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Conspiracy Archive

Vaccine Conspiracies

Claim: The COVID-19 vaccine was rushed and untested

This claim is that the covid-19 vaccines weren't tested properly and are unsafe


Early 2020, a new strain of coronavirus: Sars-Cov-2 is confirmed in Wuhan China which causes Coronavirus Disease 2019, or Covid-19. It originated from very late 2019. Originally called nCov2019 (novel coronavirus 2019).

Covid-19 cripples the world. Countries lock down multiple times, hospitals get overwhelmed in various locations, and the world starts masking up and avoiding each other.

December 2020 Pfizer and Moderns have completed phase 2 and 3 clinical trials and are trying to get the FDA to authorise their vaccines for emergency use (EUA).


Mark Toshner is the Director of Translational Biomedical Research at the University of Cambridge. In an article to TheConversation, he wrote about why 10 years to develop a vaccine is not a good thing:

"I submit grants, have them rejected, resubmit them, wait for review, resubmit them somewhere else, sometimes in a loop of doom. When I am lucky enough to get trials funded, I then spend months on submitting to ethics boards. I wait for regulators, deal with personnel changes at the drugs company and a “change of focus” away from my trials, and eventually, if I am very lucky, I spend time setting up trials: finding sites, training sites, panicking because recruitment is poor, finding more sites. I then usually have more regulatory issues and, finally, if my big pot of luck is not used up, I might have a viable therapy – or not."

"It’s not ten years because that is safe, it’s ten hard years of battling indifference, commercial imperatives, luck and red tape. It represents barriers in the process that we have now proved are “easy” to overcome. You just need unlimited cash, some clever and highly motivated people, all the world’s trial infrastructure, an almost unlimited pool of altruistic, wonderful trial volunteers and some sensible regulators."

Bottom line: The trials went through the proper phase 1-2-3 stages of vaccine development. They have submitted their results for emergency use, which was reviewed and accepted. This current rollout (December 2020) will server as durther testing and monitoring for general use (stepping into phase 4).

The phase 1-2-3 trials are the meat and potatoes of testing a vaccine, and after that comes the monitoring of deployment for safety. The years to make a vaccine aren't from years of testing - they're from years of inefficiency.

The following clinical trials are all completed phase 3 vaccine trials:

For example: Here's clinical trial data for an Influenza vaccine. Study start: November 28, 2016, Finished January 8, 2017.
Here's another Flu trial: Study start: July 15, 2016, Finished February 13, 2017.

Here's another one: Study start: April 2007, Finished July 2007.

Here's a H1N1 phase 3 trial: Study start: August 2009, Finished October 2009.

Some phase 3 trials last 2 months, some last a year, I've seen some last 2 years.

Here's an Anthrax vaccine phase 3 trial: Study start: November 2011, Finished May 2012.

Here's another Anxthrax vaccine: Study start: March 11, 2019, Finished August 6, 2020.

The timeline of these current vaccines aren't anything abnormal - only in terms of the total turnaround. The phase 3 clinical trial timeline isn't anything out of the ordinary.


Florian Krammer is a professor of microbiology. He wrote the following article in Nature in late September:

SARS-CoV-2 vaccines in development

There’s a lot in this article, but it’s a good read. He explains the problems with prior vaccine attempts at Sars-Cov and Mera-Sov, and explains who it relates to the current Sars-Cov-2 vaccines. 


“No vaccines against coronaviruses have yet been licensed for use in humans. Their development had previously been considered as low priority because the coronaviruses that were circulating in humans caused relatively mild disease; in addition, a vaccine would need to be quadrivalent—effective against four different viruses—and even then would prevent only a minor proportion of colds, because the majority are caused by other viruses. As such, the development of vaccines against human coronaviruses was not pursued.”


“Antibodies that bind to the spike protein, especially to its receptor-binding domain (RBD), prevent its attachment to the host cell and neutralize the virus. On the basis of this knowledge, and information gained from preclinical studies with SARS-CoV and MERS-CoV13, the spike protein was identified as an antigenic target for the development of a vaccine against SARS-CoV-2 at a very early stage.”


So essentially, vaccines were never fully developed for prior coronaviruses’, but what we learned from preclinical trials allowed us to springboard into the development of the current Sars-Cov-2 vaccines.


“Vaccine development for SARS-CoV-2 is following an accelerated timeline. Because of knowledge gained from the initial development of vaccines for SARS-CoV and MERS-CoV, the discovery phase was omitted. Existing processes were adopted, and phase I/II trials were started. Phase III trials were initiated after the interim analysis of phase I/II results, with several clinical trial stages running in parallel. ”


Does accelerated mean rushed? Rushed implies cutting corners so no, not rushed. Moving forward with haste and not wasting time is a more apt description. The knowledge gained from prior coronaviruses allowed scientists to get a handle on development early on.


“Traditional vaccine development is a lengthy process, and a development time of 15 years is common (Fig. 1a). The process begins with exploratory work on vaccine design and evaluation in animal models, which can take years. This is then followed by a stage in which more formal preclinical experiments are conducted, a process for vaccine production is designed and formal toxicology studies are performed; this stage can also last for several years.”


As seen in the graph provided: Years have been removed before we normally get to clinical trials. 10 years to make a vaccine is what people are claiming is necessary. A good chunk of those years aren’t even spent in the phase 1-3 trials.

“Next, an application for an investigational new drug is filed and phase I clinical trials (testing in fewer than 100 individuals; approximately 2 years) are performed to generate an initial safety profile of the vaccine candidate and to obtain preliminary immunogenicity data. If the results are promising and funding is available, a vaccine candidate is then moved into phase II clinical trials (testing in a few hundred individuals, also lasting about 2 years) to further investigate immunogenicity and to determine an appropriate dose and optimal vaccine regimens. If the results of phase II trials are encouraging, the decision might be made to move forward with very costly phase III clinical trials (in thousands of individuals; approximately 2 years) in which efficacy and safety are evaluated.”


“If the outcome of phase III trials meets the pre-defined end points, a biologics license application is filed with regulatory agencies (for example, the United States Food and Drug Administration (FDA) or the European Medicines Agency). The licensing process can take another 1–2 years, especially if additional data are requested. ”


Before we move on, this is the typical length of vaccine development - it is not saying that this is the necessary timeline. Funding plays a role, as does profitability. No one will fund a vaccine that won’t make money back unless they’re super generous and well-intentioned.


“Importantly, because it is very expensive, the overall process of vaccine development is slowed by economic risk assessment at every step. Vaccine development progresses through these stages only if the developer is convinced that the data are promising, that the risk of failure is relatively low and that there is (still) a market for the vaccine.”


Dependant on funding. Slowed by economic risk at every step. Risk of failure should be low. There needs to be a market for the vaccine. These are things which normally grind vaccine development to a bit of a crawl.


“Data from the preclinical development of vaccine candidates for SARS-CoV and MERS-CoV enabled the initial step of exploratory vaccine design to be essentially omitted, saving a considerable amount of time. In many cases, production processes were simply adapted from those of existing vaccines or vaccine candidates, and in certain cases preclinical and toxicology data from related vaccines could be used.”


“It is very important to point out that moving forward at financial risk is the main factor that has enabled the accelerated development of SARS-CoV-2 vaccine candidates, and no corners have been or should be cut in terms of safety evaluation.”


As Florian says - the timeline has been accelerated. This does not mean rushed.


It’s amazing what can be accomplished when funding, money, resources, and market are of no concern and vaccines can be developed with necessity. We are in a pressing time - we don’t have years to conduct exploratory preclinical studies. We don’t have 2-4 years to conduct toxicology studies in animals. The FDA are not going to spend 1-2 years reviewing the vaccine before authorising it. People are dying right now, infections are rising, and we need to get back to normal. 


The UK first started their emergency vaccination on 8th of December 2020. The next day we saw a report of 2 people having strong allergic reactions to the Pfizer jab. As reported in the Telegraph.

"UK regulators have issued a warning that people who have a history of "significant" allergic reactions should not currently receive the Pfizer/BioNTech Covid-19 vaccine after two NHS staff members who had the jab suffered allergic reactions."

"The NHS in England said all trusts involved with the vaccination programme had been informed."

"The Medicines and Healthcare products Regulatory Agency (MHRA) has given precautionary advice to NHS trusts that anyone who has a history of "significant" allergic reactions to medicines, food or vaccines should not receive the vaccine."

"It is understood both staff members have a significant history of allergic reactions - to the extent where they need to carry an adrenaline auto injector with them."

So, two people with existing significant allerigic reactions suffered allergic reactions from the vaccines. The MHRA gave precautionary advice that people with a history of strong allergic reactions to medicine, food, or vaccines shouldn't take it, and the NHS alerted all trusts involved.

This is being used to prove the vaccine is unsafe and untested, and that someone how we're being used as labrats. If we were being used as labrats, they wouldn't have advised against vaccinating people with a history of allergic reactions, and they would just blindly deploy it to everyone. They're not. In fact, the only people being vaccinated are health care workers, people who work in care homes, and the elderly over 80. Doesn't sound very lab ratty to me. Sounds quite conserviative and careful.

Even this has been seen as a step too far to say reactions to medicine, medications, and vaccines. As reported in Reuters:

"Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.”"

They're being very careful, and some have argued they're being overly careful. Does this sound like the behaviour of people treating the public like lab rats? I don't think so. Not at all.

