Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed
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, 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. Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. 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. Measuring differences amongst only those infected by SARS-CoV-2 underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.
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 only that they prevent moderate symptoms which may be as mild as cough, or headache.
The greatest fear people have is dying from this disease. A vaccine must significantly or entirely reduce deaths from Covid-19. Over two hundred thousand people have died in the United States and nearly a million worldwide. None list mortality as a critical endpoint.
We recognize that the influenza vaccine does not prevent infection with that virus, but does have a measurable impact on hospitalization and death. The moderate protections from the influenza virus can potentially be replicated and improved on with Covid-19, but only with extensive trials that ensure the efficacy of a future vaccine.
Vaccine efficacy is typically proved by large clinical trials over several years. The pharmaceutical companies intend to do 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. The vaccine or placebo will be given to thousands of people in each trial. For Moderna, the initial interim analysis will be based on the results of infection of only 53 people. The judgment reached in interim analysis is dependent upon the difference in the number of people with symptoms, which may be mild, in the vaccinated group versus the unvaccinated group.
Moderna’s 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.
One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection. If someone takes this vaccine, are they far less likely to become infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-19, and not infections themselves. Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance.
It appears that all the pharmaceutical companies assume that the vaccine will never prevent infection. Their criteria for approval is the difference in symptoms between an infected control group and an infected vaccine group. They do not measure the difference between infection and noninfection as a primary motivation.
A greater concern for the millions of older people and those with preexisting conditions is whether these trials test the vaccine’s ability to prevent severe illness and death. 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.
If total infections, hospitalizations, and death are going to be ignored in the preliminary trials of the vaccines, then there must be phase four testing to monitor their safety and efficacy. This would be long term massive scale monitoring of the vaccine. 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.
These protocols do not emphasize the most important ramifications of Covid-19 that people are most interested in preventing: overall infection, hospitalization, and death. It boggles the mind and defies common sense that the National Institute of Health, the Center for Disease Control, the National Institute of Allergy and Infectious Disease, and the rest would consider the approval of a vaccine that would be distributed to hundreds of millions on such slender threads of success.
It appears that these trials are intended to pass the lowest possible barrier of success. As this is being written, the FDA is poised to announce tougher standards for a Covid-19 vaccine in the near future. It is my hope that these new standards for an EUA will at a minimum include requirements for protections from infection itself, protections from severe virus-related disease leading to hospitalization, and a significant improvement in Covid-19 related mortality.
It is clear from these studies that the vaccines currently under trial will not be the silver bullet needed to end the pandemic. We must do all we can public health measures to control Covid-19 as China and other Asian countries have successfully done.
Correction (10/7/20): A former version of the article stated that 53 people received a vaccination for interim analysis in the Moderna trial. The vaccine was in fact given to thousands of people, with 53 being the number of people who must be infected with Covid-19 to run the analysis.
About the author: William A. Haseltine is a scientist, businessman, author, and philanthropist. For nearly two decades, he was a professor at Harvard Medical School and Harvard School of Public Health where he founded two academic research departments, the Division of Biochemical Pharmacology and the Division of Human Retrovirology. He is perhaps most well known for work on cancer, HIV/AIDS, genomics and, today, on COVID-19. His autobiography, My Lifelong Fight Against Disease, publishes this October. He is chair and president of ACCESS Health International, a nonprofit organization.
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richard
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WHO recommendations for lock down and track and trace in 2019- “Not recommended”
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Charles Higley
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“The moderate protections from the influenza virus can potentially be replicated and improved on with Covid-19,”
It’s not that easy in that influenza has marker proteins HxNy that they use when developing vaccines. Cooronaviruas, like influenza, are RNA viruses and mutate very rapidly. Any vaccine made now would, of course, lose effectiveness relatively quickly, if it was at all effective in the first place.
It is not as if we have not been trying for decades to make vaccines against coronaviruses. It’s not easy and not going to be accomplished quickly, if at all.
If the PCR test is used on the vaccine test group to monitor C-19, the whole thing becomes a joke. The PCR test is not specific for a single virus but detects coronaviruses in general, the common cold rhinovirus, and even some human genetic sequences. It is simply not fit for purpose and it is egregiously damaging to pretend it is a good test and infallible, which is how the politicians and poets that be clearly consider it.
