MERE MONTHS OF "TESTING" VERSUS THE 'GOLD STANDARD' OF TEN-YEAR STUDIES? WOULD YOU TAKE THIS VACCINE, OR GIVE IT TO YOUR CHILD?
Pfizer is a New-York based Big Pharma company. It’s known for its products like Advil, Viagra, Xanax and Zoloft. It was the second-largest pharmaceutical company in revenue in 2017.
But the medical industry giant has had its share of legal troubles and scandal. This includes marketing fraud allegations and unapproved clinical trials.
Pfizer has had many triumphs. It discovered citric acid. It mass produces penicillin and vitamin C. But for all its successes, it has also seen its fair share of lawsuits and scandal.
Consumers have accused Pfizer of selling defective products.
The U.S. government has charged the company with health care fraud.
Fortune magazine named Pfizer the world’s most admired pharmaceutical company in 1997.
But in 2017, a Reputation Institute report ranked Pfizer last among the top 17 drug makers.
Pfizer Vaccine 90% Effective Claim Is Unsubstantiated by Peer-Review Journals or by the World Health Organization.
Can the public afford to trust vaccine companies who deliberately withhold information and data and have preyed on the public’s desperation to escape lockdowns, while, at the same time, reaping the rewards from the stock market that has responded to a premature and unsupported announcement?
The Phase 3 trial of the Pfizer-BioNTech mRNA-based vaccine, named BNT162b2, is one of 48 vaccines under clinical evaluation that aims to protect against COVID-19.
The primary source of the news, headlined by a “90% effective” claim, is NOT a peer reviewed journal article. Nor is it a claim by the World Health Organization (WHO). Rather, it’s a media release issued on Monday by Pfizer, the commercial partner linked to the young German biotech company BioNTech, that developed the vaccine.
The news that the vaccine has been shown to be “90% effective” has sent Pfizer stocks flying, and caused the company’s recently appointed, ex-veterinarian chairman, Dr. Albert Bourla, to sell off 62% of his personal stock in Pfizer.
Pfizer was conspicuous, given its position as one of the largest drug companies in the world, in excluding itself from the U.S. government Operation Warp Speed.
The news that the vaccine has been shown to be “90% effective” has sent Pfizer stocks flying, and caused the company’s recently appointed, ex-veterinarian chairman, Dr. Albert Bourla, to sell off 62% of his personal stock in Pfizer.
Pfizer was conspicuous, given its position as one of the largest drug companies in the world, in excluding itself from the U.S. government Operation Warp Speed.
The downside for Pfizer was that it didn’t benefit from the U.S. government (taxpayer) funding support that the likes of Moderna, Johnson & Johnson and Astra-Zeneca have been privy to. But don’t feel too bad, BioNTech received funding from the German government.
The plus side for Pfizer was that it didn’t need to be dictated to by others, and it didn’t need to data share or have its data analysed by a shared, Operation Warp Speed data monitoring committee. Remember this as you read on.
So, what do the headlines really mean?
So, what do the headlines really mean?
Here’s the first problem. We only have a press release to go on. At ANH, we’re always keen to get to primary data sources so we had to look further. The press release refers to an interim report on the Phase 3 trial by an “external, independent Data Monitoring Committee (DMC)”.
An article by the Kaiser Family Foundation suggests that Pfizer’s DMC is anything but independent. The anonymity of its 5 members also makes it anything but transparent.
A September editorial in one of the world’s most influential journals, Nature, argued “COVID vaccine confidence requires radical transparency”.
WE WON'T GET THAT FROM PFIZER.
The interim report found at the WHO was only a “Draft landscape of COVID-19 candidate vaccines” page, that incidentally “disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents”.
Alas, while the WHO page has updated, the report still isn’t there. What you will find there is the now outdated trial design for the vaccine as a link to the NIH ClinicalTrials.gov portal. But no interim study results.
A September editorial in one of the world’s most influential journals, Nature, argued “COVID vaccine confidence requires radical transparency”.
WE WON'T GET THAT FROM PFIZER.
The interim report found at the WHO was only a “Draft landscape of COVID-19 candidate vaccines” page, that incidentally “disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents”.
Alas, while the WHO page has updated, the report still isn’t there. What you will find there is the now outdated trial design for the vaccine as a link to the NIH ClinicalTrials.gov portal. But no interim study results.
A web search using the terms ‘“Data Monitoring Committee” BNT162b2 BioNTech Pfizer’ and similar didn’t make it magically appear either, just lots of references to the “90% effectiveness” claim across a plethora of media channels.