Nadhim Zahawi is the UK minister of business & industry, and COVID 19 vaccine deployment. He Tweeted the following:

"A really good start to the vaccination program. It’s been 7 days and we have done: England:108,000 Wales: 7,897 Northern Ireland: 4,000. Scotland:18,000 U.K Total 137,897. That number will increase as we have operationalised hundreds of PCN (primary care networks)"

I'm trying to find evidence of severe reactions outside of those two nurses with a history of allergic reactions, but I can't. We've vaccinated almost 140 000 people in a week, and 2 people have bad reactions. That's very good going so far.

Infertility and Pregnancy

Another talking point I've seen is that it will cause infertility or cause birth issues. Let's look at the NHS page on this.

They advise breastfeeding mothers and pregnant women don't get the vaccines. Aha! Gotcha! That proves it's unsafe. No, not quite.

"There's no evidence it's unsafe if you’re pregnant or breastfeeding. But more evidence is needed before you can be offered the vaccine."

There is no evidence to assume it is unsafe, but to be safe they're advising these people don't take it. There isn't enough evidence to say with enough confidence that it is absolutely safe. There's a difference. Again, this is pure caution. Lab rats? This is awfuly bizarre mad-scientist behaviour.

"It has met strict standards of safety, quality and effectiveness set out by the independent Medicines and Healthcare products Regulatory Agency (MHRA)."

"So far, thousands of people have been given a COVID-19 vaccine and reports of serious side effects, such as allergic reactions, have been very rare. No long-term complications have been reported."

Talking of reactions. Let's go for the minimal number. Let's take "thousands" as only 2000. If 2 people with a history of strong allergies has a reaction, that would put the adverse event rate at 0.1%. That's being as ultra-liberal as possible. In reality the number is north of 2000. Compare that with the covid 0.5-1.5% IFR and it's looking like a much better option. Note that I'm comparing fatality with allergic reactions that clear up in a few days. It's like comparing apples to puppies, to be honest.

Where did the fertility stuff come from? Here's a page from the UK government website. I'd like to just point out the irony here. The same people saying "the government lies" and "don't believe what you're told" are using the government's website as evidence. I guess when they say what you don't agree with they're lies, but when you like what you see all of a sudden "aha! they admit it". Anyway.

Before we move onto the fertility section, let's read the rest of it.

"Excipients with known effect: For the full list of excipients, see section 6.1"


OK, so the ingredients with known effects are in section 6.1. Let's go to section 6.1.

"This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159.

ALC-0315 =(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),

ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide,



potassium chloride,

potassium dihydrogen phosphate,

sodium chloride,

disodium hydrogen phosphate dihydrate,


water for injections"

So not only do they make safety calls to caution against safety concerns which can't be for sure stated, they list all ingredients so if you're allergic to them you can notice before-hand. Still... we're lab rats, apparently.

Moving on to fertility. Here is the section being used as a "smoking gun".

"There are no or limited amount of data from the use of COVID-19 mRNAVaccine BNT162b2.Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2is not recommended during pregnancy."

"It is unknown whetherCOVID-19 mRNA Vaccine BNT162b2is excreted in human milk.A risk to the newborns/infants cannot be excluded.COVID-19 mRNA Vaccine BNT162b2should not be used during breast-feeding."

"It is unknown whether COVID-19 mRNA Vaccine BNT162b2has an impact on fertility."

So what does this mean? Let's quickly look at a separate page on the government website.

"Evidence so far reviewed by the MHRA raises no concerns for safety in pregnancy.

Because of the new formulation of this particular vaccine the MHRA wants to see more non-clinical data before finalising the advice in pregnancy.

It is standard practice when waiting for such data on any medicine, to avoid its use in those who may become pregnant or who are breastfeeding. This will be kept under review as more evidence becomes available."

"Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.No data are available about concomitant use of immunosuppressants."

Some more info

While we're on this page, let's keep reading. Why? If you're prepared to use one part of this document as proof, then you've got to give the rest of it equal weighting, right?

"Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older. In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of COVID-19 mRNA Vaccine BNT162band 21,728 participants 16 years of age or older received placebo.Out of these, at the time of the analysis,19,067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536placebo)were evaluated for safety 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2."

"The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (>80%), fatigue (>60%), headache (>50%), myalgia (>30%), chills (>30%), arthralgia (>20%) and pyrexia (>10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination"

"In Study 2, approximately 44,000 participants 12 years of age and older were randomised equally and received 2 doses of COVID-19 mRNA Vaccine or placebo with a planned intervalof 21 days. The efficacy analyses included participants that received their second vaccination within 19to 42 days after their first vaccination. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19disease."

"There were 8 confirmed COVID-19 cases identified in the COVID-19 mRNA Vaccine group and 162 cases in the placebo group, respectively. In this analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine BNT162b2from first COVID-19 occurrence from 7 days after Dose 2 in participants without evidenceof prior infection with SARS-CoV-2 was 95.0%"

"In a separate analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine from first COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidenceof prior infection with SARS-CoV-2 was 94.6%"

"Non-clinical data reveal no special hazard for humans based on a conventional study of repeat dose toxicity.Animal studies into potential toxicity to reproduction and developmenthave not been completed."

So the same "smoking gun" document people are sharing out says that:

-In a study of 44,000 people who were evaluated for 2 months, all reactions were resolved in days and not that bad

-They will be followed for 24 months to continue safety monitoring

-That much less people in the vaccine arm contracted vocid-19 vs the placebo group

-A separate analyis also showed a 95% efficacy

So just to reiterate. The same people saying the government can't be trusted, are sharing the government website, and using a document stat shows extensive testing and safety procedures to prove it isn't tested. This really is a topsy-turvey world. But I used to do this, so I can relate. It's about finding what you're looking for. I can guarantee you that the vast majority of people sharing this as a "smoking gun" have only read the fertility section and clicked off it.

Before we look at the FDA report, a news article in the New York Times says:

"More than 100 F.D.A. employees have worked nearly round the clock to review the application Pfizer submitted on Nov. 20, compressing months of analysis into weeks as they pored over thousands of pages of clinical trial and manufacturing data."

It's amazing what we can do when we're all invested in a single direction.


Next, let's look at the FDA report after scuitinising the Pfizer phase 1,2, and 3 trial data.

First, let's take a moment to read some snippets from their introduction which basically sumnmarises everything. I will of course be quoting the entire document end to end below this.

"The EUA request includes safety and efficacy data from an ongoing phase 3 randomized, double-blinded and placebo-controlled trial of BNT162b2 in approximately 44,000 participants."

"efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%"

"Secondary efficacy analyses suggested benefit of the vaccine in preventing severe COVID-19, in preventing COVID-19 following the first dose, and in preventing COVID-19 in individuals with prior SARS-CoV-2 infection, although available data for these outcomes did not allow for firm conclusions."

"2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA"

"severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent afterDose 2 than after Dose 1, and were generally less frequent in participants≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%). The frequency of serious adverse events was low (<0.5%)"

"based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older, and the known and potential benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its known and potential risks for use in individuals 16 years of age and older."

"The committee will also discuss what additional studies should be conducted by the vaccine manufacturer following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine."

"Pfizer, in partnership with BioNTech Manufacturing GmbH, is developing a vaccine to prevent COVID-19 which is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNP)"

Background on the Pfizer vaccine

Let's look at the background for an emergency use authorisations and what the FDA requires in order to grant it.

In order to meet the requirements of an EUA (emergency use authorisation) the following criteria has to be met:

1) "The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition."

2) "it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2"

3) "The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product."

4) "There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition."

"FDA has been providing regulatory advice to COVID-19 vaccine manufacturers regarding the data needed to determine that a vaccine’s benefit outweigh its risks. This includes demonstrating that manufacturing information ensures product quality and consistency along with data from at least one phase 3 clinical trial demonstrating a vaccine’s safety and efficacy in a clear and compelling manner."

"In the event an EUA is issued for this product, it would still be considered unapproved and it would be under further investigation (under an Investigational New Drug Application) until it is licensed under a Biologics License Application (BLA). Licensure of a COVID-19 vaccine will be based on review of additional manufacturing, efficacy, and safety data, providing greater assurance of the comparability of licensed product to product tested in the clinical trials, greater assurance of safety based on larger numbers of vaccine recipients who have been followed for a longer period of time, and additional information about efficacy that addresses, among other questions, the potential for waning of protection over time."

"An EUA request for a COVID-19 vaccine should include all safety data accumulated from studies conducted with the vaccine, with data from phase 1 and 2 focused on serious adverse events, adverse events of special interest, and cases of severe COVID-19 among study participants. Phase 3 safety data should include characterization of reactogenicity (common and expected adverse reactions shortly following vaccination) in a sufficient number of participantsfrom relevant age groups and should include a high proportion of enrolled participants(numbering well over 3,000) followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen."

"Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile. From a safety perspective, a 2-month median follow-up following completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate postvaccination period."

"Adverse events considered plausibly linked to vaccination generally start within 6 weeks of vaccine receipt.7 Therefore, a 2-month follow-up period may allow for identification of potential immune-mediated adverse events that began within 6 weeks of vaccination"

"To minimize the risk that use of an unapproved vaccine under EUA will interfere with long-term assessment of safety and efficacy in ongoing trials, it is critical to continue to gather data about the vaccine even after it is made available under EUA. An EUA request should therefore include strategies that will be implemented to ensure that ongoing clinical trials of the vaccine are able to assess long-term safety and efficacy"

So that's a pretty detailed and exhaustive list. Keep in mind this is just me pulling out extended quotes. The original document is considerably more beefy than this.

