This Week's Meeting Shows the Full Failure of this FDA
Thank you Dr. P for keeping us in this terrifying and depressing and unscientific loop.
How in the heck is this being allowed with no agency, oversight committee or anything yelling from the roof tops about this absolute negligence and dare say it criminality!!!
Any real study of who does and does not benefit from these shots and how effective they are at things like transmission and so on would require some admission that they have short circuited all of this from the start. One may argue that they believed this was a necessary shortcut given the pandemic but the issue is that if they do discover some substantial sub-clinical issues even in some subgroups they are forced to admit that they should not have rushed things even early on in everyone and they are never going to do that I don't think. Of course they could also find that there is no increased risk in subgroups but I suspect if that were the case we would have seen those study results already.
It reminds me of that famous line in Exodus when God “hardened Pharaoh’s heart.” Faced with all the plagues, they just keep doubling down, refuse to relent or admit error.
I’d almost be relieved if it were simply a case of financial corruption, that would be an easier explanation! But why did the French Revolutionaries keep doubling down, and guillotining more and more? There wasn’t a profit in it, it was a form of puritanical madness. Also maybe fear of what would happen to them if they ever lost power. But it’s not just the money, I think…
Is this the same FDA that just complained about Moderna not giving enough data about their bivalent booster? Now, they are fine with Pfizer giving no data. So shameful. Zero trust left in these clowns.
'There is no talk of: Running randomized trials to ensure annual boosters actually lower severe disease in healthy young adults and kids"
However, the problem is: can you trust the RCTs? For example, in the original mRNA RCT trials, the very serious adverse effects suffered by several young participants simply wasn't recorded (or coded as a "stomach ache"). Ironically, I'd suggest watching the thoughtful movie "Anecdotals" [ https://www.anecdotalsmovie.com/ ] for a discussions of this subject with a "compassionate exploration of the nuanced vaccine debate. While the vaccine debate grows more divided, those with adverse reactions get stuck in the middle."
I don't know if Dr. Jha will end up getting a sweetheart deal from Pfizer (or maybe some other drug maker) after he leaves his current position in Washington. I wish him well. To borrow a very tired expression overused by the amusing, self-promoting Pierre Korey, "I will tell you that" Jha would look spiffy in the crisp uniform of a Security Guard in charge of policing the back parking lot at Pfizer headquarters (no gun but lots of keys, a huge flashlight, a billy club, and a small pepper spray device). Not saying Jha isn't a great epidemiology maven with some very solid academic credentials, but in my opinion he did not exploit the skills that come with this status after he joined with the grease-and-grin gang that now surrounds Sleepy Joe. Some folks will be very tempted to cry out for assembly of a Blue Ribbon Panel (say, 15 members) to investigate in depth the annoying issue of "Actual mRNA Vaccine Risks vs. Actual Benefits" except that there is already a telling exemplar of how a presumably solid, official investigation can generate some huge tome advertised as "the last word" after deposing all kinds of witnesses, and after dredging up more than 3,000 exhibits, but in fact while doing clumsy stuff enroute to its Conclusion section that backfires and spawns new layers of murk and mess and confusion after a big squeeze that has given not much juice (Ref. The Report of The Warren Commission, 1964. 888 pages). If you think that Jack Ruby was a Mafia hit man paid to exterminate Lee Oswald, peruse the applicable chapter(s) in the Warren Report to see precisely how that was dealt with. Then "go to your happy place" to do some deep breathing as you visualize how *any* analogous vaccine mystery might be handled "definitively" by some Blue Ribbon Gang comprising only top-ticket folks from the virology, vaccinology, and epidemiology "communities". God help us.
CRIMINAL. Medical Malpractice!!!
Oh God when will this end?
It falls upon the VRBPAC members to be vociferous about the lack of data, and the painfully slow and long timeline given to Pfizer to produce sub clinical myocarditis data. This isn’t complex data collection. The troponin is either elevated or not. The values can be reported as categorical data. The problem is during this 16 month period granted to Pfizer to do the study how many young men mandated to take the vaccine to work, attend university or serve in military had sub clinical myocarditis that could have longterm implications? The VRBPAC is complicate here. It’s time they speak up like Gruber and Krause.
