US approves Pfizer vaccine as millions of doses begin shipping
Saturday December 12 2020
By AFP News
The US green lighted the Pfizer-BioNTech Covid-19 vaccine late Friday, paving the way for millions of vulnerable people to receive their shots in the world's hardest-hit country.
President Donald Trump immediately released a video on Twitter, where he hailed the news as a "medical miracle" and said the first immunizations would take place "in less than 24 hours."
It comes as infections across America soar as never before, with the grim milestone of 300,000 confirmed deaths fast approaching.
The US is now the sixth country to approve the two-dose regimen, after Britain, Bahrain, Canada, Saudi Arabia and Mexico.
The move came earlier than expected, and capped a day of drama after it was widely reported that the White House had threatened to fire Food and Drug Administration chief Stephen Hahn if he did not grant emergency approval Friday.
Trump's intervention reinserts politics into the scientific process, which some experts have said could undermine vaccine confidence.
The US is seeking to inoculate 20 million people this month alone, with long-term care facility residents and health care workers at the front of the line.
The government also said Friday that it is buying 100 million more doses of the Moderna vaccine candidate, amid reports the government passed on the opportunity to secure more supply of the Pfizer jab.
The purchase brings its total supply of Moderna doses to 200 million, enough to immunize 100 million people with the two-shot regimen that could be approved as early as next week.
Both frontrunners are based on mRNA (messenger ribonucleic acid), a major victory for a technology that had never previously been proven.
Two other vaccine candidates stumbled Friday: France's Sanofi and Britain's GSK said their vaccine would not be ready until the end of 2021.
And in Australia, the development of a vaccine at The University of Queensland was abandoned Friday after clinical trials produced a false positive HIV result among subjects involved in early testing.
Sputnik mix
The mixed news on the vaccine front comes as infections accelerated fast in North America and parts of Africa but started to stabilize in Europe and drop in Asia and the Middle East.
Around the world more than 1.58 million lives have been lost to Covid-19 since it emerged in China a year ago, according to an AFP tally from official sources.
Brazil on Friday crossed 180,000 deaths, despite President Jair Bolsonaro's insistence the crisis was at the "tail end."
But across the Pacific Ocean, New Zealand, which has been praised for its handling of the virus, took its first tentative steps towards reopening its borders -- with the tiny Cook Islands.
Countries which have approved the Pfizer-BioNTech jab meanwhile were preparing for roll out, as the World Health Organization warned of a potentially grim Christmas season.
Following Britain's lead, the first vaccine shipments to 14 sites across Canada are scheduled to arrive Monday with people receiving shots a day or two later.
Israel, which accepted its first shipment of the Pfizer vaccine on Wednesday, is targeting a rollout on December 27.
And Hong Kong said Friday it had struck deals for two vaccines -- one from Pfizer and the other from Beijing-based Sinovac -- with plans to launch a campaign in early 2021.
A new combined approach is also being tested by AstraZeneca, whose Russian operation said it would mix its shot with the locally-made Sputnik V vaccine in clinical trials.
Russia and China have already begun inoculation efforts with domestically produced vaccines that have seen less rigorous vetting.
EU countries are eagerly awaiting clearance on the Pfizer and Moderna vaccines, in late December and early January respectively.
Carbon down
As Europe's surge eases off slightly, France is planning to lift a six-week-long lockdown from Tuesday but impose a curfew from 8.00 pm, including on New Year's Eve.
Greece also announced new plans Friday to slash quarantine time for incoming travelers and reopen churches for Christmas.
But Switzerland, which is seeing a sharp resurgence in cases, announced a 7:00 pm curfew for shops, restaurants and bars.
While lockdowns have brought economic pain, boredom and myriad other woes, the effect on the environment has been more positive.
Carbon emissions fell a record seven percent in 2020 as countries imposed lockdowns, according to the Global Carbon Project.
What’s Not Being Said About the Pfizer Coronavirus Vaccine. “Human Guinea Pigs”?
https://www.globalresearch.ca/what-not-said-pfizer-coronavirus-vaccine/5729461
Bill Gates is actively financing and promoting new untested vaccines supposed to keep us at least somewhat safe from a ‘ghastly” death from the novel coronavirus and supposedly allow us to resume somewhat “normal” lives. The Pharma giant Pfizer has now announced what they claim were spectacular results in initial human tests. They use an experimental technology known as gene editing, specifically mRNA gene-editing, something never before used in vaccines. Before we rush to get jabbed in hopes of some immunity, we should know more about the radical experimental technology and its lack of precision.
