copenlu/druid huggingface dataset:
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2020-07-06): If, at the recommendation of a friend, you decided to "do your own research" on the topic, I understand the resulting confusion. The World Health Organization had to convene an expert panel on the issue of placebos in vaccine trials after acknowledging that guidance documents from different international bodies were conflicting. This is because vaccines don’t exist in a vacuum: their circumstances help dictate the kind of control they should be pitted against. A vaccine can be the first of its kind against a disease or it may be a challenger to the throne. It may immunize against more strains than a preexisting vaccine or it may be identical to a vaccine on the market except for the addition of a special molecule meant to boost the immune reaction. A saline injection may be an ethically valid control in some of these instances but not in others. [...] This being said, there is a persistent argument online that contaminates minds like a bad virus: that no vaccine has ever been compared to a saline solution. This is simply untrue. The website Virology Down Under lists specific trials of important vaccines that were placebo-controlled and this article from the Vaccines Work Blog specifically lists a number of saline placebo vaccine studies.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2021-03-16): Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group [...] From a scientific standpoint, it is important for the clinical trials of vaccines granted an EUD to continue to their completion. But the provision of a candidate vaccine under an EUD to millions of people raises urgent questions about the continuation of the control-group arm of these and other trials, and whether trial blinding is still warranted. Current research-ethics guidance documents7,8,9 were not drafted with emergency-use deployment in mind. Given such dilemmas and guidance gaps, the WHO ACT-Accelerator Ethics & Governance Working Group (ACT: Access to COVID-19 Tools; called ‘Working Group’ here) has developed a policy brief to guide ethical decision-making in these circumstances: ‘Emergency Use Designation of COVID-19 candidate vaccines: Ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding’10. [...] World Health Organization. https://apps.who.int/iris/bitstream/handle/10665/337940/WHO-2019-nCoV-Policy_Brief-EUD_placebo-controlled_vaccine_trials-2020.1-eng.pdf?sequence=1&isAllowed=y (18 December 2020).
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2022-12-13): A phase I/II randomized, double-blinded, placebo-controlled trial of a self-amplifying Covid-19 mRNA vaccine [...] Coronavirus disease-19 (Covid-19) pandemic have demonstrated the importantance of vaccines in disease prevention. Self-amplifying mRNA vaccines could be another option for disease prevention if demonstrated to be safe and immunogenic. Phase 1 of this randomized, double-blinded, placebo-controlled trial (N = 42) assessed the safety, tolerability, and immunogenicity in healthy young and older adults of ascending levels of one-dose ARCT-021, a self-amplifying mRNA vaccine against Covid-19. Phase 2 (N = 64) tested two-doses of ARCT-021 given 28 days apart. During phase 1, ARCT-021 was well tolerated up to one 7.5 μg dose and two 5.0 μg doses. Local solicited AEs, namely injection-site pain and tenderness were more common in ARCT-021vaccinated, while systemic solicited AEs, mainly fatigue, headache and myalgia were reported in 62.8% and 46.4% of ARCT-021 and placebo recipients, respectively. Seroconversion rate for anti-S IgG was 100% in all cohorts, except for the 1 μg one-dose in younger adults and the 7.5 μg one-dose in older adults. Anti-S IgG and neutralizing antibody titers showed a general increase with increasing dose, and overlapped with titers in Covid-19 convalescent patients. T-cell responses were also observed in response to stimulation with S-protein peptides. [...] Low, J.G., de Alwis, R., Chen, S. et al. A phase I/II randomized, double-blinded, placebo-controlled trial of a self-amplifying Covid-19 mRNA vaccine.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2024-08-06): This multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial evaluated the efficacy, immunogenicity, and safety of two doses (day 0 and day 28) of CoronaVac® in healthy children and adolescents aged from 6 months to 17 years. Participants were enrolled from Chile, South Africa, Malaysia, and the Philippines, with 37 sites. The enrollment ran from September 10, 2021, to March 25, 2022. [...] Palacios, R. et al. Double-blind, randomized, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of treating healthcare professionals with the adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac - PROFISCOV: a structured summary of a study protocol for a randomised controlled trial. Trials21, 853 (2020).
