Unproven technologies, unsafe ingredients and inadequate testing — fortunately, current law prohibits mandating unlicensed vaccines approved for “emergency use.”
“It works!” trumpeted the normally stoic Nature journal about Pfizer’s early release results in a Phase III trial of its vaccine for COVID-19. Pfizer stated the vaccine was 90% effective when trial participants were exposed to SARS CoV-2, the virus said to cause COVID-19 symptoms.
Not so fast. Pfizer’s study protocol states cases count even if a trial participant has a positive test and only one symptom — like a cough, chills or diarrhea — that could easily be caused by one of 1,400 human pathogens, including 200 viruses known to infect humans. Except for Hepatitis A, B, C and HIV, the study protocol is silent on testing for other infectious causes of the participant’s symptoms.
In other words, the study suffers from confirmation bias. A cough and a positive test equals COVID, even when an “alternative possible diagnosis” could be the real cause of the symptoms. Absence of evidence is not evidence of absence.
Pfizer, partnering with BioNTech, uses new messenger RNA (mRNA) technology in their vaccine, and will apply for a coveted Emergency Use Authorization from the U.S. Food and Drug Administration (FDA), likely before the end of November. Pfizer’s announcement comes after 94 trial participants — of more than 43,000 — tested positive for SARS CoV-2. Pfizer has not released data on whether the cases were mild, moderate or severe.
Early results may sound encouraging to some, but experts like Eric Topol, director of the Scripps Research Translational Institute, indicated “the vaccine may not turn out to be as effective once the trial is complete and all the data has been analysed [sic],” however “its effectiveness is likely to stay well above 50%.” Pfizer’s study protocol (p. 103) states “success at the final analysis” will achieve a minimum 30% efficacy, with greater than 98% certainty. We hope the vaccine is not 30 to 90% effective against mild illness.
Will the Pfizer vaccine work, and is it safe? Questions remain. Any vaccine, including all COVID-19 vaccines, must be proven both safe and effective before being administered to high-risk groups or to the global population.
A successful vaccine must prevent severe illness, hospitalizations or death, without serious adverse events that outweigh these benefits. It cannot just claim to prevent mild cases that would resolve on their own. It must also prevent person-to-person transmission. The trial data must be sufficiently powered to answer these questions, not just for the healthy, but for high-risk groups such as the elderly and those with underlying conditions.
Any initial protection from COVID-19 symptoms should also endure, and not wane after a few weeks or a few months. Questions remain about these valid criteria as applied to COVID-19 vaccine candidates. Recent publications in leading medical journals indicate that the answers to safety and efficacy questions may be less than assuring.
As most of the world still suffers under lockdowns, many wonder if these magic keys dangled to unlock us — the vaccines being developed for COVID-19 — will avert more injuries and deaths than those caused by COVID-19 illness.
Illegal to mandate vaccines under Emergency Use Authorization
Any COVID vaccine(s) approved for emergency use should be voluntary, since the vaccine(s) are considered investigational and are held to a much lower standard for both efficacy and safety. For example, compared to the non-emergency approval process to get full licensure, an emergency approval allows for a vaccine that “may” be effective, compared to the non-emergency approval process where a vaccine must demonstrate “substantial” effectiveness.
Emergency Use Authorization (EUA) law is clear: States are barred from mandating a vaccine approved for emergency usage. (See Section VI. Preemption.) It also should be illegal for private businesses, airlines or your employer to mandate a vaccination while it is approved under an EUA.
The New York Bar Association somehow missed this materially important barrier to mandates. Their attorneys published a position statement urging states to make COVID vaccination mandatory, allowing only a medical exemption. It appears that these lawyers either have supernatural foresight that COVID vaccines will be granted full licensure sometime in the future, or they have great hubris thinking they can override EUA law.
Only if the FDA were to grant full licensure, which normally takes years, would the states or businesses be allowed to consider vaccine mandates. The PREP Act exempts COVID vaccine manufacturers from liability, even if the vaccine(s) harm recipients, so the idea of mandates is particularly frightening.
Settling for a ‘new normal’
Public health authorities tantalize us with the idea of a “new normal” after a vaccine for COVID-19 is widely available. The term implies, and has been widely interpreted to mean, that for society to return to normal, the vaccine would prevent person-to-person transmission so everything could “open up.”
As appealing as this may sound to those harmed by lockdowns, only 42% of Americans now say they would get a COVID vaccine, according to the latest YouGov poll. Even among this sanguine minority, two-thirds harbor concerns about COVID vaccine safety. If public health authorities want high uptake of the vaccine, they need to push manufacturers to provide transparent trial information to address concerns, as the vaccine will have to be voluntary if any EUAs are granted.
In June, vaccine industry spokesperson Dr. Peter Hotez said, “Ideally, you want an antiviral vaccine to do two things. … First, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
However, last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and White House coronavirus spokesperson, moved the goalpost and admitted the goal of COVID vaccines is to provide personal protection only, not to prevent death, or person-to-person transmission. Fauci said he and his colleagues would “settle for … the primary endpoint to prevent clinically recognizable disease.”
“Settle for” could be used when someone cannot afford the house they want, or when their favorite pizza topping is not available, so someone settles for cheese pizza instead of pepperoni. It is hard to imagine the words “settle for” would ever be uttered in reference to a vaccine, let alone by the guy leading the COVID vaccine program for the U.S.
Settling for a vaccine that does not meet the initially lofty promises will not make more people voluntarily line up to get it.
Flawed trial design
As conceded by Fauci, there are indeed some concerning issues with the trial design, spelled out nicely by Dr. Peter Doshi in the British Medical Journal. Doshi focuses on the two biggest issues. First, none of the leading vaccine candidate trials is designed to test if the vaccine can reduce severe COVID-19 symptoms, defined as: hospital admissions, ICU or death. And, second, the trials are not designed to test if the vaccine can interrupt transmission.
If neither of these conditions is met, the vaccine in essence performs like a therapeutic drug, except a vaccine would be taken prophylactically, even by the perfectly healthy, and more than likely carries a higher risk of injury than a therapeutic drug. If this were to be true, then therapeutic drugs would be superior to any COVID vaccine…
The statements, views and opinions expressed in this column are solely those of the author and do not necessarily represent those of The Duran.