THREE years after the launch of mRNA gene therapy vaccines, all now proven to be both harmful and ineffective, the share prices of all three of the companies involved – BioNTech, Pfizer and Moderna – have plummeted. The invisible hand of the market is acting where governments and regulators refused. Investor confidence matters. The 2023 share price drop shows it is on the wane as consumer demand diminishes and the vast profits of 2021 and 2022 (from government contracts and all-but-compulsory mass vaccination) become a distant memory.
Pfizer, BioNTech’s partner, and the largest of the companies, has suffered the most: its stock is currently trading at a ten-year low of $26. Yet in 2022 alone the company recorded $100.3billion in sales revenue, $31.4billion of it from the BioNTech mRNA covid vaccine and $24.6billion from Paxlovid, a covid-19 therapeutic. The company is currently suing Poland for €1.38billion in compensation for an alleged breach of contract over doses of covid vaccine Poland decided it didn’t want.
Pfizer does not always win. It was ordered to pay the largest criminal fine in US history in 2009 when the US Department of Justice issued a $2.3billion judgment against it for fraudulent marketing. Investors will be wary of a number of court cases wending their way through the US courts. Pfizer and Moderna are suing each other for patent infringement, a high-stakes game with market dominance as the potential prize. Pfizer has also failed so far to see off a False Claims Act case in the US lodged by Brook Jackson, the whistle blower who managed some of its covid vaccine clinical trial sites and who was fired after reporting fraud in these vaccine trials to the Food and Drug Administration (FDA).
Pfizer, which had $44.18billion in cash in its coffers last September against liabilities (representing potential claims against them) of $117.817billion, has just bet the house on a new oncology division. On December 14 it announced a $43billion cash deal (one of the largest in its history) to acquire a cancer-focused firm called Seagen. Pfizer chief executive Albert Bourla said, ‘We are going all in on cancer with the goal of delivering breakthroughs that drastically improve the lives of people with cancer.’
With far more ‘turbo-boosted’ cancer around that oncologist Angus Dalgleish attributes to the covid vaccine programmes, it hard not to see the opportunism and cynicism.
At the moment, BioNTech and Moderna have healthier balance sheets than Pfizer but both are still heavily dependent on government contracts and their covid gene therapy vaccines are their only currently licensed products. With consumer demand falling, to maintain profitability they desperately need additional products to be authorised by drug regulators quickly. June Raine and the Medical Health products and Regulatory Agency of which she is chief executive will doubtlessly be doing their best to enable this.
BioNTech’s share price of $16.50 when it floated on the NASDAQ stock exchange in October 2019 reflected the reality that it had never turned a profit and had no authorised products. Its share price rose to a peak of £389.01 in August 2021 but has now fallen back to a little over $100, reflecting falling demand for its covid gene therapy Comirnaty, which generated only $4billion in sales in 2023 and for which there is little remaining consumer demand as judged by booster uptake. Having feathered its nest with its covid vaccine profits in 2022, as of September 2023 it was still sitting on a cash reserve of $17.141billion with liabilities of $2.547billion.
Prior to the commencement of its covid vaccine trial in March 2020, BioNTech was the top sponsor of trials for mRNA oncology products. But, between 2009-2015 more than half (55.5 per cent) of the trials’ candidate therapies were withdrawn or terminated due to poor efficacy and reports that the company was struggling to recruit clinical trial participants. As of October 2019 its products had been tested on only 250 people with 17 different tumour types.
Yet at the beginning of this year the UK government signed a memorandum of understanding with BioNTech to accelerate clinical trials of its personal cancer therapies that promised to deliver 10,000 personalised treatments to NHS patients by 2030 in conjunction with Genomics England and the National Institute for Health and Care Research. Part of this agreement was that the company would build a new research facility in the UK.
Ugur Sahin, BioNTech’s chief executive officer, claims the agreement is a result of the lessons learnt from the pandemic: ‘Drug development can be accelerated without cutting corners if everyone works seamlessly together towards the same goal. Today’s agreement shows we are committed to do the same for cancer patients.’ He went on to ‘commend the exemplary way’ in which the NHS, academia, MHRA and the private sector ‘successfully delivered Covid-19 vaccines so quickly’.
Some might object strenuously to Sahin’s characterisation since this accelerated authorisation was enabled by a collusion which involved the UK Vaccine Taskforce and a fraudulent bait and switch that the MHRA turned a blind eye to, whereby an inferior mass-produced product, contaminated with endotoxin, was substituted for the product used in clinical trials. BioNTech also failed to advise regulators that a gene segment from SV40, a cancer promoting virus first detected in polio vaccines, was used in the e-coli plasmid used to ferment the RNA used in the so-called vaccine.
