Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed | Forbes - William A. Haseltine:
September 23, 2020 - "Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are leading candidates for the completion of a Covid-19 vaccine likely to be released in the coming months. These companies have published their vaccine trial protocols. This unusually transparent action during a major drug trial deserves praise, [but] close inspection of the protocols raises surprising concerns. These trials seem designed to prove their vaccines work, even if the measured effects are minimal.
"What would a normal vaccine trial look like? Prevention of infection must be a critical endpoint.... Prevention of infection is not a criterion for success for any of these vaccines. In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated.... We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols — Moderna, Pfizer, and AstraZeneca — do not require that their vaccine prevent serious disease.... The greatest fear people have is dying from this disease.... None list mortality as a critical endpoint....
"Vaccine efficacy is typically proved by large clinical trials over several years ... trials ranging from thirty thousand to sixty thousand participants. This scale of study would be sufficient for testing vaccine efficacy. The first surprise found upon a closer reading of the protocols reveals that each study intends to complete interim and primary analyses that at most include 164 participants. These companies likely intend to apply for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) with just their limited preliminary results.
"Interim analysis success requires a seventy percent efficacy. For Moderna, the interim analysis includes giving the vaccine to only 53 people. Their success margin is for 13 or less of those 53 to develop symptoms compared to 40 or more in their control group. For Johnson & Johnson, their interim analysis includes 77 vaccine recipients, with a success margin of 18 or less developing symptoms compared to 59 in the control group. For AstraZeneca, their interim analysis includes 50 vaccine recipients, with a success margin of 12 or less developing symptoms compared to 19 in the 25 person control group. Pfizer is even smaller in its success requirements. Their initial group includes 32 vaccine recipients, with a success margin of 7 or less developing symptoms compared to 25 in the control group.
"The primary analyses are a bit more expanded, but need to be less efficacious for success: about sixty percent. AstraZeneca, Moderna, Johnson & Johnson, and Pfizer have primary analyses that distribute the vaccine to only 100, 151, 154, and 164 participants respectively. These companies state that they do not 'intend' to stop trials after the primary analyses, but there is every chance that they intend to pursue an EUA and focus on manufacturing the vaccine rather than further thorough testing.
"The second surprise from these protocols is how mild the requirements for contracted Covid-19 symptoms are. A careful reading reveals that the minimum qualification for a case of Covid-19 is a positive PCR test and one or two mild symptoms. These include headache, fever, cough, or mild nausea. This is far from adequate. These vaccine trials are testing to prevent common cold symptoms.
"These trials certainly do not give assurance that the vaccine will protect from the serious consequences of Covid-19. Johnson & Johnson is the only trial that requires the inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.... Again we find that severe illness and death are only secondary objectives in these trials. None list the prevention of death and hospitalization as a critically important barrier....
"There must be an indication that the authorized vaccines are reducing infection, hospitalization, and death, or else they will not be able to stop this pandemic.... It appears that these trials are intended to pass the lowest possible barrier of success.... It is clear from these studies that the vaccines currently under trial will not be the silver bullet needed to end the pandemic."
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