US-based human rights lawyer breaks down the contradictory claims of “effectiveness”, the incomplete studies and legal minefield of forced use of experimental vaccines
by P Jerome (civil rights attorney based in Washington, D.C.)
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.
This announcement is virtually identical to the EUAs previously issued for Covid-19 vaccines produced by Pfizer-Biontech and Moderna.
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
The FDA’s Briefing Document analyzing clinical trial data for the Pfizer vaccine, released the day before the FDA’s issuance of an EUA for that vaccine, noted (on page 47):
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 CDC Advisory Committee that recommended emergency use of the Moderna vaccine noted:
“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 FDA issued Emergency Use Authorizations (EUAs) for the Pfizer, Moderna and Janssen vaccines on December 11 and December 18, 2020, and on February 27, 2021, respectively.
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.
According to comments from vaccine scientists in September 2020 (prior to the Covid-19 EUA issuances), no vaccine had ever before been distributed on an EUA basis.
“We don’t do EUAs for vaccines,” [Dr. Peter] Hotez said, “It’s a lesser review, it’s a lower-quality review, and when you’re talking about vaccinating a large chunk of the American population, that’s not acceptable.”
Three months later, the FDA issued EUAs for the Pfizer and Moderna vaccines, but with explicit guidance that the vaccine “has not undergone the same type of review as an FDA- approved or cleared product.”
Indeed, the highly experimental nature of the Moderna Covid-19 vaccine, in particular, is extraordinary as that vaccine is the first and only product the company has ever been allowed to distribute, and it was allegedly developed in only two days.
Any use of an experimental vaccine under an EUA must be voluntary and recipients must be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
This information is repeated in small print on each of the FDA Covid-19 vaccine Fact Sheets, but it is largely ignored.
Dr Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked in October 22, 2020, if the new Covid-19 vaccines could be legally required. She respondedthat, under a EUA:
Vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.”
Under EUA status, the government is not permitted to require Covid-19 vaccinations because the vaccines are not FDA-approved and recipients are clinical trial participants. This is why states cannot legally require vaccination, despite suggestions by some legislators to do just that.
Indeed, the US military is barred from mandating the vaccines. This ban on government vaccine mandates explains why some private companies are trying to require vaccination of employees, which makes the Equal Employment Opportunity Commission (EEOC) guidance on this issue potentially relevant.
THE EEOC GUIDANCE ON COVID-19 VACCINATION DOES NOT AUTHORIZE VACCINE MANDATES
The EEOC updated its guidance on the issue of Covid-19 vaccination on December 16, 2020.
This update appeared five days after the FDA issued an EUA for the Pfizer vaccine and two days prior to issuing the Moderna EUA. Based on this timing, we can safely assume that the EEOC was well-aware of the contents of the FDA briefing documents and Fact Sheets, specifically the FDA statements about the lack of proof that the vaccines prevent infection with or transmission of the virus (SARS-CoV-2).
The EEOC guidance evaluates the idea of employer Covid-19 vaccine mandates under the Americans with Disabilities Act’s (ADA) “direct threat” analysis:
The ADA allows an employer to have a qualification standard that includes ‘a requirement that an individual shall not pose a direct threat to the health or safety of individuals in the workplace.’“
But the EEOC’s analysis presupposes that vaccines protect against infection, which is false.
The “direct threat” doctrine is an employer’s potential defense to a claim of disability discrimination under the ADA. According to the EEOC, “A conclusion that there is a direct threat would include a determination that an unvaccinated individual will expose others to the virus at the worksite.”
The specific but theoretical “direct threat” described here is one allegedly posed by an unvaccinated person who might become infected with the virus (SARS-CoV-2) and then spread infection to the workplace.
But no “determination” of such a threat is possible. The EEOC was careful to state only that a direct threat defense “would include” such a “determination.” The EEOC took no position on this issue because officials there were likely aware there has been no determination that vaccination prevents infection or transmission, and none is possible with current data.
Aspirational claims that vaccination “might” [be eventually be shown to] prevent infection or that “some data tends to show” such an effect are insufficient bases for a direct threat defense.
The US Supreme Court ruled in Bragdon v Abbott (1988) that the assertion of a direct threat defense must be evaluated “in light of the available medical evidence,” noting that “the views of public health authorities, such as the U.S. Public Health Service, CDC, and the National Institutes of Health, are of special weight and authority.”
Overcoming the long-standing protections of the right to bodily integrity and informed, voluntary consent to medical treatment requires articulation of an actual and imminent, not theoretical, threat presented by an unvaccinated person in the workplace.