So what exactly is this vaccine?

"The Pfizer-BioNTech COVID-19 Vaccine is a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection. The vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. The vaccine also includes the following ingredients: lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose."

So to unravel this and lay it out flat on the table:
-It's an mRNA vaccine
-It encodes for the spike protein of the Sars-Cov-2

What this essentially means is that it tells a cell to create the spike protein which initiates an immune response to combat that spike protein. In the event you contract covid-19, then your immune system should be able to attack the virus right away because it has a memory of proteins with that spike protein.

They then go on to explain the type of study performed.

"Study C4591001 is a multi-center, multi-national Phase 1,2,3 randomized, blinded, placebo-controlled safety, immunogenicity, and efficacy study"

"Study C4591001 is an ongoing, randomized, placebo-controlled, phase 1/2/3 study being conducted in the US, Argentina, Brazil, Germany, South Africa and Turkey"

Randomised = Study participants were assigned to the vaccine or placebo arm randomly

Blinded = The participants didn't know whether they got the vaccine or placebo

Placebo = Saline solution injection instead of the vaccine

Immunogenicity = The ability to provoke an immune response

Efficacy = How effective it is

Safety = you know what safety is

In these studies, 21823 got the vaccine and 21828 got the placebo. The trials are still ongoing.

"The study population for phase 2/3 includes participants at higher risk for acquiring COVID-19 and at higher risk of severe COVID-19 disease, such as participants working in the healthcare field, participants with autoimmune disease, and participants with chronic but stable medical conditions such as hypertension, asthma, diabetes, and infection with HIV, hepatitis B or hepatitis C. "

"The phase 2 portion of the study evaluated reactogenicity and immunogenicity for 360 participants enrolled early-on, and these participants also contribute to the overall efficacy and safety data in the phase 3 portion."

On to safety:

"Unsolicited adverse events (AEs) are collected from Dose 1 to 1 month after the last dose and serious AEs (SAEs) from Dose 1 to 6 months after the last dose"

For following subjects to maintain safety they're following the subjects for a set period of time post-vaccination:
-Non-serious adverse events for 2 months
-Serious adverse events for 6 months

-Serious adverse events and death for 2 years

"the Sponsor did not request inclusion of this age group in the EUA because the available data, including number of participants and follow-up duration, were insufficient to support favorable a benefit-risk determination at this time"

As of November 14th, over half of the participants were followed up for at least 2 months. This was due to a gap in enrollment between the initial study participants and late comers.



In the vaccine arm, 2 people died. *alarm bells finging*. 4 people in the placebo arm died. People unfortunately die all the time, and  just because people died mid-trial doesn't mean the trial caused the deaths. The report conclused that the deaths in this study are to expected from the background rate normally expected in a population and aren't associated with the vaccine.

Onto the participant information

"Overall, the phase 2/3 evaluable efficacy population included 49.4% females, 81.9% White, 9.8% African American, 4.4% Asian participants, and <3% from other racial groups; 26.2% of participants were Hispanic/Latino; 21.4% of participants were >65 years of age. The median age was 51 years. The most frequently reported comorbidities were obesity (35.1%), diabetes (with and without chronic complications, 8.4%) and pulmonary disease (7.8%). Geographically, 76.7% of participants were from the US, 15.3% from Argentina, 6.1% from Brazil, and 2% from South Africa."

"Overall, the phase 2/3 safety population included 83.1% White, 9.1% African American, 4.3% Asian participants, and <3% from other racial groups; 28.0% of participants were Hispanic/Latino; 21.6% of participants were >65 years of age. The median age was 52 years, and safety data from a total of 103 participants 16 and 17 years of age were included in this submission. The most frequently reported comorbidities were obesity (35.1%), diabetes (without chronic complications, 7.8%) and chronic pulmonary disease (7.8%). Geographically, 76.7% of participants were from the US, 15.3% from Argentina, 6.1% from Brazil, and 2.0% from South Africa"

Vaccine efficacy

Let's get on to the meat and potatoes os what we're here for. How well does it protect from covid-19? VE = vaccine efficiency.

"The 95% credible interval for the vaccine efficacy was 90.3% to 97.6%, indicating that the true VE is at least 90.3% with a 97.5% probability, which met the pre-specified success criterion"

"For participants with and without evidence of SARS-CoV-2 infection before and during vaccination regimen, VE against confirmed COVID-19 occurring at least 7 days after Dose 2 was 94.6%, with 9 and 169 cases in the BNT162b2 and placebo groups respectively"

So in the placebo control arm of the study, 169 people got symptomatic covid-19, which only 9 people in the vaccine arm got covid-19. That's where this 95% number comes from, roughly speaking.

"The 95% credible interval for the vaccine efficacy was 89.9% to 97.3%, indicating that the true VE is at least 89.9% with a 97.5% probability given the available data."

"VE point estimates were uniformly high across the subgroups examined with the exception of participants identifying as multiracial and participants with evidence of prior SARS-CoV-2 infection at enrollment, for which too few COVID-19 cases occurred to interpret efficacy data for these subgroups"

So there's an important distinction. Vaccine effictiveness wansn't high in people who were multiracial or who had evidence of prior infection at enrollment. This is due to the low infection numbers. This could be confounded by the fact that most participants were white, so other racial groups wouldn't be as widly represented.

"Additional analyses of the first primary efficacy endpoint were conducted to evaluate the vaccine efficacy, by comorbidity status. VE point estimates were uniformly high across the comorbidities examined, though for some interpretation of the results is limited by small numbers of participants and/or cases."

"Based on the cumulative incidence curve for the all-available efficacy population after Dose 1, (Figure 2), COVID-19 disease onset appears to occur similarly for both BNT162b2 and placebo groups until approximately 14 days after Dose 1, at which time point, the curves diverge, with more cases accumulating in the placebo group than in the BNT162b2 group, and there does not appear to be evidence of waning protection during the follow-up time of approximately 2 months following the second dose that is being evaluated at this point in time."

This graph demonstrates the above.

Vaccine and placebo arms both contracted covid-19 equally up until a certain point post-vaccination, which then saw the covid infections level out in the vaccine arm and continue to climb in the placebo arm.

Protection isn't immediate and requires two doses spread apart.

This is quite obviously reflected in the analysis.

pfizer dosage days vs infection.JPG

"In the all-available efficacy population, ten participants had severe COVID-19 disease after Dose 1 (one subject who received BNT162b2 and nine participants who received placebo). Five of the remaining six placebo recipients who had severe COVID-19 disease were hospitalized, two of whom were admitted to an intensive care unit. Five of these remaining six placebo recipients who had severe disease had at least one risk factor for severe disease. The total number of severe cases is small, which limits the overall conclusions that can be drawn; however, the case split does suggest protection from severe COVID-19 disease."

"In the planned interim and final analyses, vaccine efficacy after 7 days post Dose 2 was 95%, (95% CI 90.3; 97.6) in participants without prior evidence of SARS-CoV-2 infection and >94% in the group of participants with or without prior infection. Efficacy outcomes were consistently robust (≥93%) across demographic subgroups."

This is good. And as they say, the sample size for severe covid is very small and to draw a conclusion from this wouldn't be scientifically accurate, but it does look like the vaccine protects from more severe covid infections. More monitoring and testing will deny or confirm this.

Injection reactions

This vaccine while effective, is no walk in the park for a small but notable percentage of people. For people under 55, 83% of people reported some kind of pain, 1% of which was severe after dose 2, and 1.2% after dose 2. About 0.3% of people reported severe swelling after dose 1, and 1.2% after dose 2. For people over 55, 0.2% of people reported severe pain and 0.5% after dose 2. Finally, 0.1% had severe swelling after dose 2, and 0.2% after dose 2.


A large percentage of people in the 10's of percentages had chills, fatigue, hadaches and joint/muscle pains. These are to be expected. These are called "solicited" events, which means events yo uexpect to see. It means the immune system is working.

Onto the unsolicited events


Now on to unsolicited events, or events you wouldn't expect to see from a vaccine.

"Reports of lymphadenopathy were imbalanced with notably more cases in the vaccine group (64) vs. the placebo group (6) , which is plausibly related to vaccinatio"

lymphadenopathy is basically a swelling of lymp nodes which are present in various places around the body. It might mean swelling in the neck, or chin, or armpit.

"Bell’s palsy was reported by four vaccine participants and none in the placebo group.[...] The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time, but FDA will recommend surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations."

This one is important. It's one of the claims which alternative-thinkers are howling from the rooftops right now. "it casuses Bell's palsy". No, it doesn't. Bell's palsey was present in the vaccine arm in 4 people out of 21 thousand people, and there is no evidence to suggest it was caused by the vaccine and is in line with the background event rate of this condition. People have jumped on this as a warning of how harmful it is - it's misleading and dangerous.

"There were no other notable patterns or numerical imbalances between treatment groups for specific categories (system organ class or preferred term) of non-serious adverse events, including other neurologic, neuro-inflammatory, and thrombotic events, that would suggest a causal relationship to BNT162b2 vaccine."

How do the FDA measure adverse events?

I didn't know this, so it was quite interesting to read about it.

