What the Daily Mail didn’t say about the latest NHS (RSV) vaccine drive
A bit for Moderna investors to consider and my free salt water cure which cures RSV, of course.
What the Daily Mail didn’t say about the latest NHS (RSV) vaccine drive
By
Paula Jardine
October 7, 2024
LAST month the Daily Mail ran a puff piece about the newest Pharma cash cow, the respiratory syncytial virus (RSV) vaccine which is being offered by the NHS to those aged between 75 and 80. RSV causes ‘cold-like symptoms’ in most people but can cause severe bronchitis in small numbers of older adults and under-fives. The Mail headline hyperbolically calls it ‘a killer virus’ yet the Office for National Statistics (ONS) recorded only 31 deaths caused by RSV-induced bronchitis between 2013-2022 in England and Wales. Nevertheless the Mail reports a Scottish review claiming 2,800 lives could be saved each year by these new vaccines which are said to be 86 per cent effective, if only 70 per cent of over-75s would overcome ‘vaccine fatigue’ and roll up their sleeves to ‘reduce the enormous pressure faced by the NHS over the winter months’. It’s not the first time the Mail have pushed these new injections. In September it ran a piece by Dr Philippa Kaye urging older adults to take up the RSV vaccine being offered ‘to protect those most-at-risk from the virus’.
What last week’s Mail article failed to mention were the brands of vaccine involved and the ‘prototype pathogen approach’ from which they were developed. This is a scheme devised by a former deputy director of the US Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), Dr Barney Graham, which has made him a wealthy pensioner. His own US National Institutes of Health (NIH) patents have been licensed for use in multiple vaccines. RSV itself was the prototype for the covid vaccines that enabled them to be surreptitiously tested in humans in advance of the pandemic. The Mail article last week also failed to mention that a class action lawsuit has been filed against Moderna on behalf of investors in the US for misleading investors by overstating the efficacy of its RSV vaccine authorised earlier this year by the Food and Drug Administration (FDA).
RSV, today recognised as one of the most common causes of childhood cold-like illness, originated in chimpanzees kept at Walter Reid Army Institute of Research for polio vaccine research and manufacturing in 1955. It was through the polio vaccine that it spread to humans.
The first attempt to make a children’s RSV vaccine in 1966 ended disastrously. Eighty per cent of the children in the trial ended up in hospital suffering from increasingly frequent and more severe respiratory infections. Two toddlers died.
More than 40 years later, Dr Barney Graham believed he had solved the problem with a new ‘stabilized prefusion protein’ design which he patented in 2014. This is what is being used in the three newly authorised RSV vaccines. This same stabilised prefusion protein patent is also licensed for use in the SARS-CoV-2 vaccines, generating more income for him.
Graham devised the very convenient Prototype Pathogen approach to pandemic preparedness to get over ‘common technical hurdles to vaccine development’ by devising generic solutions that could be applied to different pathogens with similar technical difficulties. RSV and coronaviruses were one such pathogen preparedness pairing. During the US government gain of function moratorium declared in October 2014 due to concerns over NIAID funded research which had made H1N1 bird flu more virulent in the laboratory, there was an FDA clinical hold on MERS and SARS vaccine trials. NIAID then cynically pivoted Graham’s RSV vaccine development design to pre-develop coronavirus vaccines.
The two RSV vaccines now on offer on the NHS are GlaxoSmithKline’s Arexvy and Pfizer’s Abrysvo, authorised by the MHRA in 2023. Both use Graham’s prefusion stabilized protein design.
GSK’s Arexvy was hailed by the FDA as ‘an important public health achievement’ and as ‘safe and effective’ when it authorised it on May 3, 2023. The European Commission authorised it under a fast-track procedure for use in adults over the age of 60 a month later on June 6, 2023, with the MHRA following suit on July 10, 2023 and relying on the EMA authorisation.
GSK claims its vaccine, which was originally intended for use in pregnant women in their third trimester to prevent infection in newborns, had an overall efficacy of 82.6 per cent in its Phase 3 trials. Earlier trials, however, showed the immune response declining after 60 days.
Pfizer’s RSV vaccine Abrysvo was authorised by the FDA on May 31 2023, for use in older adults. The EMA, again using the fast-track procedure, authorised it for use in the elderly and in pregnant women on July 21, 2023. Pfizer had conducted the combined Phase 1 and Phase 2 clinical trial of this vaccine in May 2018.
