By P Jerome
US-based human rights lawyer breaks down the contradictory claims of “effectiveness”, the incomplete studies and legal minefield of forced use of experimental vaccines
The efforts to require every American to be injected with an experimental vaccine for Covid-19 are based on the false notion that vaccination will protect recipients from becoming infected with SARS-Cov-2, the virus that causes Covid-19, or protect them from passing along the infection to other people.
The FDA, the CDC, the NIH and the pharmaceutical companies involved have all stated very clearly that there is no evidence to support this idea.
None of the three experimental Covid-19 vaccines now being distributed in the United States have been demonstrated to protect against infection with or transmission of the virus believed to cause Covid-19 (SARS-CoV-2), or even prevent symptoms of Covid-19 disease from developing.
This fact is indisputable, yet media, medical providers, and politicians continue to repeat the lie that vaccination provides “immunity to Covid” and even sources like the Mayo Clinic make irresponsible and unsubstantiated claims that vaccination “might prevent you from getting” or “spreading” Covid-19. The same lies are the basis for President Biden’s hard press for mass vaccination to “make this Independence Day truly special.”
On February 27, 2021, the Food and Drug Administration (FDA) announced it had “issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19),” the Janssen (Johnson&Johnson) Covid-19 vaccine.
In each of the EUAs, the FDA has been careful to avoid any claim that the vaccines provide protection against infection or transmission of the virus. Similarly, the Centers for Disease Control (CDC), the World Health Organization (WHO), and the National Institutes of Health (NIH) have each publicly stated that the vaccines have NOT been shown to prevent infection or transmission.
All of their regulatory documents and commentary addressing the issue state clearly that there is no evidence that the vaccines affect either infection with or transmission of the virus, nor do they prevent symptoms of Covid-19 from appearing.
THE US GOVERNMENT POSITION
Data are limited to assess the effect of the vaccine against asymptomatic infection
Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 [virus] from individuals who are infected despite vaccination.”
The FDA Briefing Document on the Moderna vaccine stated the same fact, while also describing plans for a future clinical trial to measure infection prevention, but that will not be completed until December 31, 2023 (p.47). The FDA’s review of the Janssen vaccine noted the same “limited” data…
to assess the effect of the vaccine in preventing asymptomatic infection… and definitive conclusions cannot be drawn at this time.”
“Limited data” means there is in fact no evidence to support those conclusions.
“the level of certainty for the benefits of the Moderna COVID-19 vaccine was… type 4 (very low certainty) for the estimates of prevention of asymptomatic SARS-CoV-2 infection and all-cause death.”
The CDC guidance to Covid vaccine administrators (January 2, 2021) asks:
Can a person who has received a Covid-19 vaccine still spread COVID-19? At this time, we do not know if COVID-19 vaccination will have any effect on preventing transmission.”
The World Health Organization (WHO) on January 26, 2021 similarly admitted:
We do not know whether the vaccines will prevent infection and protect against onward transmission.”
This is all very confusing due to the language the FDA, NIH and other agencies use to describe the potential effectiveness of the vaccines. For example, in the NIH analysis of the Janssen vaccine data, the authors note the vaccine’s reported effectiveness in “preventing moderate and severe COVID-19 in adults.”
This deliberately blurs the distinction between infection with a virus (SARS-Cov-2) and the illness called Covid-19.
The NIH claims the Janssen vaccine prevents or lessens symptoms of the illness Covid-19, but is silent on whether the vaccine prevents infection or transmission of the virus said to cause Covid-19 (SARS-CoV-2). The similar analysis for the Moderna vaccine notes, however:
“[T]here is not yet enough available data to draw conclusions as to whether the [Moderna] vaccine can impact SARS-CoV-2 transmission.”
Unfortunately, we have seen many reports over the last few months of deaths attributed to Covid-19 days and weeks after vaccination (see here and here (video)), confirming that vaccinated people can and do become infected with the virus.
Health officials have avoided blaming these deaths on side effects from the vaccines themselves. Instead, they say these deaths are the result of infections with the virus (SARS-Cov-2) acquired after receiving the vaccines.
Particularly devastating reports from an isolated Kentucky monastery describe how two nuns died of Covid-19 after receiving Covid-19 vaccines, despite the complete absence of any cases of infection in the monastery during the ten months prior to vaccination.
Moderna’s chief science officer was quoted in the British Medical Journal about the clinical trials in 2020 that resulted in the FDA’s decision to grant a EUA to the Moderna shot:
Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.”
The most important questions about the experimental Covid-19 vaccines were not even asked during the clinical trials: Do these experimental vaccines prevent infection with the virus and do they prevent transmission of that virus? The short answer is No.
The FDA has stated clearly in each of the Covid vaccine Briefing Documents (see Moderna document here, Pfizer here, Janssen here) that the trials were not even designed prove or disprove a hypothesis that the vaccines prevent infection or transmission of the virus, or even prevent symptoms of Covid-19 from developing.
The EUAs indicate that the vaccines “prevent severe Covid-19,” that is, they don’t prevent infection or development of symptoms after infection, but they may make the illness less severe.
The EUAs explicitly deny any evidence that the Pfizer, Moderna or Janssen vaccines prevent infection, or prevent hospitalization or even death from Covid-19 after vaccination. The highly publicized “success rates” of the vaccines refer only their potential ability to lessen the severity of those symptoms, but there is “no data” that they prevent the infection that could cause those symptoms.
MANDATING VACCINATION UNDER EMERGENCY USE AUTHORIZATION IS IMPERMISSIBLE
An EUA is not “FDA Approval.”
An EUA indicates that a product has not been fully tested but, despite the obvious risks, distribution is permitted because the government declared a “public health emergency” in January 2020.
As the FDA notes in its Information Sheet for the Moderna shot:
The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA- approved or cleared product.”
The FDA granted EUAs for all three experimental vaccines after less than five months of clinical trials, with most of trial data still to be collected. All three vaccines will be in clinical trial status through January 31, 2023 (…more)
The statements, views and opinions expressed in this column are solely those of the author and do not necessarily represent those of The Duran.