Bowling for Pfizer: Who’s Behind the BioNTech Vaccine?

From Development to Approval

When it was revealed, at the end of November, that the Oxford Vaccine Group had conducted the clinical trial showing its vaccine for COVID-19 had an efficacy of 90 per cent on volunteers aged 55 and below, thereby excluding precisely the demographic most at risk from the disease, shares in its business partner, the British-Swedish multinational pharmaceutical company AstraZeneca, dropped 6 per cent in one week, and the race to be the first to release a vaccine on the world was back on. This has since been won by the US multinational Pfizer, by revenue the second largest pharmaceutical company in the world. Like GlaxoSmithKline, Johnson & Johnson, Moderna, Roche, Sanofi and the other 23 companies working on coronavirus treatments and vaccines back in May, Pfizer had begun tests for a vaccine developed by the German biotechnology company, BioNTech. In July, Pfizer’s CEO, Albert Bourla, stated that companies in the private sector producing a vaccine for COVID-19 should make a profit, and dismissed suggestions they shouldn’t as ‘fanatic’ and ‘radical’. That same month, trials on the BioNTech vaccine were fast-tracked by the US Food and Drug Administration (FDA), and Pfizer agreed a $1.95 billion deal with the US Government to produce 100 million doses. The US deal priced the two-dose course at $39, and Pfizer stated that it would not lower the rates for other developed countries until coronavirus is no longer deemed to be a ‘pandemic’ by the World Health Organisation. In September, Pfizer announced it had agreed to supply an initial 200 million vaccine doses to the European Union, and expects to produce approximately 1.3 billion doses worldwide by the end of 2021. In October, Pfizer started testing the BioNTech vaccine on children as young as 12. In November, Pfizer claimed their vaccine is ‘95 per cent effective’, and applied to the FDA for its Emergency Use Authorisation.

This does not mean, however, that 95 out of every 100 people vaccinated will be protected from COVID-19. Pfizer conducted their clinical trial on nearly 38,000 people, took those who showed symptoms of COVID-19 within a week after the second dose, and tested them for SARS-CoV-2. Out of these, 172 had received a placebo shot, while just 9 had received the BioNTech vaccine. Although the percentage of volunteers who fell sick was tiny in both the vaccinated and placebo groups (0.04% and o.83% respectively), the relative difference between them was calculated as the vaccine’s ‘efficacy’. If there was no difference between them its efficacy would be zero; if none of the people falling sick had been vaccinated, the efficacy would be 100 per cent. In contrast, the actual effectiveness of the vaccine in real-world circumstances is very different from its efficacy rating calculated from such clinical trials. As the AstraZeneca trial of people exclusively under the age of 55 revealed, volunteers are likely to constitute a very different demographic from the people who, because of age or infirmity, are likely to need the vaccine. In the Pfizer trial, 42 per cent were over 55, and 20 per cent had at least one co-morbidity. In contrast, among the 41,600 deaths in hospitals in England attributed to COVID-19, 92 per cent were over 59 and over 95 per cent had co-morbidities. Not only that, but after the first dose was administered, the difference between those given the vaccine and those given a placebo was far lower, with 50 ‘cases’ of COVID-19 in the former and 275 in the latter, which reduced the efficacy of the vaccine to 82 per cent. Between the first and second dose the difference was even smaller again, 39 to 82, resulting in a vaccine efficacy of just 52 per cent. Moreover, given that up to 80 per cent of infections with SARS-CoV-2 are asymptomatic, there were almost certainly far more people in Pfizer’s clinical trial who became infected after taking the vaccine. Above all, and quite incredibly given all the evidence against its accuracy and suitability for this purpose, the entire clinical trial was conduced using the RT-PCR (reverse transmission-polymerase chain reaction) test. On 27 November, the Corman-Drosten Peer Review Report, published by an international consortium of scientists in life-sciences, identified the RT-PCR test as having ‘10 major scientific flaws at the molecular and methodological level’ for detecting, identifying or diagnosing infection with SARS-CoV-2. None of this is reflected in Pfizer’s claim, which has been uncritically published around the world, of a ‘95 per cent efficacy’ for the BioNTech vaccine.

