(My) Highlights from the FDA's Public Comments portion of the Pfizer Booster Hearing

(link to full 8+ hour video at bottom)

The FDA voted against a general rollout of Pfizer's booster shot, but voted in favor of it for 65+ and those at high risk for covid, following an 8 hour public hearing on the matter a few days ago. Included was time allotted for comments and presentations from the public, wherein some that we could consider 'healthcare professionals and experts' had some interesting things to say not only about the boosters, but about the vaccines in general and even the political climate surrounding them. I've included some transcript with timestamps and I recommend watching (listening) for yourself. Emphasis is probably mine, though some of them were pretty emphatic.

Viral immunologist and biologist Dr. Jessica Rose, starts at 4:09:50
At 4:10:56, she says “There's an over 1000% increase in the total number of adverse events for 2021 and we’re not done with 2021. This is highly anomalous on both fronts. These increase recording (unintelligible) are not (linked?) to increased rates in injections and not due to (simulated reporting?). …(next sentence unintelligible)… The onus is on the public health officials, the FDA the CDC and policy makers to (unintelligible) these anomalies and acknowledge the clear risk signals emerging from VAERS data, and confront the issue of covid injectable products use risk that, imo, outweigh any potential benefit associated with these products, especially for children.”


Dr. Joseph Fraiman, Emergency Physician, Cornel Medical, residency with Charity Hospital in New Orleans.
4:17:23
“I’m here today to ask for help for those working the front lines to help us reduce vaccine hesitancy. For this we need larger trials that demonstrate the vaccines reduce hospitalization without finding evidence of serious harm. I know many think the vaccine hesitant are dumb or just misinformed. That’s not at all what I’ve seen. In fact typically, independent of education level, the vaccine hesitant I’ve met in the ER are more familiar with vaccine studies and more aware of their own covid risks than the vaccinated. Next slide please. For example, many of my nurses have refused the vaccine despite having seen covid 19 cause more death and devastation than most people have. I ask them- why refuse the vaccine? They tell me while they’ve seen the first hand dangers of covid in the elderly, the obese, diabetics, they think their risk is low. They’re not wrong. Next slide please. One nurse showed me this oxford risk calculator. A 30 year old female has about a 1 in 7000 chance of catching covid and being hospitalized over 90 days. She asked me- can I assure her that the studies found her risk of serious harm from the vaccine is lower than her risk of hospitalization? The truth is I can’t. Our trials weren’t big enough. They weren’t big enough to identify the vaccines caused myocarditis. Yet now we know they do. Next slide please. A recent observational study suggests the risk of vaccine induced myocarditis in young males is higher than their risk of hospitalization from covid. Is this true? We don’t know. Its based on observational data. To know its not true, we need a large trial that proves the vaccines reduce hospitalization more than they cause myocarditis in this age group. Next slide please. The former FDA commissioner said the premise of the vaccine was to reduce death and hospitalization. And that was the data that came out of the initial clinical trials. Except -and you all know very well, and fortunately, unfortunately so did my nurse- the initial clinical trials did not find a reduction in death or hospitalization, likely because they were inadequately powered. Yet the former commissioner is correct- the initial trials should have been powered to find a reduction in hospitalization. Next slide please. We need your help on the front lines to stop vaccine hesitancy. Demand the booster trials are large enough to find a reduction in hospitalization. Without this data, we the medical establishment cannot confidently call out anti-covid vaccine activists who publicly claim the vaccines harm more than they save especially in the young and healthy. The fact that we do not have the clinical evidence to say these activists are wrong should terrify us all.


