Covid-19 News

Quote from Wyttenbach

But as the UK data shows. 71 of about 270'000 age < 50 did die from delta so far. May be THH can dig out some more - like victims of car accidents that have been PCR+ unborn babies....

So, the latest PHE data shows 25 deaths in the latest 7 days under 45. Adding the 45-49 cohort that would go up to at least 35?

We have had 4 weeks at least of roughly level all-delta deaths - so that is 140. (deaths were 40% lower 4 weeks ago so knock of 20%) - 110.

Another Wyttenfact.

What about the ratio of infections / deaths? Again we can get a tolerable estimate because infections have been fairly stable in the UK over the last 4 weeks.

The ONS data has incidence rates per 10,000 people per day. latest (Aug 7th) is around 10. Since then cases have been roughly stable.

So 10/10,000 * 7 * 70,000,000 = 49,000/day. that checks nicely with case rates of 30,000/day.

so per week we have 350,000 infections, nearly all of which are under 50 (see below).

So overall IFR in this cohort is 1 in 10,000 = 0.01%

The vaccine is doing a lot of good in the UK.

Quote from THHuxleynew

remdesivir wins out (an old trial - but I had not seen it)

If you consider one measly study a "win", I could show you a real winner with 31 RCT's backing it. And it does not cost $3100 US per patient.

Unfortunately it can't be used here or in the UK without the prescribing doctor being snitched on by whistle blowers, hounded by the media, and investigated by state medical boards.

But an expensive drug with one, ONE, study saying it works is the standard of care, and accepted because the establishment makes a lot of money off of it. Follow the money...oops, I mean the science.

Quote from Wyttenbach

The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.

This is old cheese and cheating fro marketing only. The primary outcome has been changed, what is not allowed during a registered study.

Fact is: The people that did survive Gilead crap remdesivir were discharged 3 days earlier but the ones that did die with the crap did live up to 10 days longer. So in average the people did stay longer in hospital...

Remember the old joke? Oh dear the stake was cheap only 1 $ ... but.. they charged 12$ for the fries...

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That is not true. It means that when they are ready to leave hospital (medically) that is given as discharge time. However in some hopsitals they had policy of keeping well patients in hospital to control infection.

Think about it, it is fine. In any case it was double-blind randomised. So they could not have fudged results by artificially changing departure dates.

Quote from Shane D.

If you consider one measly study a "win", I could show you a real winner with 31 RCT's backing it. And it does not cost $3100 US per patient.

Shane. Not sure if here you are deliberately being stupid, or it is the real article. I suspect deliberate

We have no high quality studies of remdesivir contradicting that one. It is high quality, low bias, double-blind randomised control (which makes bias impossible unless those conducting it fraudulently change the data). It has 1000 patients, easily big enough to show this effect as the confidence limits indicate.

And hospitals have been using this for quite a while - if it did not do what it said you would get administrators complaining at the cost!

Now, your 31 RCTs. Did you read carefully that nice paper that compared GRADE bias with results and showed that it was only the highly likley biased studies that overall gave ivermectin positive, and the (large number) of low bias studies showed it negative. There were a whole load of confirmatory details there, like the fact that other clinical measures were negative and only deaths (low likelihood and therefore more random, easier to bias) show positive on the whole cohort of trials. It does not yet mean we know ivermectin does not work, just that there is no good evidence it works, and quite a bit of evidence it does not have a large effect, if it has any. No single high quality trial has results anything like as good as that remdesivir trial.

Quote from THHuxleynew

Not sure if here you are deliberately being stupid, or it is the real article. I suspect deliberate

"Stupid" is a little uncomfortable, but yes...I was having a little fun. That is why the smiley.

Quote from THHuxleynew

Now, your 31 RCTs. Did you read carefully that nice paper that compared GRADE bias with results and showed that it was only the highly likley biased studies that overall gave ivermectin positive, and the (large number) of low bias studies showed it negative

Yes, yes I read the paper. I marveled when reading how human bias could be so scientifically quantified. I trust your friends doing these studies are confident their input (subject to personal bias), are confident their studies output/conclusions are unbiased.

It reminded me when back in the 90's some of the big Wall Street firms hired real life rocket scientists to exploit the market using sophisticated algorithms. Worked for a short time, but because their techniques became part of the complicated mix that makes the market unpredictable, the market adjusted, and they lost a lot of money.