Undeterred by any of this, on 2 December the UK Government jumped the gun and approved the COVID-19 vaccine for emergency use, the first country in the world to do so, even though studies of its unknown long-term effects are ongoing after just 7 months of clinical trials. Importantly, neither the Pfizer-BioNTech vaccine nor those being developed by AstraZeneca and Moderna have been shown either to prevent infection or to reduce the transmission of SARS-CoV-2 in the population. So the Government making it a condition of lifting restrictions in the UK has, like so many of its other statements, no basis in science, and is likely to be renounced as soon as enough people have taken the vaccine to make it a condition of access to public life. Moreover, both the Pfizer and Moderna vaccines use new and experimental mRNA (messenger ribonucleic acid) technology, which encodes the viral protein spikes with synthetic genetic material, and has never been licensed for use on humans before. The instability of the Pfizer vaccine also means it must be stored at minus 70 degrees celsius, which will present a considerable challenge to the unlicensed wholesale distributors now authorised by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 to transport it. And yet, despite all these concerns and unknowns, on 8 December the unlicensed Pfizer-BioNTech vaccine was released in the UK, where, following further amendments to Regulations, it can be administered by unregistered healthcare professionals, and promoted, advertised and the public informed about its use and safety by the company manufacturing it.

Pfizer Inc.

The result of this decision was immediate. From a share price of $27.48 on 23 March, the day the first lockdown was imposed in the UK, shares in Pfizer closed at $42.56 yesterday. In an interview with CNBC News back in September, Pfizer’s CEO said that anyone refusing to take the vaccine will become ‘the weak link that will allow the virus to replicate’, and assured the public that ‘we will develop our product, develop our vaccine using the highest ethical standards’. It’s an odd claim to make, even for a CEO, since Pfizer has a long history of paying out vast sums in out-of-court settlements to avoid not only claims in civil cases but prosecution on criminal charges resulting from the fraudulent promotion, unapproved prescription and injury, including death, from use of their products, as well as offering millions in payments and bribes to doctors and scientists to prescribe, test, approve and recommend them to the public. So let’s have a look at what Albert Bourla means by Pfizer’s ‘ethical standards’.

• In 1992, Pfizer agreed to pay between $165 million and $215 million to settle lawsuits arising from the fracturing of the Bjork-Shiley Convexo-Concave heart valve, which by 2012 has resulted in 663 deaths.
• In 1996, Pfizer conducted an unapproved clinical trial on 200 Nigerian children with its experimental anti-meningitis drug, Trovafloxacin, without the consent of their parents and which led to the death of 11 children from kidney failure and left dozens more disabled. In 2011, Pfizer paid just $700,000 to four families who had lost a child, and set up a $35 million fund for the disabled. This cover-up was the basis to the John Le Carré book and film, The Constant Gardener.
• In 2004, Pfizer’s subsidiary, Warner-Lambert, was fined $430 million to resolve criminal charges and civil liabilities for the fraudulent promotion of its epilepsy drug, Neurontin, paying and bribing doctors to prescribe it for uses not approved by the Food and Drug Administration.
• In 2009, Pfizer spent $25.8 million lobbying Congressional lawmakers and federal agencies like the Department of Health and Human Services. But its expenditure on federal lobbying between 2006 and 2014 came to $89.89 million. Last year it spent $11 million lobbying the federal government.
• In 2009, Pfizer set a record for the largest health care fraud settlement and the largest criminal fine of any kind, paying $2.3 billion to avoid criminal and civil liability for fraudulently marketing its anti-inflammatory drug, Bextra, which had been refused approval by the FDA due to safety concerns.
• In 2009, Pfizer paid $750 million to settle 35,000 claims that its diabetes drug, Rezulin, was responsible for 63 deaths and dozens of liver failures. In 1999, a senior epidemiologist at the Food and Drug Administration warned that Rezulin was ‘one of the most dangerous drugs on the market’.
• In 2010, Pfizer was ordered to pay $142.1 million in damages for violating a federal anti-racketeering law by its fraudulent sale and marketing of Neurontin for uses not approved by the FDA, including for migraines and bi-polar disorder.
• In 2010, Pfizer admitted that, in the last 6 months of 2009 alone, it had paid $20 million to 4,500 doctors in the US for consulting and speaking on its behalf, and $15.3 million to 250 academic medical centres for clinical trials.
• In 2012, Pfizer paid $45 million to settle charges of bribing doctors and other health-care professionals employed by foreign governments in order to win business. The Chief of the Securities and Exchange Commission Enforcement Division’s Foreign Corrupt Practices Act Unit said: ‘Pfizer subsidiaries in several countries had bribery so entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers’.
• By 2012, Pfizer had paid $1.226 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer.
• In 2013, Pfizer agreed to pay $55 million to settle criminal charges of failing to warn patients and doctors about the risks of kidney disease, kidney injury, kidney failure and acute interstitial nephritis caused by its proton pump inhibitor, Protonix.
• In 2013, Pfizer set aside $288 million to settle claims by 2,700 people that its smoking cessation drug, Chantix, caused suicidal thoughts and severe psychological disorders. The Food and Drug Administration subsequently determined that Chantix is probably associated with a higher risk of heart attack.
• In 2013, Pfizer absolved itself of claims that its antidepressant, Effexor, caused congenital heart defects in the children of pregnant woman by arguing that the prescribing obstetrician was responsible for advising the patient about the medication’s use.
• In 2014, Pfizer paid a further $325 million to settle a lawsuit brought by health-care benefit providers who claimed the company marketed its epilepsy drug, Neurontin, for purposes unapproved by the FDA.
• In 2014, Pfizer paid $35 million to settle a law suit accusing its subsidiary of promoting the kidney transplant drug, Rapamune, for unapproved uses.
• In 2016, Pfizer was fined a record £84.2 million for overcharging the NHS for its rebranded and deregulated anti-epilepsy drug, Phenytoin, by 2,600 per cent (from £2.83 to £67.50 a capsule), increasing the cost to UK taxpayers from £2 million a year in 2012 to about £50 million in 2013.
• In May 2018, Pfizer still had 6,000 lawsuits pending against claims that its testosterone replacement therapy products cause strokes, heart attacks, pulmonary embolism and deep vein thrombosis, and were fraudulently marketed at healthy men for uses not approved by the FDA.