What we’ve been told...
Back to the press release. The key pieces of information that fall out of it are as follows:
--The claim in its full glory: “more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2.”
-- A link to an updated study design (protocol) which presumably replaces the one listed on ClinicalTrials.gov.
43,538 participants enrolled to-date (89% of which have received the second dose)
-- 42% of participants have “ethnically diverse backgrounds” (which begs the question what ethnicity is the non-diverse 58%; surely not Caucasian? But probably.)
-- 94 people out of the 43,538 participants (i.e. just 0.2%) have contracted COVID-19 so far, these being split between the vaccinated and placebo groups, the split not being reported.
What we’ve been told...
Back to the press release. The key pieces of information that fall out of it are as follows:
--The claim in its full glory: “more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2.”
-- A link to an updated study design (protocol) which presumably replaces the one listed on ClinicalTrials.gov.
43,538 participants enrolled to-date (89% of which have received the second dose)
-- 42% of participants have “ethnically diverse backgrounds” (which begs the question what ethnicity is the non-diverse 58%; surely not Caucasian? But probably.)
-- 94 people out of the 43,538 participants (i.e. just 0.2%) have contracted COVID-19 so far, these being split between the vaccinated and placebo groups, the split not being reported.
It’s misleading, far too premature and disingenuous for Pfizer to be telling the world that the trial has demonstrated 90% effectiveness so far because most people will assume that that means, regardless of age, health status, ethnicity or underlying conditions, if they get vaccinated with an emergency approved vaccine that has undergone just 2 months of safety evaluation, they will have only a 10% chance of getting seriously ill if they become infected — and it will be safe.
There are insufficient data to support either outcome.
It’s difficult to judge the effectiveness claim against what your chances might be if you remain unvaccinated. But if you’re healthy and under 75-years-old, the chances of serious disease are very low, probably much less than 10% following infection.
But accurate estimates still cannot be made because we continue to be blind to the number of people who have been infected, and therefore, also to the true rate of serious disease and mortality among those infected.
What we are also aware of are big variations in estimates of the number who are likely asymptomatic (infected but without symptoms).
Nothing can be said about the risk of harms from vaccination with two doses of BNT162b2 such as triggering autoimmune conditions as the trials need to run their course and most of these kinds of problems are generally not picked up until years after the product is first marketed. And that’s assuming a normal 6-year development program. Two months of post-vaccination adverse event reporting just doesn’t cut it if you want a proper handle on safety.
If this vaccine fails to be effective a few months after its second doses has been administered, is there going to be a justification made for its mass roll-out, given the huge economic cost to society, the risk of harms, and the fact that healthy people seem to tolerate SARS-CoV-2 more than adequately?
Remember, it was the alternate BioNTech vaccine, BNT162b1, that was found to enhance the T-cell response more, but had an unacceptable safety profile so was dropped.
Where is the risk-cost-benefit analysis by governments showing that roll-out is both necessary and justified?
Disturbingly, this announcement, and the lack of data associated with the press release, demonstrates that Pfizer and BioNTech have an incapacity for real and meaningful transparency.
This leads to one central question: Can the public truly afford to trust vaccine companies who deliberately withhold information and data and have preyed on the public’s desperation to escape lockdowns, while, at the same time, reaping the rewards from the stock market that has responded to a premature and unsupported announcement?
[Call me a conspiracy theorist for asking questions.
I'd rather wear that label than :"MINDLESS, UNQUESTIONING SHEEP".]
“No serious safety concerns have been observed” ??? which does not mean moderate or severe adverse reactions have not been observed. Two months of safety data will be available at the time Pfizer applies for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA).
TWO LOUSY MONTHS.
Key information that hasn’t yet been put into the public domain and could have accompanied the interim release includes:
--The number of people in the vaccinated or placebo groups who were exposed to SARS-CoV-2.
--The demography (age, gender, ethnicity, etc) of those who were infected and how many of these represent the most vulnerable groups i.e., the elderly or those with comorbidities.
--On what particular outcome parameters was the effectiveness determined? Was it, for example, based on lack of COVID-19 disease symptoms combined with elevated antibody responses, and if so which ones?
--How serious was the manifestation of COVID-19 disease in the equivalent vaccinated and placebo groups (i.e., similar ages, gender, ethnicity and underlying disease pattern)?
--What is the composition of the placebo that is being delivered to 50% of the 44,000-strong study population? Does it include the lipid nanoparticle minus the mRNA that encodes for the full-length spike protein of SARS-CoV-2?