They were fired and WS went back to ripping-off us little guys the old fashioned way.

As the story of the weak field around earth but seeing the lightning from the boundry layer "on high" with now solar pushing the layer ...

just something to think about.

Quote from Wyttenbach

But as the UK data shows. 71 of about 270'000 age < 50 did die from delta so far. May be THH can dig out some more - like victims of car accidents that have been PCR+ unborn babies....

Quote from THHuxleynew

Another Wyttenfact.

No THH. You never commit your fraudulent errors. You made a wrong calculation based on an UK official paper - not my data not my facts your bullshit calculation!

You are XXXX simple minded person that always likes to blame others for his own mistakes.

Quote from THHuxleynew

In any case it was double-blind randomised.

Yes: Was is the correct term.Then it was changed and the outcome faked. So formally this study not even exists! as it never has been properly registered.

Quote from Shane D.

your friends doing these studies are confident their input (subject to personal bias), are confident their studies output/conclusions are unbiased.

(1) I do not know any of the people doing that report; your statement above is a sort of subtle implication of bias on my part ?

(2) The best way to determine that would be to look at the differences between their judgments and those of Byant et al. Bryant et al simply said inconclusive for bias - and treated evidence (including that badly written and fraudulent - in the sense that the data and the text was cut and pasted - paper) as all good. which naturally leads to a positive outcome. So the question is whether a judgement of possible bias can be made objectively. you might think not, from politics, where bias is viewed as somone who does not agree with you. The paper uses a methodology in which possible bias can be determined objectively from methodology without looking at what the results are, or whether you agree with them

It is clear that some such method is needed when there are a very large number of low quality studies, as here.

No work is free from bias, but that paper is muhc more likley to be free - because it uses rigorous and clearly explained methodology, than the low quality ivermectin papers. Overall it is as good as it gets in terms of summarising the stae of research. i don't see how you could do it in a less biassed way?

If you believe that is biassed, then no such summary (of very inconsistent trails) can be trusted and there is just no evidence on ivermectin. Slightly more positive than the actual - there is some evidence that overall is negative, but does not preclude possible effect.

Don't think all drug trials are like this - with drugs that work you gte a much more consistent pattern of results!

Quote from THHuxleynew

I do not know any of the people doing that report; your statement above is a sort of subtle implication of bias on my part ?

I believe you try very hard not to be biased, but your politics get in the way of being totally so. Nothing wrong with having a political stance to the left/right (left in your case), but you express it so often, strongly, and at times personally...it is hard to imagine your conclusions are not at times more your politics talking, rather than your science.

We are all like that I guess, and to your credit you do better than most balancing it all out. That is why you have such a big following here.

Quote from Fm1

Didn't I read you were going to leave the thread for awhile?

Needs a break from posturing... the reactive stance gives you back ache sometimes..

Maybe Remdesivir is good for that.

Quote from Shane D.

because the establishment makes a lot of money off of it.

The establishment is not in the Indian subcontinent in a big way

.. all though some Bangladesh pharmas get some peanuts..

India is a huge market unfortunately the Gilead trial was overriden by Solidarity trial.

the Indian CDCSCO did not grant full approval.(.I think the WHO was similar.)

so the sales of Remdesivir are not grand.

"Exactly a week later, the US FDA approved Gilead's New Drug Application for the use of remdesivir in adults and pediatric patients for the treatment of COVID-19 which necessitates hospitalization.[¹]

This FDA approval changed the status of remdesivir from emergency use approval to full approval.[¹] In contrast, the COVID-19 Subject Expert Committee of the CDCSCO did not grant full marketing authorization and opined to continue the restricted emergency use of remdesivir during its meeting on October 29, 2020.[⁴]

Placing the results of the SOLIDARITY trial with regards to ... : Lung India

ebates in social media and the press about the utility of the drug. Both preclinical and clinical data demonstrated its efficacy in COVID-19. The recently…

journals.lww.com

Quote from Shane D.

I believe you try very hard not to be biased, but your politics get in the way of being totally so. Nothing wrong with having a political stance to the left/right (left in your case), but you express it so often, strongly, and at times personally...it is hard to imagine your conclusions are not at times more your politics talking, rather than your science.

We are all like that I guess, and to your credit you do better than most balancing it all out. That is why you have such a big following here.