As no one anywhere has isolated a virus and shown that it causes the symptoms claimed for C-19, it is impossible to produce an effective virus. At best, it might be against coronaviruses in general, but it is a LIE to pretend that it is targeted against a specific virus, let alone C-19.
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Tom O
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Well written but why bother? The first and biggest tissue with this is that it assumes that there IS such a thing as SARS-CoV-2. Until proven that it is such a thing, trying to design criteria for it’s vaccine is sort of like whistling in a hurricane Now, with regards to the criteria that has been set up for these vaccines, they make absolute sense. two bits of comments made in this article –
“These trials seem designed to prove their vaccines work, even if the measured effects are minimal.
The greatest fear people have is dying from this disease. A vaccine must significantly or entirely reduce deaths from Covid-19. Over two hundred thousand people have died in the United States and nearly a million worldwide. None list mortality as a critical endpoint.”
First, these “vaccines” have no virus, as yet, to work on, so it doesn’t matter if they work. Since most people get sick and don’t know they have it because the effects were so slight, the vaccine will have worked.
Second, regarding the fear of death – the vaccines will work perfectly regarding reducing deaths. They will go back to reporting flu deaths as flu, pneumonia deaths as pneumonia, and COVID deaths will drop like a rock, so obviously, the vaccines will have worked.
The only unanswered question will be, of course, will not be whether or not the vaccines worked against a virus that doesn’t exist, it will be what were the real components in the vaccine that were the intended things to be delivered to the vaccinated? Will we be the same afterwards or not, or is there some other agenda that has been fulfilled that we can’t even guess?
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Tom O
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Every notice how you can write something so stupid and not notice it until you hit the submit button? When I wrote biggestissue, then went back and put a space in the run on word, I didn’t notice that I left the t on issue, thus added a to bigges to make it correct. SO, that is “issue” not “tissue.”
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Alan
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Finally, some common sense about these trials. I suspect the government will pass laws ensuring that we must accept the vaccine. They will have to catch me and tie me down first.
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Michael Abbott
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This will be misunderstood by the general public and could lead to an increase in the infection rate as people will think they are protected and stop taking measures to scale distance etc. This is a dangerous step but will still be promoted by governments as big pharma will do their best to maintain the ignorance of our politicians
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Brian James
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Nov 7, 2020 Healthcare Worker Exposes Real Covid-19 Cases
My talk with Healthcare Worker Shelley Tasker who has exposed the truth about hospital Covid19 cases.
https://youtu.be/YN_t5oKPESA
OCTOBER 30, 2020 Dr. Simone Gold: I DO NOT CONSENT!
By Neenah Payne Note: This article is for informational purposes only and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider.
https://www.naturalblaze.com/2020/10/dr-simone-gold-i-do-not-consent.html
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Betty Boop
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Included link to paper in WHO’s Bulletin, published 14 October 2020, by Professor John P A Ioannidis of Standford.
https://who.int/bulletin/online_first/BLT.20.265892.pdf
https://profiles.stanford.edu/john-ioannidis
Publication: Bulletin of the World Health Organization; Type: Research Article ID: BLT.20.265892
The infection fatality rate of COVID-19 tended to be much lower than estimates made earlier in the pandemic. If one could sample equally from all locations globally, the median infection fatality rate might be even substantially lower than the 0.23% observed in my analysis.
Acknowledging these limitations, based on the currently available data, one may project that over half a billion people have been infected as of 12 September, 2020, far more than the approximately 29 million documented laboratory-confirmed cases. Most locations probably have an infection fatality rate less than 0.20% and with appropriate, precise non-pharmacological measures that selectively try to protect high-risk vulnerable populations and settings, the infection fatality rate may be brought even lower.
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JG
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Dear Bill
You are a virologist. What vaccine in history did prevent infection? You know the answer: Not a single one. This is not about infection. It is about viral spread and disease. A vaccine, as you might know, does prime an immune system to fight an intruder. It cannot prevent infection. It may, however, prevent severe disease (for the recipient) or spread (to your spouse/neighbor/client …).
As do other precautions. I like to cite a British colleague: “It’s a piece of cloth, not a land mine.”
Best
JG
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