Moderna Boosters
Moderna will soon unleash their latest arsenal of injections as the company prepares to inculcate the public with a third booster. This time however, the company suggests half doses, as opposed to Pfizer, suggesting a third full dose for the full regiment.
Moderna sent an amendment request to the FDA to expand their current standing emergency use authorization. Moderna said it chose a “lower dose” booster because it reduces the risk of vaccine reactions, and allows greater distribution to the global vaccine supply.
Moderna applied for FDA authorization of a booster dose on September 1st, 2021. Data from June 10th, 2021, during the Open-Label Portion (Part B) of Moderna’s Ongoing Phase 2 Clinical Trial involved 171 participants, that were injected with 50 micrograms mRNA 1273 booster shots six months after being given a two-dose mRNA 1273primary series.
A look a Moderna’s patient website shows that both the double dose coronavirus vaccines, and the new booster shot describes the emergency use authorization of the medical products.
“The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA- approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.”
Moderna’s Clinical Trial Data [From Double Dose Vaccines] -
Moderna’s clinical trial involved 30,420 participants, randomized 1:1 by vaccines and placebo. By the end of the experiment, 11 participants who received the vaccines became infected with coronavirus, while 185 who received the placebo tested positive for COVID-19. The participant’s health was surveilled for two years after the injections, per protocol occurrence of COVID, with or without symptoms
This data resulted in Moderna’s vaccine efficacy rate set at 94.1%. Unfortunately, the duration of protection is not fully known, as the company begins to promote third doses to those applicable.
How effective are Moderna’s boosters?
While the company states their vaccines are 94.1% effective against contracting COVID-19, how effective are the booster shots? How long will the effectiveness of the original injections last?
The company Moderna states,
“Effectiveness of a booster dose with a COVID-19 vaccine can be evaluated based on the efficacy of the manufacturer’s authorized prototype vaccine made by the same manufacturing process and for which a clinical disease endpoint efficacy study has been conducted that met FDA’s pre-specified success criteria. A determination of effectiveness of a booster dose should be supported by conducting clinical immunogenicity studies. Based on available data in humans and animal models, FDA considers neutralizing antibody titers (a functional measure of the vaccine immune response against SARS-CoV-2) to be clinically relevant for immunobridging to infer effectiveness of a booster dose of COVID-19 vaccines. Because no specific neutralizing antibody titer has been established to predict protection against COVID-19, two immunogenicity endpoints (geometric least squares mean titer and seroresponse rate) are considered appropriate for comparing the range of neutralizing antibody responses elicited by a booster dose vs. after completion of the primary series.”
Reported Side-effects
Moderna’s vaccine is not without side effects. Though most serious side effects reported involved a small percentage, a sufficient portion of Moderna patients did share a common range of side effects. Here is what to expect with Moderna mRNA and booster vaccines:
For patients willing to participate in their continuously evolving mRNA injection process, Moderna’s mRNA vaccine’s common reported side effects include,
Pain at injection site (92.0%)
Fatigue (70.0%)
Headache (64.7%)
Myalgia (61.5%)
Arthralgia (61.5%)
Chills (45.4%)
Nausea/vomiting (23%)
Axillary swelling/tenderness (19.8%)
Fever (15.%)
Moderna’s “Vaccine” Ingredients
What are ingredients of the Moderna vaccine?
The Moderna COVID-19 Vaccine, and booster, contains the following ingredients:
messenger ribonucleic acid (mRNA)
lipids
SM-102
polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG]
cholesterol,
1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC])
tromethamine
tromethamine hydrochloride
acetic acid
sodium acetate trihydrate
sucrose.
SM-102
What is SM-102?
SM-102 is a synthetic lipid used in combination with other lipids (fat vesicles) to form a nanoparticle for use with mRNA delivery. This very artificial substance is [partially] responsible for the effectiveness of Moderna’s mRNA concoction.
The safety data sheet for the substance, as written by SM-102’s manufacturer and supplier, Cayman Chemical Co. located in Ann Arbor, Michigan. Cayman Chemical’s product safety department, defines SM-102as “Not for human or veterinary diagnostic or therapeutic use. It is the responsibility of the purchaser to determine suitability for other applications.”
SM-102 is classified and labeled according to the Global Harmonized System, with GHS06 Skull and crossbones (toxic if swallowed, toxic if inhaled), as well as [GHS02] highly flammable. The Safety Data Sheet for the substance SM-102 states it is also label SM-102 with GHS08 citing the substance as a“Health hazard” claiming it “may cause cancer.”
SM-102 is also known to cause the following acute and delayed symptoms:
Anemia
Cough
CNS Depression
Drowsiness
Headache
Heart Damage
Lassitude (weakness, exhaustion)
Liver Damage
Narcosis
Reproductive “effects”
Teratogenic “effects”
First aid measures include, as cited by the OSHA HCS safety data sheet, “In case of irregular breathing, or respiratory arrest provide artificial respiration. In case of unconsciousness place patient stably in side position for transportation.” stating that there was “no further relevant information available” on the chemical.
Read the full SM-102 Safety Data Sheet here
Statements
“It's more a gut feeling rather than based on really truly serious data," said Patrick Moore, a member of the committee and a professor of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. "The data itself is not strong, but it is certainly going in the direction that is supportive of this vote."
National Institutes of Health -
“I don’t really see a need for a ‘let it rip’ campaign for everyone,” said Dr. Michael Kurilla of the National Institutes of Health National Center for Advancing Translational Sciences
Dr. Kurilla added, "I'm very uncomfortable with the language in the midst of pandemic and with limited supply available, a blanket statement for 18 and older is too broad,"
“The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh.
“I’m uncomfortable with how we’ve sort of tripped down the line for the thought of universal booster dosing, which I just think is wrong,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
"If we're trying to prevent what is inevitable, which is a decline in neutralizing antibodies and an erosion in protection against mild or asymptomatic infection, that is a high bar to which we hold no other vaccine," said Dr. Paul Offit.
Conclusion
Moderna’s vaccines have shown their effectiveness despite also displaying their side effects. While the longevity and long term effects of these mRNA concoctions still have yet to reveal themselves, humanity gains a deeper understand of the operating of our complex genome with each day.
While mRNA is a breakthrough technology that could potentially have the power to end disease globally, the long term effects of continuous temporary DNA manipulation (the forced short-term production of proteins, not a permanent change to DNA) have yet to be seen. How does mRNA’s artificial impact of gene activity effect the natural immunity response of the human genome?
Although science can be a necessary element for survival, that often borders the cusp of social ethics, it also provides opportunity for corruption, under the guise of “medical research.”
As the race to gain approval for the incoming fleet of booster shots continues, how will mutating the definition of “fully vaccinated”, effect COVID-19 vaccine statistics? How many boosters will be ultimately required, and for how long? Should choosing not to take a emergency use authorization vaccine, (or any vaccine) be an individual right?