Given this record of ongoing corruption and malpractice from which only its enormous profits have saved it from criminal prosecution, it seems extraordinary that Pfizer is still permitted to manufacture and sell any health care products. Yet this is the pharmaceutical company we’re being asked by the UK Government to trust with the mass vaccination of 68 million people with a product that has been rushed through clinical trials in 7 months, using an experimental technology that has never before been approved and whose side effects are still unknown, for a disease with the fatality rate of seasonal influenza, which statistically is a threat only to those over 70 years old with pre-existing medical conditions, and for which there is no evidence that it prevents infection with a virus for which only 1 per cent of the population is currently testing positive with a testing programme that has an average false positive rate of 2.3 per cent, and from which anything from 50-60 per cent of us have developed or already had immunity.

The Conspiracists

Of equal concern, perhaps, is who and what is promoting — if not yet advocating mandating — the taking of vaccines for COVID-19 by the entire UK population. To take just one example of the vast campaign of propaganda conducted in the lead up to the release of this vaccine — not only by the Governments of the UK, Scotland, Wales and Northern Ireland, the Department of Health and Social Care, Public Health England, Scotland and Wales, the National Health Service, the Medicine and Healthcare products Regulatory Agency, the Prime Minister, the Health Secretary, the First Minister of Scotland, and the Chief and Deputy Chief Medical Officers, but also by every privately-owned newspaper and media outlet in the UK — last week the Telegraph published an article titled ‘Is the COVID vaccine safe and will it work? Three experts answer your questions’. These three experts were:

• Trudie Lang, Professor of Global Health Research at the University of Oxford, who works in malaria vaccine development and sat on the Ebola vaccine safety board;
• Heidi Larson, Professor of Anthropology, Risk and Decision Science at the London School of Hygiene and Tropical Medicine and Director of the Vaccine Confidence Project;
• Dr. Michael Fitzpatrick, GP and author of MMR and Autism: What Parents Need to Know.

As I related in my article Bread and Circuses: Who’s Behind the Oxford Vaccine for COVID-19?, over the past decade the University of Oxford has received $208 million in grants from the Bill & Melinda Gates Foundation, including $11.64 million for vaccine development over the past 3 years. But more specifically, Professor Lang’s Global Health Research programme has received $7.68 million in 2020 alone from the BMGF. Again, the London School of Hygiene and Tropical Medicine has received $190 million in grants from the Bill & Melinda Gates Foundation over the past decade, $5.8 million of it this year, of which $1.5 million has been for vaccine development. But in addition, Heidi Larson’s Vaccine Confidence Project, which was given a platform on the BBC’s Newsnight programme without a declaration of its conflicts of interest, has received funding from vaccine manufacturers GlaxoSmithKline and Merck, as well as the Bill & Melinda Gates Foundation, the Wellcome Trust, 3ie, Innovative Medicines Initiative and others.

Financial influence, of course, even from the BMGF — which a decade ago invested $10 billion in vaccines and this June invested a further $1.6 billion in Gavi, the Global Alliance for Vaccines and Immunisation — isn’t in itself proof of influence over the opinions and judgements of those being funded. But in the Telegraph interview with these three ‘experts’ there are numerous examples of statements or absences that display such influence. Professor Lang, for instance, when asked about the fact that Pfizer still hasn’t published the data from its trials, responded that ‘when you submit to a regulatory body — the MHRA, the FDA or EMA — you have to send absolutely everything, the good, the bad, the whole lot’. As I reported in Bread and Circuses, the 2013 investigation by the Public Accounts Committee into the funding, withholding and selective vetting of the data for the anti-influenza drug, Tamiflu, by its manufacturer, the Swiss pharmaceutical company Roche, regulatory bodies, including the European Medicines Agency (EMA), the WHO and the CDC, all approved, recommended and encouraged its use without having first vetted the underlying data. This is, at best, naivety or ignorance unforgivable in a designated ‘expert’ given such a platform; at worst, even more unforgivable and deliberate lying to the public. Throughout this year, doctors and scientists have been exposed for making decisions about what they think the public should know in order to ensure compliance with what they or the Government have decided in advance is the best course of action. This sounds very much like another instance of such practices; but it is not for scientists funded by global investors and manufacturers of vaccines to decide for us what information we should have before deciding what we allow in our body. Perhaps most revealingly, neither these experts nor the interviewer raises the burning question of why we need such a vaccine and to what ends.