The financial world went ballistic on November 9 when the pharma giant Pfizer and its German partner, BioNTech, announced in a company press release that it had developed a vaccine for Covid19 that was “90%” effective.
The controversial US head of NIAID, Tony Fauci (right) rushed to greet the news and the EU announced it had purchased 300 million doses of the costly new vaccine. If you believe financial markets, the pandemic is all but past history.
Suspicious events
However it seems Albert Bourla, the CEO of Pfizer, doesn’t share the confidence of his own claims. On the day his company issued its press release on the proposed vaccine trials, he sold 62% of his stock in Pfizer, making millions profit in the deal. He made the sell order in a special option in August so it would not appear as “insider selling”, however he also timed it just after the US elections and the mainstream media illegitimately declared Joe Biden President-elect. It seems from appearances that Bourla had a pretty clear conflict of interest in the timing of his press release on the same day.
Bourla lied and denied to the Press that his company had received any funds from the Trump Administration to develop the vaccine when it came out they contracted in summer to deliver 100 million doses to the US Government. Further adding to the suspect actions of Pfizer was the fact the company first informed the team of Joe biden rather than the relevant US government agencies.
But this is far from the only thing alarming about the much-hyped Pfizer announcement.
The German Partner
Pfizer, famous for its Viagra and other drugs, has partnered with a small Mainz, Germany company, BioNTech, which has developed the radical mRNA technique used to produce the new corona vaccine. BioNTech was only founded in 2008. BioNTech signed an agreement with the Bill & Melinda Gates Foundation in September, 2019, just before announcement in Wuhan China of the Novel Coronavirus and just before BioNTech made its stock market debut. The agreement involved cooperation on developing new mRNA techniques to treat cancer and HIV. Curiously that press release, “The Gates Foundation sees BioNTech potential to ‘dramatically reduce global HIV and tuberculosis’” 05. September 2019, has now been deleted.
BioNTech also has an agreement with one of the largest drug producers in China, Shanghai Fosun Pharmaceutical Co., Ltd (“Fosun Pharma”) to develop a version of its mRNA vaccine for novel coronavirus for the Chinese market. Ai-Min Hui, President of Global R&D of Fosun Pharma said in an August statement, “Dosing the first Chinese subject with BNT162b1 marks a milestone of the global co-development program in China. We are closely working with BioNTech and regulatory authorities to evaluate the safety and efficacy of BNT162b1 and other mRNA vaccine candidates…”
This means that the same German biotech company is behind the covid vaccines being rushed out in China as well as the USA and EU. The vaccine is being rushed through to eventual approval in an alarmingly short time.
Both US and EU authorities and presumably also Chinese, waived the standard animal tests using ferrets or mice and have gone straight to human “guinea pigs.” Human tests began in late July and early August. Three months is unheard of for testing a new vaccine. Several years is the norm. Because of the degree of global panic engendered by WHO over the coronavirus, caution is thrown to the wind. Vaccine makers all have legal indemnity, meaning they can’t be sued if people die or are maimed from the new vaccine. But the most alarming fact about the new Pfizer-BioNTech gene edited vaccine is that the gene edited mRNA for human vaccine application has never before been approved. Notably, two year peer reviewed tests with mice fed genetically modified corn sprayed with Monsanto glyphosate-rich Roundup first showed cancer tumors after nine months as well as liver and other organ damage. Earlier Monsanto company tests ended at three months and claimed no harm. A similar situation exists with the gene edited mRNA vaccines that are being rushed out after less than 90 days human tests.
“Explicitly experimental”
Dr. Michael Yeadon replied in a recent public social media comment to a colleague in the UK; “All vaccines against the SARS-COV-2 virus are by definition novel. No candidate vaccine has been… in development for more than a few months.” Yeadon then went on to declare,
“If any such vaccine is approved for use under any circumstances that are not EXPLICITLY experimental, I believe that recipients are being misled to a criminal extent. This is because there are precisely zero human volunteers for…whom there could possibly be more than a few months past-dose safety information.”
