STORY AT-A-GLANCE<\/h3>\n\n\n- Vaccine makers rarely use inert placebos (such as a saline shot), which is the gold<\/span> standard for drug trials. Instead, they typically assess the safety of a new vaccine against another vaccine. This hides side effects, as most vaccines have side effects and risks<\/span>
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<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n\n\n- The Oxford\/AstraZeneca COVID-19 vaccine is being tested against a meningitis vaccine, which shares many of the side effects reported from COVID-19 vaccines<\/span><\/li>\n
- Pfizer and Moderna have started offering placebo recipients in their trials the real mRNA gene therapy, which means it will be even more difficult to tease out which side effects are actually caused by the shot and which ones aren\u2019t, over the long term<\/span><\/li>\n
- In one clinical trial for the Moderna vaccine in Lenexa, Kansas, virtually all of the 650 volunteers who initially received the placebo have opted to get the real vaccine, which means there\u2019s essentially no comparison group left for the ongoing study, which was slated to run for two years<\/span><\/li>\n
- Some argue that placebo arms aren\u2019t needed in COVID-19 vaccine trials, but their argument hinges on the idea that the vaccine being tested is known to be safe, which it absolutely is not at this point, and won\u2019t be for many years<\/span><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n
The flaws of vaccine trials in general are really highlighted by current COVID-19 vaccine studies, one of the most egregious ones being the fact that vaccine makers rarely use inert placebos (such as a saline shot), which is the gold standard for drug trials.<\/p>\n
As noted in a January 25, 2021, article in The Defender,1<\/span><\/sup>\u00a0vaccine developers typically assess the safety of a new vaccine against another vaccine, and by so doing, they effectively hide side effects as most vaccines have side effects and risks.<\/p>\nAs just one example, the Oxford\/AstraZeneca COVID-19 vaccine is being tested against a meningitis vaccine,2<\/span><\/sup>\u00a0which just so happens to share many of the side effects reported from COVID-19 vaccines. As reported by the National Vaccine Information Center:3<\/span><\/sup><\/p>\n“According to the CDC, at least 50% of individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) experience mild side effects \u2026<\/em><\/p><\/blockquote>\nAdverse events reported by Sanofi Pasteur in the Menactra vaccine product insert include \u2026 headache; fatigue \u2026 joint pain; chills; anaphylaxis; wheezing; upper airway swelling; difficulty breathing; hypotension \u2026 lymph node swelling; Guillain-Barre syndrome; convulsions; dizziness; facial palsy; vasovagal syncope; paresthesia; transverse myelitis; acute disseminated encephalomyelitis \u2026<\/em><\/p><\/blockquote>\nAdverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of Menveo vaccine include \u2026 headache; joint and muscle pain; malaise; nausea; chills \u2026 acute disseminated encephalomyelitis \u2026 pneumonia \u2026 suicidal depression and suicide attempts.”<\/em><\/p><\/blockquote>\nLong-Term Safety Analysis Tossed by the Wayside<\/h2>\n
Now, Pfizer and Moderna have started offering placebo recipients in their trials the real mRNA gene therapy, which means it will be even more difficult to tease out which side effects are actually caused by the shot and which ones aren’t, over the long term. As reported by NPR, February 17, 2021:4<\/span><\/sup><\/p>\n“Tens of thousands of people who volunteered to participate in the Pfizer and Moderna COVID-19 vaccine studies are still participating in follow-up research, though that’s somewhat hampered because many people who had been given a placebo shot opted to take the vaccine instead.”<\/em><\/p><\/blockquote>\nIn fact, according to Dr. Carlos Fierro, who runs the clinical trial for the Moderna vaccine in Lenexa, Kansas, virtually all of the 650 volunteers who initially received the placebo have now opted to get the real vaccine, which means he had “essentially no comparison group left for the ongoing study,” which was slated to run for two full years.<\/p>\n
As Dr. Steven Goodman at Stanford University told NPR,5<\/span><\/sup>\u00a0getting rid of the initial control groups makes it far more difficult to assess the safety and effectiveness of the COVID vaccines since they won’t have anything to compare the vaccine recipients against.<\/p>\nJustification for Elimination of Controls Is Flimsy at Best<\/h2>\n
Ironically, both the use of an active placebo and the elimination of control groups are being justified on “moral grounds” by pro-vaccine advocates who say it’s unethical to not provide volunteers with something of value, such as another vaccine in the case of active placebos, or a vaccine they know is effective in the case of giving placebo recipients the real McCoy.<\/p>\n
Both of these arguments are beyond questionable.\u00a0As mentioned, no vaccine is 100% safe, so getting an active vaccine placebo comes with risk, not merely benefit, and when it comes to the novel mRNA technology used in COVID-19 vaccines, historical data are troubling to say the least, and the U.S. Vaccine Adverse Event Reporting System (VAERS) is rapidly filling up with COVID-19 vaccine-related injury reports and deaths.<\/p>\n
- \n
- Vaccine makers rarely use inert placebos (such as a saline shot), which is the gold<\/span> standard for drug trials. Instead, they typically assess the safety of a new vaccine against another vaccine. This hides side effects, as most vaccines have side effects and risks<\/span><\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n\n