I've always believed that politics and science are different, and I try to be clear about my political views keeping them separate from science. In the US - you seem to have lot of overlap. But, in the UK, it is quite common for scientists to work in a way that is quite disconnected from politics. And both the main parties in the UK (in fact all the UK parties) are equally pro-science.

I think the key political dimension to COVID is the lockdown / no lockdown decision. I don't think I am political about that. I admire the governments like Sweden that don't lockdown and face things honestly. I see the impossibility politically of holding out against lockdown when health systems fall apart. I see the exponential thing - if you lockdown early you get much lower cost than if you lockdown late. Personally I am sort of in the middle because I see the costs of lockdown. Personally i don't mind it, but it impacts those who cannot work remotely, and also tend to have muhc lower salaries, much much worse than it impacts those like me who can work remotely (and even in some ways prefer this).

Where I am not in the middle is I want honesty and common sense. If COVID rates get high without good vaccination more people die. COVID is not the same as Flu, it is much worse. After vaccination, if your country can get rates up high, it is still a bit worse than Flu, though comparable. Unlike Flu COVID delivers long COVID which together with the debt and children's developmental issues from lock-downs are the things to watch for that will persist. (I don't actually think the debt is such a big deal - but that is a complex economic question and it certainly could be a big deal if handled wrong. Governments are not like households, they do not have to balance the books).

The politicians (and sometimes scientists) who try to distort the science on these issues to fit their preferred way out I have no sympathy for. But I have every sympathy with anyone taking those hard decisions whichever way they go, if it is honest. Both sides in the US have been dishonest but the current Republican party is avowedly anti-science. It is not surprising that it ends up being dishonest more often.

I think my one definitely political view here is on the question of freedom. I can't see why being forced to comply with regulations, vaccine or masks, to use public spaces, do jobs in contact with others, is a problem. We have rules to prevent road deaths, to prevent industrial accidents, etc, etc. This is a particularly extreme version of that. Where I don't agree is with vaccine mandates as a way to force vaccination. That is because stigmatising those who are not vaccinated might drive them into a tribe where they are just less likely to get vaccinated, and feel aggrieved. In a free society we cannot force vaccination on anyone, we can prohibit where they go if it is private space, or public space and there is a health risk. But the health risk overall matters less in terms of long term good than upping the vaccination rates to reduce COVID, or at least reduce the burden on hospitals. So i am quite pragmetic about that balance.

People going on demos with placards saying "Freedom" just seems silly to me. Pretty well every Western country now has stopped doing lockdowns, and is not likely to restart whatever happens. If freedom is about mask mandates I don't agree. We restrict smoking in public places because it harms others. This is the same thing.

Ok, so if by in your face politics you mean that bit it is true. But I do not think it is a left/right thing. And whereas to lockdown or no is a big deal that affects many things, to wear face masks has no significant adverse effects. Those who can't see the difference between the two cases are the ones being political.

Glad I have such a big following. You would not know it from posts here. I tend to feel I am with Jed and occasional very competent help from a few others fighting a losing battle against the forces of unreason and darkness

If you have to judge politics I'd say a good first rule is: anyone in the US at the moment is much more political (in bad ways) than in other countries. I cannot think of another country where scientific issues have become political footballs with one party overtly saying they do not trust scientists and seeking out the mavericks who support weird views (COVID, global warming, evolution).

THH

Quote from RobertBryant

"Exactly a week later, the US FDA approved Gilead's New Drug Application for the use of remdesivir in adults and pediatric patients for the treatment of COVID-19 which necessitates hospitalization.[1]

As we now know the promoting FDA guy (also blocking HCQ, Ivermectin) has been promoted to director of a big pharma company....

In any non Banana republic state people in such a position are not allowed to switch side for the next 10 years...

Quote from THHuxleynew

We have had 4 weeks at least of roughly level all-delta deaths - so that is 140.

And guess!!? The ICU death rate for age <50 remains the same .03%...About the same as the durable vaccine damage rate..