Yeadon is well qualified to make the critique. As he notes in the comment, “I have a degree in Biochemistry & Toxicology & a research based PhD in pharmacology. I have spent 32 years working in pharmaceutical R&D, mostly in new medicines for disorders of lung & skin. I was a VP at Pfizer & CEO…. of a biotech I founded (Ziarco – acquired by Novartis). I’m knowledgeable about new medicine R&D.” He was formerly with Pfizer at a very senior level.
Human guinea pigs?
The Pfizer-BioNTech vaccine is experimental and far from guaranteed safe, despite the fact that Pfizer, the EU and the notorious Dr Tony Fauci seem ready to roll it out even before year end to hundreds of millions of humans.
The experimental technology is based on a rather new gene manipulation known as gene editing. In a major article in the 2018 New York Council on Foreign Relations magazine, Foreign Affairs, Bill Gates effusively promoted the novel gene editing CRISPR technology as being able to “transform global development.” He noted that his Gates Foundation had been financing gene editing developments for vaccines and other applications for a decade.
But is the technology for breaking and splicing of human genes so absolutely safe that it is worth risking on a novel experimental vaccine never before used on humans? Contrary to what Bill Gates claims, the scientific answer is no, it is not proven so safe.
In a peer reviewed article in the October, 2020 journal Trends in Genetics, the authors conclude that “the range of possible molecular events resulting from genome editing has been underestimated and the technology remains unpredictable on, and away from, the target locus.”
Dr. Romeo Quijano, retired professor of Pharmacology and Toxicology at the College of Medicine, University of the Philippines Manila, noted some of the dangers of the experimental gene editing when applied to human vaccines. Quijano warns of,
“the danger that the vaccine might actually “enhance” the pathogenicity of the virus, or make it more aggressive possibly due to antibody-dependent enhancement (ADE), as what happened with previous studies on test vaccines in animals. If that should happen in a major human trial the outcome could be disastrous. This serious adverse effect may not even be detected by a clinical trial especially in highly biased clinical trials laden with conflicts of interest involving vaccine companies. Even when a serious adverse event is detected, this is usually swept under the rug.”
He cites the case of another Gates mRNA vaccine candidate, Moderna, where “three of the 15 human experimental subjects in the high dose group suffered serious and medically significant symptoms. Moderna, however, concluded that the vaccine was “generally safe and well tolerated,” which the corporate-dominated media dutifully reported, covering-up the real danger…”
He notes,
“Exogenous mRNA is inherently immune-stimulatory, and this feature of mRNA could be beneficial or detrimental. It may provide adjuvant activity and it may inhibit antigen expression and negatively affect the immune response. The paradoxical effects of innate immune sensing on different formats of mRNA vaccines are incompletely understood.” Quijano adds, “A mRNA-based vaccine could also induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity… and may promote blood coagulation and pathological thrombus formation.”
Quijano writes in the extensively documented article,
“among other dangers, the virus-vectored vaccines could undergo recombination with naturally occurring viruses and produce hybrid viruses that could have undesirable properties affecting transmission or virulence. The…possible outcomes of recombination are practically impossible to quantify accurately given existing tools and knowledge. The risks, however, are real, as exemplified by the emergence of mutant types of viruses, enhanced pathogenicity and unexpected serious adverse events (including death) following haphazard mass vaccination campaigns and previous failed attempts to develop chimeric vaccines using genetic engineering technology.”
Bill Gates, the mRNA vaccine makers including Pfizer/BioNTech and Moderna, and their close allies such as Dr. Tony Fauci
of the NIAID are clearly playing fast and loose with human lives in
their rush to get these experimental vaccines into our bodies. Notably,
the same Dr. Fauci and his NIAID owns the patent on a vaccine for dengue
fever known as Dengvaxia, marketed by Sanofi-Pasteur and promoted as an
“essential” vaccine by Tedros’ WHO since 2016. Robert F. Kennedy Jr. (right)
noted that Fauci and NIAID “knew from the clinical trials that there
was a problem with paradoxical immune response,” but they gave it to
several hundred thousand Filipino kids anyway. It was estimated that as
many as 600 vaccinated children died before the government stopped the vaccinations.