"FDA independently conducted standard MedDRA queries (SMQs) using FDA-developed software (MAED) to evaluate for constellations of unsolicited adverse event preferred terms that could represent various diseases and conditions, including but not limited to allergic, neurologic, inflammatory, and autoimmune conditions. The SMQs, conducted on the phase 2/3 all-e nrolledsafety population, revealed a slight numerical imbalance of adverse events potentially representing allergic reactions, with more participants reporting hypersensitivity-related adverse events in the vaccine group (137 [0.63%]) compared with the placebo group (111 [0.51%]). No imbalances between treatment groups were evident for any of the other SMQs evaluated."

"In the all-enrolled population of (total N=43,448), the proportions of participants who reported at least 1 SAE during the time period from Dose 1 to the data cutoff date (November 14, 2020)were 0.6% in the BNT162b2 vaccine group and 0.5% in the placebo group."

That's something not to gloss over. The serious adverse event rate was 0.6% in the vaccine arm, but in the placebo arm it was 0.5%. People have reactions and conditions all the time. The background rate is something you have and will see in this report because you can't connect every bit of ill-health with the trial because the timing happend to coinside with it. The background rate it the frequency of disease and conditions you would expect to see in the general population.

"In FDA’s opinion following review of the adverse event narratives, two of these events were considered as possibly related to vaccine: shoulder injury possibly related to vaccine administration or to the vaccine itself, and lymphadenopathy involving the axilla contralateral to the vaccine injection site. For lymphadenopathy, the event was temporally associated and biologically plausible"

Only two reactions were considered as possibly vaccine-related, and note that infertility and Bell's palsey aren't among them.

"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, and occurrence of solicited, unsolicited, and serious adverse events in these subgroups were generally consistent with the overall study population."

"Unsolicited AEs related to pregnancy include spontaneous abortion and retained products of conception, both in the placebo group. Pregnancy outcomes are otherwise unknown at this time."

This is an important distinction to make. Both adverse events happened in the placebo group. Not enough data exists to conclusively attest to the vaccine's safety for pregnancy in terms of the mother and the baby, so they clearly state this. This does not mean it is harmful to pregnant women or babies, it simply means we don't know.

Summary time!

"Local site reactions and systemic solicited events after vaccination were frequent and mostly mild to moderate. The most common solicited adverse reactions were 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%); severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1, and were generally less frequent in adults ≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%)"

It's like I said earlier: this vaccine isn't going to be a walk in the park, but you're not going to die from it. You most likely won't see a reaction strong enough to put you in hospital. It is the far better option.

"The frequency of non-fatal serious adverse events was low (<0.5%), without meaningful imbalances between study arms. The most common SAEs in the vaccine arm which were numerically higher than in the placebo arm were appendicitis (0.04%), acute myocardial infarction (0.02%), and cerebrovascular accident (0.02%), and in the placebo arm numerically higher than in the vaccine arm were pneumonia (0.03%), atrial fibrillation (0.02%), atrial fibrillation (0.02%) and syncope (0.02%). Appendicitis was the most common SAE in the vaccine arm. There were 12 participants with SAEs of appendicitis; 8 in the BNT162b2 group. Of the 8 total appendicitis cases in the BNT162b2 group, 6 occurred in the younger (16 to 55 years) age group and 2 occurred in the older (>55 years) age group (one of the cases in the older age group was perforated). One of the 6 participants with appendicitis in the younger age group also had a peritoneal abscess. Cases of appendicitis in the vaccine group were not more frequent than expected in the general population."

The key words in this paragraph are "no meaningful imbalances between study arms". This means that over vaccine and placebo arms in the trial, the rate of serious adverse events didn't suggest that there was some kind of causal relationship between either arm. As I've said, background events are rates of conditions you expect to see in the general population. These conditions will appear in the study whether the study caused them or not.

"The Sponsor plans to offer vaccination to participants ≥16 years of age who originally received placebo and who become eligible for receipt of BNT162b2 according to local or national recommendations. The Sponsor proposes that these participants will be unblinded upon request and will have the opportunity to receive BNT162b2 as part of the study. The Sponsor also proposes that all placebo recipients ≥16 years of age will be offered BNT162b2 after completing 6 months of follow-up after Dose 2, if they did not request and receive vaccine previously. The participants will provide consent to receive vaccination and to continue follow-up. For these participants, the Sponsor plans a total follow up period of 18 months, with one visit 1- month postvaccination and subsequent phone contacts at 1, 6, and 18 months postvaccination. Safety and efficacy monitoring during this period will include collection of AEs, SAEs, and screening and diagnosing COVID-19 cases."

I think this is a nice sentiment. While you would keep more standardised controls if you didn't give the vaccine to the placebo group, they are keeping some kind of continuity while also knowing that the placebo arm are people. They gave their time and potentially their health to better our advancement of a covid vaccine and leaving these peopel defenseless in the name of consistent placebo results isn't right. Good move on their end, I applaud it.

"Use in pregnancy and lactation and vaccine effectiveness are areas the Sponsor identified as missing information."

Again - it isn't known. People are taking this to mean it is untested or being used as lab rats. The total opposite is true.

This isn't the end !

Finishing up this report with the follow-up safety studies and monitoring that the sponsor (Pfizer) will do after authorisation. Ask yourself: does this look like the behaviour of a company (Pfizer) or an institution (FDA) who's actions are dictated by corruption and bribery? No. They do not. I am reminded of all of the FDA conspiracies I used to absorb. I abandoned those views years ago, but this document was eye-opening to just how incredibly wrong I was back then.

"The Sponsor will conduct both passive and active surveillance activities for continued vaccine safety monitoring. Passive surveillance activities will include submitting spontaneous reports of the following events to the Vaccine Adverse Event Reporting System (VAERS)"

"The Sponsor will also conduct periodic aggregate review of safety data and submit periodic safety reports at monthly intervals."

"Sponsor studies will include completion of long-term follow-up from ongoing clinical trials as well as the following three planned active surveillance studies. Of note, the Sponsor will submit plans for a clinical study to assess safety and immunogenicity in pregnant women and has proposed active surveillance studies designed to monitor vaccination during pregnancy within populations expected to receive the vaccine under EUA."

"The Sponsor proposes to survey 20,000 U.S. health care workers enrolled in the COVID-19 HERO registry as well as health care workers in certain participating health care facilities about adverse events of special interest"

"Study Protocol Number C4591011. This study is an active safety surveillance evaluation conducted within the Department of Defense Health System Databases using data derived from electronic health records and medical service claims among covered U.S. military and their families. Rates of safety events of interest in vaccinated participants will be compared to unvaccinated comparators. The study will be conducted for 30 months."

"Study Protocol Number C4591012. This study is an active surveillance study for adverse events of special interest and other clinically significant events associated with the Pfizer-BioNTech COVID-19 Vaccine using the Veteran’s Health Administration electronic medical record database. Vaccinated participants will be compared to unvaccinated participants or to recipients of seasonal influenza vaccine. The study will be conducted for 30 months."

"An additional source of VAERS reports will be through a program administered by the CDC known as v-safe. V- safe is a new smartphone-based opt-in program that uses text messaging and web surveys from CDC to check in with vaccine recipients for health problems following COVID-19 vaccination. The system also will provide telephone follow-up to anyone who reports medically significant (important) adverse events"

A little more summary

"The protocol-specified 2-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19 occurring at least 7 days after completion of the vaccination regimen."

"Efficacy findings were also consistent across various subgroups, including racial and ethnic minorities, participants aged 65 years and older, and those with one or more of the following conditions: obesity, diabetes, hypertension, and chronic cardiopulmonary diseases. While limited, available data suggest that individuals with previous SARS-CoV-2 infection can be at risk of COVID-19 (i.e., re-infection) and may benefit from vaccination."

"Among participants with no evidence of COVID-19 prior to vaccination, the vaccine was effective in reducing the risk of COVID-19 and severe COVID-19 after Dose 1. Fewer severe cases were also observed in the vaccine recipients relative to recipients of placebo during the follow up period after Dose 1."

Finally onto the obvious limitations

I've said this over multiple pages, but studies or analysis which transparently outline their limitations and say "this is what we don't know", are typically the most objective and well-thought.

"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."

"Although the proportion of participants at high risk of severe COVID-19 is adequate for the overall evaluation of safety in the available follow-up period, the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy outcomes."

"The representation of pediatric participants in the study population is too limited to adequately evaluate efficacy in pediatric age groups younger than 16 years. No efficacy data are available from participants ages 15 years and younger."

To sum these few bits up:
-No one has been followed longer than 2 months (give or take)

-Data is too limited for certain groups such as those who are immunocompromised

-Not enough people under 16 were tested to make claims of efficacy in this age group

"Data are limited to assess the effect of the vaccine against asymptomatic infection as measured by detection of the virus and/or detection of antibodies against non-vaccine antigens that would indicate infection rather than an immune response induced by the vaccine. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization."

"Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination. Demonstrated high efficacy against symptomatic COVID-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake, though it is possible that if efficacy against asymptomatic infection were lower than efficacy against symptomatic infection, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission."

"Additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection."

To sum this bit up:
-It is unclear if the vaccine supressed asymptomatic infection

-Data on transmission is limited

-If asymptomatic spread is less hindered by the vaccine, relaxiong measures could continue the spread

"There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals."

"Following authorization of the vaccine, 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 at this time. Active and passive safety surveillance will continue during the post authorization period to detect new safety signals."

And finally, to wrap this up:
-Data on under 16's is too limited to make claims of safety

-Pregnancy hasn't been studied (by design)

-Immunocompromised individuals don't have enough safety data

-As the vaccine is administered, safety will be monitored

Things I've seen online include such claims as "they're using us as lab rats", "it hasn't been tested", "it isn't safe". Do these claims pan out? In my opinion, not one bit.

