MODERNA COVID 19 vax leaflets continued More data!!! Singapore, FDA and Canada
The leaflet hunt is about this:
I think it sets a basis of what ‘countries’, governments and regulators knew. It sets out that that differential knowledge was NOT disseminated to the public, to the doctors and nurses injecting and the administration through media pushing it.
And since we have data points of actual knowledge, then these leaflets also show data OMMISSION.
I think it sets a basis for differential ‘knowledge’ and the differential availability of that knowledge. It set’s up a Nuremberg type of evidence system for the informed consent: either totally retained at source and not disseminated, or provided with limited information, or even without available content.
I am exposing it as a form of liability since it is a public disclosure on which to base allegations of lack of informed consent.
When you get asked to take the BIRD FLU HOLOMODOR HUNGER GAMES VACCINE, let’s hunt for their world disclosure or leaflet system.
Here is FDA’s:
“Side effects that have been reported in clinical trials with SPIKEVAX and Moderna COVID-19 vaccines include:
• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, and rash
Other side effects that have been reported include:
• Severe allergic reactions
• Urticaria (itchy rash/hives)
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)
• Fainting in association with injection of the vaccine
These may not be all of the possible side effects of SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.”
https://www.fda.gov/media/155762/download
Here is SINGAPORE SPIKEVAX OMNICRON LEAFLET INFORMATION.
2. What you need to know before you are given Spikevax bivalent Original / Omicron
The vaccine must not be given if
- you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Spikevax bivalent Original / Omicron if:
- you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given Spikevax in the past.
- you have any allergies
- you have a very weak or compromised immune system
- you have ever fainted following any needle injection.
- you have a bleeding disorder
- you have a fever
- you are pregnant or plan to be pregnant
- you are breastfeeding
- you have any serious illness
- you have received another COVID-19 vaccine
- if you have anxiety related to injections
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Spikevax (original) (see section 4).
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males.
The chance of having this occur is very low. You should avoid strenuous physical activity for two weeks after vaccination. You should seek medical attention right away if you have any of the following symptoms after receiving Spikevax bivalent Original / Omicron:
• Chest pain
• Shortness of breath
• Feelings of having a fast-beating, fluttering, or pounding heart
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Spikevax bivalent Original / Omicron.
As with any vaccine, a booster dose of Spikevax bivalent Original / Omicron may not fully protect all those who receive it and it is not known how long you will be protected.
(LL: UNKNOWN EFFICACY- AS WITH ALL VACCINES????)
Children and adolescents
Spikevax bivalent Original / Omicron is not recommended for children aged under 18 years. Other medicines and Spikevax bivalent Original / Omicron
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax bivalent Original / Omicron may affect the way other medicines work, and other medicines may affect how Spikevax bivalent Original / Omicron works.
Immunocompromised individuals
If you are immunocompromised, you may receive a third dose of Spikevax. The efficacy of Spikevax even after a third dose may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Driving and using machines
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines. Spikevax bivalent Original / Omicron contains sodium
Spikevax bivalent Original / Omicron contains less than 1 mmol (23 mg) sodium per dose and, that is to say, essentially ‘sodium-free’.
3. How you will be given Spikevax bivalent Original / Omicron
Table 1.Spikevax bivalent Original / Omicron dosing for booster doses
Vaccination Spikevax bivalent Original / Omicron 0.1 mg/mL
Booster dose Adults 18years of age and older: 0.5 mL
Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.
During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for around 30 minutes to monitor for signs of an allergic reaction.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:
- feeling faint or light-headed;
- changes in your heartbeat;
- shortness of breath;
- wheezing;
- swelling of your lips, face, or throat;
- hives or rash;
- nausea or vomiting;
- stomach pain.
