Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
A request for Emergency Use Authorization in the US was submitted the same month; and the vaccine was then authorized in the US on December 11 (shortly after UK authorization on December 2).
The trial is not over, however: as all subjects are monitored for a further two year period. And the next step is to test the vaccine in groups that cannot currently receive the vaccine due to a lack of data – such as pregnant women and children (Pfizer has already started a trial in pregnant women and one in children is set to follow later this year).
This hunger games scenario of a middle-aged, potentially pre-infected and already immune health secretary taking a nominal, rushed, improperly trialled novel-technology vaccine after the pandemic has already passed on live TV is as unethical and obscene as any of the propaganda we have been subjected to. What have we become? If it happens, the supposed vaccinator, the TV station, the secretary of state, and the vaccine company should all be roundly condemned. It proves nothing and risks everything. Obnoxious and dangerous as he is, he hasn’t a clue what might happen to him. He is still that sacred thing: somebody’s patient. A power-crazed, ignorant man for whom the mantras “whatever it takes” and the “end justifies the means” are dear, offering himself for a macabre, televised ritual sacrifice fit for the Incas to appease his political masters. It is truly grotesque. There is no medical reason for him to have these chemicals.
COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
- Vaccine produced by a partnership between a University of Oxford research institute, Vaccitech, and AstraZeneca, does not need to be stored at freezing temperatures.
- Cheaper and easier to produce than the high-efficacy vaccines produced by BioNTech-Pfizer and Moderna.
- The price of AstraZeneca’s shares dropped on the news, and an analysis from an investment bank concluded, “We believe that this product will never be licensed in the US.”
- A closer look at the the Oxford-AstraZeneca trials reveals some very shaky science.
- Cherry-picked the data
- Dosing issues
- Opaque planning and data analysis procedures
- Age group selection
Article date: Monday 6 April 2009
At stake at one point last year was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.” Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.
|Actual Study Start Date :||April 29, 2020|
|Estimated Primary Completion Date :||June 13, 2021|
|Estimated Study Completion Date :||December 11, 2022|
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
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.
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.”
- 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.
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.
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|
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.