The FDA and Pfizer have been very clear about the precautions needed such as not vaccinating pregnant women, and children under 16. They are transparent with areas with too few data. Safety has been considered in every step, whether it is Pfizer offering the vaccine to the placebo arm after authorisation, or their decision not to test on pregnant women.

Nothing about this says "we're lab rats". It is absolutely unfounded.


In the New England Journal of Medicine, there is a, article titled: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.

Before we start, they explain what the vaccine is:

"a lipid nanoparticle–formulated,5 nucleoside-modified RNA (modRNA)6 encoding the SARS-CoV-2 full-length spike"

Just in case you're getting alarmed by "nano" after nearing about nano technology microchips - don't be. Nano refers to size, nothing more. It means it's on the nanometer scale. Anyway. As I understand it (which isn't very much), the lipid capsule is what allows the rna to enter a cell, which then releases the mRNA, which can then start encoding for spike proteins.

This study is Pfizer's phase 2/3 study results.

"Site staff who were responsible for safety evaluation and were unaware of group assignments observed participants for 30 minutes after vaccination for any acute reactions."

I didn't know this before. The site staff who oversaw safety were blinded, so a portion of this study was double-blinded to a degree.

"Per protocol, safety results for participants infected with HIV (196 patients) will be analyzed separately and are not included here"

This is why the immunocompromised data isn't broad enough to make a claim about the vaccine in immunocompromised individuals. The sameple size is 196 which is pretty small.

"The modified intention-to-treat (mITT) efficacy population includes all age groups 12 years of age or older (43,355 persons; 100 participants who were 12 to 15 years of age contributed to person-time years but included no cases)."

This is the reason for saying the data is lacking for under 16's. It's not that it is thought to be unsafe, but the data isn't extensive enough to say for sure, so scientifically you can't make calls on such small sample sizes of 100 people. None of these people got symptomatic covid-19.


On to the results and adverse events

For the full table of the reactions by severity seen in the trial, check out the study graph.

"The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days."

I extracted this above in the FDA document. It was possibly these were vaccine-related, but it's also possible they were not.

"Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the vaccine and placebo groups reported temperatures above 40.0°C."

Adverse events which yo uexpect to see like fever are generally OK, but high fevers are dangerous. Luckily, only two people from each group had a high fever, which would suggest some kind of abnormality, especially as this happened in the placebo arm.

"Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter."

While 2 months isn't a follow-up time of several years, it is worth remembering that all of these reactions occured within that time, and onset of these kinds of symptoms are quick and get resovled relatively fast.

"Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia)"

"Safety monitoring will continue for 2 years after administration of the second dose of vaccine."

The safety testing looks very good. They are continuing to monitor people for 2 years after they finish the second dose of vaccination. I don't know what else they could do, to be honest.

"indicating early protection by the vaccine, starting as soon as 12 days after the first dose."

12 Days. Just because you get vaccinated doesn't mean it's time to be reckless. Protect yourself and those around you. Be cautions for at least 2 weeks after the second dose.

The numbers

As of Christmas eve, more than 600 000 people in the UK have been given the jab according to the government website.

According to the CDC, over 1 000 000 people in the US have had the first jab of the Pfizer vaccine.

Atleast 8 people have had severe allergic reactions so far. That's higher than other vaccines, but it's still a small number. I can't find more instances online than that.

1 600 000 vaccinations - 8 allergic reactions. That's 1 in 200 000. That's 0.000005%. Double it. Triple it. Multiply it by 10. That's still a low number - and these aren't fatal. Compare that with the IFR of covid-19, and it's clearly the better option.


In the New England Journal of Medicine, the Moderna phase 3 interim data has been published in a study titled: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.

First it starts off by explaining the type of study.

“This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. sites.”


“Safety is reviewed by a protocol safety review team weekly and by an independent data and safety monitoring board on a continual basis.”


This is a study where participants were randomised, the vaccine was measured against a placebo control, and the observers didn’t know who got the placebo or vaccine. Independent safety monitoring on a weekly basis, too. Off to a good start.

“The trial is ongoing, and the investigators remain unaware of participant-level data. Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board; all other trial staff and participants remain unaware of the treatment assignments.”


Further clarification over who knew what. This reduces the prospect of introducing observer bias which could subtly mess with the results in one way or another.


“Eligible participants were persons 18 years of age or older with no known history of SARS-CoV-2 infection and with locations or circumstances that put them at an appreciable risk of SARS-CoV-2 infection, a high risk of severe Covid-19, or both.”


The participants were over 18 and ranged between noticeably able to become infected to contracting a severe case of covid infection.

“To enhance the diversity of the trial population in accordance with Food and Drug Administration Draft Guidance, site-selection and enrollment processes were adjusted to increase the number of persons from racial and ethnic minorities in the trial, in addition to the persons at risk for SARS-CoV-2 infection in the local population.”


This is very good news. It has become apparent during this pandemic that ethnic minorities were at greater risk, so representing those demographics in a meaningful way would help diversify and strengthen the dataset collected.

“Participants were randomly assigned in a 1:1 ratio, through the use of a centralized interactive response technology system, to receive vaccine or placebo. Assignment was stratified, on the basis of age and Covid-19 complications risk criteria, into the following risk groups: persons 65 years of age or older, persons younger than 65 years of age who were at heightened risk (at risk) for severe Covid-19, and persons younger than 65 years of age without heightened risk (not at risk)”


So an even number of people received the vaccine and the placebo. People were arranged by age and covid risk to better match up participants while still being randomised.

“Once the injection was completed, only trial staff who were unaware of treatment assignments performed assessments and interacted with the participants. Access to the randomization code was strictly controlled at the pharmacy.”


More bias prevention. This is the marker of a good study. The more you prevent the possibility for bias, the more faithful the results are likely to be.

“Safety assessments included monitoring of solicited local and systemic adverse events for 7 days after each injection; unsolicited adverse reactions for 28 days after each injection; adverse events leading to discontinuation from a dose, from participation in the trial, or both; and medically attended adverse events and serious adverse events from day 1 through day 759.”


This gives you an idea of the time-frame we’re looking at. 1 week post-injection for both injections they were monitored for solicited (expected) events, and systemic adverse events, and serious events are being monitored for roughly 2 years.


“Cases of Covid-19 and severe Covid-19 were continuously monitored by the data and safety monitoring board from randomization onward.”


All cases were monitored by a safety board throughout the trial. This is what you do when you want to conduct an ethical and protective study on people. Next we get onto the results and definitions.


“The primary end point was the efficacy of the mRNA-1273 vaccine in preventing a first occurrence of symptomatic Covid-19 with onset at least 14 days after the second injection”


“Covid-19 cases were defined as occurring in participants who had at least two of the following symptoms: fever (temperature ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder, or as occurring in those who had at least one respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia) and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if the participant was hospitalized) that was positive for SARS-CoV-2 by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test.”


“Participants were assessed for the presence of SARS-CoV-2–binding antibodies specific to the SARS-CoV-2 nucleocapsid protein (Roche Elecsys, Roche Diagnostics International) and had a nasopharyngeal swab for SARS-CoV-2 RT-PCR testing (Viracor, Eurofins Clinical Diagnostics) before each injection. SARS-CoV-2–infected volunteers were followed daily, to assess symptom severity, for 14 days or until symptoms resolved, whichever was longer. A nasopharyngeal swab for RT-PCR testing and a blood sample for identifying serologic evidence of SARS-CoV-2 infection were collected from participants with symptoms of Covid-19.”


So to summarise that up, symptomatic covid had to include one of those symptoms, and a positive PCR test result. If anyone was infected, they were tested and followed daily until the symptoms disappeared or for 14 days (whichever was longer). 


“A secondary end point was the efficacy of mRNA-1273 in the prevention of severe Covid-19 as defined by one of the following criteria: respiratory rate of 30 or more breaths per minute; heart rate at or exceeding 125 beats per minute; oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg; respiratory failure; acute respiratory distress syndrome; evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or a need for vasopressors); clinically significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death.”


The second endpoint was the vaccine's ability to prevent severe covid infections which require one of the above symptoms. Simple enough.

“Between July 27, 2020, and October 23, 2020, a total of 30,420 participants underwent randomization, and the 15,210 participants in each group were assigned to receive two doses of either placebo or mRNA-1273”


“Common reasons for not receiving the second dose were withdrawal of consent (153 participants) and the detection of SARS-CoV-2 by PCR before the administration of the second dose on day 29 (114 participants: 69 in the placebo group and 45 in the mRNA-1273 group).”


“As of November 25, 2020, the participants had a median follow-up duration of 63 days (range, 0 to 97) after the second dose, with 62% of participants having more than 56 days of follow-up.”


Heading into the results, we’re looking at 15000 people who were randomised, who received two doses of placebo or vaccine.


Adverse events


“In the mRNA-1273 group, injection-site events were mainly grade 1 or 2 in severity and lasted a mean of 2.6 and 3.2 days after the first and second doses, respectively (Table S5). The most common injection-site event was pain after injection. Delayed injection-site reactions (those with onset on or after day 8) were noted in 244 participants (0.8%) after the first dose and in 68 participants (0.2%) after the second dose.”


“The severity of the solicited systemic events increased after the second dose in the mRNA-1273 group, with an increase in proportions of grade 2 events (from 16.5% after the first dose to 38.1% after the second dose) and grade 3 events (from 2.9% to 15.8%). Solicited systemic adverse events in the mRNA-1273 group lasted a mean of 2.9 days and 3.1 days after the first and second doses, respectively”


Essentially, the second dose is generally harder on the person than the first, and the severity of the adverse events are generally mild to moderate with a small percentage being severe. 


