jesuitsdidit

I wanted to make a title for the 4th post - Gung-ho, or time for serious reflection? And add PFIZER VACCINE MAY CAUSE ADEI AND NARCOLEPSY but not able to edit it.

https://www.bmj.com/content/371/bmj.m4037/rapid-responses Skip to main content Intended for healthcare professionals Toggle navigation The BMJ logo Toggle top menu covid-19 Research Education News & Views Campaigns Archive For authors Hosted Feature Will covid-19 vaccines save lives? Current trials aren’t designed to tell us BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037(Published 21 October 2020)Cite this as: BMJ 2020;371:m4037 Linked Editorial Covid-19 vaccine trial protocols released Read our latest coverage of the coronavirus outbreak Article Metrics Responses All rapid responses Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles. Sort byDate Published OrderAscendingDescending Items per page510204060 The goal posts have moved (from the horse’s mouth) Dear Editor “'If the vaccine also allows you to prevent initial infection, that would be great...what I would settle for, and all of my colleagues would settle for, is the primary endpoint to prevent clinically recognizable disease.' ” Dr Anthony Fauci quoted by Megan Sheets, Daily Mail [1]. So, what might happen if people have suppressed symptoms but are contagious? And what will doctors tell their patients if vaccines are rolled out as early as next month [2,3]. [1] Megan Sheets, ‘ Dr Fauci warns that early COVID-19 vaccines will only prevent symptoms from arising - not block infection’, Daily Mail 27 October 2020, https://www.dailymail.co.uk/news/article-8884031/Dr-Fauci-warns-early-CO... [2] Zoe Tidman, ‘ Coronavirus: Doctors to be 'put on standby for potential December vaccine rollout'’, The Independent 4 November 2020,https://www.independent.co.uk/news/health/coronavirus-vaccine-uk-when-ro... [3’] John Stone, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue? Vaccines are a matter of individual autonomy too’, 20 October 2920,https://www.bmj.com/content/371/bmj.m3933/rr-0 Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor 04 November 2020 John Stone UK Editor AgeofAutism.com London N22 @JohnStone32 Re: Will covid-19 vaccines save lives? Current trial designs ignore an important confounding factor There is a fundamental problem with vaccine trials extending beyond short-term that could indavertently lead to a vaccine appearing to be more effective in reducing C-19 severity than it really is. Commercial and political pressures might lead to intentional exploitation of this possibility. Most populations exhibit a seasonal rise in summer of serum 25(OH)D3 . Vitamin D promotes a lower severity of C-19 and lower risk of testing PCR-positive. If vaccine testing protocols fail to be completed (in northern hemisphere populations) before March the results will be void. Likewise trials run south of the equator in Oct-March will embrace the benefits of higher serum 25(OH)D3 that will likely not pertain in UK in winter. The secosteroid hormone D3 has such profound actions upon innate immunity that it should be mandated as a confounding factor in vaccine trials , and controlled for. It follows that extending UK trials beyond March in order to build the numbers should be disallowed. Personally as an ageing biologist I rely upon 4000 IU pd D3 : evolution trumps invention. Competing interests: No competing interests 31 October 2020 Peter H Cobbold Emeritus Professor, Cell Biology University of Liverpool, UK North Wales. Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us Dear Editor A newly published article by Timothy Cardozo and Ronald Veazey “Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease” reports on a study to determine whether or not sufficient literature exists “to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.” (1) The authors concluded that it did. The results of the study…………. “……..that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralizing antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.” The authors concluded that…………. “The specific and significant COVID‐19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.” Along with an inability to prove a reduction in the likelihood of severe illness and hospitalisation and prevent infection in interrupting transmission etc the current trials may also be falling foul of what constitutes informed consent from trial participants in failing to disclose a “specific and significant” Covid-19 risk of ADE. Looking to the future, the authors concluded that the risk should also be disclosed to “future patients after vaccine approval”. The fact that Covid-19 vaccines could worsen disease when exposed to challenge or circulating virus, is something that every individual should be aware of before consenting to vaccination. It will be interesting to see if this comes to pass. ( 1) https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795 Competing interests: No competing interests 30 October 2020 Wendy E Stephen Retired nurse Stonehaven, Scotland Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us Dear Editor, Peter Doshi discusses shortcomings of randomised placebo controlled trials (RCTs) of COVID-19 vaccines which aren't powered to evaluate admission or mortality endpoints in elderly people or minority populations. He observes a lack of placebo RCTs even to demonstrate if influenza vaccines save lives of elderly people in the community. In the 2014-16 Ebola global public health emergency vaccine studies demonstrated efficacy without a placebo controlled arm,(1) showing that more acceptable vaccine evaluations than traditional placebo RCTs are possible in the current global emergency. Kind regards, Dr John Bremner (1) doi: 10.1371/journal.pntd.0004866. Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model. Ibrahim Diakite, Eric Q. Mooring, Gustavo E. Velásquez,and Megan B. Murray. PLoS Negl Trop Dis. 2016 Aug; 10(8) Competing interests: No competing interests 29 October 2020 John A G Bremner Consultant Virologist NHS Lothian Department of Microbiology, Royal Infirmary of Edinburgh, Little France, Edinburgh, EH16 4SA Will FDA listen? Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us Dear Editor: Peter Doshi’s article provides an excellent overview of the shortcomings of the FDA’s proposed standards for Covid-19 vaccines. For months, the public has been told that when a vaccine becomes available, “life will go back to normal.” But that is only true if a vaccine protects most people from the most serious form of Covid-19 for an extended period of time, and especially protects the people most at risk – people over 65, people of color, and people with co-morbidities such as Type 2 diabetes, heart disease, and obesity. Doshi drew similar conclusions in his oral remarks before the FDA Advisory Committee considering Covid-19 vaccine standards, held remotely on October 22.[1] This was a crucial opportunity to urge the FDA to improve their study requirements, at a time when the FDA is under tremendous pressure to get a Covid vaccine on the market as soon as possible. Doshi pointed out that the primary endpoint for the studies focused on people who tested positive and had at least one symptom, but that those symptoms could be a mild cough or sore throat. While some company protocols called for at least 2 symptoms, they also could be mild. Some point out that Johnson & Johnson’s protocol lists the primary endpoint as “moderate to severe/critical disease” [2], which sounds more stringent, but they define the term as moderate “or” severe, so it is actually a distinction without a difference. As Doshi’s editorial points out, a cough a headache with a positive lab test would suffice.[3] In fact, all the protocols have a primary endpoint that combines outcomes that are at least mild but can also include moderate or severe symptoms, including those requiring hospitalization or causing death. The secondary endpoints for the vaccine studies focus specifically on “severe” disease, but the FDA defines “severe Covid-19,” as Doshi pointed out at the FDA Advisory Committee meeting, such that it could include an otherwise mild case of Covid-19 with a blood oxygen saturation of less than or equal to 93%, which is a level experienced by thousands of apparently healthy people over 65.[4] Moreover, there is no guarantee the trials will include enough hospitalizations or other truly severe cases to draw any conclusions with statistical certainty. Several Advisory Committee members expressed similar concerns. For example, Dr. Luigi Notarangelo, a laboratory chief at the National Institute of Allergy and Infectious Diseases, described the efficacy measures as “skewed towards mild disease.” Dr. James Hildreth, the CEO of Meharry Medical College, pointed out that "Since severe disease and death occur primarily among minorities with this virus, if we put a vaccine out there that does not address that issue, it's just going to perpetuate the perception that exists that [the nonwhite] segment of our population does not matter much in dealing with this challenge."[5] In contrast, the chair of the FDA Advisory Committee, Dr. Arnold Monto, defended the FDA standards, stating that “things that prevent infection ... typically prevent serious disease." Similarly, Dr. Philip Krause, deputy director of the FDA's Office of Vaccines Research and Review, stated at the meeting that "there simply does not exist an example in vaccinology of vaccines that are effective against mild disease that are not more effective against severe disease."[5] As Doshi points out, not enough is known about Covid-19 to know whether those statements are accurate. He reminds us that only two placebo controlled trials of the impact of influenza vaccines in the community-dwelling elderly have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths. And, real world evidence has failed to document that the increased popularity of influenza vaccines in the U.S. has resulted in a decline in mortality. Moreover, even if the trend against mild disease and severe disease trend in the same direction, the magnitude of the effect could be quite different. The target enrollments for most of the vaccine studies are 30,000 adults each, but it is likely that most of those volunteers will not be exposed to SARS-CoV-2 during the first months of the study and relatively few of those will develop severe disease. An additional point brought up at the meeting is that the FDA was only requiring a MEDIAN of 2 months follow-up after the vaccine was administered. The FDA defended the 2 months as a compromise intended to evaluate short-term adverse events, which usually occur within 2 months, while missing some longer-term risks. However, the 2-month median follow-up also drastically limits information about efficacy, by reducing the number of people in the study who will become infected, as well as