Pediatric Physicians Group Sends Strong Message: Don’t Vaccinate Children Under 12 Off-Label

Pediatric Physicians Group Sends Strong Message: Don’t Vaccinate Children Under 12 Off-Label

The American Academy of Pediatrics (AAP) recently came out with a message cautioning the American public not to inoculate children 16 and under off-label

trialsitenews.com

The American Academy of Pediatrics (AAP) recently came out with a message cautioning the American public not to inoculate children 16 and under off-label even though the Pfizer-BioNTech vaccine was formally approved by the U.S. Food and Drug Administration (FDA). TrialSite reported in a strange anomaly of a registration, emergency use authorization (EUA) still stands thus, even though the label precludes under 16, young people aged 12 to 15 can still receive the vaccine under that mechanism. While, of course, not acknowledged by authorities, the branched EUA/approval ensures that existing EUA products in circulation can be used up while mounting employer mandates now have tremendous legal authority backing them. Regardless, the AAP is on record that no child under 12 should be vaccinated off-label until sufficient clinical trial data is collected, analyzed and the authorities deem such a move safe.

In a piece authored by AAP News, Editor Melissa Jenco, AAP President Lee Savio Beers, MD, FAPP issued a statement, declaring, “The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children.” The organization’s head continued, “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 (years) until authorized by the FDA.”

What follows is a breakdown of this influential physician association’s logic and points of view followed by a critical question for all.

What are the current COVID-19 vaccination rates in America?

AAP reports that among those 16 -17 years, 43% have received a vaccine while 33% of adolescents aged 12-15 are fully vaccinated, reports Ms. Jenco. The senior editor reminds all that at this point, 62% of all adults in America are fully vaccinated based on data from the Centers for Disease Control and Prevention (CDC) as well as an AAP analysis.

Why does AAP recommend not vaccinating kids under 12?

The current FDA licensure of the vaccine (Comirnaty) applies to kids and adolescents aged 16 and older, the same group that was covered by the emergency use authorization granted in December 2020.

But how can kids age 12 to 15 still be vaccinated if the FDA label is for 16+?

Because under a carefully engineered registration, the FDA essentially allowed a two-track program where the EUA continues as well as the formal approval. Meaning, under the EUA, children 12 to 15 could receive the vaccine. Thus the AAP “strongly encourages all eligible individuals to receive the COVID-19 vaccine, including those who are 12-15 years old”—but again that would be under the EUA legal mechanism.

What milestone is the AAP awaiting to greenlight kids 12 and under?

As the organization’s president declared, ongoing clinical trials for children 11 and younger are on their way, the physician organization dedicated to pediatrics declared they must first view the data before recommending any vaccines for this vulnerable young cohort.

Was the FDA’s authorization influenced by political or policy considerations?

TrialSite believes it was so. The AAP acknowledges that “FDA officials are on the record recently that “they hope full authorization of the vaccine will help address concerns among people who have been hesitant.”

TrialSite suggests the way the registration was designed it also serves to legally back vaccine mandates of wide numbers of public employees, from 800,000 military personnel to state and municipal employees. But this is the TrialSite opinion based on the data and facts as we see them.

But how could the registration of the vaccine be done when the clinical Pfizer-BioNTech clinical trial is ongoing?

First of all, technically, that’s correct—the pivotal Phase 3 study still has a couple of years to go. A lot can happen in that span of time. The clinical trial was scheduled to run a couple of years, but given the urgency of the pandemic and data in hand, the FDA made the call that the time was now. In fact, Janet Woodcock, FDA’s Acting Commissioner, declared, “This is a pivotal moment for our country in the fight against the pandemic.” Woodcock, who recently did the right thing calling for an external investigation of the Gold Standard agency after the Biogen Alzheimer’s disease drug’s approval seemed rushed, went on, “While this and other vaccines have met the FDA’s rigorous and scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be confident that this meets the FDA’s gold standard for safety, effectiveness, and manufacturing quality that we require of an approved product.”

Did the FDA follow standard guidelines ensuring transparency?

No, they did not. As TrialSite reported, the agency bypassed the standard process for the Comirnaty decision, bypassing Advisory Committee participation, for example. This included preclusion of any consumer representation.

On the other hand, the FDA declares they have met their public obligation via an iterative methodology during the EUA process. So the answer to this question depends on one’s point of view.

Is TrialSite alone in this concern about a rushed approval?

No, not at all. Many people across society are very concerned. A notable mainstream medical journal’s senior editor of the prestigious medical journal The BMJ is quite concerned. Recently he outlines several concerning elements involving this unprecedented, accelerated approval in an opinion piece. Note that Doshi and others formed the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to halt the COVID-19 vaccine approvals this year. More can be read here.

But what about vaccine safety with so many incidents in VAERS?