4:20:15 Steve Kirsch, executive director of the Covid-19 Early Treatment Fund

“I’m going to focus my remarks today on the elephant in the room that nobody likes to talk about: that the vaccines kill more people than they save. Today, we focus almost exclusively on COVID death saves and vaccine efficacy because we were led to believe that vaccines are perfectly safe. But this is simply not true. For example, there are four times as many heart attacks in the treatment group in the Pfizer 6-month trial report. That wasn’t bad luck. VAERS shows heart attacks happened 71x more often following these vaccines compared to any other vaccine. In all, 20 people died who got the drug, 14 died who got the placebo. Few people noticed that. If the net all-cause mortality from the vaccine is negative, vaccines, boosters, and mandates are all nonsensical. This is the case today. Death rates. Slide number 7. Advance to slide number seven in the lower up part. This shows the all caused death:life(?) rate in 3 cases. Only the VAERS numbers are statistically significant, but the other numbers are troubling. Even if the vaccines had 100% protection, it still means we killed two people to save one life.”

Kirsch also claims the Pfizer trial results were ‘gamed’ at 4:22:57

Kirsch also claims at 4:23:12 that a child involved in the Pfizer phase 3 trial for kids is paralyzed for life from the trial, it wasn’t recorded in the Pfizer results, and there was no investigation as to why.

At 4:24:00 is David Wiseman, PhD, who among other things, claims evidence “reveling that the primary driver for approving Cominarty was to overcome hesitancy through regulatory misdirection. We agree with others that this has become politicized.”
Wiseman also claims/demonstrates Pfizer’s booster evidense is “weak”.
Wiseman’s presentation as a hole is too fast and with too much information for me to record- I recommend watching yourself 4:24:00-4:27:13.


Peter Doshi, PhD, Associate professor at the University of Maryland School of Pharmacy and Senior Editor at the BMJ, begins at 4:30:26
Doshi asks why it makes sense to approve a third dose for a regimine that already meets the efficacy bar with 2 doses, and claims we’re “still in the dark” regarding safety because of the unsatisfactory trials. But I find his last point particularly important. At 4:32:57, Doshi says:
“I’ll end with a question. Last week three medical licensing boards said that they could revoke doctors medical licenses for providing covid vaccine misinformation. I’m worried about the chilling effect here. There are clearly many remaining unknowns, and science is all about probing unknowns. But in the present supercharged climate, and I’ll point out that many members of this committee are certified by these boards, I want to ask FDA -what is FDA doing to ensure that those advising it are able to speak freely without fear of reprisal?”

Dr. Paul Alexander, Health Research Methodologist Evidence Based Medicine, starts 4:55:04
-also says the safety studies are inadequate “We currently do not have the safety data” and “the reality is covid is not a life ending, life threatening situation for children. Right now CDC and the NIH have not prosecuted the case as to why these children should be vaccinated. Period. I say do not do this and I beg your consideration.”

There were also professionals/experts that called in during this session urging FDA to certify the boosters asap, and others who apparently only called in to remind the FDA that we're all counting on them to make the right choice... have a listen, full 8 hours is here:



Part of my purpose here is to illustrate that many of the 'vaccine hesitant' are, contrary to the narrative, listening to experts. But I did not watch the whole thing. Did I miss anything you find particularly relevant or interesting?

 

You're comparing a small risk associated with vaccines to the considerable risk of long-term health problems even for children and teenagers.

I'm going to add that the economy will not recover sufficiently even if we eliminate all mitigation measures unless the new case count comes wayyyy down. Rolling waves of covid infections, if that turns out to be a result of too low vaccination rates, will likely cause a serious economic downturn as we cut down the truly massive government spending.

 

Actually I'm highlighting some medical professionals who say the data doesn't yet confirm that claim, and who are begging the FDA to require the studies that would. I quoted them in OP.

 

These "medical professionals" are in the minority. Concerns about VAERS are grossly overblown since they record ANY and ALL symptoms and death regardless of any established causality. Of course the reports went up! We vaccinated 180 million people!!! They continued to have symptoms and to have fatalities (the vaccines only protect against Covid; they don't protect against all the other conditions humans have so people will continue to have symptoms and to die after vaccination OF OTHER CAUSES, but because VAERS ask for ANY event to be reported, duh, the reports are up, but the number actually proven to be due to the vaccines is minimal. These "medical professionals" should brush up in the difference between causality vs. correlation.

A medical professional saying that the risks of the vaccines outweigh the benefits, sorry, is a full-blown moron. Unfortunately, these do exist, like they do in all professions. So, yes, some of these morons chimed in. So what?

