Reminder: Pfizer & Moderna & FDA MADNESS, just sheer insanity approving Fall Bivalent booster (Wuhan legacy strain & BA 4/BA5 sub-variants); no human trial data? based on BA.1? antibodies? 8 mice??
by Paul Alexander
I wrote about this prior but I had to again for it is sheer recklessness and insanity and danger by the FDA to approve these via EUA, there is no science, no evidence, no emergency, no basis!
It is time these COVID gene injections be stopped, immediate, given the insanity of Pfizer, Moderna, and FDA and their booster decision making. We are no longer in any emergency and we are entering into the endemic phase of SARS-CoV-2 and no longer in a hyperacute situation.
Key facts for the bi-valent injection that make us want to pull the hair out of our heads and show just how reckless FDA is:
1.the bi-valent vaccine is based on original Wuhan strain and the BA.4 and BA.5 sub-variants; note that the Wuhan strain has been long gone and if used, will drive antibody dependent-enhancement of infection (and disease); this will also result in original antigenic sin (OAS) whereby there will be recall of Wuhan antibodies (immune imprinting or fixation on the initial Wuhan exposure (via vaccine or natural infection); that the antigen in the vaccine stays same (stayed same) as different sub-variants emerged (due to selection pressure from sub-optimal non-neutralizing vaccinal antibodies)
2.human data was only available on the BA.1 booster
3.small sample study numbers and not collected over a long duration, so poor safety data, in fact, no safety data
4.the BA.1 booster data (humans) only based on antibodies
5.so we do not have any evidence to show that the BA.1 (human data) as well as the new bi-valent Wuhan/BA.5 (animal data) will protect against severe illness, hospitalization, or death; just based on antibodies but who cares about antibodies; Again, the new bi-valent booster has elements of the Wuhan spike, the BA.4, and the BA.5 spike. No human data is available for the booster and only based on 8 mice. Moreover, the human data referred to as a basis to approve the new bi-valent booster is based on a different vaccine e.g. Wuhan spike plus BA.1 spike, NOT the Wuhan plus BA.4 & BA.5 spike. Notice that slip of hand? No human study shows the new bi-valent booster is safe or effective. None!
6.Findings provided by Pfizer to FDA is based on antibody increments in 8 mice, and now authorizes the vaccine for the US population, approximately 200 million or so doses; so they want to vaccinate 200 million people with a bi-valent booster based on information that indicates that all the mice, all 8, got COVID and in all 8 mice, there was the same viral load in their nasal pharyngeal cavity as the unvaccinated mice
7.the clinical trials will begin by Pfizer in a couple months (on the bi-valent vaccine) so they have approved it based on 8 mice without human studies, those studies to begin in the future; should the human studies not be done prior to authorization? Should they not have done the studies first? This makes no sense.
8. these vaccines do not stop infection, so what is the benefit of these shots?
This bi-valent vaccine IMO, is pure junk and garbage, has no need, no basis, no justification, no EUA needed. There should have been randomized controlled trials (RCTs) before these boosters were given the clearance to be rolled-out. RCTs that could look at patient-important outcomes and test safety etc. Run for long durations of follow-up.
What was presented to the FDA was absurd science for in short, the FDA made a decision to grant EUA based on BA.1 human data (based on antibodies and no hard patient-important outcomes like death or severe illness) to be extrapolated to the BA 4 and BA 5 clade, where only 8 mice (antibodies in mice) were available for the BA 4 and BA 5 (rodent data). Moreover, there was no proper safety data collected as part of the BA.1 study.
The bottom line is that any booster today etc. has to be based on the most trustworthy, highest-quality, robust underlying data and evidence, and the evidence has to focus on mitigation and prevention of severe illness and death (including infection) and not on surges in neutralizing antibody levels. Where are the randomized controlled trials (RCTs)? There was more than enough time and still there is time before Fall. There are high-risk aged populations, it can be done, IF they want it done!
Does it make sense what the FDA has authorized as to the booster? See my prior stack.