failing to provide information about how long immunity generated by the vaccine is likely to last. Krause defended the mild Covid-19 endpoint, saying “the trials may need to be almost 10 times as big” if the goal is to focus on severe disease. [5] However, requiring more than 2 months of follow-up for all participants would also increase the number of severe cases for those already enrolled. Several panel members, such as Dr. Haley Alman-Gans from Stanford University Medical Center and Archana Chatterjee, Dean of Chicago Medical School, also expressed concern about the low standards to determine safety. [6] Despite these and other concerns expressed at the FDA’s public meeting, the outcome of the meeting will not necessarily reflect them. When the 9-hour meeting ended, Monto briefly summarized the discussion in a way that seemed to reflect his own views that the FDA standards were appropriate, rather than reflecting the concerns expressed by many panel members. The FDA’s Marion Gruber then added her own brief summary, concurring that in her view the Advisory Committee generally agreed with the FDA standards. That wasn’t even close to my impression, but it will be what the FDA’s written summary will say, and what the agency will quote to support their decisions in the future. Sincerely, Diana Zuckerman, PhD References [1] “Covid-19 Vaccine Trials” (Public statement at FDA advisory committee (VRBPAC) meeting, Oct 22, 2022; video begins at 5:21:23, and slides) [2] A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants, Janssen, ClinicalTrials.gov identifier NCT04505722, https://clinicaltrials.gov/ct2/show/record/NCT04505722 [3] Doshi P. Covid-19 vaccine trial protocols released. BMJ 2020; 371:m4058. https://doi.org/10.1136/bmj.m4058 [4] Alejandro Rodrıguez-Molinero, A, Narvaiza, L Ruiz, J. MS Galvez-Barron C. “Normal Respiratory Rate and Peripheral Blood Oxygen Saturation in the Elderly Population”, Journal of the American Geriatrics Society, https://onlinelibrary.wiley.com/doi/pdf/10.1111/jgs.12580 [5] Overley, J. “FDA Advisers Fear Coronavirus Vaccines Won't Help Enough”, Law360, October 22, 2020 https://www.law360.com/health/articles/1322025/fda-advisers-fear-coronav... [6] Edney A, Langreth R. “FDA Vaccine Rules Challenged as Weak at Advisory Panel Meeting,” Bloomberg Business News, October 22, 2020.https://www.bloomberg.com/news/articles/2020-10-22/fda-vaccine-rules-cha... Competing interests: Peter Doshi was the invited speaker at our research center’s November 14, 2020 press teleconference on standards for Covid-19 vaccines. The National Center for Health Research is a nonprofit think tank that does not accept funding from pharmaceutical, biotech, or device companies. I have inherited stock in Johnson & Johnson, however. 26 October 2020 Diana Zuckerman President National Center for Health Research 1001 Connecticut Ave, NW, Suite 1100, Washington, DC 20036 twitter.com/NC4HR Methodologic Considerations in COVID-19 Vaccine Trials Dear Editor: Peter Doshi’s commentary underscores the importance of understanding the type of outcomes the present COVID-19 vaccine studies can measure (1). From his investigation it is evident that these studies are not designed to address hard end points including number of hospitalizations, deaths or a reduction of transmission. Although these limitations are important to highlight, other potential methodologic limitations in these trials are worth mentioning. Some of the published phase-2 studies of the SARS-CoV-2 vaccine have shown a 2 to 3.5 fold higher risk of adverse reactions (2,3) in the vaccine group compared with control subjects. Although in many of these studies the participants are blinded to treatment, it will be difficult to maintain blinding if more subjects in the vaccine group experience adverse events compared to the control subjects. A potentially higher adverse events risk in the vaccine group can lead to bias. For example, patients who suspect they may have received the vaccine (as a result of experiencing side effects) might feel more protected against the virus and engage in situations that might increase their chance of exposure to the virus. Conversely, patients in the control group who might be less likely to experience side effects might suspect not receiving the vaccine and choose to change their life style such that they are less likely to be exposed to the virus. This can potentially confound a true assessment of the benefits of the vaccine. This situation can also lead to selection bias since in some of the studies (Moderna trial) subjects were followed for up to two years and were allowed to have pre-existing conditions (4). A potentially higher rate of adverse events among the vaccinated group (compared with the control group) can lead to a subject’s withdrawal from the study due to a pre-existing condition. For example, joint pain secondary to the vaccine in a patient with pre-existing musculoskeletal disease (5) might prompt that subject to withdraw from the study leading to selection bias. Although the COVID-19 vaccine studies have strong methodologic attributes including randomization, a potentially higher incidence of adverse events in the vaccine group along with a long follow up periods might make these studies prone to biases that are often found in observational studies. References: 1. Doshi P. Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037 2. Xia S, Duan K, Zhang Y, et al. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020;324(10):951-960. 3. Edward E. Walsh, Robert Frenck, Ann R. et al. RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. medRxiv 2020.08.17.20176651; doi: https://doi.org/10.1101/2020.08.17.20176651 4. A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19https://clinicaltrials.gov/ct2/show/NCT04470427 5. Folegatti PM, Ewer KJ, Aley PK et al. Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4 Competing interests: No competing interests 26 October 2020 Mahyar Etminan Associate Professor University of British Columbia Department of Ophthalmology and Visual Sciences and Medicine Gung-ho, or time for serious reflection? Dear Editor I view with concern the headline in yesterday’s Mail on Sunday [1]: "At last! NHS workers are 'set to get a vaccine in weeks' as the Government accelerates timetable for a mass roll-out before Christmas - while ministers introduce new laws to bypass EU approval for jab" So, we have this message of reckless speed at the same time as grave doubts about the effectiveness [2]. If those who get the vaccine operate on the principle - on which we are all conditioned - that they are unlikely to get the disease, they may well be mistaken. The evidence is not there that these products are game changers in terms of the epidemic. But perhaps most disturbingly in this unnecessarily febrile atmosphere we are failing to have a discussion about the ethics and long term implications of the entirely new technologies of the mRNA vaccines including products from Pfizer and Moderna [3,4]. It is doubtful, whether with their faith in technology that our politicians have pondered the ethics or wisdom of this deeply. The removal of safeguards rather than otherwise does not suggest it. The public, and perhaps most of all the frontline workers, after all these months of "we know best" chaos should not be treated like this, or for that matter taken for granted (as when in 2009 only about 10% of the public would have the Pandemrix H1N1 vaccine, and as it turned out were correctly cautious [5]). [1] Michael Powell and Glen Owen, 'At last! NHS workers are 'set to get a vaccine in weeks' as the Government accelerates timetable for a mass roll-out before Christmas - while ministers introduce new laws to bypass EU approval for jab', Mail on Sunday 24 October 2020, https://www.dailymail.co.uk/news/article-8875931/Coronavirus-vaccine-wee... [2] Peter Doshi, 'Will covid-19 vaccines save lives? Current trials aren’t designed to tell us' BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037(Published 21 October 2020) [3] Jeniffer Abbasi, 'COVID-19 and mRNA Vaccines—First Large Test for a New Approach', 3 September 2020, https://jamanetwork.com/journals/jama/fullarticle/2770485 [4] John Stone, 'Government proposing to roll out “Triumph” and “Ambush” vaccines next month?', 8 October 2020, https://www.bmj.com/content/370/bmj.m3757/rr-3 [5] John Stone, 'Fear of the disease is not a reason for confidence in the product...', 21 March 2019, https://www.bmj.com/content/364/bmj.l1259/rr Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor 26 October 2020 John Stone UK Editor AgeofAutism.com London N22 @JohnStone32 Covid-19: another vaccine treadmill of dubious benefit? Dear Editor Should we be scandalized to learn that Covid-19 vaccine trials may not prove the vaccines to be lifesavers, for the elderly or anyone else? Should we be further scandalized by the suggestion that influenza vaccines have not saved lives? (Doshi, BMJ 2020;371:m4037, Oct 21) A little history may put this in perspective: 1972: Macfarlane Burnet, Nobel Laureate and developer of one of the first influenza vaccines, states that “A vaccine is available but it reduces ones chance of catching flu by only about half. This hardly measures up to our expectations for a modern vaccine.” (Burnet & White, Natural History of Infectious Disease, 4th edition, page 212)….. 2000: Kenneth McIntosh warns against recommending influenza vaccine in healthy young children until randomized trials of the safety and effectiveness of vaccination are conducted and continued through several epidemics in populations large enough to identify any risks of adverse events. (Editorial, NEJM 2000;342:275) His advice is ignored….. 2005: Lone Simonsen and her colleagues report that from 1968 to 2001 US flu deaths in the elderly progressively increased, right along with their increasing use of influenza vaccines. (Arch Intern Med 2005;165:265)….. 2005: Peter Doshi reports that the CDC has been exaggerating influenza mortality figures to promote uptake of the influenza vaccine. They have developed a “Seven-Step Recipe” for providing information to the news media to boost demand. (BMJ 2005;331:1419)….. 2009-2011: Roger Bodewes refers to the “double-edged sword” of annual vaccination because it subverts broad and lasting immunity against influenza. (Lancet Inf Dis 2009;9:784. J Virol 2011;85:11995)….. 2010: Danuta Skowronski and her Canadian collleagues report that the 2008-2009 flu shot doubled the risk of illness from the 2009 H1N1 pandemic flu; the risk is further increased with the number of flu shots received in previous seasons. (PLoS Med 2010;7(4)e1000256). This study altered vaccine recommendations in Canada but was ignored in the US….. 2012: A randomized, placebo-controlled trial in Hong Kong children found that flu shots increased the risk of illness from non-influenza respiratory viruses/NIRVs nearly fivefold. (Cowling et al, Clin Infect Dis 2012;54:1778)….. 