An ER doc... a guy from the Early Treatment Covid Fund - the latter people want to sell alternatives to the vaccine and often they have a vested financial interest in discrediting the vaccines. So this Kirsch comes up with some unproven anecdotes...

Sorry, color me not impressed.

 

We should continue looking into the side-effects, but nothing at this point suggests we should stand down on vaccinations.

 

Of course. We'll see if @modernpaladin accepts your explanation.

 

I'm not holding my breath. People have cognitive biases and they tend to only believe in the people who say what they already think. @modernpaladin won't listen to 1,000 professionals saying that the benefits of the vaccine far outweigh the risks. He will listen to the 1 moron who says otherwise, or to the 1 snake oil salesman who has a vested interest in discrediting the vaccines.

 

I can see the vaccine hesitancy, but why the big deal about masks?

He wouldn't be the first.

 

I think it's a conservative stance. Conservatives have been a lot more likely to be anti-masks and anti-vaccines. The myth is that these simple biological devices that are public health tools that make sense, infringe upon their freedoms. Of course this is an extremely boneheaded stance... but it is, nevertheless, very popular among conservatives. I can empathize to a certain degree because I think the authorities went the wrong way about this, from the beginning. First, saying that masks were useless (big lie). Second, imposing mask mandates (made people mad). Third, never going the educational way (we never saw on TV informative pieces about why masks make sense like I've seen countless time in foreign TV I subscribe to over my satellite service). Fourth, conservative politicians made a point of deriding masks.

Look at Japan: the government simply asked the people to wear masks. Compliance = 98%. I wish no mandates were ever issued here, but instead, non-politicized informative TV clips were made, to be played in commercial breaks of popular shows and sports, simply showing to the population that there is a deadly disease out there and the odds of catching it decrease with mask wearing (although it doesn't eliminate it). And then, I think that high quality N95 masks should have been massively produced domestically using the Defense Production Act and distributed for free to the population.

The thing is, if you explain and ask for cooperation, it's not seen as infringement upon freedoms.

And then the vaccine mandates are also seen as an imposition on someone's freedom. Again, I'd have preferred an intense campaign to debunk the myths and the conspiracy theories, rather than mandates.

We are culturally rebellious people who are suspicious of government. It's a cultural trait, as opposed to the Japanese who trust their government and are very cooperative with community-based measures. Usually I like our freedom-loving traits, but in this particular case of a pandemic, they backfired on us.

No, he wouldn't. But at least he is an intelligent fellow and a polite poster so I don't have him on Ignore. There are many others here with similar positions who lack these qualities therefore belong to my Ignore list.

 

All we want is the truth. Admit that 7600 people (just in the US alone) have died from the vaccines and that tens of thousands have suffered severe adverse medical events due to the vaccines and give people the choice of whether they want to add to that list or not. Don't blow sunshine up everyone's asses and just say, "oh it's just a very small percentage" and then not even tell Americans what the numbers actually are. Americans have the right not to have vaccines mandated to them when we do have numbers such as those. People shouldn't be forced to get a vaccine which could literally kill them, even if the chance is very small. Being unvaccinated they only face a death risk of less than 2%. Isn't that a very small number to?

 

CF never offers an explanation, but he always offers Pharma talking points and propaganda.

 

Oh brother, the de rigueur Covidian responses...no one, BUT NO ONE, is an expert in ANY field save those who toe the party line. Sorry, but your precious non-vaccine (YEAH, what it IS and should be called) is starting to show the holes in it's underwear. Gotta quadruple down on suppressing the EQUALLY EDUCATED EXPERTS....why, all those millions of "vaccinated" equal a whole lot of potential torches and pitchforks.

 

Yep, notice how he didn't even try to address any of the quotes in the OP? Just a hand wave and quips about Drs in the "minority".

 

anti-vaxers trying to take away our freedom to get a booster shot

 

You can get as many shots as you like AFAIC. Knock yourself out. If 2 shots are good then 10 MUST be better, am I right?