--What was the response of the cell-mediated (T cell) side of the adaptive immune system (which are not included in the endpoints according to the trial protocol)?
The October publication of the Phase 1 results in the New England Journal of Medicine indicated it was the sister vaccine, BNT162b1, that produced a strong T-cell response but this was dropped as the vaccine induced some serious adverse reactions.
--What was the nature, severity and extent of adverse events to BNT162b2 reported until now in the Phase 3 trial?
How long will immunogenicity against SARS-CoV-2 persist in different people?
TOO MANY UNKNOWNS, TOO LITTLE DATA REVEALED, TOO SHORT A "TRIAL"
There are also many unknowns that may well remain unknowns. Top of my list would be these two:
--The possibility that some of the NAAT-confirmed cases involve infection with other human coronaviruses and it is these non-SARS-CoV-2 viruses that have triggered the measured immunogenicity and the NAAT results are either false positives or the result of SARS-CoV-2 viral fragments.
--The presence of non-replicable viral fragments of (‘dead’) SARS-CoV2 have triggered immunogenic reactions so infection could not anyway have occurred.
As transparent as a big black box.
Is COVID-19 Vaccine Development Moving Too Fast?
Biotech firm Moderna Inc., along with the National Institutes of Health said they're ready to move onto the largest study of the potential vaccine's efficacy at the end of the month.
It's the fastest a vaccine has been developed for a novel virus.
It begs the question, are the scientists moving too quickly?
Spectrum News spoke to Johns Hopkins All Children's Hospital’s Dr. Allison Messina, who’s the Chief of Infectious Disease and Medical Director of Infection Prevention at the hospital.
Dr. Messina explained how the process works.
Stage 1: Looks for safety or rather there are no side effects when someone gets the vaccine coupled with someone building the immunity.
Stage 2: Targets the vaccine on a specific larger group.
Stage 3: Determines how effective it works on an even larger group (compared to a control group), while also looking for no side effects.As so appropriately put by Peter Doshi, an associated editor of the BMJ and also associate professor of pharmaceutical health services at the University of Maryland School of Pharmacy, “The lack of data is very concerning … All we have right now is a headline by Pfizer.”
“To get a vaccine from concept to market is done in a very regimented way,” said Dr. Messina. “And is reviewed by lots and lots of scientists and regulatory bodies all along that process to make sure that product does what it says it's going to do and is safe for use in the population."
THAT HAS NOT HAPPENED AND LIKELY WON'T.
THE DESIRE OF THE WORLD POPULATION TO SEE AN END TO ILLEGAL, LIFE-RIPPING LOCK-DOWNS, DRACONIAN MEASURES TO CONTAIN A VIRUS THAT WILL NEVER, EVER BE CONTAINED WILL SIMPLY ALLOW PFIZER TO MARKET ITS VACCINE.
THOSE WHO SEE THE MANY DANGERS OF THAT WON'T WILLINGLY GET THE VACCINE; THOSE WHO JUST WANT THE LOCK-DOWNS TO END, WILL.
FROM USNEWS:
Whistle-blower Rick Bright Warns Against Developing Vaccine Too Quickly
The ousted vaccine director and expert believes the predicted timeline for developing a vaccine will take longer than 12 to 18 months.
How long will immunogenicity against SARS-CoV-2 persist in different people?
TOO MANY UNKNOWNS, TOO LITTLE DATA REVEALED, TOO SHORT A "TRIAL"
There are also many unknowns that may well remain unknowns. Top of my list would be these two:
--The possibility that some of the NAAT-confirmed cases involve infection with other human coronaviruses and it is these non-SARS-CoV-2 viruses that have triggered the measured immunogenicity and the NAAT results are either false positives or the result of SARS-CoV-2 viral fragments.
--The presence of non-replicable viral fragments of (‘dead’) SARS-CoV2 have triggered immunogenic reactions so infection could not anyway have occurred.
As transparent as a big black box.
Is COVID-19 Vaccine Development Moving Too Fast?
Biotech firm Moderna Inc., along with the National Institutes of Health said they're ready to move onto the largest study of the potential vaccine's efficacy at the end of the month.
It's the fastest a vaccine has been developed for a novel virus.
It begs the question, are the scientists moving too quickly?
Spectrum News spoke to Johns Hopkins All Children's Hospital’s Dr. Allison Messina, who’s the Chief of Infectious Disease and Medical Director of Infection Prevention at the hospital.
Dr. Messina explained how the process works.