Although Abrysvo is not an mRNA vaccine, under Pfizer and BioNTech’s July 20, 2018 research collaboration and license agreement, which granted Pfizer an exclusive licence to manufacture products using BioNTech’s technology, Pfizer has the right of first refusal to develop, manufacture or commercialise mRNA RSV and cytomegalovirus vaccines. This is the same provision that enabled them to develop the coronavirus vaccine under this collaboration, using the NIH RSV patent.
Publicly the companies said they were collaborating on an influenza vaccine project. Flu may have been the title of the skeleton research plan, but it is only mentioned four times in the collaboration agreement and the context elsewhere in the document is revealing. It sets out a formula for payments based on net sales to be renegotiated in the event of compassionate use of an mRNA product ‘in jurisdictions or to vulnerable populations experiencing emergency pandemic, or crisis epidemic, flu conditions’. Conveniently, Pfizer’s payments to BioNTech for the development of a vaccine were also to be renegotiated in the event of a government asking them to develop one due to ‘pandemic flu emergency conditions’ coronavirus, being a ‘flu-like’ virus that isn’t influenza.
A third RSV vaccine, Moderna’s mRESVIA, was authorised this year, by the FDA on May 31, 2024. The EMA anounced its authorisation on August 23. Stéphane Bancel, Chief Executive Officer of Moderna, stated that RSV causes a ‘high burden of disease’ and mRESVIA will ‘protect older adults from the severe outcomes of RSV infection’ and that it ‘is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors’. With Moderna’s revenues shrinking, mRESVIA is certainly intended to inject more cash. Bancel also boasted that this is the first time an mRNA vaccine has been approved for a disease other than Covid-19: ‘With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.’
But these grand claims are about to be tested in a class action lawsuit being brought on behalf of investors who say that the company has misled them over the efficacy of this vaccine. Specifically their complaint is that ‘the Company’s press release indicated a vaccine efficacy of only 78.7 per cent, significantly lower than the 83.7 per cent vaccine efficacy that Moderna had previously identified in its mRNA-1345 BLA rolling submission to the FDA [and that] following this announcement, analysts and market observers were quick to note mRNA-1345’s lower-than-expected efficacy rate’. Moderna in fact disclosed to the US Centers for Disease Control (CDC) in May 2024 that efficacy fell to below 50 per cent after 18 months.
These efficacy rates are considerably lower than the specious 95 per cent efficacy rate that both Moderna and Pfizer/BioNTech claimed in November 2020 for the stabilized prefusion spike protein mRNA vaccines had against SARS-CoV-2.
Moderna began developing its RSV vaccine in 2015 under a collaboration agreement with Merck who were financing its development and originally had the exclusive right to commercialise it. Moderna ran a phase 1 clinical trial on 67 people in Australia in 2017. The Mail might have found out from a 2018 securities commission filing in the public domain that from this very small trial, no fewer than 15 serious adverse events were reported, including one death from cardiac arrest. The company said the adverse events were unrelated to its product. In May 2019, having returned the rights to mRNA-1278 (Moderna’s secret MERS vaccine) to Moderna and having released the company from an exclusivity provision with respect to a particular family of respiratory viruses (in other words coronaviruses), Merck elected to test a version of Moderna’s RSV vaccine itself. It is of note that in October 2020 Merck also returned the rights to the RSV vaccine to Moderna and publicly announced on December 2, 2020 that it had divested from them although it retained an interest in Moderna’s cancer therapeutics, a separate collaboration under which Merck financed the construction of Moderna’s factory in 2016.
Although the MHRA has not yet authorised mRESVIA, the NHS Clinical Trials Network is currently testing it for use in infants. The first baby was dosed at Norfolk and Norwich University Hospitals this summer. The Daily Mail did not inform the public of this either.
TCW
SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Moderna, Inc. of Class Action Lawsuit and Upcoming Deadlines - MRNA
Fighting for victims of securities fraud for more than 85 years (PRNewsfoto/Pomerantz LLP)
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Pomerantz LLP
Sep 25, 2024, 10:00 ET
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NEW YORK, Sept. 25, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Moderna, Inc. ("Moderna" or the "Company") (NASDAQ: MRNA) and certain officers. The class action, filed in the United States District Court for the District of Massachusetts, and docketed under 24-cv- 12058, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Moderna securities between January 18, 2023 and June 25, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased or otherwise acquired Moderna securities during the Class Period, you have until October 8, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
Moderna is a biotechnology company that discovers, develops, and commercializes messenger RNA ("mRNA") therapeutics and vaccines for the treatment of infectious diseases, immuno-oncology, rare diseases, autoimmune, and cardiovascular diseases in the United States, Europe, and internationally. The Company's products include, inter alia, mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus ("RSV") vaccine, intended to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
In July 2023, Moderna initiated a rolling submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA")—or the process by which a pharmaceutical company may submit completed sections of a BLA for review by the FDA before all sections become available—for real-time review of mRNA-1345 backed by late-stage data, which indicated a vaccine efficacy rate of 83.7% as defined by two or more RSV symptoms related to the lower respiratory tract.