 

and you can choose not to get a shot, no one stopping you from not doing so.... that is my point

 

It's not about the freedom to get a shot or not get a shot, its the safety in getting a shot. As the doctors quoted here have said, the public tests were shortened, it was called the 'Trump vaccine' and there was the propaganda that Trump was trying to get them out in order to affect the elections. After that, how could we the public have confidence?

The thing with all of the other vaccines is that they'd been tested for years and used for years. The new MRNA technology has not been, and the heart/clog issue seems to have also been found in mices as well. Speaking as someone with a family of known heart conditions, have there been ANY studies that show that the vaccine doesn't increase the risk of heart complications with those of heart issues?

In the ideal world, there should have been therapeutics to deal with covid-19, while they ironed out the vaccines instead of the public being a petri-dish as @Eleuthera would say.

 

Im opposed to neither vaccines nor masks. Im opposed to mandates. Specifically I oppose mandating a vaccine that has and still is killing people (yea i know its a 'small number'), and I oppose mask mandates that dont compel the use of effective masks and the proper usage of them. Theres no benefit in wearing the same coughed-thru hanky all day, yet thats what most people do because most people are just complying with the mandate.

 

I agree. I think Biden dividing this country by throwing shame on unvaxed and blaming republicans was a major strategy fail. Number one we've since learned 44% of African Americans are unvaxed, the highest level of education unvaxed are the PHD's. Those are not Republican only stats.

When I go to a DR and ask about a medicine or treatment he gives me data pro and con, we discuss side effects and I make a decision. This administration has done a horrible job rolling out this vaccine's and giving the data like a DR would. Then you start alienating people and the battle lines begin. Just a really dumb way to go about things. I think the American people are being told things that don't end up being true.
Masks work but the didn't in states with mandates
Shutdowns work but the didn't
Vaccine will prevent you from getting it but it doesn't
Vaccine will prevent you from spreading but it doesn't
Vaccine will prevent you from getting sick but it doesn't

I fully understand why people question this because our government has been wrong every step of the way.

 

The pandemic caught us in a moment where lower- and middle-income reactionaries were organized and exploited by a demagogue.

A perfect storm. I submit, however, even moderate Republicans are okay with stoking lower-income reactionary anger because they want these folks to vote against their economic interest.

I don't see why government couldn't hand out better quality PPE free-of-charge and do so knowing anyone wearing it properly cuts transmission. At least try the idea. See how people react to having it handed out.

Sure. It makes too much sense.

We could have at least seriously tried it.

My inclination is to agree.

 

Why would I agree to something I have seen?

You have a choice. We who have been vaccinated took our chances to do our part to cut transmission. If you choose not to take yours, you can do your part by staying away from places with faces--restaurants, theaters, bars, gyms, clubs, sporting events, planes, trains, etc.

This is what came out of a huge study:

"The strongest tie between the vaccine and an adverse event was myocarditis, with an excess risk of 1 to 5 events per 100,000 people, an RR of 3.24 (95% confidence interval [CI], 1.55 to 12.44), and a risk difference of 2.7 events per 100,000 (95% CI, 1.0 to 4.6). Myocarditis after vaccination was seen mostly in men aged 20 to 34.

In contrast, previous SARS-CoV-2 infection among unvaccinated patients was associated with a significantly elevated risk of myocarditis (RR, 18.28 [95% CI, 3.95 to 25.12]; risk difference, 11.0 events per 100,000 persons [95% CI, 5.6 to 15.8].

Other vaccine-linked adverse events included swollen lymph nodes (RR, 2.43 [95% CI, 2.05 to 2.78]; risk difference, 78.4 events per 100,000 persons [95% CI, 64.1 to 89.3], appendicitis (RR, 1.40 [95% CI, 1.02 to 2.01]; risk difference, 5.0 events per 100,000 persons [95% CI, 0.3 to 9.9], and herpes zoster infection, or shingles (RR, 1.43 [95% CI, 1.20 to 1.73]; risk difference, 15.8 events per 100,000 persons [95% CI, 8.2 to 24.2]). The increased risk of Bell's palsy (facial-nerve palsy) was small (RR, 1.32).