2013: The AS03-adjuvanted pandemic A/H1N1 2009 vaccine is reported to be causally-related to narcolepsy in children and adolescents, OR=14.4. (Miller at al, BMJ 2013;346:f794)….. 2014: Margaret McCartney calls for randomized trials of influenza vaccines. Referring to a Cochrane review and the lack of evidence supporting it as a public health measure she states, “Flu vaccination is offered millions of times every year at huge opportunity cost; given so much uncertainty this policy is impossible to justify.” (BMJ 2014;349:g6182)….. 2015: Citing the increased number of ARIs associated with influenza vaccines and their low efficacy, Peter Collignon and his colleagues argue against routine influenza vaccination of children. (Clin Infect Dis 2015;60:489)….. 2016: A large cohort study finds that flu shots given during the first trimester of pregnancy are associated with a 20% increase in the risk of autism spectrum disorder in the offspring (P=0.01), with an attributable risk of 4 extra ASD cases per 1000 women vaccinated. (Zerbo, JAMA Pediatr, online November 28, 2016. Hooker et al, JAMA Pediatr 2017;171:600)….. 2020: A 14-year study finds that influenza vaccines are associated with an 8.9% increase in the risk of all-cause mortality in elderly men (VE -8.9%, CI -19,6% to 1.8%) During six A/H3N2-predominant seasons their all-cause mortality increase was 16.6%! (VE -16.6%, CI -32.2% to -1.1%). (Anderson et al, Ann Intern Med, online March 3, 2020. The unfortunate history of influenza vaccines should warn us against repeating the process with Covid-19 vaccines. Peter Doshi may be understating the case when he suggests that influenza vaccines have not saved lives. The foregoing history and other observations suggest that in whole populations over the long run seasonal flu campaigns have actually cost lives…..This idea is hard to grasp in the face of massive publicity and reports of “vaccine effectiveness.” The vaccines provide modest short-term protection against seasonal flu, but the VE studies completely ignore adverse effects (e.g. high fever, seizures, narcolepsy, oculo-respiratory syndrome, Guillai-Barre syndrome). They ignore also the increased risk of NIRVs associated with influenza vaccines. (https://www.bmj.com/content/370/bmj.m3720/rr) Perhaps the foregoing considerations were part of what prompted Els Torreele to warn us against the rush to create a Covid-19 vaccine. (BMJ 2020;370;m3209, August 18) Perhaps they are part of what prompts Peter Doshi to repeat the warning…..We don’t need another vaccine treadmill that could do more harm than good. ALLAN S. CUNNINGHAM 23 October 2020 Competing interests: No competing interests 23 October 2020 Allan S. Cunningham Retired pediatrician Cooperstown NY 13326 USA <[email protected] Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us Dear Editor, I am disturbed by Peter Doshi's article, and I write this response as a concerned member of the public. As someone who worked in industrial physics & chemistry for twenty years, before moving into technological spheres, I am well aware of the scientific strictures that we must work to, but having also been in other roles over the past ten years, I appreciate science from the public viewpoint too. Britannica defines a vaccine as "a suspension of weakened, killed, or fragmented microorganisms or toxins or of antibodies or lymphocytes that is administered primarily to prevent disease." Dictionary.com defines a vaccine as "any preparation used as a preventive inoculation to confer immunity against a specific disease, usually employing an innocuous form of the disease agent, as killed or weakened bacteria or viruses, to stimulate antibody production." I quote the two definitions above because, between them, they convey what the public believes a vaccine to be and what it is intended to do. Let me be clear what the public want and expect. A vaccine should prevent people becoming infected, by conferring immunity, without causing harmful side-effects. Hence, surely there are only two questions that need to be answered by any trials? Namely, does the vaccine prevent infection in the individuals who have taken it, and did the vaccine harm them in the process of achieving immunity? Clearly, we are then into the world of statistics and acceptable rates, and also population demographics, but the fundamental questions are straightforward. Is medical science really in such a parlous state as this article suggests? If so, then we must do something about it. Yours sincerely, Marcus J. Swift. Competing interests: No competing interests 23 October 2020 Marcus J. Swift Science & Technology None Kendal, Cumbria. Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us Dear Editor Congratulations to Peter Doshi for bringing these inconvenient truths to the mainstream medical media and to the BMJ for publishing this important information. How is the UK Government planning to tell the people these truths about any putative forthcoming vaccine? Perhaps through its seemingly convenient mouthpiece the BBC? Competing interests: My group researches the safety of aluminium adjuvants used in vaccines. Funded by the MRC, CMSRI and individual donations. 