I can’t tell you how many times I’ve been asked this question, “should I take the COVID-19 Vaccine?”,”is the COVID vaccine safe.” I want to share some “opinions” from medical journals and some good articles and you can do a deeper dive on the links I’m giving you.
Disclaimer: I’m not a vaccine expert. I’m not suggesting that you do not get the vaccine. I’m an educator and feel it is my role to educate you so you can make an informed decision.
A good article by William Haseltine, former Harvard Medical School professor, sums up one of my concerns. The size of the group with which efficacy would be proven is important to look at.
“Both Pfizer and Moderna have touted the large number of participants in their trials, at upwards of 30,000 participants slated for each. But while the full trial sizes might be large, the protocols suggest that efficacy can be proved in an initial test group of just 106 for the Moderna vaccine and in a group of 64 for Pfizer. But keep in mind, only half of each group receives the vaccine, the other half receives a placebo.”
Another concern, these clinical trials have been designed to ensure the greatest possible success for these candidates — and that could overstate their effectiveness. In both trials the objective is to prevent any occurrence of COVID-19, not necessarily a severe case. Yet it is the severe cases that have caused over a million people worldwide to die of COVID.
These candidates were not the “high risk” group that is having severe symptoms and even death from COVID. Should these trials have included the elderly, immune-compromised, diabetics, and those with auto-immune disorders? You have probably heard that these groups are at a higher risk of severe symptoms and death, and yet the trial participants consisted mostly of younger, healthier adults.
“Are the right endpoints being studied? Contrary to prevailing assumptions, none of the vaccine trials are designed to detect a significant reduction in hospital admissions, admission to intensive care, or death. Rather than studying severe disease, these mega-trials all set a primary endpoint of symptomatic covid-19 of essentially any severity: a laboratory positive result plus mild symptoms such as cough and fever count as outcome events. These studies seem designed to answer the easiest question in the least amount of time, not the most clinically relevant questions.”
Reactions to the Vaccine
You may have heard of some of the reactions people are having to the vaccine. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer to conduct immunogenicity (Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body ) testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?
However, despite the FDA’s own guidance recommending that information about immunogenicity be included on the vaccine package inserts, no such information is included on either the Pfizer-BioNTech or Moderna COVID-19 vaccine inserts. The immune response by individuals can vary greatly, from none to extremely dangerous.
I recently read an article by the Weston A. Price Foundation called COVID-19 Vaccines: Important Points and it brought up some of the same concerns we are reading in other articles. What was good though, was another article written in rebuttal by Biosciences PhD and MD students at Stanford entitled Safety and Efficacy of the COVID-19 Vaccine. This shows us that not everything we are reading is accurate and we must take into consideration all sides of the story.
British Medical Journal
In a recent article in the British Medical Journal, dated October 21, 2020, which was before the release of the vaccine, the author shares his concerns. I’ll share a few quotes from that article.
“There is much to critique.” “None of the vaccine trials are designed to detect a significant reduction in hospital admissions, admission to intensive care, or death.” “Sixty years after influenza vaccinations became routinely recommended for people aged 65 or older in the US, we still don’t know if vaccination lowers mortality. Randomized trials with this outcome have never been done.” “Rather than studying severe disease, these mega-trials all set a primary endpoint of symptomatic COVID-19, mild to severe outcome events.”
Another good article in the British Medical Journal, Will COVID-19 vaccines save lives?, again reveals that they are not designed to do that. Wouldn’t you want a vaccine to be an assurance that you won’t get a severe case of COVID?
A great article was written by Lynn Redwood, RN, MSN, entitled 5 Questions Fauci and the FDA Need to Answer on Pfizer and Moderna Vaccines, brings up the concern of one of the ingredients in the vaccines called PEG (polyethylene glycol). I’ll quote her here….“In our letter to the FDA, Children’s Health Defense recommended that additional steps must be taken to reduce the risk of exposing trial participants to a substance (PEG) to which up to 72% of the U.S. population may have pre-existing antibodies.” I bet you’ve never heard of PEG, I hadn’t.
I do believe we still have many questions about the vaccine that are going unanswered as it’s rushed to the public.
A colleague of mine, Dr. Jim McAfee, PhD, Clinical Nutritionist, shared this summary which shares my questions and concerns as well.
- The vaccine has NOT been tested on children, pregnant women, people taking medications, and individuals with comorbidities (two or more diseases), yet the plan is for all of the above to receive the vaccine.
- Pfizer doesn’t plan to release the results data for independent scrutiny for another 2 years (as they track the vaccinated.)
- Pfizer did not assess vaccine reactions in all 43,000 participants (just a random subset of 8000)
- Pfizer only reported severe reactions that occurred in more than 2% (860 people). In other words, if 800 people suffered a severe immune reaction, they did not have to report it because it occurred in less than 2%.
- Pfizer will not submit the study for peer-review until they’ve completed their analysis of safety data. Let that sink in – the vaccine is approved and they have not finished analyzing the data.
Obviously, this is a very personal decision. As I continue to read articles and research papers I will keep you informed!
On a Positive Note….
We traveled to Texas for a week at Thanksgiving and we traveled to Oregon for a week after Christmas and no colds, flu, or COVID! Continue to stay up on all your immune support, sleep, lowered stress, and get some sunshine if it comes out where you live!
Here’s to a great 2021!! (I’m believing it’s going to be a good one:-)
Beware of COVID Vaccine Trials Designed to Succeed from the Start, William Haseltine, Washington Post, September 22, 2020, https://www.washingtonpost.com/opinions/2020/09/22/beware-covid-19-vaccine-trials-designed-succeed-start/
COVID-19 Vaccine Trials Protocol Released, Peter Doshi, BMJ 2020;371:m4058
Will COVID Vaccine Save Lives?, Peter Doshi, BMJ 2020;371:m4037
5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines, Lyn Redwood, RN, MSN, The Defender, 12/23/20, https://childrenshealthdefense.org/defender/fauci-fda-pfizer-moderna-covid-vaccines/