“Three deaths occurred in the placebo group (one from intraabdominal perforation, one from cardiopulmonary arrest, and one from severe systemic inflammatory syndrome in a participant with chronic lymphocytic leukemia and diffuse bullous rash) and two in the vaccine group (one from cardiopulmonary arrest and one by suicide).”


It’s important to distinguish the cause of death. Proponents of anti-vaxx pseudoscience will always resort to correlation. They will usually say death occured after vaccination, therefore the vaccine killed them. When vaccinating essentially a global population, the normal rate of disease and death won’t be going anywhere - they can’t be attributed to the vaccine purely from a correlation standpoint. 


“The frequency of grade 3 adverse events in the placebo group (1.3%) was similar to that in the vaccine group (1.5%), as were the frequencies of medically attended adverse events (9.7% vs. 9.0%) and serious adverse events (0.6% in both groups). Hypersensitivity reactions were reported in 1.5% and 1.1% of participants in the vaccine and placebo groups, respectively (Table S12). Bell’s palsy occurred in the vaccine group (3 participants [<0.1%]) and the placebo group (1 participant [<0.1%]) during the observation period of the trial (more than 28 days after injection).”


The important thing to take away isn’t that Bell's Palsy is 3x more likely with the vaccine, it’s that these things occur at a background rate in the population in general. It’s important for safety experts to assess causality instead of inferring from potential coincidence.


“No evidence of vaccine-associated enhanced respiratory disease was noted, and fewer cases of severe Covid-19 or any Covid-19 were observed among participants who received mRNA-1273 than among those who received placebo”


“For the primary analysis, 196 cases of Covid-19 were diagnosed: 11 cases in the vaccine group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0) and 185 cases in the placebo group (56.5 per 1000 person-years; 95% CI, 48.7 to 65.3), indicating 94.1% efficacy of the mRNA-1273 vaccine (95% CI, 89.3 to 96.8%; P<0.001) for the prevention of symptomatic SARS-CoV-2 infection as compared with placebo”



No vaccine enhanced disease found, and symptomatic covid was reduced by 94.1% in the vaccine arm. Symptomatic infections become hospitalisations, severe covid, and ICU admissions. Imagine reducing the load on health care workers by 94% - that’s huge.


“A key secondary end point evaluated the efficacy of mRNA-1273 at preventing severe Covid-19. Thirty participants in the trial had severe Covid-19; all 30 were in the placebo group (indicating vaccine efficacy of 100% [95% CI, could not be estimated to 1.0]), and one death among these participants was attributed to Covid-19 ”


“The vaccine efficacy to prevent Covid-19 was consistent across subgroups stratified by demographic and baseline characteristics”


That’s also very important. While the vaccine didn’t prevent all cases of covid (albeit in the mid 90’s), of those remaining 5-ish percent, none of them had a severe case of covid. This is the same as the Pfizer trial data.


“Of note, the trial was designed for an infection attack rate of 0.75%, which would have necessitated a follow-up period of 6 months after the two vaccine doses to accrue 151 cases in 30,000 participants. The pandemic trajectory accelerated in many U.S. regions in the late summer and fall of 2020, resulting in rapid accrual of 196 cases after a median follow-up of 2 months.”


“This high apparent efficacy of mRNA-1273 is based on short-term data, and waning of efficacy over time has been demonstrated with other vaccines.20 Also, the efficacy of the vaccine was tested in a setting of national recommendations for masking and social distancing, which may have translated into lower levels of infectious inoculum.”


I want to draw attention to two things here: the acknowledgement of potential confounding variables and caution over lasting efficacy, and the inclusion of viral inoculum being potentially lower after social distancing and mask wearing. Lower viral inoculum is something I have shared on the covid face masks page at being a hypothesised byproduct of mask wearing. It’s interesting seeing it mentioned here, too.


“Overall, the local reactions to vaccination were mild; however, moderate-to-severe systemic side effects, such as fatigue, myalgia, arthralgia, and headache, were noted in about 50% of participants in the mRNA-1273 group after the second dose. These side effects were transient, starting about 15 hours after vaccination and resolving in most participants by day 2, without sequelae.”


It’s also important to know the timeframe for expected events to last. 2 days or so is the general time period observed in the study.


“The overall incidence of unsolicited adverse events reported up to 28 days after vaccination and of serious adverse events reported throughout the entire trial was similar for mRNA-1273 and placebo. A risk of acute hypersensitivity is sometimes observed with vaccines; however, no such risk was evident in the COVE trial, although the ability to detect rare events is limited, given the trial sample size. The anecdotal finding of a slight excess of Bell’s palsy in this trial and in the BNT162b2 vaccine trial arouses concern that it may be more than a chance event, and the possibility bears close monitoring.”


They make an important distinction here. While the Bell’s Palsy occurred in both groups and at around the background rate, they still give it weighting as a potential effect to monitor and look out for. This should show that efficacy in vaccine trials is taken incredibly seriously.


“Whether mRNA-1273 vaccination results in enhanced disease on exposure to the virus in the long term is unknown.”


“Key limitations of the data are the short duration of safety and efficacy follow-up. The trial is ongoing, and a follow-up duration of 2 years is planned, with possible changes to the trial design to allow participant retention and ongoing data collection.”


Long-term effects are unknown, but this doesn’t mean they are expected. “We don’t know” isn’t up in the air or chaotic randomness. The vaccine has a great safety profile by the looks of things, and this should be evidence again to how seriously vaccine safety is taken.


“although our trial showed that mRNA-1273 reduces the incidence of symptomatic SARS-CoV-2 infection, the data were not sufficient to assess asymptomatic infection, although our results from a preliminary exploratory analysis suggest that some degree of prevention may be afforded after the first dose.”


“Evaluation of the incidence of asymptomatic or subclinical infection and viral shedding after infection are under way, to assess whether vaccination affects infectiousness.”


They can’t comment on asymptomatic cases and viral shedding, but the study is ongoing and they’re looking at it. Evidence not being in yet isn’t the same as the opposite being true. 


“Pregnant women and children were excluded from this trial, and additional evaluation of the vaccine in these groups is planned.”


Further reason data on pregnancy isn’t well-known - it wasn’t studied by design. The fact that Pfizer and Moderns chose not to experiment on pregnant women in my opinion is a very good thing warranting brownie points for ethics.

This graph is from the Moderna study above.

This shows the days vs incidence of covid infections. It takes around 12 days before immunity to develop, afterwhich the difference is massive.


In The Lancet journal, is the phase 3 interim analysis titled Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

This is the study in The Lancet on the AstraZeneca study data titled Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

“We report on the first clinical efficacy results of ChAdOx1 nCoV-19 in a pooled analysis of phase 2/3 trials in the UK and Brazil, and safety data from more than 20 000 participants enrolled across four clinical trials in the UK, Brazil, and South Africa”


That’s our study size: 20 000. Not the largest, but it’s good.


“The ChAdOx1 nCoV-19 vaccine (AZD1222) was developed at Oxford University and consists of a replication-deficient chimpanzee adenoviral vector ChAdOx1, containing the SARS-CoV-2 structural surface glycoprotein antigen (spike protein; nCoV-19) gene.”


As I understand, this means it’s an inactivated adenovirus, not a live-attenuated virus. This means the possibility for it to cause the illness it’s protecting against isn’t there like with, for example, the live-attenuated Polio vaccine.


“This interim analysis of the efficacy and safety of the ChAdOx1 nCoV-19 vaccine includes data from four ongoing blinded, randomised, controlled trials done across three countries: COV001 (phase 1/2; UK), COV002 (phase 2/3; UK), COV003 (phase 3; Brazil), and COV005 (phase 1/2; South Africa). The interim efficacy is being assessed by a prespecified global pooled analysis combining data from COV002 and COV003.”


I’m only interested in COV002 and COV003 as these are phase 3 trials. These are the focus of the paper, too, so it makes things easier. They’re blinded randomised control trials which is a good standard. Blinded means the participants were unaware, double-blinded would mean the trial staff were, too. This looks less robust compared to the Pfizer and Moderna trial.


“COV002 is a continuing single-blind phase 2/3 study in the UK that began on May 28, 2020, and enrolled participants in 19 study sites in England, Wales, and Scotland. Enrolment particularly targeted individuals working in professions with high possible exposure to SARS-CoV-2, such as health and social care settings.”


That’s our study participant information to be aware of. It’s important to know who is tested as it gives an idea of how reflective the efficacy might be on the population. Favourable results in high-exposure settings would be a good place to test a vaccine.

“The 18–55-year-old cohorts were originally planned as single-dose efficacy cohorts. However, the protocol was modified on July 20, 2020, to offer a second dose to the participants in these cohorts as a result of robust booster responses identified in the evaluation of the early immunogenicity cohorts”


This could mess with the results a little, but recognising that boosters gave a better efficacy and changing the protol to fit shows they’re following an evidence-based protocol.


“COV003 is a continuing single-blind phase 3 study in Brazil that began on June 23, 2020. The focus of recruitment was targeted at those at high risk of exposure to the virus, including health-care workers at six sites across Brazil. Participants were aged 18 years or older, and this trial included individuals with stable pre-existing health conditions.”


Relatively similar to the UK trial in that it included people at high-risk. 