23 October 2020 Christopher Exley Scientist Keele University The Birchall Centre Pages 1 2 next › last » Tweet Widget Facebook Like See other articles in issue 8265 Article tools PDF13 responses Respond to this article Print Alerts & updates Citation tools Request permissions Author citation Add article to BMJ Portfolio Email to a friend UK jobs International jobs Hull University Teaching Hospitals NHS Trust: Consultant in Acute Medicine NHS Tayside: Consultant in CAMHS NHS Tayside: Consultant Psychiatrist The Royal Surrey NHS Foundation Trust: Paediatric Emergency Medicine Consultant The Royal Surrey NHS Foundation Trust: Consultant in Emergency Medicine View more Who is talking about this article? See more details Picked up by 88 news outlets Blogged by 3 Tweeted by 2922 On 8 Facebook pages Reddited by 6 On 1 videos 26 readers on Mendeley This week's poll Has the pandemic made you less likely to practise defensive medicine? 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Extracted from next post @ BMJ Gung-ho, or time for serious reflection? Dear Editor I view with concern the headline in yesterday’s Mail on Sunday [1]: "At last! NHS workers are 'set to get a vaccine in weeks' as the Government accelerates timetable for a mass roll-out before Christmas - while ministers introduce new laws to bypass EU approval for jab" So, we have this message of reckless speed at the same time as grave doubts about the effectiveness [2]. If those who get the vaccine operate on the principle - on which we are all conditioned - that they are unlikely to get the disease, they may well be mistaken. The evidence is not there that these products are game changers in terms of the epidemic. But perhaps most disturbingly in this unnecessarily febrile atmosphere we are failing to have a discussion about the ethics and long term implications of the entirely new technologies of the mRNA vaccines including products from Pfizer and Moderna [3,4]. It is doubtful, whether with their faith in technology that our politicians have pondered the ethics or wisdom of this deeply. The removal of safeguards rather than otherwise does not suggest it. The public, and perhaps most of all the frontline workers, after all these months of "we know best" chaos should not be treated like this, or for that matter taken for granted (as when in 2009 only about 10% of the public would have the Pandemrix H1N1 vaccine, and as it turned out were correctly cautious [5]). [1] Michael Powell and Glen Owen, 'At last! NHS workers are 'set to get a vaccine in weeks' as the Government accelerates timetable for a mass roll-out before Christmas - while ministers introduce new laws to bypass EU approval for jab', Mail on Sunday 24 October 2020, https://www.dailymail.co.uk/news/article-8875931/Coronavirus-vaccine-wee... [2] Peter Doshi, 'Will covid-19 vaccines save lives? Current trials aren’t designed to tell us' BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037(Published 21 October 2020) [3] Jeniffer Abbasi, 'COVID-19 and mRNA Vaccines—First Large Test for a New Approach', 3 September 2020, https://jamanetwork.com/journals/jama/fullarticle/2770485 [4] John Stone, 'Government proposing to roll out “Triumph” and “Ambush” vaccines next month?', 8 October 2020, https://www.bmj.com/content/370/bmj.m3757/rr-3 [5] John Stone, 'Fear of the disease is not a reason for confidence in the product...', 21 March 2019, https://www.bmj.com/content/364/bmj.l1259/rr Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor 26 October 2020 John Stone UK Editor AgeofAutism.com London N22 @JohnStone32 XXXXXXXXXXXXXXXXXX Google search https://www.google.com/search?q=(Doshi%2C+BMJ+2020%3B371%3Am4037%2C+October+21)&oq=(Doshi%2C+BMJ+2020%3B371%3Am4037%2C+October+21)&aqs=chrome..69i57.2507j0j4&client=ms-android-ee-uk-revc&sourceid=chrome-mobile&ie=UTF-8#scso=_Bn-1X9XECZOigAaI5JHIDw2:180 www.bmj.com › content › 371 › bmj Web results Will covid-19 vaccines save lives? Current trials aren't designed to tell us | The BMJ by P Doshi · 2020 · Cited by 2 Current trials aren't designed to tell us. BMJ 2020; 371 doi: https://doi.org/10.1136/ bmj.m4037 (Published 21 October 2020) Cite this as: BMJ 2020;371:m4037 ... Covid-19 vaccine trial ... Will covid-19 vaccines save ... Related content Article metrics Peer review www.bmj.com › 371 › bmj.m4037 Covid-19: another vaccine treadmill of dubious benefit? | The BMJ 21 Oct 2020 — (Doshi, BMJ 2020;371:m4037, Oct 21) A little history may put this in perspective: 1972: Macfarlane Burnet, Nobel Laureate and developer of one ... www.bmj.com › rapid-responses Will covid-19 vaccines save lives? Current trials aren't designed to tell us | The BMJ 21 Oct 2020 — BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037 (Published 21 ... (Doshi, BMJ 2020;371:m4037, Oct 21) A little history may put this in ... www.bmj.com › 371 › bmj.m4037 Freedom of speech and the generic ban of vaccine criticism on social media | The BMJ Current trials aren't designed to tell us. BMJ 2020; 371 doi: https://doi.org/10.1136/ bmj.m4037 (Published 21 October 2020) Cite this as: BMJ 2020;371:m4037 ... www.bmj.com › 371 › bmj.m4037 Methodologic Considerations in COVID-19 Vaccine Trials | The BMJ Current trials aren't designed to tell us. BMJ 2020; 371 doi: https://doi.org/10.1136/ bmj.m4037 (Published 21 October 2020) Cite this as: BMJ 2020;371:m4037 ... www.bmj.com › 371 › bmj.m4037 Will FDA listen? Re: Will covid-19 vaccines save lives? Current trials aren't designed to tell us | The BMJ Current trials aren't designed to tell us. BMJ 2020; 371 doi: https://doi.org/10.1136/ bmj.m4037 (Published 21 October 2020) Cite this as: BMJ 2020;371:m4037 ...

