Title : Why You Should Be Concerned About the COVID-19 Vaccine 10-12-2020 Pamela A. Popper, President
link : Why You Should Be Concerned About the COVID-19 Vaccine 10-12-2020 Pamela A. Popper, President
Why You Should Be Concerned About the COVID-19 Vaccine 10-12-2020 Pamela A. Popper, President
The Forbidden COVID-19 Chronicles
Why You Should Be Concerned About the COVID-19 Vaccine
10-12-2020
Pamela A. Popper, President
Wellness Forum Health
William A. Haseltine is a former professor at Harvard Medical School and Harvard School of Public Health. While at Harvard, Dr. Haseltine founded two academic research departments - the Division of Biochemical Pharmacology and the Division of Human Retrovirology. He is best known for his work on cancer, HIV/AIDS, and genomics.
In a recent article, he discusses the highly unusual protocols being used by drug companies that expect to release a COVID-19 vaccine sometime during the next few months. According to Haseltine, the trials appear to be designed to make sure the vaccines appear to work when they may offer no real benefit at all.[1]
The purpose of a vaccine is to prevent infection, and to lower the possibility of hospitalization and death. But these endpoints are not being measured for any of the vaccines produced by Moderna, Pfizer, AstraZeneca, or Johnson & Johnson. Instead, the only endpoint being measured is the difference in symptoms between vaccinated and unvaccinated subjects who are infected with COVID-19.
Which symptoms are being evaluated? Those associated with the common cold such as headache, fever, cough, and mild nausea. The trials will, essentially, assure people that these vaccines prevent symptoms of common cold, not serious flu, or death from serious flu.
A major limitation of these trials is that vaccine efficacy generally requires trials that take place over a period of several years, and include between 30,000 and 60,000 participants. By comparison, the COVID trials are being completed in a very short period of time and include a few hundred patients.
Interim analysis is standard in vaccine trials, but it’s hard to imagine that much can be made of an analysis of such a small cohort. Moderna’s protocol only involves 53 vaccinated people; Johnson & Johnson’s protocol only includes 77 vaccinated subjects, and AstraZeneca’s interim analysis only includes 50 subjects. Pfizer’s initial group is the smallest with only 32 vaccinated people.
A 70% efficacy rate is considered "success." Based on this target, here is the threshold for each company in order to claim success:
Monderna: only 13 or fewer people out of 53 develop symptoms compared to 40 in the control group
Johnson & Johnson: 18 or fewer people out of 77 develop symptoms as compared to 59 in the control group
AstraZeneca: 12 or fewer people out of 50 develop symptoms as compared to 19 in the control group
Pfizer: 7 or fewer people out of 32 develop symptoms as compared with 25 in the control group
Summary: The drug companies can claim that their vaccines work by collectively showing that 50 or fewer vaccinated and infected people have milder symptoms of cold than unvaccinated and infected controls.
The requirements are not much more stringent for primary analysis, which requires that the four companies administer the vaccine to a total of only 569 subjects. All four companies state that they will continue trials after this point, but that they will pursue an Emergency Use Authorization (EUA) and invest more effort in manufacturing vaccines than in further testing.
The bottom line: Total infections, hospitalizations and deaths – the things people are most concerned about – will not be evaluated in these trials. Yet the National Institutes of Health, the Centers for Disease Control, and of course, Fauci’s agency – the National Institute of Allergy and Infectious Disease – seem to be ready to approve these vaccines anyway.
What About Side Effects?
A full report on side effects is not yet available, but there are some concerning preliminary reports. Results from Moderna’s Phase I trial showed that 100% of patients in the high-dose group experienced side effects including fatigue, chills, headache and muscle pain, and 21% had one or more severe events.[2]
CNBC reported that three subjects in the Moderna trial and two of Pfizer’s subjects had severe side effects. One Moderna patient told reporters, "If this proves to work, people are going to have to toughen up. The first dose is no big deal. And then the second dose will definitely put you down for the day for sure…You will need to take a day off after the second dose."
Another patient also reported severe side effects after the second Moderna dose. According to Luke Hutchison, age 44, just hours after the shot, he was bedridden with shakes, chills, a terrible headache, and shortness of breath.
Yet another Moderna patient reported a fever so high that he said, "I wasn’t sure if I needed to go to the hospital or not because 104 is pretty high."
A Pfizer subject reported flu-like symptoms after the second dose that became so severe that "It hurt to just lay in my bedsheet." He said he was shaking so hard that he cracked a tooth.[3]
Conclusion
It is important to remember, in considering side effects, that the patients in vaccine trials are younger and healthier than most of the people in the general public who will get these vaccines after approval.
Another important consideration is that vaccine makers are not liable for injuries or deaths resulting from their products due to immunity which was granted by Congress in 1986.
Last but not least, vaccine makers have never succeeded in making a flu vaccine that was effective. Even package inserts acknowledge this. For example, the package insert for FLULAVAL 2013-2014 formula for Influenza subtype A viruses and type B virus states, "…there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccinations with FLULAVAL."[4] With so few subjects and such a rushed time schedule it is almost impossible to think that a successful vaccine will result.
My Advice
Say no to this vaccine, and make sure that your children do not receive it either. If you live in a state that requires this vaccine in order to attend school, plan to home school. If your employer requires it, find a new job, or organize co-workers to refuse.
And join Make Americans Free Again (www.makeamericansfreeagain.com). We have the best plan for preventing new vaccine mandates and addressing those that have already been passed.
[1] William A Haseltine. "Covid-19 Vaccine Protocols Reveal That Trials Are Designed to Succeed." Forbes September 23 2020
[2] Jackson LA, Anderson EJ, Rouphael NG et al. "an mRNA Vaccine against SARS-CoV-2 – Preliminary Report." NEJM 2020 Jul DOI: 10.1056/NEJMoa2022483
[3] Christina Farr and Berkeley Lovelace Jr. "Coronavirus vaccine trial participants report day-long exhaustion, fever, and headaches – but say it’s worth it." CNBC Oct 1 2020
[4] Highlights of Prescribing Information FLULAVAL. http://www.fda.gov/.../Vac.../ApprovedProducts/UCM112904.pdf accessed 9.2.2020
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