In the third and final part of her investigation into the politics that allowed the experimental, gene therapy Covid ‘vaccine only solution’ fast passage through the approval process, Paula returns to the winter of 2020 and the decision to ‘smash’ conventional wisdom on vaccines.
TO understand how the world arrived at a vaccine-only solution for Covid-19, we must go back to where it started. Fortuitously, while the World Health Organisation (WHO) China office was making its first field visit to the outbreak epicentre on January 20, 2020, all the right people were in the Swiss Alps at a business networking event. The Coalition for Epidemic Preparedness Innovations (CEPI) founded by Bill Gates and Dr Jeremy Farrar, director of the Wellcome Trust, to prevent an Ebola repeat, got up and got going. By the end of the week, Moderna, a company yet to succeed in getting any product licensed, was being funded to develop a vaccine. mRNA vaccines are designed on computers from the genetic sequence, avoiding the need for anyone physically to handle the dangerous virus. Who needs a virus to make a vaccine any more? That’s so last century.
Declaring his company eager to help, Moderna’s CEO Stephane Bancel said, Press Conference: Coronavirus (COVID-19) | DAVOS 2020 – YouTube ‘The design of the vaccine has been done over the last few weeks at the NIH [National Institutes of Health] in the US, because they have access to the sequence of the virus. The US government had access very quickly to the sequence, which is very important information to start making a product. We will be providing this clinical grade material to the NIH who will be running the clinical study . . .
‘We don’t have a timeline yet, because this has never been developed before. Trying to go so fast for a vaccine has never been done before. We have done nine vaccines in the clinic but we have never done it on the compressed time that we are doing it now which is why we are doing it together. The US government is helping us with doing the design because there is great expertise there. What we are doing is we are going to make the product, quality clinical grade material, thanks to the support of CEPI.’
Richard Hatchett, the former US Homeland Security official now at the helm of CEPI, spoke optimistically about human clinical trials starting in the summer of 2020. ‘Dr Fauci from NIAID [the US National Institute of Allergy and Infectious Diseases] who I just mentioned, also mentioned those timelines with respect to the Moderna program. Those certainly depend on the development programs going well. I think they are a best estimate of how quickly we could feasibly get there if we don’t encounter roadblocks. It will also be very important for our regulatory partners to work with us and to help us understand what exactly is required before we can move vaccines into clinical trials.’
Hatchett’s confidence about the timeline was down to the vaccine platforms. ‘The advantage of the platform technologies is that they have been, with the same platform, in clinical trials, different vaccines, but same platform, have already been in trials with humans both for Moderna and Inovio, one of our other partners, so we think that will expedite the ability to move these into clinical trials.’
The lesson taken by industry from the death in 1999 of 18-year-old Jesse Gelsinger, who as I reported in Part 1 volunteered to take part in a gene therapy experiment, was that the main problem with gene therapies when they’re used in humans is how to bypass the body’s defences to get the gene editing material into the cells without stimulating an immune response that kills the patient. If that technical problem could be overcome, what that genetic material itself did wasn’t seen to be an issue.
Viral vectors, like the one used to edit Gelsinger’s genes, are themselves genetically modified organisms (GMOs), disabled to prevent them replicating and implanted with genetic material to edit the host’s genome. mRNA gene therapies skip the virus altogether and instead encapsulate the genetic material in lipid nanoparticles that will pass through the cell membrane to deliver the new instructions for the cells to make their own medicine, as Bancel puts it.
Consider them like Cornish pasties. The genetic material is the meat and potatoes, the business end of things, encapsulated in a shell in order to be transported to where it’s needed. In declaring the platform proven, the companies are simply saying that the pastry is safe and after a few ‘quick safety tests’ they can put whatever filling they like in it. The final remaining problem to be addressed were overly cautious regulators.
Jeremy Farrar, an infectious disease specialist who cut his teeth working in Vietnam when first SARs-1 and then Avian H5N1 influenza struck, was also there in Davos. He said: ‘This is not SARS. The virus is in a similar family to SARS but this looks different to SARS and the difference is, probably, that it’s easier to pass between human beings. It’s spread by the respiratory tract, that means that somebody with symptoms would have a cough, a sore throat and would pass it to somebody else by coughing or sneezing in the same way that influenza is spread around.’
He did worry a few minutes later that travel restrictions wouldn’t do much to restrict the spread as ‘in the end, if I were infectious with no symptoms, I could pass it on, even though you may not know that I was sick,’ he said.
One reporter, up earlier than the rest, asked Farrar what the panic was this time, pointing out that SARS-1 killed only 774 of the 8,098 people who caught it, and H5N1 killed 149, and it was now winter when these sorts of cold and flu things were expected. Farrar appeared momentarily startled when she proceeded to mention the ‘usual suspects’, as she put it, comorbidities like obesity, diabetes and hypertension, which were often present when people died.
‘Why panic?’ Farrar said slowly as he gathered his thoughts. ‘Er, well, the world has sort of been prepared, if you like, sort of er, getting ready for something like this, really since SARS, er, 18 years ago and it’s left really deep scars, particularly on the Asian and Toronto systems and also of course we had the pandemic [he didn’t say which one] so whenever you see an animal virus coming across to humans, passing between humans and causing mild and severe disease, of course the world is really now primed to know about that, and inevitably that causes a degree of panic . . .