From https://www.godlikeproductions.com/forum1/message4595889/pg1 https://www.bmj.com/content/371/bmj.m4347/rr-4# Covid-19 vaccine candidate is unimpressive: NNTV is around 256 Skip to main content Intended for healthcare professionals Toggle navigation The BMJ logo Toggle top menu covid-19 Research Education News & Views Campaigns Archive For authors Hosted Rapid response to: Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4347 (Published 09 November 2020)Cite this as: BMJ 2020;371:m4347 Read our latest coverage of the coronavirus outbreak Article Related content Article metrics Rapid responses Response Rapid Response: Covid-19 vaccine candidate is unimpressive: NNTV is around 256 Dear Editor Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant? We already know that current Covid-19 vaccine trials are unlikely to show a reduction in severe illness or deaths. (Doshi, BMJ 2020;371:m4037, October 21) Will they be like seasonal influenza vaccines, which have not proved to be lifesavers, and may even have increased overall mortality in the elderly? (Anderson et al, Ann Intern Med 2020;172:445) We need a lot more time and a lot more data, especially in view of massive uncertainties about Covid-19 case definitions and statistics. ALLAN S. CUNNINGHAM 13 November 2020 Competing interests: No competing interests 13 November 2020 Allan S. Cunningham Retired pediatrician Cooperstown NY 13326 USA <[email protected] Follow us on Twitter Facebook YouTube Pinterest RSS Content links Collections Health in South Asia Women’s, children’s & adolescents’ health Zika virus Research Education News and views BMJ Opinion Rapid responses Archive About us About us Editorial staff BMJ in the USA BMJ in South Asia Advisers Policies Submit your paper Resources Authors Reviewers BMA members Readers Subscribers Advertisers and sponsors Media Recruiters Explore BMJ Our company BMJ Careers BMJ Learning BMJ Masterclasses BMJ Journals BMJ Student Academic edition of The BMJ BMJ Best Practice The BMJ Awards My account Email alerts Activate subscription Information Contact us Complaints Cookie settings Cookie Policy Privacy policy Website T&Cs Revenue Sources HighWire Press Sitemap Copyright © 2020 BMJ Publishing Group Ltd 京ICP备15042040号-3

