quote:

Originally posted by wcb6092:
President Joe Biden’s administration has ruled out nominating Janet Woodcock as permanent head of the Food and Drug Administration, people familiar with the matter say, as the search continues for a leader during a crucial period for full approval of coronavirus vaccines

Woodcock takes one for the team

The approval of a so-called ‘vaccine’ with the control-group in the safety / efficacy study deliberately sabotaged.

From Treehouse -

With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety

Pfizer clinical trial results. More vaccinated people died vs unvaccinated. See for yourself.

It is under adverse events.


https://www.scribd.com/documen...59v1-full#from_embed

quote:

Originally posted by wcb6092:

It is under adverse events.


https://www.scribd.com/documen...59v1-full#from_embed

How's that? Two years? Yet these shots are now getting full FDA approval.

quote:

Originally posted by wcb6092:

Some experts, including one of the developers of the AstraZeneca COVID-19 vaccine, said that trying to work toward “herd immunity” isn’t possible with the virus, as it will constantly mutate and breach vaccine protection.

“I think [herd immunity] is a pretty distant prospect and we need to get used to the concept that this will become what we call an endemic disease rather than a pandemic disease,” Andrew Pollard, the director of the Oxford Vaccine Group, said on Aug. 10. “A disease that is with us all the time—probably transmits seasonally a bit like influenza where we see winter outbreaks.”

Wow, some "experts" finally admitting that there is no cure for Wu Flu, just like we've always known the same for the common cold or flu. Why is that? Because it mutates faster than any vaccine can be developed and given to everyone. It just proves that all the lockdowns, restrictions and mandates have been BS from the beginning and accomplish nothing except destroy your economy, drive many people into a panic, turn everyone against each other, and provide an opportunity for gov't officials to grab unlimited power.

Why would it be a shorter monitoring period if you took the dose post unblinding?

Did the serum change for each group?

https://blog.nomorefakenews.co...ing-no-transparency/

It all happened behind closed doors

by Jon Rappoport

August 23, 2021

(To join our email list, click here.)

The fix is in.

We raced from “emergency use authorization” of experimental vaccines to “full approval.” Boom.

Despite the promise of “transparency” prior to giving full approval to the COVID vaccines, the FDA gave its final green light today. Slam-dunk.

And there was NO public hearing.

“Full approval” means the vaccine marketing/intimidation/mandate campaigns will ramp up much higher. “Well, now there is NO reason for anyone to refuse the shot. The FDA states it is completely safe and effective.”

Obviously, the FDA didn’t want to allow even mainstream “experts” to speak in a public hearing before approval; the agency is running a very tight ship. No slip-ups. No defections.

An 8/20 article in the BMJ (“Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data”) quotes a few of these dissenting mainstream pros. For example:

“Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data.”

“’These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,’ she said. ‘The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval’.”

“Witczak is one of the more than 30 signatories of a citizen petition calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a [public FDA] meeting ‘we have no idea what the data looks like’.”

“’It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed’.”

“’Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals’.”

Understand—this devastating criticism of the FDA is coming from a person who operates WITHIN the public-health establishment.

Amidst a tsunami of reports of vaccine injuries and deaths from around the world, the FDA is proving it is an agency that will certify maiming and killing without hesitation.

Of course, now the response from these charlatans and their media co-conspirators will be "There's just no pleasing these paranoiacs."

quote:

Originally posted by JoseyWales2:

quote:

Originally posted by wcb6092:

Some experts, including one of the developers of the AstraZeneca COVID-19 vaccine, said that trying to work toward “herd immunity” isn’t possible with the virus, as it will constantly mutate and breach vaccine protection.

“I think [herd immunity] is a pretty distant prospect and we need to get used to the concept that this will become what we call an endemic disease rather than a pandemic disease,” Andrew Pollard, the director of the Oxford Vaccine Group, said on Aug. 10. “A disease that is with us all the time—probably transmits seasonally a bit like influenza where we see winter outbreaks.”

Wow, some "experts" finally admitting that there is no cure for Wu Flu, just like we've always known the same for the common cold or flu. Why is that? Because it mutates faster than any vaccine can be developed and given to everyone. It just proves that all the lockdowns, restrictions and mandates have been BS from the beginning and accomplish nothing except destroy your economy, drive many people into a panic, turn everyone against each other, and provide an opportunity for gov't officials to grab unlimited power.