Don't dare to require this. My kids, unfortunately, believe the CDC, Pfizer, etc. They will give my granddaughters these boosters. Give me some solid evidence from carefully laid trials that this is necessary. Don't get me wrong, I want my grandchildren to get all necessary disease preventative injections, but from the get-go, continuing to lead people to believe that all of this is necessary borders on mind control. Most people can not tease out the necessary information that is there or is lacking to make an educated decision. Do not lead them down that garden path of fairies and roses.
FAA also seems to be corrupted by the bio-pharmaceutical complex. Many pilots are claiming vaccine injuries, but there is no investigation by FAA officials into these claims. The FAA hasn’t even returned calls or emails made on these injured pilots behalf. Pretty strange for a bureaucracy supposedly prioritizing safety.
I won’t be “tasked” with anything. No one is going to force me to get the Covid shot anymore than the flu shot.
You couldn't be more correct on this one Vinay. Well said. It is absolutely crazy to vaccinate young people who are at such low risk of any severe outcome from Covid, let alone the current variants.
“The FDA has posted briefing documents from VRBPAC … Conspicuously absent is information about subclinical myocarditis. … Kids and older Americans will have to get 2 doses of the bivalent shot and then placed on the perpetual booster train. Pfizer will keep earning billions.”
. . .
Besides an absence of myocarditis safety study results, the little safety data provided in the VRBPAC briefing materials is concerning. For example, the safety of Moderna's bivalent shot was evaluated with only 71 children (Way too small of a sample size to detect most safety signals!). In this trial, adverse event's were reported by about 60%, Grade 3 fevers [> 103 degrees F] were deemed “rare” (ONLY reported by about 1%), and one child (1.4%) developed asthma. But rest easy, this asthma SAE “was assessed as unrelated to study vaccine by the investigator.” Regardless, this isn't what I would consider “safe” for children.
It's worth noting that several young participants in previous mRNA trials have testified that their SAE's were also “assessed as unrelated” by the PI and not included in the published trials (see the movie “Anectdotals” https://www.anecdotalsmovie.com/ )
As noted by Aigor Chudov, “The above-mentioned FDA briefing is the only source of information about Moderna study P306 because the clinical trial results were not yet published in peer-reviewed journals. Should the FDA, and the general public, believe Moderna’s assurance that asthma, developing 13 days after Dose 2, is unrelated to the study vaccine? Asthma is an inflammatory disease, and it is quite conceivable that it could be triggered by inflammation-causing mRNA vaccination.”
Here's a link to the source document, from VRBPAC 01-16-23 Briefing Document, p. 11-12 https://www.fda.gov/media/164699/download
“On January 14, 2023, Moderna submitted preliminary data (datasets not [!] submitted for
independent analyses) from an ongoing, open-label [!] Phase 3 study (Study P306 Part 1) … The primary immunogenicity analysis population consisted of participants with or without
evidence of prior SARS-CoV-2 infection at baseline and included 71 mRNA-1273.214 recipients …
Within 7 days after any dose, solicited adverse reactions (ARs) were reported by 57.0% and 63.1% of mRNA-1273.214 recipients after Dose 1 and Dose 2, respectively. Grade 3 fever … was rare [!] and reported by 1.1% and 1.4% of participants after Dose 1 and Dose 2, respectively.
Within 28 days after any dose, unsolicited adverse events were reported by 30.7% [!] of mRNA-1273.214 recipients ... All were mild to moderate in intensity, except for one [7%] serious adverse event of asthma in a 5-year-old participant with onset 13 days after Dose 1, which was assessed [!] as unrelated to study vaccine by the investigator.”
Well said Dr P. If health organizations start requiring this booster annually, they will lose even more staff. I really don’t think they will though. I think they see the science or lack there of. And because of the lack of evidence of efficacy for their young staff (<55-60 I would have to say is the vast majority of staff), they have to know the American people will not accept the mandate again. They are hemorrhaging key staff left and right, the staff that make the hospitals clinics and offices run, ie the staff that help patients. NOT the million dollar CEOs.