Previous SARS-CoV-2 infections were also associated with multiple serious adverse events in addition to myocarditis, including pericarditis (inflammation of the sac surrounding the heart), heart rhythm abnormalities, deep vein thrombosis (blood clot), pulmonary embolism (blood clot that travels to a lung artery), heart attack, intracranial hemorrhage (bleeding inside the skull), and thrombocytopenia (low blood platelet count).

The authors quantified the COVID-19–related risks thus: abnormal heart rhythms (a 3.8-fold increase, or an increase of 166 cases per 100,000 infected patients), kidney damage (14.8-fold increase; 125 excess cases per 100,000), pericarditis (5.4-fold increase; 11 excess cases per 100,000), pulmonary embolism (12.1-fold increase; 62 excess cases per 100,000), deep vein thrombosis (3.8-fold increase; 43 excess cases per 100,000), heart attack (4.5-fold increase; 25 excess cases per 100,000), and stroke (2.1-fold increase; 14 excess cases per 100,000)."​

https://www.printfriendly.com/p/g/sPU4y9

See above about the unvaccinated avoiding places with faces.

 

That's just nonsense.

 

What should the unvaccinated who haven't tested positive do to cut transmission? I think avoiding "places with faces" is key. Vaccine passports.

Do you have a plan to cut the number of new covid cases and save the economy? Vaccinations and vaccination passports are one approach.

I'd give people quality masks...


P100 respirator

... and show people how to use them. I'd hand them out, door to door.

The masks do cut transmission, but not even close to a P100 respirator.

 

LOL@giving a mask used to remove lead paint. you've obviously never worn one- they are restrictive and uncomfortable.


Personally, I'm not getting the Trump vaccine. I am a 54 year old man with diabetes that just recovered from COVID. I took the 99.7% survival rate.

I am not going to put anything in my body that due to an emergency approval I or my loved ones can not litigate in court. The "science" is bought and sold.

 

Everyone who is worried about getting covid should certainly avoid being near other people. This goes for the vaccinated and unvaccinated, since both can contract and spread covid and particularly delta. What we can do about it now, I have no clue. Even Israel, the most vaccinated, locked down, contact traced, tested and controlled population on the planet is still surging infections. What we should've done at the beginning (and I said so at the time in this forum) was, instead of locking everyone down, just allocate the funding to allow the at-risk to self quarantine, and instead of shutting down all the businesses, instead require essential services to free up a half day, one or two days a week for only those at-risk and self quarantined, so they could get to the grocery, pharmacy, public transit, etc without being exposed to a crowd. This thing is never and was never going to 'contained.' But we could've protected the more vulnerable of us as it was clear pretty early on that the young and healthy are not at much risk of serious injury or death. But instead, we put infected patients in nursing homes, gave all the emergency money to young people who just didn't want to go to work, and now were trying to force the entire population to take a vaccine that is roughly 50% effective at preventing transmission and decreasing every day and creating a segregated society of 'clean' and 'unclean'... I think we've just F'ed it up about as much as is possible and I don't know of a way to fix it now.

Its true the P100s are far better than what most people are using, and they would probably make a difference if everyone had one (along with a steady supply of replacement filters- even P100s don't filter out all the viral load and must be replaced before they become saturated). But even if everyone were just using regular surgical masks and replacing them regularly and disposing of them properly, that would make a difference as well. Apparently the govt doesn't think it could even enforce that (otherwise it would, wouldn't it?). So, as usual, we get the half-assed 'just wear anything' response that makes the problem worse instead of better. I say worse for two reasons- first of all, wearing the same dirty scarf that you and a hundred other people have been breathing on all day is more likely to increase your viral load than decrease it, and second of all, people know the 'just wear whatever' mandate is a huge crock of ****. At least if they were being compelled to actually help prevent the spread of the virus, there would be a lot less resentment. But what we're doing now is effectively just compelling cooperation in virtue signalling, and that's why there's so many people so adamantly opposed to it.