Talk to your doctor or nurse if you develop any other side effects. These can include:
Very common (may affect more than 1 in 10 people):
- swelling in the underarm
- headache
- nausea
- vomiting
- muscle ache, joint aches, and stiffness
- pain or swelling at the injection site
- redness at the injection site (some of which may occur approximately 9 to 11 days after the injection)
- feeling very tired
- chills
- fever
Common (may affect up to 1 in 10 people):
- rash
- rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the injection)
Uncommon (may affect up to 1 in 100 people):
- itchiness at the injection site
- dizziness
Rare (may affect up to 1 in 1,000 people)
- temporary one-sided facial drooping (Bell’s palsy)
- swelling of the face (Swelling of the face may occur in patients who have had facial cosmetic injections.)
- decreased sense of touch or sensation
- unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
- raised, itchy rash (urticaria) (some of which may occur approximately 7 to 13 days after the injection)
Very rare (may affect up to 1 in 10,000 people)
- inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain
Frequency unknown
- severe allergic reactions (anaphylaxis)
- hypersensitivity
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.”
WHAT IS IN THE SINGAPORE SHOT?
éOne dose (0.5 mL) contains 25 micrograms of
elasomeran, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles), and 25 micrograms of imelasomeran, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles).
Elasomeran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS--CoV-2.
Imelasomeran is mRNA, 5’-capped, encoding a full-length, codon-optimised pre-fusion stabilised conformation variant (K983P and V984P) of the SARS-CoV-2 spike (S) glycoprotein (Omicron variant, B.1.1.529).
The other ingredients are lipid SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG), trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.”
But the kicker has to be the Canadian Publication leaflet I located HERE. It is 52 pages of content. Did your Canadian Doctor, pharmacist, nurse, teacher, etc. have it. Well maybe because of you they do have it.
SPECIAL POPULATIONS:
“7.1.1 Pregnant Women
The safety and efficacy of SPIKEVAX Bivalent in pregnant women have not yet been established. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SPIKEVAX Bivalent during pregnancy. Women who are vaccinated with SPIKEVAX Bivalent during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762).
7.1.2 Breast-feeding
It is unknown if SPIKEVAX Bivalent is excreted in human milk. A risk to the newborns/infants cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunization against COVID-19.
7.1.3 Pediatrics
The safety and efficacy of SPIKEVAX Bivalent in children under 6 years of age have not yet been established.
7.1.4 Geriatrics
Clinical studies of SPIKEVAX Bivalent include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see ADVERSE REACTIONS and CLINICAL TRIALS sections). “
LOT’S OF admissions there isn’t there.
Next up: What is a ‘solicited adverse event’ vs. an unsolicited adverse event? where they are looking vs where they are not looking?
8.1 Adverse Reaction Overview
The safety profile of SPIKEVAX Bivalent in participants ≥ 18 years of age presented below is based on data generated from an ongoing Phase 2/3 open-label study in participants 18 years of age and older (mRNA-1273-P205). In this study, 437 participants received the SPIKEVAX Bivalent 50 mcg booster dose SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 11 of 52 (mRNA-1273.214, as 25 mcg elasomeran and 25 mcg imelasomeran), and 377 participants received the SPIKEVAX original 50 mcg booster dose (mRNA-1273).
Overall, the frequency of solicited adverse reactions after the SPIKEVAX Bivalent 50 mcg booster dose was similar to that observed following the SPIKEVAX (elasomeran) original 50 mcg booster dose. The most frequently reported adverse reactions after the SPIKEVAX Bivalent 50 mcg booster dose were pain (77.3%), fatigue (54.9%), headache (43.9%), myalgia (39.6%), arthralgia (31.1%) and axillary swelling or tenderness (17.4%). The median duration of local and systemic adverse reactions was 2 days. The most common adverse reactions after the SPIKEVAX original 50 µg booster dose was fatigue (51.4%), headache (41.1%), myalgia (38.6%), and arthralgia (31.7%). The median duration of local and systemic adverse reactions was 2 days.
