Yesterday we published the first part of Paula Jardine’s three-part investigation into the political decisions that allowed the experimental, gene therapy Covid ‘vaccines’ fast passage through the approval process. In it she explored the UK’s role in bouncing other regulators into rolling out unlicensed products. You can read it here. Today she looks at the part played by Bill Gates.
GENE editing, high-tech tinkering with DNA, the delicate thread of all organic life, is a Fourth Industrial Revolution (4IR) technology. Pre-Covid, its application was largely confined to agriculture to improve the rapidity of plant breeding. After the death of 18-year-old Jesse Gelsinger, who as I reported yesterday volunteered to take part in a gene therapy experiment, expectations for such therapies as medicines were dampened. Commercial interest was mainly restricted to ‘last resort’ therapies for rare diseases and hard-to-treat cancers. mRNA cancer therapies, personalised to a patient’s own genome, were the holy grail of 21st century medicine, but with 55.5 per cent of mRNA cancer drug candidates being withdrawn between 2009 and 2016, and none being licensed, trial results were underwhelming.
BioNTech, CureVac and Moderna, the companies developing mRNA vaccines for Covid-19 were all in the cancer cure business, backed by deep-pocketed investors prepared to invest in unprofitable ventures for the long term. BioNTech alone disclosed cumulative net losses of €336.5million as it went public on Nasdaq in 2019. Having failed to bring any of the cancer therapies to market, all three firms became interested instead in repurposing them as vaccines for infectious diseases.
Moderna was the first to venture into infectious diseases, an area derided by one former Moderna employee as a loss leader. In 2013, the US government’s Defense Advanced Research Projects Agency (DARPA) awarded it $25million to develop its messenger RNA technology into what DARPA called an ‘antibody-producing drug’. Regular folks call such drugs vaccines, even if the mRNA ones are not by any definition ordinary ones. Moderna said: ‘The goal is to develop platform technologies that can be deployed safely and rapidly to provide the US population with near-immediate protection against emerging infectious diseases and engineered biological weapons, even in cases when the pathogen or infectious agent is unknown.’ To enhance the prospects of success, Moderna partnered with the leading vaccine manufacturer Merck & Co in 2015, with Merck taking a 50 per cent equity stake in the spinoff.
The technology captured the imagination of Bill Gates, the founder of Microsoft. Having ascended the pinnacle of business and becoming the world’s richest man, Gates found himself needing a new calling. Two decades ago, he and his then wife Melinda began applying themselves, with messianic zeal, to the business of vaccines. Today, their philanthropic vehicle, the Bill and Melinda Gates Foundation (BMGF) is the largest funder of vaccines in the world.
Gates equates global health, as he calls it, with vaccines which he sees as a software-style solution to upgrade the human immune system. The small downside is that vaccines work in the immune system like hired muscle paid to do one job only. Due to a phenomenon called Original Antigenic Sin, the hired muscle can sometimes fail to detect non-identical threats, variants as they’re now called, which it isn’t looking out for; meanwhile the body’s natural defences become impaired by dependency on the hired help. Total system failures are detrimental to the health of the vaccinee.
When an outbreak of the deadly Ebola virus struck some of the poorest countries in West Africa in 2014, western audiences knew what was coming if someone didn’t do something because they’d seen the movie. By the time the vaccines reached Phase III trials, the outbreak was already burning out. As Gates explained regretfully, the vaccines arrived too late to make much of a difference. More than 11,000 died.
Dr Maurice Hilleman was Merck & Co’s chief vaccine scientist, credited with creating more than 40 vaccines. It took Hilleman four years to develop the mumps vaccine, the quickest result he ever achieved. In Gates’s estimation, even that improvement on the customary ten years was pedestrian. The great man’s mile record needed to become a hundred-yard dash and mRNA seemed to the computer guy like the ideal performance-enhancing substance.
‘There’s early animal data that shows real promise and there’s a lot of entities, government entities, our foundation and others who have been working with the pharma companies and new entrants like Moderna and CureVac and saying “Ok, what kind of diseases would this work for?”’ Gates told attendees at a 2017 Davos explainer on the Coalition for Epidemic Preparedness Innovations(CEPI) which he and Dr Jeremy Farrar, director of the Wellcome Trust, founded to ‘create a world in which epidemics are no longer a threat to humanity’ by providing ‘just in case, just in time’ solutions. ‘So if the platform comes along, it will be a valuable tool for the ongoing infectious diseases where we still have a tremendous burden, and it will be valuable for epidemics and potentially as a tool to limit the effects of bioterrorism.’
CEPI’s stretch target was to shorten epidemic response times with people-ready vaccines produced in as little as six weeks. One problem particular to vaccines was put to Gates by John Micklethwait, Bloomberg’s editor-in-chief. ‘They’re quite difficult drugs, aren’t they? You give them to people when they’re well and so there’s the danger of making them less well and firms are always nervous about that.’
Gates replied: ‘You are right that the safety threshold is really, really, extremely high because we have to maintain the reputations of all the vaccines, convince parents in all these countries that these shots are really there to help your child out. Anything that you do to healthy people is going to have a tougher standard than say a new cancer drug, where if you don’t have the new drug, the outcome is going to be quite negative.’
He went on: ‘With Ebola we had a scientific challenge in that these platforms weren’t ready. We didn’t understand which country, what type of indemnity, and so there was a lot of fumbling around, although I will say the pharma industry was stepping up, offering to help in any way. They took a lot of their top people off and worked really hard but it’s only by fixing those regulatory uncertainties and using these new platforms that we have a chance of getting that time to be less than a year.’
On New Year’s Eve 2019, the Chinese reported a cluster of patients in Wuhan sick with a severe pneumonia. Three weeks later, with 17 dead, they put the 12million residents of Wuhan under house arrest to stop the spread of the SARS-CoV-2 virus. Encouraged by the World Health Organisation (WHO), governments around the world followed their lead and began confining their citizens to their homes to prevent hospitals filling up with sick or dying people with Covid-19 pneumonia. Sooner than he’d hoped, Gates got the chance to complete his mission.
In April 2020 he wrote:‘One of the questions I get asked the most these days is when the world will be able to go back to the way things were in December before the coronavirus pandemic. My answer is always the same: when we have an almost perfect drug to treat Covid-19, or when almost every person on the planet has been vaccinated against coronavirus . . .
‘Humankind has never had a more urgent task than creating broad immunity for coronavirus. Realistically, if we’re going to return to normal, we need to develop a safe, effective vaccine. We need to make billions of doses, we need to get them out to every part of the world, and we need all of this to happen as quickly as possible.’
Having considered the two alternatives, either a miracle treatment for the sick that he calculated needed to be at least 95 per cent effective, or a vaccine to prevent people getting sick in the first place that he estimated might take anywhere from nine months to two years to develop, the world’s most successful solution provider opted for the obvious one, deciding there was simply no alternative to a miracle vaccine. For Gates, an opportunity for repeat subscribers was not one to be missed.