thevaccinereaction--2020-11-09--How COVID-19 Vaccine Trials are Designed

There ’ s been a lot of talk lately about whether or not the fast-tracked COVID-19 vaccine will in fact be safe and effective .
While vaccine makers insist that any vaccine reaching the market will have undergone rigorous testing , the way trial protocols are designed suggests these vaccines may leave a lot to be desired .
As reported1 by Forbes contributor William Haseltine , a former professor at Harvard Medical School and Harvard School of Public Health , while Moderna , Pfizer , AstraZeneca and Johnson & Johnson have all published their vaccine trial protocols in a rare @ @ @ @ @ @ @ of the protocols raises surprising concerns.
” In a nutshell , the trial designs are such that the vaccines will get a passing grade even if their efficacy is minimal .
Of course , we must also consider vaccine side effects and I ’ ve also written several articles about mounting safety concerns .
As noted by Haseltine , prevention of infection would typically be a critical endpoint of any vaccine trial .
In other words , you want to ensure that when you take the vaccine , your risk of infection is @ @ @ @ @ @ @ comes to the COVID-19 vaccine , shockingly , preventing infection is not a criterion for success in any of these trials .
The only criterion for a successful COVID-19 vaccine is a reduction of COVID-19 symptoms , and even then , the reduction required is minimal .
“ We all expect an effective vaccine to prevent serious illness if infected .
Three of the vaccine protocols—Moderna , Pfizer , and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough , @ @ @ @ @ @ @ : To get a “ passing ” grade in the limited interim analysis , a vaccine must show a 70 percent efficacy .
However , again , this does not mean it will prevent infection in seven of 10 people .
As explained by Haseltine:3 The other vaccine makers are basing results on a similar protocol , where only a limited number of vaccinated participants are exposed to the virus to evaluate the extent of their symptoms .
Johnson & Johnson ’ s interim analysis will include results from 77 vaccine recipients who @ @ @ @ @ @ @ if fewer than 18 of them develop symptoms of COVID-19 , compared to 59 in the control group , the vaccine will be considered successful .
In AstraZeneca ’ s case , the interim analysis includes 50 vaccine recipients .
The vaccine will be a success if 12 or fewer develop symptoms after exposure to SARS-CoV-2 , compared to 19 in the 25-person control group .
Pfizer ’ s interim analysis is the smallest of the bunch , with just 32 vaccine recipients .
Their success margin is seven or fewer vaccine recipients @ @ @ @ @ @ @ the control group .
In the primary analysis , efficacy is set to about 60 percent , and at most , 164 volunteers will be included in that analysis .
Especially concerning are that those receiving the vaccine in these trials are young and healthy individuals who are not really at high risk of dying from COVID-19 .
This makes the results of these trials highly questionable in the far more vulnerable population of the elderly .
Trials Are Merely Testing Reduction of Common Cold Symptoms As if that ’ s not eyebrow-raising @ @ @ @ @ @ @ “ case of COVID-19 ” amounts to just one positive PCR test and one or two mild symptoms , such as headache , fever , cough or mild nausea .
As noted by Haseltine , “ This is far from adequate.
” All they ’ re doing is testing to see if this COVID-19 vaccine will minimize common cold symptoms .
They are not actually ensuring the vaccine will prevent serious COVID-19 complications .
Johnson & Johnson ’ s trial is the only one that requires at least five severe COVID-19 cases to @ @ @ @ @ @ @ “ One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection .
If someone takes this vaccine , are they far less likely to become infected with the virus ?
These trials all clearly focus on eliminating symptoms of COVID-19 , and not infections themselves .
Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance .
It appears that all the pharmaceutical companies assume that the vaccine will never prevent infection .
Their criteria for approval is @ @ @ @ @ @ @ control group and an infected vaccine group .
They do not measure the difference between infection and noninfection as a primary motivation , ” Haseltine writes.4 Severe illness and death are also secondary objectives in these trials , and none of them include failure to prevent hospitalization or death as an important barrier to success .
The increasingly disappearing common sense tells us that if the vaccine can not reduce infection , hospitalization or death , then it can not end the pandemic , which means everyone who takes the vaccine will be @ @ @ @ @ @ @ Vaccine Trials Are Not Using Inert Placebos In addition to all of that , some COVID-19 vaccine trials are using other vaccines as “ placebo ” rather than truly biologically inert substances such as saline , which effectively makes if far easier to hide any vaccine side effects .
