RECENT announcements from President Trump, ordering that USAID, the CIA cutout, be closed down, and an Executive Order cutting all US government funding to South Africa have ended the South African Medical Research Foundation established consortium BRILLIANT’s trials of Moderna’s mRNA-HIV vaccine immunogen candidates. The BRILLIANT consortium, whose partners included the US Military HIV Research Program, were awarded $45million in grant funding by USAID in January 2024 to begin testing candidates. It was the entirety of their funding.
One person who will be especially disappointed is Bill Gates. On January 17, 2025, it was reported that Gates and an unnamed Bill and Melinda Gates Foundation (BMGF) staffer had a three-hour dinner with President-elect Trump and his new chief of staff Susie Wiles during which Gates was apparently lobbying Trump to back accelerating an HIV vaccine project. The meeting became public after Gates gave an interview to the Wall Street Journal.
‘I spoke a lot about HIV and that the Foundation is literally working on a cure for that. We’re at an early stage,’ said Gates. ‘He [Trump], in the covid days, accelerated the vaccine innovation. I was asking him if maybe the same kind of thing could be done here.’
An early stage? HIV vaccines have been a pipedream since Genentech first tried and failed to make one in the 1980s. It’s been about as fruitful a quest as the search for a universal flu vaccine, or a covid vaccine that actually works, for that matter. Dear old Bill, the vaccine evangelist, couldn’t be trying to find a way to milk more money out of his miracle cure mRNA vaccines via a Warp Speed 2 for the developing world, could he?
All Bill Gates’s investments in the three major mRNA companies, BioNTech, Curevac and Moderna, involve HIV mRNA vaccine development projects. He got in early and spread his bets.
The BMGF’s first investment in an mRNA HIV vaccine came in March 2015 when it invested $52million in the German company Curevac, which was topped up with $24million from Curevac’s long-term financial backer Hopp Biotech.
‘If we can teach the body to create its own natural defences, we can revolutionize the way we treat and prevent diseases,’ said Gates, the software titan. ‘Technologies like mRNA give us confidence to place big bets on the future.’
Under this 2015 agreement with the BMGF, Curevac, which was founded in 2000 but has never brought a product to market, began constructing a new mRNA vaccine factory. Curevac’s BMGF-sponsored mRNA HIV and rotavirus vaccines were intended from the outset for distribution to developing countries as, unlike Moderna and BioNTech’s versions, Curevac says its mRNA products are thermostable and don’t require cold-chain storage and infrastructure.
Curevac and Mr Gates will have been disappointed that its SARS-CoV mRNA vaccine was never authorised. It was only 48 per cent effective in clinical trials unlike its competitors whose vaccines achieved a mere 1 per cent absolute reduction in risk, purported to be 95 per cent and 94.5 per cent effective respectively. Dr Peter Doshi, the deputy editor of the British Medical Journal, pointed out in November 2020 that five times as many subjects in the vaccine arm of the Pfizer / BioNTech phase 3 trial were removed for minor protocol amendments than from the placebo arm. When he added them back in and recalculated the efficacy rate of BNT162b2, it dropped to an abysmal 29 per cent.
Curiously neither Operation Warp Speed nor the UK Vaccine Taskforce entered into contracts with Curevac in July 2020, when close on each other’s heels they agreed terms with its competitors Moderna and Pfizer / BioNTech with their almost impossible-to-tell-apart vaccines. Curevac’s vaccine also licensed the National Institute for Allergy and Infectious Diseases’ (NIAID) pre-fusion stabilised protein design but unlike its competitors it didn’t modify the RNA with the University of Pennsylvania’s Nobel Prize-winning pseudouridine.
A year after its Curevac HIV collaboration, the BMGF began investing in a second mRNA-HIV vaccine, awarding Moderna just shy of $20million in grant funding in 2016 to develop it and ‘potentially other infectious diseases [vaccines] that disproportionally affect the world’s poorest people’. Stephane Bancel, Moderna’s CEO who thanks to the pandemic now has a net worth estimated at $4.1billion, said: ‘The foundation’s mission to help all people lead healthy and productive lives is well aligned with Moderna’s mission to deliver on the promise of transformative mRNA science to bring new medicines to patients.’
In September 2019, when the BMGF paid $55million to acquire a stake in BioNTech a month before the company’s assiduously well-timed US Initial Public Offering, HIV and tuberculosis were said to be the reason for the collaboration. Even without the HIV vaccines making it to market the tax-exempt foundation profited from its big and well-timed bets on the mRNA companies. In 2021 following the authorisation of the Pfizer / BioNTech and Moderna mRNA-SARS-CoV2 vaccines, BMGF pocketed $240million when it sold 86 per cent of its BioNTech stock at its peak share price and a further $50million when it sold a little under 70 per cent of its Curevac shares.
Barely any time was wasted after the roll out of mRNA-SARS-CoV2 vaccines before succession planning began. HIV was on the radar early. In April 2021 the World Health Organization put out a call to host a regional mRNA technology transfer hub to produce mRNA vaccines for developing and low income countries, announcing on June 21, 2021, that it would be located in South Africa. IAVI, the International AIDS Vaccine Initiative run by former Rockefeller Foundation trustee Dr Seth Berkley, the man who first proposed Gavi, the Vaccine Alliance to Gates and persuaded him to put up the money for it, has been working since 2018 to bring ‘new-generation’ experimental HIV vaccines into human clinical trials.
In 2022, the NIAID, IAVI and BMGF announced they were commencing a phase 1 trial of three Moderna mRNA HIV vaccine antigen candidates to evaluate which were the most promisingly immunogenic. The trial drew bad publicity recently when it was reported that between 7-18 per cent of an unknown number of trial participants receiving the mRNA-HIV vaccine have suffered from what it calls ‘skin events’, which are hives and itchiness.
‘The history of vaccine experiments, and the vaccine experiments in this field, [HIV] have not been stellar,’ said John Moore, a professor of microbiology and immunology at the Cornell Weill Medical College in 2018. ‘Lots of immunogens over the years have tended to be put into trials because they exist. We need to understand what antigens are going to work best in animals, and at some point, humans. There are many aspects of these immunogens that remain to be understood.’
Little has changed. In December 2023 it was announced that a European-supported HIV vaccine trial in Africa called PrEPVacc that began in 2020 was being stopped as ‘neither of the two experimental vaccine regimens tested reduced HIV infections among the study population’. Imperial College London and University College London were amongst the participating institutions.
Undaunted, IAVI says it is developing new approaches to ‘coax’ the immune system into making antibodies. It says these are particularly needed ‘against harder-to-combat pathogens for which an empirical approach would take too long and would be too expensive’. A cynic might call IAVI’s new approaches cost-saving shortcuts. Its new approach to HIV vaccine development, called ‘germline targeting’, uses a multi-stage regimen to sequentially genetically modify the immune systems, first targeting the precursor B-cell lymphocytes, then T-cell lymphocytes before finally introducing the mRNA HIV antigen. Genetically modifying the immune system couldn’t possibly go wrong, could it?