The CDC, the National Institutes of Health and numerous other “public health authorities” have all stated that there is no evidence to show that vaccination prevents viral infection or transmission, a fact the EEOC should have presented but did not.
The EEOC guidance does not provide any legal cover for employers to require vaccination. The guidance proposes that employers might be successful in proving a direct threat if they were able to prove facts which, it turns out, cannot be proven.
Even more importantly, according to the CDC, more than 29 million Americans (and likely many, many more) have already contracted the virus (SARS-CoV-2) and recovered from it.
A recent NIH study demonstrates that these millions of “recovered” people have long-lasting, and likely permanent protection from re-infection. They present no threat of infection or transmission of the virus. However, under a blanket employer vaccine requirement, these people who are already immune would still be required to get vaccinated. It makes no sense logically or legally to require the vaccination of people who already have more protection from the virus than people who get vaccinated.
WHAT IS THE THREAT PREVENTED BY MANDATORY VACCINATION?
Outside the employment context, companies are demanding proof of vaccination from travelers and even movie- and concert-goers, based on the same debunked idea that vaccination with one of the Covid-19 vaccines will prevent the theoretical spread of the virus in trains, planes, movie theaters and concert halls among low-risk populations. But the relevant government agencies have all stated clearly that that the vaccines do not prevent infection or the spread of infection.
The benefit from any vaccination lies with the recipient of the vaccine. In the case of Covid-19 vaccines, vaccinated people may have fewer symptoms after becoming infected. While this is an important consideration for many people, this benefit has nothing to do with preventing the spread of the virus SARS-Cov-2.
A vaccinated person presents at least the same “risk” of infection and transmission of the virus (if not more risk) as a person who is not vaccinated. At best, vaccination might prevent a more serious case of Covid-19 illness from developing. The vaccines do not prevent infection or the spread of the virus that causes Covid-19. They can have little or no impact on stopping transmission.
Because no one has shown that vaccination prevents infection or transmission of the virus SARS-CoV-2, a fact undisputed by all official sources, this also means that vaccination cannot help to achieve the goal of herd immunity.
“Herd immunity” means that a population can be protected from a virus after enough of the population has become immune to infection, either through exposure to the virus and later recovery, or through vaccination.
But with Covid-19, there is no proof that vaccination makes anyone immune to the virus SARS-CoV-2. Covid-19 vaccination cannot play any meaningful role in the pursuit of herd immunity because the Covid-19 vaccines do not provide immunity from infection.
Oddly, the WHO contradicts itself in arguing that Covid-19 vaccination promotes herd immunity to the virus that causes Covid-19, claiming:
To safely achieve herd immunity against COVID-19, a substantial proportion of a population would need to be vaccinated, lowering the overall amount of virus able to spread in the whole population.”
This statement is simply false. It also contradicts the WHO’s prior admission that “We do not know whether the vaccines will prevent infection and protect against onward transmission.”
If the WHO has already acknowledged that it “does not know if” the Covid-19 vaccines protect people from becoming infected or transmitting the virus, it is a deliberate lie to claim that somehow these vaccines can lead to herd immunity.
A far more useful strategy than forcing people to accept an experimental vaccine that does not even protect them from infection would be to instead protect those most vulnerable to serious illness or death as a result of infection. Tens of thousands of renowned doctors and scientists in the U.S. and around the world proposed such a strategy in October 2020.
Unfortunately, the media and Silicon Valley tech monopolies attacked and effectively censored discussion of this common sense approach as “anti-science” and “right wing” by removing discussion of the proposal from nearly all media platforms.
Yet the fake “scientific” approach to herd immunity touted by the WHO, US government agencies and politicians, and media monopolists is blatantly dishonest, and has nothing to do with “science.” The push by private companies to require vaccination and “immunity passports” is similarly based on private financial interests, not scientific research.
Government scientists admit that the Covid-19 vaccines do not prevent infection or transmission of the virus they say causes Covid-19, but many of these same scientists also dishonestly claim the vaccines will somehow prevent the spread of the virus, leading to herd immunity.
Such an approach is not only unscientific and dishonest. It’s nonsense.
P Jerome is civil rights attorney based in Washington, D.C. He can be reached at email@example.com
Please share this, pass it along,
comment and start a conversation.
2 thoughts on “Covid Vaccine Sense or Nonsense”
[…] the difference between EAU-Emergency Use Authorization and FDA Approval Please also see: Covid Vaccine Sense or Nonsense the following is an […]
[…] Covid Vaccine Sense or Nonsense […]