Stage 1: Looks for safety or rather there are no side effects when someone gets the vaccine coupled with someone building the immunity.
Stage 2: Targets the vaccine on a specific larger group.
Stage 3: Determines how effective it works on an even larger group (compared to a control group), while also looking for no side effects.As so appropriately put by Peter Doshi, an associated editor of the BMJ and also associate professor of pharmaceutical health services at the University of Maryland School of Pharmacy, “The lack of data is very concerning … All we have right now is a headline by Pfizer.”
“To get a vaccine from concept to market is done in a very regimented way,” said Dr. Messina. “And is reviewed by lots and lots of scientists and regulatory bodies all along that process to make sure that product does what it says it's going to do and is safe for use in the population."
THAT HAS NOT HAPPENED AND LIKELY WON'T.
THE DESIRE OF THE WORLD POPULATION TO SEE AN END TO ILLEGAL, LIFE-RIPPING LOCK-DOWNS, DRACONIAN MEASURES TO CONTAIN A VIRUS THAT WILL NEVER, EVER BE CONTAINED WILL SIMPLY ALLOW PFIZER TO MARKET ITS VACCINE.
THOSE WHO SEE THE MANY DANGERS OF THAT WON'T WILLINGLY GET THE VACCINE; THOSE WHO JUST WANT THE LOCK-DOWNS TO END, WILL.
FROM USNEWS:
Whistle-blower Rick Bright Warns Against Developing Vaccine Too Quickly
The ousted vaccine director and expert believes the predicted timeline for developing a vaccine will take longer than 12 to 18 months.
He gave a broader warning during his testimony before Congress that the federal government still doesn't have a "standardized, centralized coordinated plan" to combat the ongoing pandemic.
FROM NBC:
Pfizer's Covid-19 vaccine promising, but many questions remain...
Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination and experts caution that much remains unknown about its safety, how long it might work and who might benefit most.
The drug-maker has not released full details on its preliminary analysis.
"We don't know anything about groups they didn't study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly," Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, said. And would people previously sick with Covid-19 be protected against reinfection? That remains unclear.
What's more, the Pfizer vaccine uses a brand new technology called messenger-RNA, or mRNA. It has never been approved for human vaccination before. Instead of using bits of virus to provoke an immune response, the mRNA trains the immune system to target the spike protein found on the surface of the coronavirus.
The spike is what allows the virus to invade human cells. In theory, blocking the spike would mean people wouldn't become infected with the virus.
This first analysis only included data on 94 confirmed Covid-19 cases, meaning there is no proof yet that the vaccine prevented infection.
It is unclear whether people who received the vaccine were less likely to be contagious.
Pfizer has said it will not apply for emergency use authorization of its vaccine candidate until it has collected two months of safety information following the final dose of the vaccine. Pfizer's vaccine requires two doses, about a month apart.
Pfizer COVID-19 vaccine trials showed ‘severe’ side effects, ‘fever and aches’...
Carrie, one of the 43,538 participants in Pfizer’s vaccine trial, “said she suffered a headache, fever and aches all over her body, comparable to the flu jab, with the first injection. But after the second these became ‘more severe.’”
Pfizer didn’t mention any of the side effects experienced by participants in the vaccine trial.
The New York Times emphasized on Monday, “The data released by Pfizer … was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.”
In fact, Pfizer’s press release mentioned 43,538 participants enrolled in the study, with only “94 confirmed cases of COVID-19 in trial participants.” This means that only 0.2 percent of participants were tested positive for the coronavirus.
As only 94 participants were tested positive, it also appears difficult to generalize the vaccine is “more than 90% effective,” since some people might have been exposed to the virus more frequently, or for a longer time.
Pfizer’s press release did not explain if participants were wearing masks, practicing so-called social distancing, or staying at home, for the most part."
WE HAVE BEEN IMPRISONED FOR ALMOST A YEAR BY A VIRUS USED AS A MEANS OF CONTROL OVER THE WORLD's POPULATION.
OUR WORLD ECONOMY IS IN RUIN.
WHAT WON'T WE DO TO BE RELEASED?
DESPERATION IS A FRIEND TO THOSE WHO SEEK TO CONTROL THROUGH FEAR.
__________________________
Hat-tip to Robert F. Kennedy, Jr and his monumental effort to expose the damnable vaccine industry, and to Dr. Robert Verkerk, author of the article that is the main source of today's blog.
He is an internationally acclaimed expert in health, agricultural and environment.
//WW
No comments:
Post a Comment