The global population is being asked to take part in an experimental medical trial, using a vaccine authorised as an “investigational product”. We have been told that a vaccine is the “only way out” of our COVID19 dilemma, and that it is safe. As the public jockeys to be the first in line, let’s look at what was included in the applications for authorisation of this never before used mRNA technology.

What does more than “90% effective” actually mean? How long were the safety trials? According to Pfizer/Biotechs own records, the final data set is not due until the end of 2022. Most importantly, what are the reported known unknowns of the mRNA BNT162b2?

Informed Consent

It is incumbent on everyone to make a fully informed decision, because every entity involved in the COVID19 vaccines currently being rolled out across the world, are indemnified against any possible harm the vaccines might cause. The developers, the manufacturers, the distributers, those who deliver the vaccine to the public, the medical profession, the pharmaceutical companies, the local pharmacies, health care workers, those in charge of storage (the mRNA vaccines must be stored at -70C), the syringe makers, those in charge of filling the syringes….every single individual in the long and complex chain.

If you were to be harmed by a COVID19 vaccine, your only recourse is to prove vaccine harm to the government. Adverse effects occurring 4 hours or more after the vaccine become increasingly difficult to prove a causal relationship. If you do manage to prove that harm was caused, and the adverse reaction has left you more than 60% disabled, the government will compensate you with a one off payment of up to £120K, although the payment is tax free, it will affect any benefits you currently receive.  In these circumstances it seems foolish not to consciously weigh up the benefits against the risks, and adjust your place in the queue accordingly.

What follows are the most important points taken directly from the 53 page Pfizer / Biotech application for authorisation of their mRNA BNT162b2 vaccine. Moderna submitted a very similar application for their mRNA vaccine. The UK govt issued an information document for the healthcare workers who will be dispensing the vaccine.   And another for the public who are receiving it. 

Under section 8

8.2.Unknown Benefits/Data Gaps

Duration of protection There is no data to support 95% effectiveness for more than two months after the vaccine. “As the interim and final analyses have a limited length of follow-up, it is not possible to assess sustained efficacy over a period longer than 2 months.”

Safety

Effectiveness in certain populations at high-risk of severe COVID-19. Although the number of at risk participants in the 2 month trial allows overall evaluation, there is no way to evaluate safety in immunocompromised indivduals.

Effectiveness in individuals previously infected with SARS-CoV-2.  Not enough data to make conclusions about benefit in people who have already had COVID19 – but limited data “suggests previously infected individuals can be at risk” of reinfection.

Effectiveness in pediatric populations. Not enough participants in the trial to assess how well it works in children 15 and younger. Only one participant in age group 16 – 17 with the infection, however, it is “biologically reasonable to extrapolate that effectiveness in ages 16 to 17 years would be similar to effectiveness in younger adults.” Are there any differences between responses of children and adults? They do not know. Additional data will need to be provided for a Biologics License Application.

What if the virus mutates, as all viruses do? Changes in the “evolution” of the pandemic “may potentially limit the generalizability of the efficacy conclusions over time.” If the virus changes, they cannot vouch for the 95% efficacy. This information will be collected as the vaccine is rolled out.

What about prevention of asymptomatic infection?  There is no data. This data will be collected from ongoing clinical trials and from the vaccine rollout.

What about Long Tail COVID19? No data on this. It’s not possible “to assess the vaccine’s impact on individuals who are infected despite vaccination”. This will be assessed in ongoing clinical trials and from the vaccine rollout.

What about preventing death from COVID19? Not enough data. “However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent disease-associated death.” The respected Cochrane Review does not agree.  “Benefits in preventing death (from COVID19) should be evaluated in large observational studies” ie. the current vaccine rollout.

What about transmission? Data is limited. At this point they do not know. “Additional evaluations including data from clinical trials and from vaccine use… (ie. the vaccine rollout) …will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.” They also suggest that mask wearing and social distancing will need to continue.

8.3.Known Risks

Follow-up data is only available for 2 months post vaccine, so information on this is limited. What they do know: increased local and systemic adverse reactions, usually lasting a few days: “the most common injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%).” Within the first week of rollout a number of allergic reactions, including cases of life threatening anaphylaxis, were reported and it is now recommended that anyone with known allergic reactions, and in particular to shellfish, should not have the vaccine. Whether this could be associated with the inclusion of the nNeonGreen ingredient, obtained from the Lancelet, a marine invertebrate, is not yet clear. Pfizer are currently investigating the possibility of allergic reactions to Polyethylene Glycol an ingredient in both the Pfizer and the Moderna vaccines, and known to cause allergic reactions in some people.

