishing.service.gov.uk/government/uploads/system/uploa... 2. https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclini... 3. https://www.ema.europa.eu/en/clinical-evaluation-new-vaccines#current-ef... 4. https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty#product-info... Competing interests: No competing interests

Norway reclassifies Covid-19: No more dangerous than ordinary flu Covid-19 is treated in the mass media as a very dangerous disease in the face of which mass vaccination and severe restrictions for the whole society are applauded despite few deaths beyond the risk groups. But in Norway, it has now been decided to treat it like other respiratory diseases, such as influenza or the cold virus, because according to the Norwegian Institute of Public Health it is no longer more dangerous than these. Published: September 23, 2021, 10:24 am The Norwegian Institute of Public Health FHI has made the remarkable, but statistically supported, decision to classify Covid-19 as a respiratory disease that is as dangerous as the common flu. It is clarified that the pandemic is not over, but that it has entered a new phase where Covid-19 is now equated with a common respiratory disease, such as a flu or respiratory infection. This is done, among other things, due to the mutations that the Coronavirus has undergone, which makes it less dangerous, together with increased natural and vaccination-induced immunity that has been achieved in Norwegian society. Geir Bukholm. Photo: FHI Although the infection itself continues to circulate in the population, this does not mean an increase in hospital stays, which in itself means that the Coronavirus no longer creates a large burden on healthcare in Norway. This is because the vast majority of those at risk are protected. Those who are vaccinated also get severe symptoms and those who are not in the risk groups also usually only get ordinary mild cold symptoms. FHI thus makes the assessment that the Coronavirus now joins the ranks of other respiratory viruses such as the common cold and seasonal flu. “It is something positive and sends out signals that at least in Norway, at the moment, they consider themselves aware of the situation,” said Niklas Arnberg, professor of virology at Umeå University and chairman of the Pandemic Foundation to Aftonbladet. More contagious but less dangerous The FHI believes that the pandemic itself is not over because it is still out in the world and is spreading at the same time as the proportion of people vaccinated worldwide is low. As long as it spreads outside the territories of rich countries, it will be a continuing pandemic, it is said. With fewer in the high-risk groups who are in need of healthcare, the burden on healthcare decreases sharply. The second factor is one that is well known, namely that viruses with very few exceptions over time on purely evolutionary grounds develop towards becoming more contagious but at the same time less lethal. Sars-CoV-2 has undergone thousands of mutations and different variants have replaced each other in the rate of spread and degree of infection, but which have continuously proved less and less deadly. This spread also continues among vaccinated people as the degree of vaccine protection against this variant is lower than against previous variants, which also enables its continued spread, even in countries where the majority of the population has been vaccinated. In the studies conducted by FHI, it has been found that both partially and fully vaccinated people who receive Covid-19 have a low risk of having to go to hospital for care, but that the same also applies to healthy people who do not belong to risk groups. In those who were partially vaccinated, it has been concluded that the degree of protection against the Delta variant is only 22 percent, which increases to 65 percent for those who received two doses of vaccine. There are still low degrees of efficacy compared with the Alpha variant of the virus, where the degree of protection was instead 55 percent and 84 percent for those vaccinated. According to the latest statistics from FHI, 67 new patients have been admitted to hospital with Covid-19 as the main cause during week 37, which is a decrease from 95 cases the week before. But of the new cases in week 37, only 9 patients needed intensive care, a decrease from 22 from the previous week. It is also believed that the risk of needing medical care increases for those who are completely unvaccinated, but this is otherwise dependent on the risk group you are in. Around 40 percent of those who needed to be admitted for care in Norway during the past week have, for example, been fully vaccinated but have then an overwhelming majority belonged to risk groups. Around 5 percent have been partially vaccinated and around 55 percent of those admitted have not been vaccinated at all. A total of 11 people died with Covid-19 during week 37, a decrease from 13 deaths the previous week. The average age of those who died in week 37 was 80 years and thus in the risk group. In Norway, 90 percent of the population over the age of 18 have received their first dose and 83 percent have received their second dose and are thus considered fully vaccinated. Influenza does not require mass vaccination The significantly improved situation in Norway means that they choose to classify Covid-19 as a respiratory infection of the same degree of danger as influenza. This does not mean that it is seen as harmless, but rather that just as in the case of influenza, it is believed that it can be managed and that the risks for patients with a Covid-19 or influenza infection are comparable and that it is for people in the risk groups. “The total societal costs for virus-caused diseases can be tens of billions of kronor every year, without us having a pandemic,” Arnberg told Swedish daily Aftonbladet. He cited common colds and stomach ailments as causes for this. Every year, between 300 000 and 1,5 million Swedes fall ill with the flu, but few still die, only between 700 and 2000 annually, with fairly large annual variations within this range. As in the case of Covid-19, it is in the risk groups that the overwhelming majority of deaths occur, but no mass vaccinations are carried out at the societal level despite this. More children aged 10-19, for example, die of the common flu each year, between five and ten children, which is more than what died with Covid-19 in 2020 and 2021, as according to the National Board of Health and Welfare’s death register only four children who died with Covid-19 so far. In terms of this age group, the flu is more dangerous than Covid-19. This is interesting in itself, because in Norway, unlike Sweden, they have chosen not to vaccinate children under 12 years of age. The future looks bright By the winter, it is suspected in Norway that the hospitals will not be burdened with patients who have fallen ill with Covid-19, but instead there will be a mixture of Covid-19, other respiratory infections and common flu. “I think we have reached the top this time. Then I think instead that we will get a winter wave that comes later. But we do not think it will be bigger than the healthcare system can handle,” Geir Bukholm told Verdens Gang. According to FHI’s assessments, the infection is on the decline, fewer people become seriously ill, very few die and Norway’s assessment that Covid-19 is no longer more dangerous than a common flu looks increasingly correct.