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2024-10-09): COVID Vaccination Studies: From Double-Blind to Hardly-Blind? [...] As expanded upon in another response [COVS5], we see an inadvertent placebo proneness due to the study design common to huge placebo-controlled vaccine studies (many thousands of subjects) whereby only a fraction of subjects (+/ 170) get diagnosed. The mechanism is a kind of unwanted (inadvertent) distillation process. This inadvertently distilled placebo proneness may interact with even a small blindness breach towards an unknown degree of overvaluation of vaccines' efficacies. [...] Bibliography [COVS1] FDA Briefing Document - Pfizer-BioNTech COVID-19 Vaccine https://www.fda.gov/media/144245/download [COVS2] FDA Briefing Document - Moderna COVID-19 Vaccine https://www.fda.gov/media/144434/download [COVS3] John Strone "Is it possible to conduct a double-blind placebo vaccine study in humans?", 28 December, https://www.bmj.com/content/371/bmj.m4924/rr-3 [COVS4] Peter Doshi, "Pfizer and Moderna’s "95% effective" vaccines—let’s be cautious and first see the full data", November 26, 2020, https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-...
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2024-01-01): Miller AE, Morgante LA, Buchwald LY, Nutile SM, Coyle PK, et al. A multicenter, randomized, double blind, placebo-controlled trial of influenza immunization in multiple sclerosis. Neurol 1997;48;312-314. [...] Reviewed by Paul A. Offit, MD, and Lori Handy, MD, MSCE, on September 11, 2018
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2022-05-16): The Phase 1/2 clinical trial is double-blind and placebo-controlled study to evaluate safety, tolerability and immunogenicity of two doses of the vaccine. 60 adults are enrolled in the trial. For more information about this clinical trial, please refer to jRCT No.:2031210269. Subject registration for this trial has been completed. In the evaluation up to 28 days of two doses of the vaccine, confirmed tolerability and safety, neutralizing antibody titer equal to or higher than that of convalescent serum. [...] This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of COMIRNATY or S-268019 in 200 adults, 6 months or more after receiving a primary series of COMIRNATY, will be compared. For more information about this clinical trial, please refer to jRCT No.:2031210470. Subject registration for this trial has been completed and the primary endpoint was achieved for the neutralizing antibody titer against SARS-CoV-2 28 days after additional dose. [...] This clinical trial is a double-blind randomized active controlled trial to evaluate a neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and the elderly people.For more information about this clinical trial, please refer to jRCT No.: 2051210151.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2019-07-01): The Finnish Otitis Media (FinOM) trial was a randomized, double-blind trial in which 1,662 infants were equally randomized to receive either Prevnar or a control vaccine Recombivax HB (Hepatitis B vaccine (Recombinant) [Hep B]) at 2, 4, 6, and 12–15 months of age. In this study, conducted between December 1995 and March 1999, parents of study participants were asked to bring their children to the study clinics if the child had respiratory infections or symptoms suggesting acute otitis media (AOM). If AOM was diagnosed, tympanocentesis was performed, and the middle-ear fluid was cultured. If S. pneumoniae was isolated, serotyping was performed; the primary endpoint was efficacy against AOM episodes caused by vaccine serotypes in the per-protocol population. In the NCKP trial, the efficacy of Prevnar against otitis media was assessed from the beginning of the trial in October 1995 through April 1998. The otitis media analysis included 34,146 infants randomized to receive either Prevnar (N=17,070), or the control vaccine (N=17,076), at 2, 4, 6, and 12–15 months of age. In this trial, no routine tympanocentesis was performed, and no standard definition of otitis media was used by study physicians.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2023-06-30): In 2006, on the basis of the findings from the Shingles Prevention Study, [122] the US Food and Drug Administration (FDA) approved Zostavax for prevention of herpes zoster in people aged 60 years and older. This randomized, double-blind, placebo-controlled trial of the vaccine enrolled more than 38,000 adults older than 60 years. The vaccine reduced the incidence by 61.1% and the incidence of PHN by 66.5%. [...] The first trial, ZOE-50, was a randomized, placebo-controlled study conducted in 18 countries in Europe, North America, Latin America, and Asia-Australia. The study evaluated the efficacy, immunogenicity, and safety of the HZ/su vaccine in adults aged 50 years or older. Participants were randomly assigned in a 1:1 ratio to receive either HZ/su vaccine (0.5 mL at month 0 and 2) or placebo. Two doses of HZ/su administered 2 months apart had a vaccine efficacy of 97.2%, compared with placebo, in reducing the risk of herpes zoster in adults aged 50 years or older. The vaccine efficacy was similar among the three age groups. [132]
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2006-05-19): Efficacy. The efficacy of HAVRIX was evaluated in a double-blind, controlled, randomized clinical trial conducted in Thailand among approximately 40,000 children aged 1--16 years living in villages that had high rates of hepatitis A (117). After 2 doses of vaccine (360 EL.U. per dose) administered 1 month apart, the efficacy of vaccine in protecting against clinical hepatitis A was 94% (95% confidence interval [CI] = 79%--99%). A double-blind, placebo-controlled, randomized clinical trial using VAQTA was conducted among approximately 1,000 children aged 2--16 years living in a New York community that had a high rate of hepatitis A (118). The protective efficacy against clinical hepatitis A was 100% (lower bound of the 95% CI = 87%) after administration of 1 dose (25 U) of vaccine. [...] Approximately 10,000 persons were administered VAQTA in prelicensure clinical studies, and no serious adverse events were reported among participants (192). Among adults, the most frequent side effects that occurred <5 days after vaccination included tenderness (53%), pain (51%), and warmth (17%) at the injection site and headache (16%). Among children, the most common side effects reported were pain (19%), tenderness (17%), and warmth (9%) at the injection site. In one placebo-controlled trial among children, adverse reactions among vaccine recipients did not differ substantially from those that occurred among persons who received placebo (118).