The FDA hasn’t recognized much of the signals in the VAERS database that many researchers have uncovered. Advocates have pleaded with them, but such calls go on deaf ears. Instead, the FDA reports that solid efficacy data derives from 40,000 people, half of whom received the vaccine and half of whom received a placebo. The data from this point of view indicate that the product, Comirnaty, is 91% effective in preventing COVID-19 disease.

Moreover, Dr. Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics for Evaluation and Research, suggests after evaluating 44,000 study participants (half receiving the vaccine), with a subset followed for at least four (4) months and another 12,000 followed for at least six months, the FDA was comfortable with that data. Again, they did not factor in numerous purported VAERS safety signals observed by independent analysts, except for risks associated with the rare risk of myocarditis and pericarditis, especially a week post the second jab. The risks for these occurrences rise for males under 40. From the FDA perspective, the vaccine is sufficiently safe, and given the risks of COVID-19, particularly with the Delta variant, the registration is appropriate.

How much risk do children face with the Delta variant?

More transmissible with a higher viral load, children definitely become carriers of the Delta variant of SARS-CoV-2. The incidence of morbidity or mortality is extremely low, but they have increased as compared to previous pandemic surges due to Delta. TrialSite reported on one CDC study demonstrating some concerning trends.

A recent study in the U.K. highlights the extremely rare occurrences of more severe conditions for children. According to this study, the probability of a child entering the ICU due to COVID is 1 in 50,000 and 2 in a million risk of death.

Yet the AAP’s editor wrote that growth in infections puts more of the young at risk, as one report from the AAP and Children’s Hospital Association reveals. This study suggests a “Four-fold increase from about 38,000 new cases since the week ending July 22,” with children making up 22% of the cases.

However, what the AAP’s Ms. Jenco doesn’t share about this report is that the authors declare, “A smaller subset of states report on hospitalizations and mortality by age; the available data indicate that COVID-19-associated hospitalization and death is uncommon in children.”

Regardless of probabilities or not, TrialSite acknowledges that parents want to protect their children. For most parents, based on the data delivered by the mainstream media, it’s a rational decision to vaccinate a young child.

TrialSite doesn’t attempt to sway individuals one way or another (this is a pro-science, pro-vaccine site) but simply seeks to provide a more objective and comprehensive picture for all health consumers to make the most informed decision. TrialSite notes that the assumption that the vaccine will inhibit transmission with the Delta variant is incorrect and antiquated.

What is the true risk-based assessment to consider for the young?

The true risks associated with children succumbing to serious infection leading to morbidity or mortality versus the probability of an adverse event is a good place to start. Children with co-morbidities face a higher risk with COVID-19.

Note that the CDC also found growing risks associated with the vaccine but still recommended vaccination.

The vaccine should ultimately not be given to children to stop viral transmission because such a decision is based on outdated and incorrect information. If a child is at heightened risk for infection, the parents and physician should objectively weigh the risks and benefits. But our children are our future, and the parents should better understand a proper understanding of true health risks and benefits.

When does Pfizer expect data from clinical trials covering young children 5-12?

APP wrote that the data is expected this fall, and the FDA’s Dr. Marks committed to expediting agency reviews.

ICER Assessing COVID-19 Treatments Including Fluvoxamine: A Victory for Steve Kirsch’s COVID-19 Early Treatment Fund

ICER Assessing COVID-19 Treatments Including Fluvoxamine: A Victory for Steve Kirsch’s COVID-19 Early Treatment Fund

One of the most influential organizations impacting drug prices that few are aware of is the Institute for Clinical and Economic Review, commonly referred

trialsitenews.com

ICER Assessing COVID-19 Treatments Including Fluvoxamine: A Victory for Steve Kirsch’s COVID-19 Early Treatment Fund

One of the most influential organizations impacting drug prices that few are aware of is the Institute for Clinical and Economic Review, commonly referred to as “ICER.” The Boston-based independent non-profit wields tremendous clout in America when it comes to the pricing of drugs as many payers look to ICER’s analyses for both a quantitative and qualitative assessment of the underlying value of the drug, tests, or procedures to the patient and broader society. Founded back in 2005 by physician-researcher Steven D. Pearson, MD, MSc, FRCP, the organization primarily focuses on evaluating health care costs rather than therapies. But the organization pivoted and intensified analyses of therapies, diagnostics, and other investigational products, drilling down into cost-effectiveness in a comparable manner to the United Kingdom’s NICE. The pharmaceutical industry hasn’t always been pleased with ICER assessments as the Boston non-profit places an actual monetary value on novel drugs. Thus evermore numbers of payers look to ICER to justify price points. They are funded by Arnold Ventures LLC (formerly the Laura and John Arnold Foundation), pharmaceutical companies, payers, and government grants. Recently, ICER announced the forthcoming assessment of the comparative clinical effectiveness and value of COVID-19 treatments, including Regeneron’s monoclonal antibody cocktail called REGN-COV (casirivimab/imdevimab); Merck’s molnupiravir; GlaxoSmithKline and Vir Biotechnology’s sotrovimab; Pfizer’s PF-O7321332; and the investigator-initiated Fluvoxamine in a win for early therapy funder, entrepreneurial and founder and CEO of COVID-19 Early Treatment Fund, Steve Kirsch.

