Posted on 05/06/2021 8:55:34 AM PDT by Cathi
Participants in Phase 2 study were tested for pseudovirus neutralization (PsVN) titers prior to boosting approximately 6 to 8 months after their primary vaccination series. Although titers versus the wild-type SARS-CoV-2 virus remained high, with 37 of 40 participants having detectable titers, titers against the variants of concern (B.1.351 and P.1) were much lower, with approximately half of participants having titers below the assay limit of quantification prior to boosting. Two weeks after receiving either mRNA-1273 or mRNA-1273.351, PsVN titers were boosted in all participants and all variants tested. Following boost, geometric mean titers (GMT) against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination1.
mRNA-1273.351 appeared more effective at increasing neutralization titers against the B.1.351 variant when compared to mRNA-1273, as evidenced by higher mean GMT levels already at 15 days following booster dose (GMT = 1400 for mRNA-1273.351; GMT = 864 for mRNA-1273). The relative decrease in neutralizing titers between the wild-type (D614G) and B.1.351 assays also improved with mRNA-1273.351 booster, from a 7.7-fold difference prior to boost to a 2.6-fold difference 15 days after boost, suggesting a potentially more balanced immune response against the tested variants.
Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. A review of solicited adverse events indicated that the vaccine boosters were generally well tolerated. The majority of adverse events were mild or moderate in severity. The frequency of any Grade 3 solicited local or systemic adverse events was 15% after the third dose of mRNA-1273 and 10.5% after the third dose of mRNA-1273.351.
(Excerpt) Read more at investors.modernatx.com ...
Thank you for posting!
This becomes important when looking at a variant like P.1 (Brazil) which has been demonstrated to readily reinfect people who already had COVID-19. Tools like these “boosters” (not really boosters, since it’s a modified formulation to deal with the different variants) help solidify immunity and keep COVID-19 out of our country.
And the recent Salk Institute reports that the spikes in COVID19 causes holes in micro blood vessels that produce blood clots. So the mRNA just keeps crankin’ out more spikes ...
What’s considered “mild”, “moderate”, and “level 3”?
Level 3 s/b Grade 3.
RideForever wrote:
“And the recent Salk Institute reports that the spikes in COVID19 causes holes in micro blood vessels that produce blood clots. So the mRNA just keeps crankin’ out more spikes ...”
Interesting...
Could you post a link to that Salk Institute report?
This report gives a more realistic picture of current vaccine efficacy against the original virus after 6-8 months...8% had no detectable titres and the titres of almost half of the participants were below the “assay limit of quantification” (measurable) against the South African and Brazilian variants.
Grade 3 systemic adverse events were 15% from an additional booster of the original wild type vaccine and 10.5% with the new mixed formulation.
I don’t believe Moderna “details” them; but this is from an earlier Moderna trial from last year.
“In the 45-person Moderna study, four participants experienced what are known as “Grade 3” adverse events — side effects that are severe or medically significant but not immediately life-threatening. Neither the company nor the National Institute of Allergy and Infectious Diseases, which is running the trial, have previously detailed the nature of those incidents, but Moderna did disclose that three, likely including Haydon, received the highest dose of the vaccine that was tested, and had reactions that involved their whole bodies. A fourth received a lower dose and had a rash at the injection site.”
Many thanks!
That thing got a turbocharger on it?
Cathi wrote:
“This report gives a more realistic picture of current vaccine efficacy against the original virus after 6-8 months...8% had no detectable titres and the titres of almost half of the participants were below the “assay limit of quantification” (measurable) against the South African and Brazilian variants.
Grade 3 systemic adverse events were 15% from an additional booster of the original wild type vaccine and 10.5% with the new mixed formulation.”
So would the people with low titers from the shots get a large/bad reaction when exposed to the virus?
Maybe not, because there’s not much left of the shot in their systems.
.....Now, a major new study shows that the virus spike proteins (which behave very differently than those safely encoded by vaccines) also play a key role in the disease itself.......
and they Big Lie continues ... these are NOT “booster” vaccines, but entirely NEW vaccines, with DIFFERENT sequences of RNA spliced in than the original vaccine, similar to the need for annual influenza vaccinations because the flu mutates so rapidly ...
an actual booster vaccine is the SAME one given originally, but given a second time, often many years later like the tetanus vaccine, because the originally triggered antibodies have diminished to the point of being ineffective or had not been made in large enough quantities from the initial vaccination ...
of course, the lying fascist propaganda media happily perpetuates the fiction that these new covid vaccines are merely “boosters” ...