In July 2023 the UK government announced that Genomics England would identify suitable NHS cancer patients who would be offered the opportunity to participate in BioNTech’s clinical trials. Amanda Pritchard, chief executive of the NHS, bragged: ‘We are developing our very first Cancer Vaccine Launch Pad, enabling us to identify thousands of NHS patients suitable for cancer vaccine trials – giving them the earliest possible access to cutting-edge technology that has the potential to change cancer care for ever.’ There’s another way of looking at it – NHS patients are now apparently a state asset to be used by the UK government to entice life sciences companies to set up research and development facilities here.
Like BioNTech, Moderna is reliant on a single commercial product, its covid vaccine called Spikevax. It projected $6billion in sales revenues for Spikevax, a third of which came from international sales. ‘These [non-USA] sales are based on government contracts and once vaccine doses are shipped and accepted by the customer, they are not returnable,’ said Arpa Garay, then Moderna’s chief commercial officer.
Moderna’s cash reserves as of September 2023 were reported to be $7.573billion with total liabilities of $5.99billion. When it made its stock market debut, a year before BioNTech, its shares were priced at $23. They rose to a peak of $449.38 in September 2021 and have now dropped to $86.
In 2023 the company’s sales of covid vaccines suffered a dramatic decline in demand. It wrote off $464million in obsolete and unsold covid-19 products and reported a further loss of $135million due to unused manufacturing capacity which led to it restructuring its ‘manufacturing footprint’. Thanks to the co-operation of the UK, Australian and Canadian governments, it has three new factories due to open in 2025 but it needs to launch new products quickly to grow its sales and profitability and to make use of these new facilities. Moderna has two new vaccines in the pipeline, one for cytomegalovirus and the second against respiratory syncytial virus (RSV) which it was originally developing for Merck and which it plans to launch in the US this year. But this will get full indemnity against harm (adverse events) only if it can persuadethe FDA to authorise it for use in children as well as adults, as explained here.
A red flag investors should take notice of is that Moderna lost two of its corporate investors during 2020. Merck announced it had divested on the day the MHRA announced that it was granting the Pfizer/BioNTech mRNA vaccine a temporary supply authorisation. AstraZeneca, whoowned a 7.65 per cent equity stake in the company and was its second largest investor, disclosed in its own 2020 annual report that it also disposed of all its Moderna shares. In fact it reported in a shareholder circular in 2021 that it first disposed of Moderna preference shares on December 9, 2019, netting $114.2million in profit. It was a significant day at Moderna as it was the same day that its director Peter Barton Hutt, a former FDA senior counsel, resigned prior to the prototype which became its Covid vaccine being sent to Dr Ralph Baric for animal testing. Reuters reported in March 2021 that AstraZeneca (which had cash reserves of $5.21billion against liabilities of $58.865billion in 2023) reported earnings of around $1billion on sales of its Moderna shares during 2020 although it made nothing in the way of a public announcement that might spook investors that it was selling up. AstraZeneca was however running clinical trials for Moderna on two of the company’s mRNA-based heart tissue regeneration therapies. It axed them in July 2022, and Moderna subsequently abandoned them altogether.
AstraZeneca received $1.2billion from the US Operation Warp Speed during 2020. This included $414.2million which was directed to the Oxford Jenner Institute to finance the development of the adenoviral vector covid vaccine which AstraZeneca licensed from Oxford. In return the UK vaccine taskforce (which had representatives from the MHRA, AstraZeneca and Oxford on its expert advisory group) appear to have colluded with Pfizer in July 2020 agreeing to help kickstart the global roll out of mRNA ‘vaccines’ via a temporary use authorisation (TUA) for the BioNTech vaccine which was signed off by Lord Bethell, the Secretary of State for Life Sciences, on December 1, 2020. The BioNTech TUA resulted in the FDA accelerating the issuance of Emergency Use Authorisations for both the Pfizer/BioNTech and the Moderna vaccines in December 2020. Foreknowledge of this collusion might be one reason AstraZeneca disposed of its Moderna shares in order to give itself clean hands.
It is a major red flag for two established pharmaceutical companies, both of whom were running their own clinical trials on Moderna products, to cut and run from Moderna just prior to the authorisation of its first product, which should require significant due diligence on the part of any new investors, including government investors. Yet the UK government entered into a strategic partnership with Moderna worth billions in 2022, exhibiting no apparent caution whatsoever. What, if any, due diligence did it do? Furthermore, Prime Minister Rishi Sunak has refused to say if he will personally profit from this investment via Theleme Partners, a hedge fund he worked for who also invested heavily in Moderna.