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Publications

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals – NIH

Actual Study Start Date :April 29, 2020
Estimated Primary Completion Date :June 13, 2021
Estimated Study Completion Date :December 11, 2022

https://www.clinicaltrials.gov/ct2/show/NCT04368728?term=Pfizer&cond=SARS-cov-2&draw=2&rank=1

Categories
Publications

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us – BMJ

The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are.

…But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.

Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths. Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality 

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News

Hancock wrong to say government scientists ran coronavirus trial on vitamin D – The Times

Ministers are to reconsider vitamin D as a potential weapon against Covid-19 after Matt Hancock wrongly claimed that government scientists had run unsuccessful tests.

The health secretary told the Commons last week that he had ordered a trial that showed vitamin D did not “appear to have any impact”. Officials now admit that no trials took place.

New evidence from Spain suggests that vitamin D, which some scientists believe helps to prevent a fatal overreaction to the virus, could save lives.

https://www.thetimes.co.uk/article/hancock-wrong-to-say-government-scientists-ran-coronavirus-trial-on-vitamin-d-m6h5tjq36

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News

The Case for a Coronavirus-Vaccine Bond – The New Yorker

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.”

http://archive.today/2020.08.15-143205/https://www.newyorker.com/news/daily-comment/the-case-for-a-coronavirus-vaccine-bond

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News

This is the hard-to-swallow truth about a future coronavirus vaccine – The Independent

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.

https://www.independent.co.uk/voices/coronavirus-vaccine-covid-19-cure-doctor-moderna-novavax-oxford-a9523091.html

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Opinion

Why vaccines are less effective in the elderly, and what it means for COVID-19 – The Conversation

A critical factor that makes the elderly more susceptible to infectious diseases is what immunologists call “immunosenescence”: the decline in the immune system’s functionality as people age. This is also associated with an increase in the incidence of inflammatory diseases, because an elderly body tends to be in a state of chronic low-grade inflammation. This “inflamm-aging” is one reason why older people have tendencies to develop more severe forms of respiratory diseases.

The key problem with SARS-CoV-2 infection is inflammation in the respiratory tract, which can be exacerbated in individuals predisposed towards potent inflammatory responses.

Immunosenescence also results in diminished responses to vaccination. Indeed, annual flu vaccines are notoriously less effective in the elderly. This phenomenon is very important in the context of the massive efforts and funds being invested worldwide into the ultra-rapid development of vaccines for COVID-19.

The fact that elderly people do not respond well to immunizations has largely been ignored in most discussions of COVID-19 vaccines, despite this being the group in greatest need. Most of the scientific community’s experience with vaccine development for any disease has been focused on vaccinating the relatively young.

https://web.archive.org/web/20200721234031/https://theconversation.com/why-vaccines-are-less-effective-in-the-elderly-and-what-it-means-for-covid-19-141971

Categories
Publications

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals – ClinicalTrials.gov

This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.

Actual Study Start Date  :April 29, 2020
Estimated Primary Completion Date  :October 29, 2021
Estimated Study Completion Date  :April 6, 2023

https://clinicaltrials.gov/ct2/show/NCT04368728

Categories
News

How the British Government subjected thousands of people to chemical and biological warfare trials during Cold War – The Independent (2015)

During the Cold War, the British Government used the general public as unwitting biological and chemical warfare guinea pigs on a much greater scale than previously thought, according to new historical research.

In more than 750 secret operations, hundreds of thousands of ordinary Britons were subjected to ‘mock’ biological and chemical warfare attacks launched from aircraft, ships and road vehicles.

Up until now historians had thought that such operations had been much less extensive. The new research, carried out by Ulf Schmidt, Professor of Modern History at the University of Kent, has revealed that British military aircraft dropped thousands of kilos of a chemical of ‘largely unknown toxic potential’ on British civilian populations in and around Salisbury in Wiltshire, Cardington in Bedfordshire and Norwich in Norfolk.

https://www.independent.co.uk/news/uk/politics/how-british-government-subjected-thousands-people-chemical-and-biological-warfare-trials-during-cold-war-10376411.html