While Moderna is using a saline solution placebo,5 AstraZeneca is using injected meningococcal vaccine rather than a true placebo.6 Another way AstraZeneca is masking potential side effects is by administering the vaccine along with certain drugs .
In one of its study arms , @ @ @ @ @ @ @ for the first 24 hours after inoculation .
The pain and fever reducer could potentially mask and downplay side effects such as pain , fever , headache or general malaise .
In addition to masking side effects , it is widely recognized among literate natural medicine physicians that using acetaminophen during acute viral infections is not a wise strategy as it impairs the immune response to fight the infection .
On Sept. 6 , 2020 , AstraZeneca paused its Phase 3 vaccine trial due to a “ suspected serious and unexpected adverse reaction @ @ @ @ @ @ @ company did not initially divulge the nature of the adverse reaction , but it has since been revealed the volunteer developed severe inflammation of the spinal cord , known as transverse myelitis.10 11 On Sept. 12 , 2020 , the British Medicines Health Regulatory Authority gave AstraZeneca the go-ahead to resume its Phase 3 trial in the U.K. , after an independent review found it “ safe to do so.
” 12 13 According to an AstraZeneca spokesperson , the incident was a case of undiagnosed multiple sclerosis.14 > Days later , on @ @ @ @ @ @ @ York Times reported15 a second case of transverse myelitis had occurred in the AstraZeneca trial .
According to one expert consulted by the NYT , the occurrence represented a “ dangerous pattern , ” and that a third incidence might shut down the vaccine trial indefinitely .
AstraZeneca , however , claims the two cases are “ unlikely to be associated with the vaccine , ” and that there ’ s “ insufficient evidence to say for certain that the illnesses were or were not related to the vaccine.
” 16 On Oct. @ @ @ @ @ @ @ that one of the volunteers in AstraZeneca ’ s Brazilian trial had died from COVID-19 complications , but that the trial would continue anyway .
On Oct. 12 , 2020 , Johnson & Johnson halted its trial due to “ unexplained illness ” in one of its participants.18 19 Like AstraZeneca , Johnson & Johnson has kept mum about the details of the illness , saying “ it ’ s important to have all the facts before we share additional information.
” The fact that more trials have not been halted is surprising @ @ @ @ @ @ @ in perfectly healthy volunteers .
As reported in “ Gates Tries to Justify Side Effects of Fast-Tracked Vaccine , ” after the first of two doses of the Moderna COVID-19 vaccine , 80 percent of Phase 1 participants receiving the 100 microgram ( mcg ) dose developed systemic side effects.21 After the second dose , 100 % reported side effects ranging from fatigue ( 80 percent ) , chills ( 80 percent ) , headache ( 60 percent ) and myalgia or muscle pain ( 53 percent ) .
Despite that , the @ @ @ @ @ @ @ on to Phase 3 trials.22 In the highest dosage group , which received 250 mcg , 100 percent of participants suffered side effects after both the first and second doses.23 Three of the 14 participants ( 21 percent ) in the 250-mcg group suffered “ one or more severe events.
” An Oct. 1 , 2020 , report24 by CNBC reviews the experiences of five participants in Moderna ’ s and Pfizer ’ s SARS-CoV-2 vaccine trials .
One of the participants in Pfizer ’ s vaccine trial “ woke up with chills @ @ @ @ @ @ @ tooth after taking the second dose.
” A Moderna trial participant told CNBC he had a low-grade fever and felt “ under the weather ” for several days after his first shot .
Eight hours after his second shot he was “ bed-bound with a fever of over 101 , shakes , chills , a pounding headache and shortness of breath .
He said the pain in his arm , where he received the shot , felt like a ‘ goose egg on my shoulder.
’ He hardly slept that night , recording @ @ @ @ @ @ @ degrees for five hours.
” 25 Two others reported similar side effects , and a third warned you would need to take a day off after the second shot .
CNBC also noted that “ as companies progressed through clinical trials , several vaccine makers abandoned their highest doses following reports of more severe reactions .
”