Drugs are a risky business and, for equity investors hoping to eventually share in the profits, each stage of development presents an escalated risk. Lo reasoned that substantially lowering the risks, even if it meant correspondingly lowering the rewards, could attract investment instead from ordinary bond markets—that is, from managers of pension funds, university endowments, and sovereign-wealth funds, who control a great deal of money and generally invest in low-risk, low-return assets.
Given how uncertain vaccine markets are, the paper notes, governments (“public-sector interventions,” and so forth), would need to guarantee a vaccine bond by committing in advance to purchase and stockpile vaccines. The paper’s most creative suggestion is for a subscription model, a kind of vaccine Netflix, where governments would pay an annual fee to a new international-development fund, one that could perhaps be managed by the G7. The fund could float a bond to both advance vaccine biotechs and to make market commitments to Big Pharma. The virus, the markets, and the science are global.
…it would be much better for the government to say that the money is not from taxpayers. “We’re borrowing it from the rest of the world. And if and when you succeed, or any of the other hundred and fifty projects—that could have been funded, but aren’t being funded right now—succeeds, all the bond holders will get paid. That would be great. Everybody earns a return.”
Moderna
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Clinical trials:
- Phase I clinical trials simply test the safety of a drug or vaccine in a small number of healthy volunteers — usually brave and naïve college students.
- Phase II trials are responsible for testing its effectiveness in a larger number of subjects.
- A hyped-up and exuberant response to a Phase I trial as seen with Moderna press release is rare and nearly unheard of.
- Little information is gleaned from an investigational drug in Phase I that has many more hurdles to overcome before it successfully gets to market
- 77 percent of vaccines for infectious diseases make it through Phase I, but only 33 percent make it through the entire process overall.
Moderna’s RNA vaccine
- Upon examining Moderna’s non-peer reviewed press release, the actual data on the vaccine’s success is even more flimsy.
- When it comes to finding out whether the vaccine elicits an antibody response that could potentially fight the coronavirus, they only had data on eight patients out of the 45 patients who received the vaccine.
- The only data Moderna mentioned when it comes to determining whether the vaccine was clinically effective against the coronavirus were from mice.
- History also proves that success in animal models is often not replicated in human studies.
- Moderna’s messenger RNA vaccine is completely new and revolutionary. Messenger RNA vaccines have never before been brought to market for human patients
- It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus.
- Some messenger RNA vaccines are self-amplifying. That means they can force the cell to replicate more copies of itself.
- There are unique and unknown risks to messenger RNA vaccines, including the possibility that they generate strong type I interferon responses that could lead to inflammation and autoimmune conditions.
Oxford Vaccine Group’s vaccine:
- Oxford Vaccine Group has a competing vaccine that does not need to invade and hijack our cells’ own machinery.
- From a medical and clinical perspective, there is less risk of generating a type I interferon response and autoimmunity because there is no messenger RNA floating around our blood, invading our cells.
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
| Actual Study Start Date : | July 27, 2020 |
| Estimated Primary Completion Date : | October 27, 2022 |
| Estimated Study Completion Date : | October 27, 2022 |
Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna (U.S. National Library of Medicine 2020). The chief medical officer at Moderna, Dr. Tal Zaks, lauded the speed with which his company has provided a potential COVID-19 vaccine: “I think we’ve set a new record here,” (Kelly 2020). However, the usual Food and Drug Administration (FDA) standard for proving safety and efficacy in animal models before moving onto testing in humans, has not been followed (Boodman 2020). Instead, safety and efficacy studies in animals will run concurrently with the Phase I clinical trial in humans. This article highlights the potential implications of this new manner of testing, while placing it in the context of the current pandemic.
https://www.tandfonline.com/doi/full/10.1080/15265161.2020.1763696