Severe adverse reactions “were more frequent after Dose 2” and affected younger participants. So it is too early to know at this stage of the rollout how this might play out.

“Lymphadenopathy occurred much more frequently in the vaccine group than the placebo group and is plausibly related to vaccination.” Serious adverse events, while uncommon (<1.0%), represented medical events that occur in the general population at similar frequency as observed in the study. Three SAEs in the BNT162b2 group were considered related: shoulder injury (n=1), ventricular arrhythmia in a participant with known cardiac conditions (n=1), and lymphadenopathy temporally related following vaccination (n=1). We considered two of the events as possibly related to vaccine: the shoulder injury possibly due to vaccine administration or the vaccine itself and lymphadenopathy. Lymphadenopathy was temporally associated and biologically plausible.”

“No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection. Although participants 16 to 17 years of age were enrolled in the phase 3 trial, safety data for this age group is limited.”

8.4.Unknown Risks/Data Gaps Safety in certain subpopulations.  Insufficient data re safety in: “children less than 16 years of age”, “pregnant and lactating individuals”, “immunocompromised individuals.”

In the UK government Reg 174 Section 4.6:

“Fertility, pregnancy and lactation

Pregnancy: There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy. For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

Breast-feeding: It is unknown whetherCOVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.

Fertility: It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.”

But back to the Pfizer’s application document.  What about adverse effects that need a longer follow up to detect? This data will be collected during the rollout. “Use in large numbers of individuals may reveal additional, potentially less frequent and/or more serious adverse events not detected in the trial safety population of nearly 44,000 participants over the period of follow up (2 months) at this time.”

An increase in cases of appendicitis and Bells Palsy in the vaccine group “do not raise a clear concern at this time for a causal relationship” to the vaccination… They will collect more data on this “with more widespread use of the vaccine”, during the vaccine rollout.

What about “Vaccine-enhanced disease”? This is the most important issue: antibody dependent enhancement / pathogenic priming / vaccine-enhanced disease. In all previous attempts to develop a vaccine against coronaviruses, this issue brought the trials to a halt, for example, in development of a vaccine for the SARs-cov-1 coronavirus back in 2011. Following vaccination antibody response was reported, but on subsequent exposure to the wild virus, the response of the animal test subjects was catastrophic, involving much more serious cases, organ damage and in many cases, death, including in a cohort of children given the vaccine, the deaths of two children. (See the discussion section for their experience with enhanced disease and concerns about exposure to other coronaviruses.)

Pfizer says: “Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period.” At this point the follow up period is 2 months. “However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in on going clinical trials and in observational studies that could be conducted following authorization and/or licensure.” This known risk for coronavirus vaccines will be evaluated during the vaccine rollout itself.

To take the vaccine is to take part in the trial of an experimental vaccine authorised as an investigational product – the results of which Pfizer/Biotech say “remains unknown”.

What happens when those that were vaccinated come into contact with the SARS-cov-2 virus in the population? NO ONE KNOWS. Not Pfizer/Biotech, not Moderna, not Astra Zeneca. Not any of the government agencies authorising these experimental mRNA vaccines.

The global population is being coerced into a medical experiment the likes of which the world has never known. None of the people or entities involved will be liable if the already well known risks of pathogenic priming / vaccine enhanced disease prove to be an issue with this vaccine. All of the main companies involved in creating the vaccines for COVID19 are convicted felons.

Perhaps if it does become an issue, the public will be assured it’s a different, more lethal virus – for which a new vaccine is needed.

The government has already made it clear that even with the vaccine rollout there will still be masks, social distancing and variations of lockdown, so it won’t be the “way out” that most people are desperate to see. Those who want to volunteer for the trial of an experimental product should be allowed to do so, in the full knowledge that it is an experimental trial with the known and currently unknown risks and limited benefits involved.

Those who prefer to use different ways to strengthen their immune system and / or use the effective treatments that already exist for COVID19, should be allowed to make that choice without penalty or restriction.