Don’t mention Ivermectin; it’ll upset the vaccine rollout 12th May 2021 by Editor By Andrew Bannister* What if there was a cheap drug, so old its patent had expired, so safe that it’s on the WHO’s lists of Essential and Children’s Medicines, and used in mass drug administration rollouts? What if it can be taken at home with the first signs COVID symptoms, given to those in close contact, and significantly reduce COVID disease progression and cases, and far fewer few people would need hospitalisation? The international vaccine rollout under Emergency Use Authorisation (EUA) would legally have to be halted. For an EUA to be legal, “there must be no adequate, approved and available alternative to the candidate product for diagnosing, preventing or treating the disease or condition.” The vaccines would only become legal once they passed level 4 trials and that certainly won’t happen in 2021. This would present a major headache for the big public health agencies led by the WHO. The vaccine rollout, outside of trials, would become illegal. The vaccine manufactures, having spent hundreds of million dollars developing and testing vaccines during a pandemic, would not see the $100bn they were expecting in 2021. In a pandemic, and for the next one, we need big pharma to react quickly, and the best way to that, is to reward them financially. Allowing any existing drug, at this time, well into stage 3 trials, to challenge the legality of the EUA of vaccines, is not going to happen easily. On the 31st of March 2021, the WHO recommended against the use of Ivermectin for COVID treatment, citing safety and lack of large RCT proof. The question of why the WHO would do this is difficult to answer, only if you ignore the importance of the legality of the EUA, and the time tested advice, of following the money. The WHO, a once noble organisation funded by the worlds countries, now receives less than 20% of its budget from member states. The Bill and Melinda Gates Foundation is the second biggest sponsor after the USA. The GAVI Alliance, a private/public organisation promoting vaccines, was founded by Gates, and now pushing for vaccine passports, are the 4th biggest sponsor to WHO. Tedros Adhanom Ghebreyesus, the WHO Director-General, served on the GAVI board for several years. The WHO, in 2021 changed the definition of “herd immunity”, to occurring only when the global population has been vaccinated. The WHO has either made serious mistakes in their analysis or deliberately undermined Ivermectin and other early treatment drugs, in favour of vaccinating the world. Obviously this is a huge windfall for vaccine manufacturers, with Pfizer set to receive over a trillion rand from vaccines over the next five years according to Morgan Stanley. In January this year, the several months long, Ivermectin research, meta-analysis of Randomised Control Trials (RCT), commissioned by WHO was released. The paper showed that Ivermectin reduces death by 74% and is 85% effective as prophylaxis. The trial leader, Dr Andrew Hill, was on Zoom meetings saying that governments should secure their source before demand outstrips supply and that it would be immoral, not to roll it out. The same month, two other independent, unsponsored meta-analysis confirmed a similar range of effectiveness at various stages of the disease. While effective at all stages of the disease, Ivermectin is most effective as a prophylaxis and about 80% in early treatment, depending on dose used. The WHO currently have no advice or recommendation’s for early treatment apart from recommending against self-medication. If you don’t heal in the first week, when symptoms are generally mild, by the time you have to go to the hospital with breathing problems, your chances of dying have increased significantly. The use of Ivermectin and other repurposed drugs, could prevent that. As its safer than paracetamol, it should be available over the counter. As is happening in Mexico City and some states in India, anyone testing positive or feeling sick should take it, and give it to those they are in close contact with. It may be possible, if you want to attend a large social event or travel in a plane, that you take a pill, four hours before, and you will have significant protection for a few days. Lockdowns could end. Ivermectin has been used in humans for 35 years and over 4 billion doses have been administered. Merck, the original patent holder, donated 3.7 billion doses to developing countries. 2015 the two individuals who developed Ivermectin were awarded a Nobel Prize for medicine. While known primarily as an anti-parasitic, Ivermectin has powerful anti-viral and anti-inflammatory properties. Its safety is documented at doses twenty times the normal. Only 19 deaths are known and side-affects are generally mild and short. As a comparison, approximately 450 US citizens die from paracetamol every year. Merck’s patent on Ivermectin expired in 1996 and they produce less than 5% of global supply. In 2020 they were asked to assist in Nigerian and Japanese trials but declined both. In 2021 Merck released a statement claiming that Ivermectin was not an effective treatment against Covid-19 and bizarrely claimed, “A concerning lack of safety data in the majority of studies” of the a drug they donated to be distributed in mass rollouts, by primary care workers, in mass campaigns, to millions in developing countries. The media reported the Merck statement as a blinding truth without looking at the conflict of interests when days later, Merck received $356m from the US government to develop an investigational therapeutic. The WHO even quoted Merck, as evidence, that it didn’t work, in their recommendation against the use of Ivermectin. It’s a dangerous world when corporate marketing determines public health policy. Global vaccine rollout, to everyone, is the policy. The vaccine rollout is worth about $100bn in 2021, and there may well be annual updates to deal with new variants of COVID. The WHO answers to nobody but its’ funders. Less than 20% of its budget comes member states, the bulk coming from other sources. The Bill and Melinda Gates Foundation is the second largest sponsor of the organisation. GAVI, a vaccine alliance, founded by Gates and WHO Director General Tedros Ghebreyesus, served on its board prior to his current position, is the fifth largest contributor. In March 2021, WHO said that Ivermectin was not recommend for the treatment of COVID outside of trials. They did this by ignoring their own months long, in-depth investigation by Dr Andrew Hill, that found Ivermectin was associated with 74% reduction in