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2019-04-21): Some of the misinformation regarding vaccines includes an argument that vaccines have not been tested against a saline placebo in a double-blinded randomized clinical trial. This misinformation is aimed at confusing the wealth of evidence regarding the safety and effectiveness of immunizations. In this blog post, we will explain what a blinded randomized clinical trial is, when this study design has been used in the development of immunizations, and why it is not used as often anymore. [...] That universe is made up of millions of people, all working every day in the trenches of public health and medicine. They know firsthand what vaccines can do for a population, and how now more than ever vaccines are safe. They also know that a randomized clinical trial for vaccines that we know work would not be ethical if it used a saline placebo that would leave a child susceptible to a deadly disease. This is why we don’t see such studies today like we did in the 1950s and 1960s. Yet we might see such studies if an HIV or malaria vaccine is developed. The misinformation talking point that there were no RCTs conducted in the testing of vaccines for safety, efficacy and effectiveness can be easily refuted just by looking back at history. There are plenty of documented trials out there... One just needs to look at reliable sources.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2014-11-01): Efficacy of an 11-valent pneumococcal conjugate vaccine against radiologically confirmed pneumonia among children less than 2 years of age in the Philippines: a randomized, double-blind, placebo-controlled trial - PMID: 19483514 - DOI: 10.1097/INF.0b013e31819637af Efficacy of an 11-valent pneumococcal conjugate vaccine against radiologically confirmed pneumonia among children less than 2 years of age in the Philippines: a randomized, double-blind, placebo-controlled trial [...] Methods: We conducted a randomized, placebo-controlled, double-blind trial in Bohol, the Philippines (ISRCTN 62323832). Children 6 weeks to <6 months of age were randomly allocated to receive 3 doses of either an 11-valent PCV (11PCV, sanofi pasteur, Lyon, France) or a saline placebo, with a minimum interval of 4 weeks between doses to determine vaccine efficacy (VE) against the primary outcome of a child experiencing first episode of community-acquired radiologically defined pneumonia in the first 2 years of life. Secondary end points were clinical pneumonia, IPD, safety, and immunogenicity.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2014-10-01): In November 2012, we performed a randomized, double-blind, placebo-controlled trial in Donghai County, Jiangsu Province, China. This trial was conducted using a cohort of healthy children created in the early phase 2 clinical trial with EV71 vaccines, all of whom were aged 6–35 months. Participants in that cohort who had received at least 1 dose of EV71 vaccine in any formulations (160 U, 320 U, and 640 U with alum adjuvant or 640 U without adjuvant) composed the target population for recruitment in this booster immunization trial. Exclusion criteria were as follows: participants’ guardians did not provide informed consent, acute febrile disease was present on the day of recruitment, acute infection due to any cause was present during the week before recruitment, any inactivated vaccine was received during the week before recruitment, any live attenuated vaccine was received during the 2 weeks before recruitment, and any medical history of laboratory-confirmed EV71-associated disease, of allergy to any vaccination or drug, of allergy to any ingredient in the inactivated EV71 vaccine, and/or of seizures or other common contraindicating conditions was present. The eligibility of participants was assessed through medical history inquiry and physical examination by investigators.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2014-11-01): Haemophilus influenzae type b capsular polysaccharide vaccine in children: a double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland - PMID: 335348 Haemophilus influenzae type b capsular polysaccharide vaccine in children: a double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland [...] A randomized, prospective field trial of a conjugate vaccine in the protection of infants and young children against invasive Haemophilus influenzae type b disease.N Engl J Med. 1990 Nov 15;323(20):1381-7. doi: 10.1056/NEJM199011153232004. N Engl J Med. 1990. PMID: 2233904 Clinical Trial.
