New Face Mask Harms and COVID Vaccines Approved Without Any Clinical Trials
The CDC and FDA know best.
There are a number of new papers out about face masks that are worth reading. So today’s Substack highlights those papers, followed by a summary and conclusions.
I end today’s Substack with an expose by Steve Kirsch, who found some astounding governmental corruption over at the FDA.
Possible toxicity of chronic carbon dioxide exposure associated with face mask use, particularly in pregnant women, children and adolescents - A scoping review
Heliyon 2023 Apr;9(4):e14117. doi: 10.1016/j.heliyon.2023.e14117. Epub 2023 Mar 3.
Abstract
Introduction: During the SARS-CoV-2-pandemic, face masks have become one of the most important ubiquitous factors affecting human breathing. It increases the resistance and dead space volume leading to a re-breathing of CO2. So far, this phenomenon and possible implications on early life has not been evaluated in depth.
Method: As part of a scoping review, literature was systematically reviewed regarding CO2 exposure and facemask use.
Results: Fresh air has around 0.04% CO2, while wearing masks more than 5 min bears a possible chronic exposure to carbon dioxide of 1.41% to 3.2% of the inhaled air. Although the buildup is usually within the short-term exposure limits, long-term exceedances and consequences must be considered due to experimental data. US Navy toxicity experts set the exposure limits for submarines carrying a female crew to 0.8% CO2 based on animal studies which indicated an increased risk for stillbirths. Additionally, mammals who were chronically exposed to 0.3% CO2 the experimental data demonstrate a teratogenicity with irreversible neuron damage in the offspring, reduced spatial learning caused by brainstem neuron apoptosis and reduced circulating levels of the insulin-like growth factor-1. With significant impact on three readout parameters (morphological, functional, marker) this chronic 0.3% CO2 exposure has to be defined as being toxic. Additional data exists on the exposure of chronic 0.3% CO2 in adolescent mammals causing neuron destruction, which includes less activity, increased anxiety and impaired learning and memory. There is also data indicating testicular toxicity in adolescents at CO2 inhalation concentrations above 0.5%.
Discussion: There is a possible negative impact risk by imposing extended mask mandates especially for vulnerable subgroups. Circumstantial evidence exists that extended mask use may be related to current observations of stillbirths and to reduced verbal motor and overall cognitive performance in children born during the pandemic. A need exists to reconsider mask mandates.
Physio-metabolic and clinical consequences of wearing face masks-Systematic review with meta-analysis and comprehensive evaluation
Front Public Health 2023 Apr 5;11:1125150. doi: 10.3389/fpubh.2023.1125150
Abstract
Background: As face masks became mandatory in most countries during the COVID-19 pandemic, adverse effects require substantiated investigation.
Methods: A systematic review of 2,168 studies on adverse medical mask effects yielded 54 publications for synthesis and 37 studies for meta-analysis (on n = 8,641, m = 2,482, f = 6,159, age = 34.8 ± 12.5). The median trial duration was only 18 min (IQR = 50) for our comprehensive evaluation of mask induced physio-metabolic and clinical outcomes.
Results: We found significant effects in both medical surgical and N95 masks, with a greater impact of the second. These effects included decreased SpO2 p < 0.001) and minute ventilation (p < 0.001), simultaneous increased in blood-CO2 (p < 0.001), heart rate (N95: p = 0.02), systolic blood pressure (surgical: p = 0.02), skin temperature (p = 0.006) and humidity (p < 0.001). Effects on exertion, discomfort , dyspnoea, heat, and humidity were significant in n = 373 with a robust relationship to mask wearing (p < 0.006 to p < 0.001). Pooled symptom prevalence (n = 8,128) was significant for: headache (62%, p < 0.001), acne (38%, p < 0.001), skin irritation (36%, p < 0.001), dyspnoea (33%, p < 0.001), heat (26%, p < 0.001), itching (26%, p < 0.001), voice disorder (23%, p < 0.03), and dizziness (5%, p = 0.01).
Discussion: Masks interfered with O2-uptake and CO2-release and compromised respiratory compensation. Though evaluated wearing durations are shorter than daily/prolonged use, outcomes independently validate mask-induced exhaustion-syndrome (MIES) and down-stream physio-metabolic disfunctions. MIES can have long-term clinical consequences, especially for vulnerable groups. So far, several mask related symptoms may have been misinterpreted as long COVID-19 symptoms. In any case, the possible MIES contrasts with the WHO definition of health.
Conclusion: Face mask side-effects must be assessed (risk-benefit) against the available evidence of their effectiveness against viral transmissions. In the absence of strong empirical evidence of effectiveness, mask wearing should not be mandated let alone enforced by law.
Face mask recommendations in schools did not impact COVID-19 incidence among 10-12-year-olds in Finland - joinpoint regression analysis
BMC Public Health 2023 Apr 21;23(1):730. doi: 10.1186/s12889-023-15624-9.
Abstract
Background: In autumn 2021 in Finland, a recommendation to use face masks was implemented nationwide in schools for pupils ages 12 years and above. While national guidelines were in form of recommendations, cities implemented mandatory masking in schools. Some cities extended this mandate for younger pupils as well. Our aim was to compare COVID-19 incidence among 10-12-year-olds between cities with different recommendations on the use of face masks in schools…
Conclusions: According to our analysis, no additional effect was gained from mandating face masks, based on comparisons between the cities and between the age groups of the unvaccinated children (10-12 years versus 7-9 years).
Physical interventions to interrupt or reduce the spread of respiratory viruses
Cochrane Database Syst Rev 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection.
The Cochrane Reviews are considered the Gold standard of meta analyses.
Current CDC Face Mask Recommendations from their website
(accessed April 26, 2023:
Yes, these are their current recommendations!
At the airport this morning, many people, including children are still wearing face masks. If an adult choses to wear a face mask, that is their choice. But children are different. They don’t have a choice.
The time is past for the CDC to come clean and admit that they were wrong about face masks.
It is systemic child abuse by the US Government to continue to advocate that children wear masks. We have hard data that masks are ineffective at stopping the spread of COVID-19 and other respiratory diseases. We have hard data that the adverse events from mask wearing are significant and some of those may be permanent. We have hard data that mask mandates on children in schools did nothing to stop the spread of COVID-19.
Their website needs to be updated immediately to reflect the science on face mask use.
Parents must be educated about the dangers of face masks. This is the responsibility of public health, the CDC to do so immediately. It is our responsibility to kindly inform our friends, neighbors and family of the dangers to children when wearing face masks. No matter how uncomfortable it may be.
At the state level, we need to work on our state legislators and the attorney generals to insist that schools and parents are educated about the dangers of mask use.
Finally, the brilliant Steve Kirsch and his ability to detect patterns (as well as BS) has pulled the pieces together to show that the FDA is again cooking the books on the COVID-19 vaccines.
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
So, Steve is absolutely correct.
Without any clinical trials for safety or efficacy, the FDA has approved the bivalent vaccine for unvaccinated adults.
Who needs clinical trials anyway?
Our government paid physicians extra - the higher the percentage of patients that got jabbed, the more $$$ physicians got in their bonuses … sick.
What more can we all say and do, Dr Malone. This information (and so much more) is readily available for all to see! People are not seeing! As they say, you can lead a horse to water, but you can't make it drink.
Congrats experts, you have arrived where we did three years ago.