And there it is. The Gates owned mRNA-1273 Moderna rises to the top. Who’da thunk?!?
Funny thing that Gates and Fauci presented their mRNA-1273 vax to the Gates Foundation Event 201 back in Oct. 2019 months before we knew of covid-19. They didn’t even bother changing the name.
Which came first - the vax or the virus?
the VAX is the reason for the ChinaFlu...
Your statement is inaccurate. The amount of spike protein produced by the vaccine is short lived and negligible in quantity in comparison to the actual virus which is pumping out live virus covered in spike proteins.
The vaccine mrna has a 10 hour average half-life and and produces isolated spike proteins that can’t replicate on their own.
It sounds like the isolated spike proteins are produced for 10+ hours by the vaccine, and the Salk report is showing that those may account for new diabetes cases and vascular disease symptoms. How long it takes to be 100% effective is how long the isolated spike proteins are produced.
Here is Moderna’s findings on mRNA vaccine tissue distribution
2.3.3. Pharmacokinetics No dedicated ADME studies with mRNA-1273 were conducted, which is acceptable as generally nonclinical PK studies are not relevant to support the development and licensure of vaccine for infectious diseases. However, distribution studies should be conducted in the case of new formulations or novel excipients used. Accordingly, the biodistribution of the vaccine platform was evaluated with mRNA-1647 in a non-GLP, single-dose, intramuscular injection study in Sprague Dawley rats.
The objectives of this study were to determine the tissue distribution and pharmacokinetic characteristics of mRNA-1647 constructs following IM administration. mRNA-1647 contains 6 mRNAs, which encode the full length CMV glycoprotein B (gB), and the pentameric glycoprotein H (gH)/glycoprotein L (gL)/UL128/UL130/UL131A glycoprotein complex (Pentamer). The 6 mRNA are formulated at a target mass ratio of 1:1:1:1:1:1 in the Sponsor’s standard proprietary SM-102–containing LNPs. It is biologically plausible that the distribution of the mRNA vaccine is determined by the lipid nanoparticle content, whereas the influence of the mRNA itself is considered very limited. Therefore, it is acceptable that the biodistribution study was performed with the same lipid nanoparticles containing another mRNA (i.e. mRNA-1647). The amount of the LNPs in the test material differed slightly in particle size from the final vaccine formulation of mRNA-1273.
Even though it is not straightforward to understand the impact that the different particle size might have on mRNA tissue distribution, if any, nevertheless the liver distribution is not affected because the average diameter of endothelial fenestrae in the liver sinusoids in the test system (Sprague–Dawley rats) is 161 nm. The observed biodistribution with smaller LNP particle size should thus represent a worst-case scenario. A qualified multiplex branched DNA (bDNA) assay was used for determination of mRNA in various tissues in the biodistribution study conducted with mRNA-1647. The LLOQ of the method were set at 0.05 ng/mL for the gB mRNA and UL130 mRNA, and 0.01 ng/mL for the gH, gL, UL128 and UL131A mRNAs.
Following single IM injection at 100 µg mRNA-1647, subgroups of 5 rats were sequentially sacrificed pre-dose and 2, 8, 24, 48, 72, and 120 hours after dosing, for quantitation of 6 mRNA constructs in blood and a pre-specified set of organs/tissues. Concentrations of mRNA-1647 were quantifiable in the majority of tissues examined at the first time point collected (2 hours post-dose) and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma. Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye. Both tissues were examined in the frame of the toxicological studies conducted with mRNA-1273 final vaccine formulation. Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although to very low levels (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that liver is a common target organ of LNPs.
The T1/2 of mRNA-1647 was reliably estimated in muscle (site of injection), proximal popliteal and axillary distal lymph nodes and spleen with average T1/2 values for all vaccine components of 14.9, 34.8, 31.1 and 63.0 hours, respectively. mRNA-1647 was rapidly cleared from plasma during the first 24 hours with the T1/2 estimated in a range of 2.7 - 3.8 hours. The mean concentrations of all vaccine components became undetectable after 24 hours, except for gH, which was detectable up to the last time point of 120 hours but which was also detectable in 2 pre-dose plasma samples. The mRNA constructs were not measurable after maximum 3 days in tissues other than the muscle, lymph nodes, and spleen (~25 hours in brain). Reference with regards to the mRNA biodistribution is made to the respective adverse findings observed in rat spleens in toxicological studies. No adverse findings were detected in the ophthalmological examinations or the brain/CNS. No dedicated studies on absorption, metabolism, and excretion for mRNA-1273 have been submitted. This is generally acceptable with regards to the nature of the vaccine product.
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