Overall, after both the SPIKEVAX Bivalent 50 mcg booster dose and the SPIKEVAX original 50 mcg booster dose there was a higher reported rate of solicited adverse reactions in younger age groups. The incidence of pain, erythema, swelling/induration, lymphadenopathy (axillary swelling/tenderness), fatigue, headache, myalgia, arthralgia, and nausea/vomiting was higher in adults 18 to 64 years of age than in those 65 years of age and above (see SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 12 of 52
Table 2, Table 3, Table 4 and Table 5 respectively).
The safety and effectiveness of a booster dose of SPIKEVAX Bivalent (elasomeran/imelasomeran) mRNA vaccine for individuals 6 through 17 years of age are inferred from studies of a booster dose of SPIKEVAX Bivalent in individuals 18 years of age and older as well as data from studies which evaluated the primary series and booster vaccination with SPIKEVAX.
Safety data in adolescents (12 to 17 years of age) were collected in an ongoing Phase 2/3 randomised, placebo-controlled, observer-blind clinical trial (Study P203, NCT04649151) conducted in the United States involving 3,726 participants who received at least one dose of SPIKEVAX (elasomeran) (n=2,486) or placebo (n=1,240). Overall, solicited adverse reactions at any dose were reported more frequently among adolescents in the vaccine group than in the placebo group. The most frequently reported adverse reactions in adolescent subjects were pain at the injection site (97.2%), headache (78.4%), fatigue (75.2%), myalgia (54.3%), and chills (49.1%) (see Table 11 and Table 12).
This study transitioned to an open-label Phase 2/3 study in which 1,364 participants 12 years through 17 years of age received a booster dose of Spikevax at least 5 months after the second dose of the primary series. The most common solicited local adverse reactions were pain (91%) and axillary swelling or tenderness (28%). The most common solicited systemic ARs were fatigue (59%), headache (57%), myalgia (40%), chills (31%), and arthralgia (24%).
Safety data in children (6 years to 11 years of age) were collected in an ongoing Phase 2/3 two-part clinical trial (Study P204, NCT04796896) conducted in the United States and Canada. Part 1 is an openlabel phase of the trial for safety, dose selection, and immunogenicity involving 380 participants who received at least one dose of SPIKEVAX (0.25 mL, 50 mcg). Part 2 is the placebo-controlled phase for safety, immunogenicity and efficacy and it included 4,002 participants 6 years to 11 years of age who received at least one dose (0.25 mL, 50 mcg) of SPIKEVAX (n=3,007) or placebo (n=995), and 2,988 SPIKEVAX participants and 973 placebo participants had received dose 2. No participants in Part 1 participated in Part 2.
Overall, solicited adverse reactions were reported more frequently among children in the vaccine group than in the placebo group. The most frequently reported adverse reactions in children 6 years to 11 years of age in Part 2 following administration of the primary series were pain at the injection site (94.8%), fatigue (64.5%), headache (54.3%), chills (30.3%) and myalgia (28.2%) (see Table 13 and Table14).
The study protocol was amended to include an open label booster dose phase that included 1,294 participants 6 years through 11 years of age who received a booster dose of Spikevax at least 6 months after the second dose of the primary series. No additional adverse reactions were identified in the openlabel portion of the study.
8.2 Clinical Trial Adverse Reactions
Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another vaccine. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse vaccine reactions in real-world use.
SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 13 of 52
SPIKEVAX Bivalent Booster Dose
Participants 18 Years of Age and Older
Solicited Adverse Reactions
The safety, reactogenicity, and immunogenicity of a booster dose of SPIKEVAX Bivalent are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older (mRNA-1273-P205). In this study, 437 participants received the SPIKEVAX Bivalent 50 mcg booster dose (mRNA-1273.214, as 25 mcg elasomeran and 25 mcg imelasomeran), and 377 participants received the SPIKEVAX original 50 mcg booster dose (mRNA-1273). Participants were followed for a median duration of 43 days and 57 days for the SPIKEVAX Bivalent 50 mcg booster dose and SPIKEVAX 50 mcg booster dose, respectively.