Bongo

Apparently there will be people on hand in Doctor's surgeries to treat people who have an immediate adverse reaction. Does this mean they know it will be bad Or They don't know because they have not done enough research?

Listen from 1800---2020 If it needs to be kept at -70C it means it's nanobots which create new DNA which replicates until all your natural cells are dead. The problem is we don't know how many Vaccines are available, will different people be getting different Vaccines? Are they just going for straight up depopulation or modified humans? Will it be immediate or delayed effect? Also, make sure you have warm winter clothes and waterproof boots because it's highly likely they will be ramping up the bad weather this winter to reduce our ability to escape/survive when the trains start rolling to Auschwitz & Treblinka.

I suggest you watch the video in post 2 Rebecca Carley lecture. If you listen to the first 10 minutes of her talking you'll want to watch all. The male intro is a bit irrelevant, about 3--5 minutes.

Also, where do they get the authority to use aborted foetus tissue in the Vaccines? Shouldn't they be asking the parents for permission? Would the parents consent if they knew their child was going to be injected into another? What Medical basis justifies this?

The real problem is the MPs will not scrutinise the Government. I have actually seen Hatt Mancock rubbish the Great Barrington Declaration twice in Parliament and they just sit there and take it. Its outrageous, its like its a pantomime. Even Professor Gupta has replied saying Hatt Mancock doesn't understand Herd Immunity. We need to list all the times they have allowed things to slip past proper scrutiny. They have just been rubber-stamping for decades so now there is no real accountability. If we expose this then we can bypass Parliament because we have shown that they are irrelevant.

Yes but now they can "see" how many people are in the house before entering so know how much force to use.

Yes and if it works in Canada too they'll probably put it in place everywhere.

Maybe the reason they are rushing to start the vaccinations is bcoz they know that when Trump is installed as the next President it could mean game over for the Deep State and the NWO.

UK basically saying the same - "This is going to be the biggest logistical operation since WW2". ie Life only goes "back to normal" (that ain't gonna happen) when everybody is vaccinated.

I've just heard Joe Biden talking on the Radio. He said it's going to be a huge job to vaccinate 300 million people. That means USA Intends to vaccinate the whole population.

If you act Illegally you will be judged by the Law. If you act Immorally you will be judged by History. It's time to come clean if you want to preserve your Dignity.

^^ Sorry DF I'm not quoting you here. I have all sorts of dodgy software inserted into my phone (by a 3 letter agency) which reduces the functionality of my phone considerably.

There are a lot of people who know what is going on. Just to remind you that it was established at the end of WW2 that you cannot use the excuse "I was just following orders". You are obliged at all times to act in a way that conforms to what is Moral & Legal. If you are being asked to do things that are Immoral or Illegal then you should resign from your jobs immediately. I suggest you take this as a warning.

Well that is another question you can ask your MP. Why did the Law need to be changed?

Yes I kind of realised that later. Although one comment pg1 said that they do use them in abbatoirs.

This is it people There's no going back Only one side wins from here It's either them or us. This is their final move. I hope you are prepared.

I imagine that initially there won't be huge Vaccine Damage coz they know we will be watching plus the fact that it's a double shot may mean that the damage isn't done till receipt of the second shot if it's a Binary Bioweapon.

Maybe you can get a nasty blast of radiation from your TV when activated?

Conclusion I am rapidly coming to is that a good number of MPs are either very stupid or they are criminal. I suppose there may be some who are genuine, not sure. I guess a £300k job (including expenses) could be attractive to many.

Actually there used to be masses of information about Vaccine Injury. There was a lot on the old David Icke forum and also on Jane Burgermeister's blog. Both now unavailable.