The recently announced assessment will publicly open up for a discussion during the organization’s Midwest Comparative Effectiveness Public Advisory Council known as Midwest CEPAC in April 2022. During this meeting early next year, the independent evidence review panel will deliberate and vote on the evidence presented in ICER’s report.

ICER Stakeholder Process

The organization recently reported in a press release that the principals spent the past five weeks engaging with targeted stakeholders, including the manufacturers of the treatments being assessed, clinical specialists, as well as payers. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document delineating the plans for the forthcoming assessment.

The COVID-19 Treatments

The following treatments are under ICER review:

COVID-19 Treatment Sponsor

REGEN-COV Regeneron

sotrovimab GSK & Vir Biotechnology

molnupiravir Merck

PF-07321332/ Pfizer

Fluvoxamine Investigator-Initiated*

*Fluvoxamine has been funded by the COVID-19 Early Treatment Fund

Interested in Participating?

Those interested in participating are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to [email protected] and must be received by 5 PM ET on September 15, 2021. ICER requests that contributors submit comments as a Word document in the following format:

· 12-point Times Roman font

· Three-page maximum (not including references or appendices)

Kudos to COVID-19 Early Treatment Fund

The generic, repurposed therapy Fluvoxamine made it on the influential ICER list thanks to the COVID-19 Early Treatment Fund founded by Steve Kirsch. A TrialSite network member, Kirsch has invested at least six million dollars of his personal wealth in advancing a mission of early treatment for COVID-19. TrialSite congratulates Kirsch for this notable achievement and sends a recognition to his contribution to fighting for patients’ health not only in the United States but beyond.

About the COVID-19 Early Treatment Fund

Funded by technology entrepreneur Steve Kirsch, The COVID-19 Early Treatment Fund was organized during the pandemic to help find adequate treatments for early-onset care. Kirsch fell in a high-risk group during the pandemic, along with tens of millions of others. He found that at the onset of the pandemic, development investment patterns focused on longer-term vaccines and novel therapeutics such as monoclonal antibodies but not more imminent practical treatments that could help inhibit disease progression in early mild-to-moderate, which represent the majority of COVID-19 cases.

Kirsch recognized that many Americans faced additional risk due to underlying conditions and financial hardship experienced by family businesses everywhere. It became clear to Kirsch and colleagues that a long-term solution such as a vaccine wasn’t enough. Action was required, and Kirsch should be considered an American hero for spending several million dollars to progress generic treatments such as Fluvoxamine.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care.

Call to Action: For more information, such as the timelines of key posting dates and public comment periods for the assessment, check out the link.

More questions for Pfizer from another Brit... go the Brits!

Slow down and get the Science right ... not the $cience

Quote from Fm1

ICER Assessing COVID-19 Treatments Including Fluvoxamine: A

These guys are crazzy. Just try to optimize profits for one more buddy. Fluvoxamine is a drug to treat mental disorder and may induce suicide.- Every application must thus be mandatory followed (at least here in Europe) by psychiatrist what means extreme costs and risks.

Obviously they have no interest in Ivermectin/HCQ, Budenoside and other cheap generics.

Quote from Wyttenbach

And guess!!? The ICU death rate for age <50 remains the same .03%...About the same as the durable vaccine damage rate..

That low death rate, in spite of delta, is because of vaccination (and the COVID age-dependence). Even without vaccination it would be maybe 0.1%. With full vaccination of 16-50 it would be even lower than 0.03%. Note that the 40-50 age group (see below) in UK has overall double vax level at 83%. So 17% unprotected.

Still, I'm glad you have stopped claiming that under 65 death rate is low.