Claim: “No childhood vaccine has ever been through a double blind placebo controlled trial.” (Social media users, 2024-02-24)
Evidence (2020-10-15): Study Design: Study 1 was a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in the US and Australia. A total of 3146 subjects 18 through 45 years of age not previously exposed to cholera were randomized 8:1 to receive 1 dose of VAXCHORA or placebo.1 [...] Study Design: Study 5 was a randomized, double-blind, saline placebo-controlled safety and immunogenicity study conducted in the US. A total of 550 subjects 2 through 17 years of age not previously exposed to cholera were randomized 6:1 to receive one dose of VAXCHORA or placebo. Randomization was stratified by age into 3 cohorts: Cohort 1: 12 to <18 years of age; Cohort 2: 6 to <12 years of age; Cohort 3: 2 to <6 years of age.1 [...] The safety of VAXCHORA in children was evaluated in a randomized, placebo-controlled, multicenter clinical trial that included a total of 543 children 2 through 17 years of age. Randomization was stratified by age, and children were enrolled in 3 separate age cohorts: 12-<18 years (Cohort 1), 6 -<12 years (Cohort 2), and 2-<6 years (Cohort 3).
Claim: The temperature is not rising nearly as fast as the alarmist computer models predicted. You know, it’s much, much less, factors of 2 or 3 less. (William Happer, 2017-04-25)
Evidence (2017-04-25): Global surface temperatures are increasing consistent with the long-term trend projected by climate models, which are useful tools for understanding the consequences of continued greenhouse gas emissions.
Claim: The temperature is not rising nearly as fast as the alarmist computer models predicted. You know, it’s much, much less, factors of 2 or 3 less. (William Happer, 2017-04-25)
Evidence (2019-06-27): So the whole basis for the alarmism is not true, it’s based on flawed computer modeling. [...] Dr. Happer’s assertion that models show 2x to 3x greater warming than observations is incorrect. At the surface (where we all live) models predict a rate of warming of 0.2°C per decade since 1970, while NASA observes warming of around 0.18°C during the same period. During this period models have been running about 10% too hot, hardly 200% to 300%. Similarly, the observations from all the different groups that measure global surface temperatures are well within the envelope of model projections: [...] Looking over the last 50 years, for example, the models and the observations are consistent in terms of the rates of global temperature warming that we expect from human activities. Over shorter decadal periods, there are natural fluctuations in climate in the real world that are much harder to predict.
Claim: The temperature is not rising nearly as fast as the alarmist computer models predicted. You know, it’s much, much less, factors of 2 or 3 less. (William Happer, 2017-04-25)
Evidence (2024-01-09): Temperatures rising ‘more exponentially’ Several months ago, there was a projection among the scientific community that warming would hit around 1.3 degrees in 2023, said Liz Bentley, chief executive of the UK’s Royal Meteorological Society. That prediction has been "annihilated," she said, as temperature records fell on the regional, national and international levels around the world, including daily and monthly records. [...] "If you look at climate projections, when we expect to see temperature changes of close to 1.5 degrees Celsius, indeed it has come sooner than many would have expected," Bentley told CNN. "We’ve definitely seen an acceleration towards that, rather than it being a kind of linear progression. It feels like it’s rising much more exponentially."
Claim: The temperature is not rising nearly as fast as the alarmist computer models predicted. You know, it’s much, much less, factors of 2 or 3 less. (William Happer, 2017-04-25)
Evidence (2021-04-20): The Earth’s temperature continues to rise unabated, with 2020 being one of the three warmest years on record, as extreme weather events combine with the COVID-19 pandemic, impacting millions. [...] "We are on the verge of the abyss", Secretary-General António Guterres said at a press conference announcing the findings. [...] The report also said that the since the mid-1980s, Arctic air surface temperatures have warmed at least twice as fast as the global average, with "potentially large implications" not only for Arctic ecosystems but also for the global climate, such as thawing permafrost releasing methane, a potent greenhouse gas into the atmosphere.
Claim: The temperature is not rising nearly as fast as the alarmist computer models predicted. You know, it’s much, much less, factors of 2 or 3 less. (William Happer, 2017-04-25)
Evidence (2022-12-28): In the late 20th century, when scientists started looking at how temperatures have changed over time, they observed a much faster rate of planetary warming from the 1980s than had previously been recorded. [...] And, as a result, Earth started warming faster. [...] Benjamin Cook, a climate scientist at the NASA Goddard Institute for Space Studies, said back in the late 20th century, when researchers started to look for answers to explain the warming trend, they examined different factors including greenhouse gases, solar energy, ocean circulation and volcanic activity.