“In efficacy cohorts for all studies, participants were randomised 1:1 to receive ChAdOx1 nCoV-19 or a control product. In COV002, MenACWY was chosen as the control group vaccine to minimise the chance of accidental participant unmasking due to local or systemic reactions to the vaccine. COV003 used MenACWY as the control for the first dose and saline for the second dose.”


“The trial staff administering the vaccine prepared vaccines out of sight of the participants and syringes were covered with an opaque material until ready for administration to ensure masking of participants.”


Honestly, I’m not super enthusiastic when a trial is single-blinded and the control isn’t a placebo saline solution but another vaccine. The reasoning given - to blind participants as to the side effects - doesn’t seem like a solid methodology to me, but hey, I’m not a scientist. Pfizer didn’t do this, neither did Moderna. Their trial data showed promising results with adverse events in both the vaccine and placebo arm. Maybe I’m missing something.


“Participants across all four trials were asked to contact the study site if they experienced specific symptoms associated with COVID-19 and received regular reminders to do so. Those who met symptomatic criteria had a clinical assessment, a swab taken for a nucleic acid amplification test (NAAT), and blood samples taken for safety and immunogenicity. In the UK and Brazil, the list of qualifying symptoms for swabbing included any one of the following: fever of at least 37·8°C, cough, shortness of breath, and anosmia or ageusia.”


“In all studies, if participants were tested outside of the trial, either in their workplace if a health-care worker or by private providers, these results were recorded and assessed by a masked independent endpoint review committee. The source of each swab was recorded plus the details of the test kit where available.”


There are the list of symptoms required + a NAAT test and the protocol for tests conducted outside of the trial. 


“To test for asymptomatic infections, participants in COV002 in the UK were asked to provide a weekly self-administered nose and throat swab for NAAT testing from 1 week after first vaccination using kits provided by the UK Department of Health and Social Care (DHSC).”


This is pretty big - it will detect asymptomatic infection. Weekly tests for the UK trials are very big. Moderna and Pfizer didn’t study asymptomatic cases. 


“In Brazil, there was no testing plan for asymptomatic infections. In South Africa, asymptomatic infections were detected from swabs obtained at study visits attended, but are not summarised here as there were only a small number of timepoints for detection of these cases.”


While I’m only looking at the Brazil and UK trials, I am interested to see the South Africa data, especially with their new variant circulating.


“All cases of COVID-19 were reviewed by two members of a masked independent clinical review team who assessed clinical details, including medical history, symptoms, adverse events, and swab results, and assigned severity scores according to the WHO clinical progression scale.8


This is good. Even though trial staff weren’t blinded, the reviewers of the data were. 


“The primary objective was to evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against NAAT-confirmed COVID-19. The primary outcome was virologically confirmed, symptomatic COVID-19, defined as a NAAT-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia).”


“Evidence of efficacy at the time of the interim analysis was not considered reason to stop the trials and all trials are continuing to accrue further data that will be included in future analyses.”


“Participants were excluded from the primary efficacy analysis if they were seropositive at baseline or had no baseline result. Other exclusions included those with NAAT-positive swabs within 14 days after the second vaccination, or those who discontinued from the study before having met the primary efficacy endpoint with a follow-up time of less than 15 days after the second vaccination. All reasons for exclusion are shown in appendix 1


Just to summarise this up a bit: A NAAT test and a qualifying symptom was required. They tested for symptomatic COVID-19, and participants who were infected at the beginning or weren’t tested weren’t included in the analysis, and neither were people with less that 15 days follow-up after the second dose. The trial is continuing.


“AstraZeneca reviewed the data from the study and the final manuscript before submission, but the academic authors retained editorial control. All other funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.”


I added this in because simply seeing “Gates” anywhere puts certain people in a rabid frenzy. Explicitly writing that no funders had any input in the trial, while important information, will still get ignored or simply denied by people who want to believe otherwise. 


“In participants who received two standard-dose vaccines, vaccine efficacy was 62·1% (95% CI 41·0–75·7), whereas in those who received a low dose as their first dose of vaccine, efficacy was higher at 90·0% (67·4–97·0; pinteraction=0·010; table 2; appendix 1 pp 12–13).”


“More than 21 days after their first dose, ten participants were hospitalised due to COVID-19 (defined as WHO clinical progression score ≥4), two of whom were assessed as having severe COVID-19 (WHO score ≥6), including one fatal case. All ten cases were in the control group”


The first dose alone from this information prevented all severe cases which is notable. It’s consistent with the Moderna and Pfizer trials.


“There were 175 events (84 in the ChAdOx1 nCoV-19 group and 91 in the control group), three of which were considered possibly related to either the experimental or a control vaccine. A case of haemolytic anaemia in the control group in the UK phase 1/2 study occurring 10 days after MenACWY vaccine was considered possibly related to the intervention and has been previously described”


This is why I have issues using a different vaccine vs a placebo saline solution as the control. Not because they don’t know what they’re doing, but in a time where misinformation is rampant, you can’t have any doubts as to the methodology.


“A potentially vaccine-related serious adverse event was reported 2 days after vaccination in South Africa in an individual who recorded fever higher than 40°C, but who recovered rapidly without an alternative diagnosis and was not admitted to hospital. The participant remains masked to group allocation, continues in the trial, and received a second dose of the allocated vaccine without a similar reaction.”


This is a single case should be taken with caution, but it does demonstrate that a bad reaction on dose 1 won’t necessarily translate to an equal or greater reaction after dose 2.


“There were two additional cases of transverse myelitis that were originally reported as potentially related but later determined to be unlikely to be related to vaccination by an independent committee of neurological experts. One case that occurred 10 days after a first vaccination with ChAdOx1 nCoV-19 was initially assessed as possibly related, but later considered unlikely to be related by the site investigator when further investigation revealed pre-existing, but previously unrecognised, multiple sclerosis.”


When someone says a reaction happened after the vaccine, therefore the vaccine caused it, it makes me sigh. Human physiology is so complicated, and we can have afflictions we aren’t aware of which are yet to manifest. That’s why reactions need to be investigated. VAERS reports and Yellow Card reports can’t be taken as gospel for this reason among others.


“There were four non-COVID-19 deaths reported across the studies (three in the control arm and one in the ChAdOx1 nCoV-19 arm) that were all considered unrelated to the vaccine, with cause of death assessed as road traffic accident, blunt force trauma, homicide, and fungal pneumonia.”


“Here, we present the first interim safety and efficacy data for a viral vector coronavirus vaccine, ChAdOx1 nCoV-19, evaluated in four trials across three continents, showing significant vaccine efficacy of 70·4% after two doses and protection of 64·1% after at least one standard dose, against symptomatic disease, with no safety concerns.”


70% isn’t as good as 95%, but the efficacy required was 50% if I remember rightly. This is way past that, so it’s an important vaccine when you consider the easier transportation of this vaccine.


“In participants who received two standard doses, efficacy against primary symptomatic COVID-19 was consistent in both the UK (60·3% efficacy) and Brazil (64·2% efficacy), indicating these results are generalisable across two diverse settings with different timings for the booster dose (with most participants in the UK receiving the booster dose more than 12 weeks after the first dose and most participants in Brazil receiving their second dose within 6 weeks of the first).”


“Efficacy of 90·0% seen in those who received a low dose as prime in the UK was intriguingly high compared with the other findings in the study. Although there is a possibility that chance might play a part in such divergent results, a similar contrast in efficacy between the LD/SD and SD/SD recipients with asymptomatic infections provides support for the observation (58·9% [95% CI 1·0 to 82·9] vs 3·8% [−72·4 to 46·3]).”


That’s why you run parallel trials in different locations, I guess. The ongoing trials will likely shed further light on this. Reduction of asymptomatic infection through these initial results are very promising.


“While a vaccine that could prevent COVID-19 would have a substantial public health benefit, prevention of asymptomatic infection could reduce viral transmission and protect those with underlying health conditions who do not respond to vaccination, those who cannot be vaccinated for health reasons, and those who will not or cannot access a vaccine, providing wider benefit for society. However, the wide CIs around our estimates show that further data are needed to confirm these preliminary findings, which will be done in future analyses of the data accruing in these ongoing trials.”


Initial results are promising, but it needs to be studied more. You can’t ask for more than that, really. The results will show what they show. Not making them out to be what they aren’t is the mark of good science.


“In our studies, the demographic characteristics of those enrolled varied between countries. In the UK, the enrolled population was predominantly white and, in younger age groups, included more female participants due to the focus on enrolment of health-care workers. This is a typically lower risk population for severe COVID-19. The demographic profile combined with the weekly self-swabbing for asymptomatic infection in the UK results in a milder case-severity profile. In Brazil, there was a larger proportion of non-white ethnicities, and again the majority of those enrolled were health-care workers.”


“Although there were many serious adverse events reported in the study in view of the size and health status of the population included, there was no pattern of these events that provided a safety signal in the study. Three cases of transverse myelitis were initially reported as suspected unexpected serious adverse reactions, with two in the ChAdOx1 nCoV-19 vaccine study arm, triggering a study pause for careful review in each case. Independent clinical review of these cases has indicated that one in the experimental group and one in the control group are unlikely to be related to study interventions, but a relationship remained possible in the third case. Careful monitoring of safety, including neurological events, continues in the trials. All safety data will be provided to regulators for review.”


This further demonstrates how seriously vaccine safety is taken. 