THH

Quote from Fm1

Was the FDA’s authorization influenced by political or policy considerations?

TrialSite believes it was so. The AAP acknowledges that “FDA officials are on the record recently that “they hope full authorization of the vaccine will help address concerns among people who have been hesitant.”

TrialSite suggests the way the registration was designed it also serves to legally back vaccine mandates of wide numbers of public employees, from 800,000 military personnel to state and municipal employees. But this is the TrialSite opinion based on the data and facts as we see them.

For a News organisation, trialsite has a very fat agenda. But as a news organidsation it can be as biassed as it likes.

In this case, after 100s of millions of vaccinations and 8 months + scrutiny of the three different safety reporting systems, we are way past the extra requirements for full approval (6 months of phase 3 data).

What everyone said is that the only thing that made authorisation emergency not full initilaly is that it is a faster process. And the motivation for going for full authorisation is that it will help reassure some people.

Nothing here folks - except TSN being TSN and shoving its perma-conspiracy theory up our noses.

What is the difference between emergency approval and full FDA approval of vaccines? - Poynter

The FDA granted full approval to the Pfizer-BioNTech vaccine for ages 16 and up on Monday morning.

www.poynter.org

A year ago, Pfizer and Moderna collected data from tens of thousands of volunteers, half of whom took the vaccine and half of whom got placebos. The Pfizer trial involved 43,000 participants, while 30,400 people took part in the Moderna trial.

Emergency use approval required the drug companies to follow the volunteers for two months after vaccination. Experts say two months is usually enough to know what reactions we can expect from a vaccine.

But full approval requires at least six months of data. Massive amounts of evidence are collected that can lead the FDA to issue warnings for possible side effects, as it has done with the Johnson & Johnson vaccine.

The FDA once required the drug companies to complete their data collection and submit it, but now the FDA has a “Fast Track” system that allows companies to collect and submit data on a rolling basis to speed the time it takes to get medicines and treatments to market faster.

FDA approval does not change who should take the vaccine. It still will not likely be approved for younger children since those drug trials are still underway.

But full approval does allow Pfizer to directly market the vaccine to the public. For example, all of those pharmaceuticals that you see in TV commercials required that the FDA fully approved those drugs first.

Full approval also pretty much closes the door on any other companies who come up with new vaccines and want fast approval. The FDA’s rules spell out that emergency approval is only given when “there is no adequate, approved, and available alternative.” And full approval allows the Pfizer vaccine to remain available even when the official “emergency” ends.

Quote from RobertBryant

More questions for Pfizer from another Brit... go the Brits!

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Slow down and get the Science right ... not the $cience

You can't have it both ways.

If medical regulators do their job, and are independent of each other, different countries will have different views as to when approval should be given. This is partly related to COVID rates - countries expecting very low COVID rates need to balance vaccine risk against a much lower COVID risk. I'd argue with delta every young person should expect to be infected (at least 80%). But regulators tend to be very cautious and look historically.

Every nation tends to prefer its own home-grown vaccines.

Thus the UK approves Astazeneca down to 18, US still has not approved it (it seems Astrazeneca may go for full approval later this year). Looking at the most recent safety and efficacy evidence it seems only slightly less good than Pfizer.

The US approves Pfizer down to age 12, the UK approves it down to age 16 - and is currently thinking about 12-15. Personally if you say the measure should be personal risk from vaccine is clearly less than personal risk from COVID Astrazeneca will never get less than 18, and it is a bit uncomfortable below 40 because Pfizer clearly has less risk than Astrazeneca for those age groups, even though both are lower risk than COVID.

These decisions are always going to be judgement calls, and it is not surprising there are differences. In the UK the decision whether or not to approve vaccination for 12-15 children is hotly contested, and those not wanting it do so on basis of global unfairness (the vaccines would do much more good in other countries used on adults). https://www.bmj.com/content/374/bmj.n1687. I guess the US conversation is more narrowly on overall benefit to US children.

As for money influencing regulators - no system is perfect - and regulatory decisions are a balance - so biasses of all sorts, including who slept well the previous night, or wants to end an evenly split meeting to get home early, will creep in at the margins. Why be cynical about that, or suppose that it leads regulatory committees to make decisions that will kill children? You have for that to assume the people on those committees are corrupt and immoral. Most are not.

This continued drip drip corrosive assumption - without evidence - that other people are bad - is one of the things that makes the modern world a poorer place.