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Opinion: mRNA Vaccines in Kids 5-11

From eNewsletter 10/27/2021

DID YOU KNOW that a first-of-its kind study from European Journal of Nutrition assessed whether vitamin C supplementation helped mental vitality in young adults? The double-blind, placebo-controlled study was conducted in healthy young adults (20–39 years), and analyzed the associations of serum vitamin C concentrations with vitality (fatigue and attention) and mood status (stress, depression, and positive and negative affect). Healthy subjects whose serum vitamin C concentrations were inadequate were randomly given 500 mg of vitamin C twice a day for 4 weeks or a placebo. Compared to the placebo, vitamin C supplementation significantly increased attention and work absorption with distinct tendency of improvement on fatigue and comprehensive work engagement. The authors concluded: "Inadequate vitamin C status is related to a low level of mental vitality. Vitamin C supplementation effectively increased work motivation and attentional focus and contributed to better performance on cognitive tasks requiring sustained attention." We love it!

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Editing Error Last week, I wrote about a JAMA Internal Medicine study about mRNA vaccine-related myocarditis. I wrote: "The conclusion was pretty much what we've said from the beginning about this issue. After one dose, myocarditis is very rare (5.8 per 1 million persons). After the second dose, based upon the current 3 week schedule, the risk goes up significantly (1 in 172,414 persons)." I should have written 0.8 per 1 million persons instead of 5.8.

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Have a happy, healthy day! Steve and Bonnie Minsky

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COVID-19 UPDATE

Steve: After listening to the FDA Advisory Committee meeting yesterday regarding Emergency Use Authorization (EUA) of the Pfizer mRNA vaccine for 5-11 year-olds, here is our what I discovered and our subsequent opinion. Highlights

  • For emergency use authorization, which means it cannot be mandated.

  • The dose is 1/3rd of what 12 year-olds and older receive.

  • The recommended time between the first and second dose is three weeks.

  • The decision was based upon one study of 1,500 5-11 year-olds, in which 750 were placebo.

  • Risk of myocarditis was significantly lower in 5-11 year-olds than in those 17 to 30 years-old.

  • There is no data that tracked rates of COVID-19 transmission after the second dose.

  • Safety was evaluated for only two months after the second dose was administered.

  • Study did not test children for naturally-acquired immunity before administering the vaccine.

Major Flaw The most alarming thing I heard was the buffering agent used in all other vaccine Pfizer formulations that preceded it was changed after the study began. Just so you can understand this more clearly: until now, every Pfizer mRNA vaccine included a PBS buffering agent as part of its formulation. Pfizer started their study in 5-11 year-olds with the PBS buffering agent. However, the formulation they want authorized does not use the PBS buffering agent. It uses a Tris buffering agent, which is different. While Pfizer explained this was a minor change to allow for storing the vaccine at lower temperatures and for longer periods of time, it is not an apples to apples comparison. Not only is the formulation different, the Tris buffering agent has only been used in three vaccines formulations prior to this. Even if what Pfizer said was true, I want to see data with the Tris buffering agent formulation before administering it to millions of children. Opinion While data showed vaccine effectiveness similar to older age groups, given that the committee says about 40% of this age group already has some form of COVID immunity, and data is not available using the Tris formulation, we do not recommend it for healthy 5-11 year-olds. Exceptions include children with:

  • Obesity;

  • Feeding tube dependence;

  • Immunocompromised children;

  • Children living in crowded conditions where many are unvaccinated;

If you choose to vaccinate your 5-11 year-old child:

  • Space out the first and second dose to six weeks minimum, but ideally 12 weeks;

  • If your child had COVID-19 already, we most definitely do not recommend a second dose;

  • Please follow our pre- and- post injection protocol that can be found at Our COVID Vaccine Opinion page.

Merck's COVID-19 Pill Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild-to-moderate COVID. The drug works by creating mutations in the virus's genome, halting the ability of the virus to replicate. The Merck trial was only performed on 775 patents. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. Here's a reality check: it's not exactly like penicillin for strep throat. The 50% reduction is not as effective as the benefit for Regeneron's intravenous monoclonal antibody treatment, which reduced COVID-19-related hospitalization or death in high-risk patients by 70%. The fact that the COVID-19 pill can be taken at home is a plus, but we need to be more data than one Merck-sponsored 775 person trial. Omega-3 In older adults with COVID-19 infections, treatment with omega-3 fatty acids significantly reduced levels of proinflammatory agents, according to results of a Frontiers in Physiology study. The patients were randomized to receive an intravenous infusion of an omega-3 emulsion containing 10 grams of fish oil per 100 mL or a saline placebo. Those who received the intravenous infusion had significant decreases in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation. In contrast, patients randomized to a saline placebo had no significant improvements. As part of our COVID-19 treatment protocol, we suggest a fish oil that contains high doses of specialized pro-resolvin mediators (SPMs), which help to resolve the inflammation phase, much as the intravenous solution did in this study. Quercetin A recent study from International Journal of General Medicine found that quercetin statistically shortens the timing of molecular test conversion from COVID-19 positive to negative, reducing at the same time symptoms severity and negative predictors of COVID-19. In the same journal, another study found that quercetin is a safe agent and in combination with standard care, when used in early stage of viral infection, could aid in improving the early symptoms and help in preventing the severity of COVID-19 disease. Andrographis In the face of an emergency situation, the Thailand Corrections Department gave the herbal remedy andrographis to 11,800 inmates with confirmed mild cases of COVID-19 and claim that 99% of them recovered, prompting the Thai Ministry of Higher Education, Science, Research and Innovation to recommend that asymptomatic patients take 180 mg of andrographis daily, divided into three doses at mealtimes. Study data is to be released by the Thai government soon. Andrographis has been our "go-to" as soon as you feel sick and has been pivotal in staving off not just severe COVID-19, but other infections as well. Melatonin A study from International Journal of Infectious Diseases examined a group of patients with severe COVID-19. The intervention group receiving 10 mg melatonin in addition to standard care versus a group who did not take melatonin. In comparison to the control group, thrombosis and sepsis developed significantly less frequently in the melatonin group during the second week of infection, while mortality was significantly higher in the control group. GI-Related COVID-19 Symptoms COVID-19 can wreak havoc in all organ systems, including crushing gastrointestinal symptoms. A new study from Biorxiv suggests treating these patients with the antifungal Nystatin could block the replication of SARS-CoV-2 in the gastrointestinal tract and reduce the length and severity of the infection. Long-Term Immune Memory According to a new study in Biorxiv, antiviral specific immunity, especially from memory B cells in COVID-19 recovering patients is long-lasting (still measurable at 15 months after infection), but the Delta variant may at least partially escape the neutralizing activity. As we have said from the beginning, much like influenza, those who had COVID-19 will get sick again, but some immune cell memory will be able to fight it without severe illness and death in healthy persons. Two New Areas of Focus in Ameliorating COVID-19 Infection A fascinating study from International Journal of Immunopathology and Pharmacology has discovered that overactivity of histamine and serotonin in those with severe COVID-19 may often lead to symptoms that persist for weeks and months. If confirmed with other research, a temporary low histamine and serotonin regime may benefit those with post-COVID syndrome. This is why we also recommend every person take an antihistamine before each COVID-19 vaccination.