fatalities, and replaced it with a hastily done analysis that cherry picked from five, seven or sixteen trials (the report contradicts itself) but only cite 5 trails. The figures ,the WHO report supplies, show a reduction of death by 81%, but with a “very low certainty of evidence”. The WHO report didn’t even mention prophylaxis, where Ivermectin’s most effective, saying that fell outside its mandate. The WHO will not approve Ivermectin’s use, without it first proving itself in a large RCT. These trials cost millions and nobody, except those with a financial interest in vaccines, have offered to fund. The WHO are best placed to run large RCT’s on existing drugs, but haven’t done so with Ivermectin, despite it being over a year, since Ivermectin was proved to kill COVID in a lab. As only big pharma can afford the large RCT, the only drugs that go through the large RCT’s, are the new ones developed by big pharma, and become the only ones approved by WHO. Almost every media house around the world has contributed to the marginalisation of Ivermectin. No mainstream journalists have investigated the evidence or questioned and debated scientists supporting it. It’s called an “animal drug” and dangerous. Ivermectin is seen as a repeat of hydroxychloroquine and not to be taken seriously. Belief in it, worthy only of derision. On 10 December 2020, at the World Press Freedom Conference, an extension to the Trusted News Initiative (TNI) was announced. Founded to prevent false information around elections, the TNI, whose members are leading media houses: AP, AFP, BBC, CBC, European broadcast Union, Facebook, Financial Times, First Draft, Google, YouTube, The Hindu, Microsoft, Reuters, Twitter and Washington Post, were now extending that to vaccines. In a surprisingly underreported event, many of the world’s biggest media, agreed to promote the global vaccine rollout and focus on combatting the spread of harmful vaccine disinformation. While noble and well-intended, this has unfortunately led to a media silence on promising, early treatments that could significantly drop hospitalisations. The March this year, New York Times broke a story, repeated around the world, reporting a trial that proved “Ivermectin had no effect”. The Lopez-Medina trial, published in JAMA, a leading medical journal, was held as the gold standard for Ivermectin RCT’s. In the trial, reminiscent of a “big tobacco” hit-job, vaccine manufactures paid the researchers (documented in the papers Conflicts Of Interests section). There are many faults in the trial. Among them, they accidentally gave Ivermectin to both arms of the trial and changed the trials primary outcome, mid-trial, three times. Normally, nobody would pay a trial any attention after these significant problems. As the trial was on a young heathy population, in an area with high Ivermectin use, freely available from the mayor during their first COVID wave, you were allowed on the trial if you hadn’t taken Ivermectin for 5 days, despite it’s effects being noticeable up to a month after a single dose. Surprisingly less than 3% of the participants had disease progression, against an expectation of 18%. The rare but specific Ivermectin side effect, blurred vision, was within 0,3% (11.3/11.6%) of both groups as were other side effects. The results were collected telephonically and no physical examination was done. From their result, with surprisingly few people having disease progression (some suggest that the trial inadvertently proves Ivermectin’s efficiency), it’s not possible to arrive at the conclusion that Ivermectin doesn’t work, which is what they did, and the media bought it. Unless you know where to look, you will find hardly any positive information on Ivermectin. Social media makes it very difficult to say anything positive about it without the poster getting blocked from the platforms for lengthy periods. YouTube has made the promotion of Ivermectin, a violation of its policies. There is no public conversation in the media about it. It’s just ignored. Respectable medical journals are sitting with piles of Ivermectin papers on their desks that they refuse to publish without providing reason, despite at least one of them having passed peer review by two FDA reviewers. The book “Manufacturing of Consent” comes to mind where Chomsky and Herman look at how mass media serves the rich. It’s a David against Goliath fight, a cheap generic vs Big Pharma. There are now 27 RCT’s, about 7 meta -analysis and many observational trials, that show Ivermectin works. There is very little evidence that it doesn’t work. The WHO were very sparse in detail and process, in their recommendation against its use. New research from the All India Institute of Medical Science (AIIMS), on a group of over 3500 health care workers, using two doses of Ivermectin as prophylactic, reduced cases among health care workers by 83% in the following month. Mexico City has for several months been using a test and treat with Ivermectin strategy. A research paper by Mexico City Health, claims that, depending on dosing, they have reduced hospitalisations by 56-73%. India in its current destructive wave, has just taken the example set by its two most successful states, and authorised the use of Ivermectin in early treatment. Doctors who use it, swear by it. As for more proof, the Gates/Together trial is ongoing, but given Gates’s large investments in vaccines, its results, already mistrusted. In Goa they have just authorised giving Ivermectin to everyone who tests, not waiting for a result. If Ivermectin works, it should soon be clearly seen unless the “Ivermectin is dangerous” group wins. We need more studies, especially on higher dosing, but we know it’s safe, so no need to wait. Ultimately what this means, is that if Ivermectin and other repurposed drugs (like the promising anti-depressant Fluvoxamine), work for early treatment, you won’t have to use a vaccine, that’s still in trial, with unknown long-term safety or ability to treat future variants, and for which, the manufactures accept no liability. In case you get sick, keep Ivermectin close by for early, household treatment, and you will prevent viral replication early and almost certainly, avoid hospital. You would have also built an immune response that will provide natural protection against future infections. Its wide-spread use, should dampen waves of disease, while vaccines can use this time to prove themselves, with long term safety and efficiency. Andrew Bannister says “I can provide proof for everything I have written” and was last published 30 years ago in the medical journal Lancet.