Clearly the well-established Precautionary Principle–if in serious doubt, don’t– is being ignored by Fauci, Pfizer/BioNTech and others in rushing to approve the new mRNA vaccine for coronavirus. Messenger RNA technology has yet to produce an approved medicine, let alone a vaccine.
What Happens if Something Goes Wrong after You Receive a COVID Vaccine?
https://www.globalresearch.ca/what-happens-something-goes-wrong-after-receive-covid-vaccine/5731896
The bottom line is that if you are injured by a vaccine or other “countermeasure” designated by the DHHS Secretary as intended for a pandemic or bioterrorism threat (Covid-19, Pandemic Flu, Anthrax, Smallpox) your options for receiving any financial benefit are very limited.
First, everyone involved with getting the vaccine to you has had their liability waived under the PREP Act. This includes everyone from the government planners of the vaccine program down to the doctor, nurse or even pharmacy intern who injects you. None can be sued in federal or state court, unless they wilfully tried to harm you. And it is virtually impossible to show wilfull misconduct.
Congress did create a program to compensate some victims, but it is much less generous than the National Vaccine Injury Compensation Program (NVICP). (And no one ever accused the NVICP of being generous.). It is called the Countermeasures Injury Compensation Program (CICP).
It is entirely administered within the Department of Health and Human Services, the same agency that sponsored the vaccine program. There are no judges. If you are dissatisfied with the decision, the only appeal is to DHHS, where your case is reviewed by different employees. DHHS is the payor, too. DHHS therefore essentially acts as the judge, jury, and defendant. Unsurprisingly, only about 9% of people who applied to the program received any funds. Of the 446 claimants to the program, 407 were denied.
Unlike the NVICP, the CICP does not pay any attorney fees, expert witness fees or costs associated with filing a claim. When I spoke to Dr. Caserta, the program’s prior director, the maximum payout, even for a death or permanent disability, was $250,000 per person.
Dr. Caserta told me the CICP was a “payor of last resort”–which meant that if the claimant had other sources of funds, such as from insurance policies, that CICP would only pay the difference. In other words, if you had a disability policy that paid out $150,000, that amount would be deducted from the maximum payout you could receive from the CICP.
The CICP has a one year statute of limitations. This has been very tough on claimants, because most people are unaware the program exists, and therefore have been barred from filing because more than a year has elapsed since they were injured.
And there is another big problem with claims for injuries from Covid vaccines: nobody knows exactly what the serious injuries are, nor how to identify them with certainty. DHHS is responsible for defining what types of injuries may be caused by each product. Will they acknowledge that the injury you suffered could be caused by the vaccines they sponsored? Will they do it in time for that one year statute of limitations? Will they ever do it?
If you become injured after receiving a designated “countermeasure” vaccine, do not anticipate that you will get help from the government nor from the manufacturers. Please inform yourself of the benefits and risks beforehand.
The Congressional Research Service explains the way the system works in detail, focusing on the “sweeping” liability immunities that characterize the program, in a booklet published in September, titled, “The PREP Act and Covid-19: Limiting Liability for Medical Countermeasures”
Let the buyer beware.
UPDATE: On December 7 I got a call back from Mr. Dale Mishler at the CICP. He would not tell me if there was a specific cap on benefits, nor the maximal amount that has so far been paid out for an injury. He told me I would have to FOIA for the information, although the CICP website was under design and in several weeks I could probably find the information there. (It is known that the average benefit paid to 39 recipients since 2010 has been $146,000.)
Mr. Mishler also told me that the CICP now follows the Public Safety Officers Benefits program managed by the DOJ. The PSOB appears to provide a maximal benefit of $370,000 for those injured on or after October 1, 202. However, the description of the program on the PSOB website is vague.
According to Reuters:
An HRSA spokesman said the CICP denies claims for a variety of reasons, including the legal requirement there be “compelling” scientific evidence that a vaccine directly caused injury. CICP only covers medical costs and lost income not covered by others, such as private health insurance.
Isn’t it ironic that experimental vaccines rushed out under emergency use, with extremely short clinical trials, are unlikely to yield the “compelling” evidence of vaccine causality within the one year statute of limitations?
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