The Compliant alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) mRNA-1345 was less effective than Defendants had led investors to believe; (ii) accordingly, mRNA-1345's clinical and/or commercial prospects were overstated; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
On May 31, 2024, Moderna issued a press release "announc[ing] that the [FDA] has approved mRESVIA (mRNA-1345) . . . to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection." However, the Company's press release indicated a vaccine efficacy of only 78.7%, significantly lower than the 83.7% vaccine efficacy that Moderna had previously identified in its mRNA-1345 BLA rolling submission to the FDA. Following this announcement, analysts and market observers were quick to note mRNA-1345's lower-than-expected efficacy rate.
On this news, Moderna's stock price fell $8.94 per share, or 5.9%, to close at $142.55 per share on May 31, 2024.
Then, on June 26, 2024, in a presentation before the Centers for Disease Control and Prevention's ("CDC") Advisory Committee on Immunization Practices, Moderna disclosed that after 18 months, mRNA-1345 proved only 49.9% to 50.3% effective against multiple symptoms of lower respiratory tract disease—a significantly lower efficacy rate than vaccines produced by Moderna's competitors.
Following this presentation, market analysts once again took notice of mRNA-1345's reduced efficacy rate. For example, in an article published the same day, Reuters stated, in relevant part, that "Moderna [. . .] opens new tab respiratory syncytial virus (RSV) shot mRESVIA showed 50% efficacy in preventing RSV after 18 months," and that, by comparison, the RSV vaccines of Moderna's competitors GSK and Pfizer were "78% effective in preventing severe RSV over a second year" and "78% effective through a second RSV season," respectively. Also on June 26, 2024, Bloomberg published an article entitled "Moderna RSV Vaccine Efficacy Sinks Over Time, CDC Documents Show," which stated, in relevant part, that "[t]he results could further raise doubts over the prospects for its shot, which is already third to the market. Moderna shares fell as much as 11%, their biggest intraday decline since November."
On this news, Moderna's stock price fell $15.15 per share, or 11.01%, to close at $122.45 per share on June 26, 2024.
As a result of Defendants' wrongful acts and omissions, and the precipitous decline in the market value of the Company's securities, Plaintiff and other Class members have suffered significant losses and damages.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
SOURCE Pomerantz LLP
Me: The RSV vaccine apparently killed lots of French kids when it was injected into them and now they want to administer it into oldies, whose deaths can be explained away as due to "old age" : RSV, today recognised as one of the most common causes of childhood cold-like illness, originated in chimpanzees kept at Walter Reid Army Institute of Research for polio vaccine research and manufacturing in 1955. It was through the polio vaccine that it spread to humans - They are trying to make a monkey of us once again:
UPDATED: 24 September 2024 My FREE Salt Water Cure for Bird Flu and Covid and MPox (virus) and any other virus.
Refuse all vaccines.
Join me in NEVER being ill with my free salt water cure. It's as yukky for me to do, as it is for you to do, but practice makes it easier with time - when the only option is potentially death by vaccines injections.
It is that simple.
3 minutes from preparation to job done: Mix one heaped teaspoon of table (or Iodine) salt in a mug of warm clean water, cup a hand and sniff or snort the entire mugful up your nose, in small lots, spitting out anything which comes down into your mouth. If burning sensation, then you have a virus, so continue morning noon and night, or more often if you want, until the burning sensation goes away (2-3 minutes) then blow out your nose with toilet paper and flush away, washing your hands afterwards, until when you do my simple cure, you don't have any burning sensation at all, when you flush - job done. Also swallow a couple of mouthfuls of salt water and if you have burning in your lungs, salt killing virus and pneumonia, there too.It washes behind the eyes, the brain bulb, brain stem (Long Covid), The Escutcheon Tubes to the inner ears and the top of the throat which is at a point roughly level with half way up your ears and not where your mouth is and it goes down the back of your throat, when infected there too.
I have been doing this simple cure for over 31 years and I am and others, never sick from viruses and there is no reason why any of you should be.
Simply put, if the inside of your nose is dry and crusty, you are OK, if your nose is runny, you really need to do a salt water sniffle as quickly as possible AND THERE IS STILL CLEAN SEA WATER, TO USE INSTEAD.
Nobody has been injured or killed by my above salt water cure