^^I remember hearing essentially the same words as your (JoseyWales2) post's second sentence way back in college Microbiology (junior year level) class; when the professor answered a question about vaccines and cold/corona viruses. And this was in 1985.

Package insert for Pfizer approved vaccine:

https://www.fda.gov/media/151707/download

Found this interesting

2 Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had
resolution of symptoms with conservative management. Information is not yet available about potential longterm sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis


A dissenting voice.


Does the FDA think these data justify the first full approval of a covid-19 vaccine?

https://blogs.bmj.com/bmj/2021...source=socialnetwork

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi


On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Delta may not be responsible

Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of July.

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.

The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Peter Doshi is a senior editor at The BMJ and on the News & Views team. Based in Baltimore, he is also an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. His research focuses on the drug approval process, how the risks and benefits of medical products are assessed and communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications. Doshi campaigns for greater transparency of clinical trial data and leads the Restoring Invisible and Abandoned Trials (RIAT) initiative, which aims to ensure clinical trial publications are accurate, complete, and data are publicly available. Doshi also has strong interests in journalism as a vehicle for encouraging better practice and improving the research enterprise. Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins and received his PhD in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology.

As of yesterday I could get ivermectin 1% solution at tractor supply. As of today it’s not available. Coincidence?

And there it is:



https://twitter.com/disclosetv...869459171422210?s=21

NYC has already mandates teachers - students will be mandated very soon.

Yes Chellim, I figured they would yank the Ivermectin off the shelves eventually. As mentioned in a previous posting, the Ivermectin I bought at Tractor Supply last year said "pharmaceutical grade" on it and the 2021 packaging changed to say "for animal use only". My neighbor is a Vet here locally and she said its the same exact stuff a physician would presrcibe via pill form. The danger, she said, was that most people have no clue how to administer dosages via the metric system. She went on to explain the massive difference between MG (milligrams) and ML (milliliters). The MG dose would be literally 3-5 drops daily for a 160lb person (which is the correct dose) The ML would be exponential and probably land someone in the ER. (which has happened recently throughout the US)

Shit, it's only a matter of time for my employer now I guess, given that I just found this out today:

Rocket builder ULA will require employees receive Covid vaccines beginning Sept. 1

September 1? that's like a little over a week from now, way to force people to make a decision with no time.

I need to started researching religious exemptions because I'll be dammed if I'm putting the clot shot into my body.

quote:

Originally posted by 95flhr:
looks like the FDA just gave the Pfizer shot full approval. Still not going to change my mind about it.

https://www.foxbusiness.com/he...13d86f150feac4866893

Same here. If it does anything, it raises more red flags for me. It was approved that fast? No long term study, not even a year?
This was for one thing and one thing only, to get vaccine mandates.

In Canada if you get killed the by the vaccine the government will help with funeral costs. What a nice perk.

Burial Costs Covered for Canadians Killed by Approved Vaccines

“In the rare event a person in Canada is seriously and permanently injured as a result of vaccination, they should be fairly supported,” wrote department staff. “The Vaccine Injury Support Programprovides financial support to individuals who are seriously and permanently injured due to vaccination with a Health Canada authorized vaccine.”

Canada’s COVID-19 health experts admit there are unknown long-term effects of vaccines, but they provide another layer of protection.

https://torontosun.com/news/na...by-approved-vaccines

https://www.nbcnews.com/politi...equirements-n1277470

There ya go.
Right now he's "calling" on private companies to make vaccine requirements. Let's see how far he goes with it.
I won't make any of my employees get the vaccine. Some already have and that's fine. Don't want to, don't.

Only way this stops is the blue flu approach.

Walk out, change employers, there is a massive shortage of workers in the USA.

Find a new employer, no COVID requirement and tell your company adios.

Easier said than done, but nothing worth doing or having comes easy...

Typical Biden. Trying to have everyone else do his dirty work for him because he's to big a pussy to mandate it himself. This FDA approval changes nothing for those of us who have done the research.

https://thehill.com/policy/hea...full-pfizer-approval

It passed the FDA. What are you waiting for? There's no excuse now.
Blah, blah, blah.
I'm trying to find the link that Pfizer and Moderna vaccinated their placebo group now that the shot is FDA approved. That was smart. Now there's no control group.