Hurrah! NIHR and Moderna launch new vaccine trial!
Your opportunity to be part of this accelerated phase 3 RCT!
The pledge by Robert F. Kennedy Jr to ‘Make America Healthy Again’ and his support for Donald Trump’s successful presidential campaign has had media outlets in alignment with big pharmaceutical companies and their investors, such as the Vanguard Group and BlackRock Inc, in rather a spin. We can only hope that the soon to be inaugurated President Trump will make good on promises to repeal legislation granting immunity to pharmaceutical companies whose products are listed on the childhood vaccine schedule. Unfortunately, back in the UK, we have no such hope of further scrutiny of vaccine safety and efficacy. Instead, the process for approving vaccines and other medical products has been accelerated. Read on for more details:
It appears with each passing month that another pharmaceutical product is unleashed on the public. In October, there was Mounjaro (brand name), containing the active ingredient Tirzepatide and produced by Eli Lilly, which is being studied to see whether it can get the obese back to work (see Big Pharma Push Another Jab - by Dr Rowena Slope). We have also seen the release of vaccines for shingles (herpes zoster), Respiratory syncytial virus (RSV), influenza, MonkeyPox (MPox) and of course the COVID-19 ‘vaccines’. Meanwhile, pharmaceutical and biotech company, Moderna, has announced that it is undertaking phrase 3 trials in the UK on an mRNA vaccine against Norovirus. So, let’s take a closer look at this new research trial, the partnership between the UK government, potential conflicts of interest, and how you too can sign up to be a research participant.
Image: Sign up here and Be Part of Research
Source: File:George the amazing guinea pig.jpg - Wikimedia Commons
The National Institute for Health and Care Research (NIHR) announced on 23 October 2024 that a phrase 3 randomised clinical trial (RCT) is being launched across 39 sites in the UK with the aim of getting 25,000 people to sign up. This trial is being sponsored by Moderna and forms part of the 10 year Moderna-UK Strategic Partnership. The trial is benefiting from the UK Vaccine Innovation Pathway (VIP) which has been designed to speed up vaccine trials through ‘accelerated contracting and set-up’. One feature of VIP is the creation of the Be Part of Research initiative that encourages people to sign up to be part of healthcare research, and according to the NIHR, over 500,000 people have signed up already!
Norovirus is indeed a horrible, although usually mild viral illness, where sufferers develop an more intimate acquaintance with their domestic sanitation and plumbing facilities. It is responsible for many hospital ward closures and has significant impacts on staff and patients alike. It is also a particular concern in closed environments such as nursing homes, cruise ships, nurseries, and schools where hand hygiene may not be optimal. The virus evolves rapidly and this presents a major challenge in trying to create a successful vaccine to combat it. Its rapidly evolving nature also poses risks associated with ‘original antigenic sin’ – whereby immune evasion of a newly emerging variant is prompted in people who have been vaccinated against a previous version of the virus (Noori et al. 2022).
Nevertheless, Moderna are keen to progress with another mRNA based ‘vaccine’, and are now busy recruiting for this RCT. Let’s hope it follows the double blind gold standard model whereby both participants and researchers are unaware of who has received the placebo and who has received the vaccine through out the entire trial period. Mass media outlets and the UK government have been promoting the research trial with announcements and newspaper articles that read more like advertisements. For example, a recent article in the Daily Mail published on 23 October 2024 entitled ‘Norovirus: World-first vaccine to combat the misery of winter vomiting bug on trial in Britain – and could ‘cut the burden on the NHS’’ lauds the Moderna trial whilst citing costs to the NHS of treating people with the virus.
What this article doesn’t mention is that the deal between the UK and Moderna was set up in 2022 by former PM Rishi Sunak who also helped set up hedge fund, Theleme Partners. This hedge fund had investments in Moderna and Sunak has so far declined to comment on whether he has financially benefited from this deal. The Good Law Project asked the Information Commissioner Office to order the former Prime Minister to reveal whether he benefited financially from this deal and the ICO validated this request but HM Treasury has since appealed this decision (Davenport 2024). So as yet we are still in the dark.
What is also interesting about the announcement from the NIHR regarding this trial is the new accelerated pathway for commercial clinical trials. The UK government commissioned an independent report on clinical trials which was completed by Lord Shaughnessy and published in 2023. This reviewed current governance regarding commercial clinical trials and was particularly interested in new accelerated pathways created during the COVID-19 pandemic response:
Case Study: The Vaccine Taskforce
Set up by and as part of UK government in April 2020, the UK Vaccine Taskforce took a dynamic and innovative approach to accelerating vaccine development, leading to one of the most successful vaccine roll outs globally. This resulted in millions of people in the UK and around the world being able to receive a COVID-19 vaccine. Bringing together government, academia and industry, the VTF was created to develop and produce a vaccine for COVID-19 as fast as possible. The VTF had 3 main objectives. To:
secure access to promising COVID-19 vaccines for the UK population as quickly as possible
make provision for international distribution of vaccines
strengthen the UK’s onshoring capacity and capability in vaccine development, manufacturing and supply chain to provide resilience for future pandemics
(Shaughnessy 2023).
This report shows how this ‘dynamic and innovative approach to accelerating vaccine development’ can be utilised to speed up clinical trials by cutting bureaucracy, incentivising GPs, and using new tools to recruit participants. The report celebrates the achievements of the COVID-19 vaccines, particularly the speed with which they were brought to market, but there is very little within it on bioethics or participant safety. And there is no reflection on the emerging concerns about the side effects or dwindling efficacy of the COVID-19 vaccines including the withdrawal of the AstraZeneca vaccine.
In conclusion, it appears that the recent deluge of pharmaceutical products being championed in the mass media in recent times is not only indicative of this emerging private/public partnership but also changes to the regulatory environment around commercial clinical trials. Given what we have witnessed in the last four years, there remains significant cause for concern about protection of research participants and the safety and efficacy of the final products released onto the public.
References:
Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report - GOV.UK
Over half a million people sign up to Be Part of Research
According to Global Health Now, RFK Jr. has no medical or scientific qualifications ,so he shouldn’t be involved in decisions about health and vaccines, unlike Bill Gates who is a fully qualified medic and vaccine scientist 🤥 so he should be listened to.
Interesting article and excellent reporting. Thank you.