‘We don’t want to overstate the panic here because there is so much uncertainty. And we want to keep a calm moderated approach to it, but we do have to take this incredibly seriously. You don’t often get an animal virus coming into humans and being spread by the respiratory route. It’s what Richard and I, and many others, would have been frightened about for the last decade.’
By summer 2020, when the mortality rate was known to be similar to influenza, Farrar told the UK Parliament: ‘It caused a clinical syndrome that went from very mild or asymptomatic all the way through, tragically, to very severe and death. That range of illness is unusual. It was an animal infection that humans have no immunity to, and we had no diagnostics, no treatments and no vaccines.’
As the clinical trials moved to clinical testing in early summer, amid the frenzy of expectation Ken Frazier, CEO of Merck & Co, the world’s pre-eminent vaccine developer, was a solitary voice urging caution. He gave a lengthy interview to Harvard Business School saying that expectations of a vaccine by the end of 2020 did the public a grave disservice. He warned about the last time a vaccine had been rushed to market. ‘We’ve seen in the past, for example, with the swine flu, that that vaccine did more harm than good’, said Frazier. ‘We don’t have a great history of introducing vaccines quickly in the middle of a pandemic. We want to keep that in mind.’
Frazier pivoted from talking about vaccine safety to the drug Mectizan, which the company proudly gives away every year as it is such a safe and effective treatment for river blindness. It’s an interesting juxtaposition. Mectizan is more commonly referred to by its other name, Ivermectin, and it costs 55 cents per pill to produce. Merck & Co never went as far as putting it forward as a candidate to treat Covid-19. Doing so would have been a major roadblock for all of the vaccines as the US Food and Drug Administration rules for emergency use authorisations prevent one being given if a therapeutic is available. The NIH, designer of the Covid-19 vaccines, may have blocked it anyway.
The starting point for Merck’s in-house scientists working on the vaccine development effort was understanding the virus itself and how it affects the immune system. As Frazier said, there was rigorous science to be done. Unlike Moderna and the other mRNA companies Merck & Co did not jump straight to manufacturing something that had been designed for them by the US government, an entity that has its own unfortunate history of non-consensual human experimentation. The bottom line, Frazier said, is ‘If you’re going to use a vaccine on billions of people, you better know what that vaccine does.’
Two days before the MHRA issued the Pfizer temporary use authorisation (TUA), Moderna submitted its own applications for emergency use authorisations (EUAs). Pfizer’s chairman Dr Albert Bourla responded to the TUA news saying, ‘Today is a great day for science and humanity.’ Meanwhile, Merck & Co, the world’s pre-eminent vaccine developer, announced it was ending its direct investment in Moderna without saying who they were selling to, or why. It would, however, ‘retain exposure to mRNA indirectly through its investment in venture funds’. Merck & Co stood down their entire Covid-19 vaccine development program in January 2021.
So why did Merck, originator of four of the seven types of licensed vaccines in common use, cut and run? It didn’t make it expressly clear. The TUA may have been a red flag. Complex investigational products becoming people-ready when you give them a new identity and shred the regulatory red tape may have been another. Hey! It just works!
The MHRA assessment records that no studies were done to evaluate how the drug moves around the body, as pharmacokinetics studies are ‘generally not considered necessary to support the development and licensure of vaccines products for infectious diseases’. It was deemed acceptable and within the guidance for vaccine products not to do toxicology studies or studies on how it interacted with other drugs. No genotoxic studies were done because the lipids and RNA ‘aren’t expected to have genotoxic potential’. No reproductive studies were done. So much for holding vaccines for healthy people to a higher standard than cancer drugs that even Bill Gates admitted was necessary.
Ethics researchers were critical of the lack of information on the risk of Antigen Dependent Enhancement (ADE) given to the trial participants themselves, ADE being what had killed Jesse Gelsinger. Once the roll-out started, people were given even less information.
Last week news broke that the FDA, which holds the full supporting data submissions had responded to a Freedom of Information request by Dr Aaron Kheriaty, a University of California, Irvine professor of psychiatry and medical ethics, saying it would take 55 years to release the information it had taken them 108 days to approve.
Millions of people have now been injected with mRNA. The largest experiment in human history which started under an open-ended but temporary compassionate use authorisation, is now rolling along like a runaway freight train. It’s being administered to children and adolescents whose immune systems cope easily with Covid-19 without any outside assistance. Governments around the world use increasingly coercive policies to pressure people to take a vaccine or an mRNA booster as the duration of any protection they give is now known to fade rapidly. Vaccine passports turn rights into permissions. No jab, no job, no choice.
Just as it arose in the Gelsinger case, there is a question over the nature and quality of the consent given by those who have had these Covid-19 ‘vaccines’. Given the circumstances under which mRNA gene therapies were pushed through the regulators as run-of-the-mill vaccines, has anyone who has received one of these next-generation vaccines given informed consent?
Giving evidence to Parliament in May 2021, Dominic Cummings said, ‘The conventional wisdom was that we were not going to be able to have any vaccines in 2020. In March, I started getting calls from various people saying, “These new MRNA vaccines could well smash the conventional wisdom, and don’t necessarily stick to it.” People like Bill Gates and that kind of network were saying that.’
When they smashed the conventional wisdom, they smashed with it the safeguards around gene therapies that were Jesse Gelsinger’s legacy. Time will tell whether that was wise.