It may sound implausible but it is feasible. Testing is much more accurate now than in the past. Minuscule levels can be detected. In my opinion the RIB should publish what the detected levels are. It is possible to eat contaminated meat and return a positive to a level that is never therapeutic nor performance enhancing.

3 in 30 years. Hardly recidivist offending.

Tauranga today is not quite as bad as Matamata yesterday - go figure they are running for less money! All the same the field sizes are: 9 9 6 9 7 8 7 10 5

(b) (4) seems to be a generic hiding of commercial information. Check out the full FDA document it is full of (b) (4)'s! August 23, 2021 Summary Basis for Regulatory Action - Comirnaty.pdf

NZ's Medsafe list of ingredients:

The Pzifer vaccine is basically mRNA encapsulated inside a lipid (fatty) nanoparticle. There is another company that produces these for Pzifer - Acuitas. It is conceivable that there is a patent pending for an ingredient. Pzifer haven't really developed the vaccine - BioNTech developed the mRNA and Acuitas the lipid nanoparticles. Pzifer is essentially just a manufacturer. The other ingredients you can buy down at the supermarket or the garden centre. Lipids – The following lipids are in the new COVID vaccine. Their main role is to protect the mRNA and provide somewhat of a “greasy” exterior that helps the mRNA slide inside the cells. ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-Distearoyl-snglycero-3- phosphocholine cholesterol Salts – The following salts are included in the Pfizer vaccine and help balance the acidity in your body. potassium chloride monobasic potassium phosphate sodium chloride dibasic sodium phosphate dihydrate Sugar – Basic table sugar, also known as sucrose, can also be found in the new COVID vaccine. This ingredient helps the molecules maintain their shape during freezing.