Finally, Dr. Michael Fitzpatrick’s hysterical and contemptuous dismissal, in an article published last month in the Daily Mail, of concerns about a vaccine produced so quickly by a pharmaceutical company with Pfizer’s record of corruption, bribery and malpractice as the ‘wild conspiracy theories and political propaganda’ of ‘anti-vaxxers’ shows only that he is on the side of fear and not science, which progresses by questions not threats, smears and crude attempts to silence those who question. Since he’s written a book about it, it’s not surprising he took this chance to plug a product; but Dr. Fitzpatrick raises the case of Dr. Andrew Wakefield, who in 1998 falsely linked the vaccine for measles, mumps and rubella (MMR) to autism. The Labour MP, Hilary Benn, referred to this example during the House of Commons debate on the Health Protection (Coronavirus, Restrictions) (All Tiers) (England) Regulations 2020, and it brought forth many a knowing smile. But Dr. Fitzpatrick says nothing, either in the Daily Mail or the Telegraph, about the far more numerous instances of vaccines and other medicines that have caused injuries, disabilities and death they have caused, not least by the pharmaceutical companies competing to develop the vaccine for COVID-19, some of which I’ve listed above. In this respect, the Wakefield case is a prime example of how conspiracy theories are being used to silence valid concerns about the vaccination programme which no scientist, let alone doctor, should be dismissing with the contempt and violence Dr. Fitzpatrick shows in this article. Unfortunately, he is not alone in employing such tactics.

Reasonable Doubt

Even if all the data from the trials of all the COVID-19 vaccines was studied by individuals and institutions without the financial ties the existing ones have to the manufacturers, distributors and investors in the products they are responsible for approving before released onto the public; even if it could be proven that there was a need for such a programme of mass vaccination for a virus that the data suggests is no longer present in the  UK population in significant numbers and which presents no threat of overwhelming the capacity of the NHS to treat those few endangered by its development into COVID-19; even if the RT-PCR testing programme currently using amplification cycle thresholds far higher (typically 40, according to Public Health England guidance, but up to 45 in the World Health Organisation protocols) than that at which the test can detect infectious virus (not exceeding 30 cycles in order to be reliable) was replaced with one that proved the purported presence, spread and dangers of the virus on which the claim for the need for a vaccine for COVID-19 is based; even if pharmaceutical companies and health professionals were not indemnified against, but held liable for, civil claims and criminal prosecution resulting from the consequences of taking a vaccine they have developed, tested, manufactured, authorised, advertised, distributed and administered; even if the vaccination was not being rolled out as part of the increasingly mandatory programmes and technologies of surveillance and control that have been implemented throughout this year on the basis of combatting this virus, and which is transforming the UK into a totalitarian state ruled by Government decree; even if the vaccine was made available on a voluntary basis for the vulnerable, just like any seasonal flu jab, and not weaponised by the Government as part of its threat to maintain restrictions on our human rights and civil liberties until we take it in sufficient numbers, or to make taking it a condition of our access to public life, including work and travel, or even to enforce the vaccine on the UK population through new legislation; even if all these conditions were met — none of which are even vaguely likely in the current atmosphere of fear, all of which should be an unnegotiable requirement for any reasonable person before taking this vaccine — there would still be the question of why every Government Minister, every scientist working for Government agencies, every newspaper, every news programme, every social media platform, has for 10 months conducted a campaign of propaganda, fear, terror, slander, lies, misinformation and censorship of anyone and anything that tries to question or contradict the official line about this crisis.

If coronavirus presented anything like a threat to public health that might possibly justify the temporary restrictions that have been legislated into our lives permanently under its cloak, there would be no need for the vast shadow of deception, fabrication and manipulation that has been cast over everything to do with this crisis. Although not in itself proof — of which there is an overwhelming and irrefutable preponderance, some of which is collected in the articles below — this is, perhaps, the strongest indication that we are being lied to at a level and to an extent that, unlike the coronavirus, truly can be described as ‘unprecedented’.

Simon Elmer
Architects for Social Housing