Solicited adverse reaction data were collected from Day 1 to Day 7 and reported by participants in an electronic diary (e-Diary) after each dose and on electronic case report forms. The reactogenicity observed for both local and systemic adverse reactions was similar for both groups with 380 (87%) of subjects in the mRNA-1273.214 group and 301 (85%) of subjects in the mRNA-1273 group experiencing any solicited adverse reactions (AR)s. The frequency of grade 3 adverse reactions was 8.0% in both groups. There were no grade 4 solicited ARs in either group. Reported solicited local and systemic adverse reactions are presented in SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 14 of 52 Table 2, Table 3, Table 4 and Table 5 respectively”
You need to look at the whole document.
When they stop looking for adverse events
there is an issue between solicited and unsolicited events.
there is an issue with the placebo - is it saline or as in other studies I looked at, is it a toxic drug in and of itself. (in which case they may have similar adverse event profiles)
You see you can design a study not to find events.
make the placebo very toxic;
make events ‘solicited’ ie fill a questionnaire that asks only about certain events;
cut off the time period of follow up.
do not provide the clinician, doctor, patient of caregiver the means to report events, and or gas light them when reports come in.
“Less Common Clinical Trial Adverse Reactions
The following events were reported in the ongoing Phase 3, placebo-controlled clinical study in participants ≥ 18 years of age:
Nervous System Disorders: Acute peripheral facial paralysis†
Skin and Subcutaneous Tissue Disorders: Rash
General Disorders and Administration Site Conditions: Injection site pruritus, injection site rash, injection site swelling, injection site erythema, injection site urticaria, facial swelling§
† Throughout the safety follow-up period, acute peripheral facial paralysis (or palsy) was reported by three participants in the SPIKEVAX group and one participant in the placebo group. Onset in the vaccine group participants was 22 days, 28 days, and 32
days after Dose 2.
§ There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of dermatological fillers. The onset of swelling was reported on Day 1 and Day 3, respectively, relative to day of vaccination.
8.4 Post-Market Adverse Reactions
The following adverse reactions have been identified during post-authorization use of SPIKEVAX (elasomeran).
Immune System Disorders: Anaphylaxis, hypersensitivity.
Cardiac Disorders: Myocarditis and/or pericarditis (see WARNINGS AND PRECAUTIONS).
Skin and Subcutaneous Tissue Disorders: Erythema multiforme, acute and delayed urticaria.
SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 33 of 52
Nervous System Disorders: facial paralysis / Bell’s palsy, hypoaesthesia / paraesthesia, dizziness.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.”
Interesting is what they excluded by deciding it is NOT RELEVANT!!!
Carcinogenicity: SPIKEVAX has not been evaluated for carcinogenicity in animals, as carcinogenicity studies were not considered relevant to this vaccine.
Genotoxicity: SM-102, a proprietary lipid component of SPIKEVAX and SPIKEVAX Bivalent, is not genotoxic in the bacterial mutagenicity and the human peripheral blood lymphocytes chromosome SPIKEVAX Bivalent (elasomeran / imelasomeran) mRNA vaccine Page 48 of 52 aberration assays.
Two intravenous in vivo micronucleus assays were conducted with mRNA therapies using the same lipid nanoparticle (LNP) formulation as SPIKEVAX Bivalent. Equivocal results observed at high systemic concentrations were likely driven by micronuclei formation secondary to elevated body temperature induced by a LNP-driven systemic inflammatory response.
The genotoxic risk to humans is considered to be low due to minimal systemic exposure following intramuscular administration, limited duration of exposure, and the negative in vitro results. “
THAT’S THE: IT STAYS IN THE MUSCLE THEORY LIE. so you don’t need to ‘look’ systemically.
Here is the whole document.
Unthinkable. In this drama, people like Trudeau, Tam, and Duclos will get away scot-free with a full pension, right?
Thank you. I use Firefox browser, that collect and sends every second all the data that it gathers. And, Firefox is in US.
I did not meant to offend you for using Safety word. I take back that word.
I'm a silent reader. Love your articles very much. Appreciate the time you have put in to gather all the details for all the topics you have covered.
Thank you,
Raj