“In this interim analysis, we have not been able to assess duration of protection, since the first trials were initiated in April, 2020, such that all disease episodes have accrued within 6 months of the first dose being administered. Further evidence will be required to determine duration of protection and the need for additional booster doses of vaccine.”


The trials are ongoing. It’ll be interesting to see how the results pan out over a longer period of time.

This graph is from the above study and shows both efficacy analysis over time as a proportion of the participants.


In the New England Journal of Medicine is the first large population-wide vaccine study titled BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.

The first covid vaccine study published after the respective vaccine phase 3 interim analysis papers came out of Israel. Israel did a great job vaccinating a huge amount of their population. 


“Although randomized clinical trials are considered the “gold standard” for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout.”


“We leveraged the integrated data repositories of Israel’s largest health care organization to evaluate Covid-19 vaccine effectiveness for five outcomes: documented SARS-CoV-2 infection, symptomatic Covid-19, hospitalization, severe illness, and death.”


This study is a large population-based study on the efficacy of the Pfizer vaccine. They assessed documented infection which would include asymptomatic infections and infections with unrecognised or unique symptoms (I’m assuming). This and the large sample size is what caught my attention (that and that it’s a published population study, of course).


“Eligibility criteria included an age of 16 years or older, not having a previously documented positive SARS-CoV-2 polymerase-chain-reaction (PCR) test, and being a member of the health care organization during the previous 12 months.”


“Population groups in which internal variability in the probability of exposure or the outcomes is high and controlling for the high variability is not feasible (e.g., high variability in infection risk among patient-facing health care workers in dedicated Covid-19 wards as compared with administrative staff) were excluded.”


This is good. It shows that the data collected is going to be more likely to be free of wild variables which won’t reflect a general populations such as in their example: patient-facing health care workers.


“Each day during the period from December 20, 2020, to February 1, 2021, all newly vaccinated persons were matched in a 1:1 ratio to unvaccinated controls. For each person, follow-up ended at the earliest of the following events: occurrence of an outcome event, death unrelated to Covid-19, vaccination (for unvaccinated controls), vaccination of the matched control (for vaccinated persons), or the end of the study period. Newly vaccinated persons were eligible for inclusion in the study, even if they had previously been selected as a control.”


Background into the groupings is always important. Looks pretty standard (and decent) to me.


“The five outcomes of interest were documented SARS-CoV-2 infection confirmed by positive PCR test, documented symptomatic Covid-19, hospital admission for Covid-19, severe Covid-19 (according to National Institutes of Health criteria)8 and death from Covid-19. Each of these outcomes includes the outcomes that follow it.”


That should be daily obvious, as I’d go out on a limb and assume death is a severe case of covid. Having said that, I’ve seen many people who don’t grasp concepts this simple.


“We considered three periods: days 14 through 20 after the first dose of vaccine, days 21 through 27 after the first dose (administration of the second dose was scheduled to occur on day 21 after the first dose), and day 7 after the second dose until the end of the follow-up.”


“We estimated the vaccine effectiveness only in analyses in which there were more than 10 instances of an outcome across the two groups.”


That’s good. You don’t want to be analysing freak occurrences and correlatory data which could be confounded by variables yet to be analysed.


“In secondary analyses, we considered the periods from day 0 through day 20 and day 0 through day 27, to avoid a potential selection bias in the main analyses that were restricted to persons whose data remained uncensored at the beginning of each period”


“We performed an additional sensitivity analysis to assess the potential for selection bias due to informative censoring.”


Bias prevention is one thing I always love to see in a good study. 


“Of 1,503,216 CHS members who were vaccinated, 1,163,534 were eligible for the study and 596,618 were matched to unvaccinated controls”

“During a mean follow-up of 15 days (interquartile range, 5 to 25), 10,561 infections were documented (0.6 infections per 1000 person-days), of which 5996 (57%) were symptomatic Covid-19 illness, 369 required hospitalization, 229 were severe cases of Covid-19, and 41 resulted in death.”


10, 561 cases and 57% being symptomatic, meaning 43% were asymptomatic. 369 hospitalisations (6% of symptomatic cases). 


“During the period from 14 to 20 days after the first dose, the estimated vaccine effectiveness for documented infection was 46% (95% confidence interval [CI], 40 to 51); symptomatic Covid-19 illness, 57% (95% CI, 50 to 63); hospitalization, 74% (95% CI, 56 to 86); severe illness, 62% (95% CI, 39 to 80); and death, 72% (95% CI, 19 to 100).”


“In the follow-up period starting 7 days after the second dose, the vaccine effectiveness for documented infections, symptomatic illness, hospitalization, and severe disease was 92% (95% CI, 88 to 95), 94% (95% CI, 87 to 98), 87% (95% CI, 55 to 100), and 92% (95% CI, 75 to 100), respectively.”


Those results are extremely close to the Pfizer trial data. Efficacy for:
Infections - 92%
Symptomatic infections - 94%
Hospitalisations - 87%

Severe disease - 92%


“The estimated vaccine effectiveness for the asymptomatic infection proxy was 29% (95% CI, 17 to 39) during the period from 14 to 20 days after the first dose, 52% (95% CI, 41 to 60) 21 to 27 days after the first dose, and 90% (95% CI, 83 to 94) 7 or more days after the second dose”


Seeing a 90% on asymptomatic infection was huge to see. True, this is a proxy test, but it shows that the vaccines (at least Pfizer and likely Moderna) very likely prevent asymptomatic infection almost as effectively as symptomatic covid.


“This study evaluates the effectiveness of the novel BNT162b2 mRNA vaccine1 against Covid-19 in a nationwide mass vaccination setting. Estimated vaccine effectiveness during the follow-up period starting 7 days after the second dose was 92% for documented infection, 94% for symptomatic Covid-19, 87% for hospitalization, and 92% for severe Covid-19”


“The estimated vaccine efficacy for symptomatic Covid-19 starting at day 7 after the second dose was 95% in the randomized trial, as compared with 94% in our study. The estimated efficacy between the first dose and the second dose was 52% in the trial, as compared with 29% in our study. This difference may reflect the high level of transmission in Israel during the study period,14 which affected both the vaccinated persons and the controls equally during the first 12 days after administration of the first dose.”


It’s important to distinguish the timeframes, as there is a period post-vaccination where immunity builds but isn’t fully developed as shown by these results and probably confounded by the variation in infection rates vs the trial as they said.

“During the study period, an increasing share of SARS-CoV-2 isolates in Israel — up to 80% in the days before data extraction — were of the B.1.1.7 variant.21 Thus, this study estimates an average effectiveness of the vaccine over multiple strains.”


Excellent news. I live in the UK, this is amazing news.


“The B.1.351 variant was estimated to be rare in Israel at the time of data extraction.23


Hopefully further studies find efficacy values for the new variant in large population studies.


“Finally, the date of onset of symptoms was not available for the analysis. Instead, for infection outcomes, the date was set to the date of swab collection for the first positive PCR test. Given that there was likely to have been a time gap between the onset of symptoms and swab collection, the observed divergence of the cumulative incidence plots for the infection outcomes between the vaccinated persons and unvaccinated controls may be slightly delayed. In parallel, there might be an underestimation of the vaccine effectiveness at each time window, since the estimate actually reflects a narrower window for the vaccine to be active”

It’s nice to know that the vaccine efficacy was potentially underweighted, too. This study gives a large amount of reassurance. 

“This study estimates a high effectiveness of the BNT162b2 vaccine for preventing symptomatic Covid-19 in a noncontrolled setting, similar to the vaccine efficacy reported in the randomized trial. Our study also suggests that effectiveness is high for the more serious outcomes: hospitalization, severe illness, and death. Furthermore, the estimated benefit increases in magnitude as time passes. These results strengthen the expectation that newly approved vaccines can help to mitigate the profound global effects of the Covid-19 pandemic.”



isreal followup.JPG

I rate this past misleading but not quite in the false category. In response to the howling on social media about fertility, pregnancy, and bells palsey, these claims are demonstratably false to the highest degree. They are misrepresenting the data to fit their toxic vaccines opinions. In reality, pregnant women were excluded from the trial, and data on immunocompromised individuals and young people is too limited to draw conclusions from.

Just the Pfizer vaccine alone took hours and days of reading, understanding, and absorbing until I wrote this page up. The people who make these claims have done none of that. They want to have an opinion, but are unwilling to put inthe effort to understand it.

After reviewing the Moderna and Astrazeneca studies, and the large population-wise Israel study, I have all the confidence that these vaccines have a very good safety profile and are extremely well tested.

As for "no long term studies" - this is true. There have been no long-term studies. However, there have been short to moderate term studies, and these have shown promising results. Where data is limited, the vaccine will not be given out. The FDA has thoroughly examined the data and concluded it meets the safety and efficacy standards to an EUA. They will monitor people after vaccination for 2+ years over multiple studies post-vaccination. When we're in a pandemic which is crippling the world, what more would you do?

Being honest, I still help some hesitancy over vaccinations from my anti-vaxx past up until a few weeks ago. However, seeing the degree to which this has been studied and scruitinised already, those thoughts have been thoroughly drowned.

The vaccines have been shown to be safe in multiple groups, effective in those groups, and the test data has been scruitinised to hell and back. Their results have been replicated in the first large followup study, and the UK variant is not immune to these vaccines.

I've seen a ton of people religiously reading VAERS to prove how many people are having reactions while disregarding the purpose to which VAERS itself says to use (or not use) this data. 3 Months into 2021, I have moved the slider down more towards false. The information against this claim is mounting weekly.

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