- \n
- The Oxford\/AstraZeneca COVID-19 vaccine is being tested against a meningitis vaccine, which shares many of the side effects reported from COVID-19 vaccines<\/span><\/li>\n
- Pfizer and Moderna have started offering placebo recipients in their trials the real mRNA gene therapy, which means it will be even more difficult to tease out which side effects are actually caused by the shot and which ones aren\u2019t, over the long term<\/span><\/li>\n
- In one clinical trial for the Moderna vaccine in Lenexa, Kansas, virtually all of the 650 volunteers who initially received the placebo have opted to get the real vaccine, which means there\u2019s essentially no comparison group left for the ongoing study, which was slated to run for two years<\/span><\/li>\n
- Some argue that placebo arms aren\u2019t needed in COVID-19 vaccine trials, but their argument hinges on the idea that the vaccine being tested is known to be safe, which it absolutely is not at this point, and won\u2019t be for many years<\/span><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
\nThe flaws of vaccine trials in general are really highlighted by current COVID-19 vaccine studies, one of the most egregious ones being the fact that vaccine makers rarely use inert placebos (such as a saline shot), which is the gold standard for drug trials.<\/p>\n
As noted in a January 25, 2021, article in The Defender,1<\/span><\/sup>\u00a0vaccine developers typically assess the safety of a new vaccine against another vaccine, and by so doing, they effectively hide side effects as most vaccines have side effects and risks.<\/p>\n
As just one example, the Oxford\/AstraZeneca COVID-19 vaccine is being tested against a meningitis vaccine,2<\/span><\/sup>\u00a0which just so happens to share many of the side effects reported from COVID-19 vaccines. As reported by the National Vaccine Information Center:3<\/span><\/sup><\/p>\n
“According to the CDC, at least 50% of individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) experience mild side effects \u2026<\/em><\/p><\/blockquote>\n
Adverse events reported by Sanofi Pasteur in the Menactra vaccine product insert include \u2026 headache; fatigue \u2026 joint pain; chills; anaphylaxis; wheezing; upper airway swelling; difficulty breathing; hypotension \u2026 lymph node swelling; Guillain-Barre syndrome; convulsions; dizziness; facial palsy; vasovagal syncope; paresthesia; transverse myelitis; acute disseminated encephalomyelitis \u2026<\/em><\/p><\/blockquote>\n
Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of Menveo vaccine include \u2026 headache; joint and muscle pain; malaise; nausea; chills \u2026 acute disseminated encephalomyelitis \u2026 pneumonia \u2026 suicidal depression and suicide attempts.”<\/em><\/p><\/blockquote>\n
Long-Term Safety Analysis Tossed by the Wayside<\/h2>\n
Now, Pfizer and Moderna have started offering placebo recipients in their trials the real mRNA gene therapy, which means it will be even more difficult to tease out which side effects are actually caused by the shot and which ones aren’t, over the long term. As reported by NPR, February 17, 2021:4<\/span><\/sup><\/p>\n
“Tens of thousands of people who volunteered to participate in the Pfizer and Moderna COVID-19 vaccine studies are still participating in follow-up research, though that’s somewhat hampered because many people who had been given a placebo shot opted to take the vaccine instead.”<\/em><\/p><\/blockquote>\n
In fact, according to Dr. Carlos Fierro, who runs the clinical trial for the Moderna vaccine in Lenexa, Kansas, virtually all of the 650 volunteers who initially received the placebo have now opted to get the real vaccine, which means he had “essentially no comparison group left for the ongoing study,” which was slated to run for two full years.<\/p>\n
As Dr. Steven Goodman at Stanford University told NPR,5<\/span><\/sup>\u00a0getting rid of the initial control groups makes it far more difficult to assess the safety and effectiveness of the COVID vaccines since they won’t have anything to compare the vaccine recipients against.<\/p>\n
Justification for Elimination of Controls Is Flimsy at Best<\/h2>\n
Ironically, both the use of an active placebo and the elimination of control groups are being justified on “moral grounds” by pro-vaccine advocates who say it’s unethical to not provide volunteers with something of value, such as another vaccine in the case of active placebos, or a vaccine they know is effective in the case of giving placebo recipients the real McCoy.<\/p>\n
Both of these arguments are beyond questionable.\u00a0As mentioned, no vaccine is 100% safe, so getting an active vaccine placebo comes with risk, not merely benefit, and when it comes to the novel mRNA technology used in COVID-19 vaccines, historical data are troubling to say the least, and the U.S. Vaccine Adverse Event Reporting System (VAERS) is rapidly filling up with COVID-19 vaccine-related injury reports and deaths.<\/p>\n
- Pfizer and Moderna have started offering placebo recipients in their trials the real mRNA gene therapy, which means it will be even more difficult to tease out which side effects are actually caused by the shot and which ones aren\u2019t, over the long term<\/span><\/li>\n
- The Oxford\/AstraZeneca COVID-19 vaccine is being tested against a meningitis vaccine, which shares many of the side effects reported from COVID-19 vaccines<\/span><\/li>\n