"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."

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"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."

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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.

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Injection reactions

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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.

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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"

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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.

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"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."

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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.

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"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."

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How do the FDA measure adverse events?

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

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"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."

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"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."

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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.

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"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"

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

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"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."

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"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."

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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.

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Summary time!

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"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%)"

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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.

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"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."

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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.

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"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."

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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.

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

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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.

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This isn't the end !

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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.

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"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)"

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

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"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."

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"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"

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"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."

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"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."

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"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"

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A little more summary

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"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."

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"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."

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"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."

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Finally onto the obvious limitations

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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."

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"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."

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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

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"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."

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"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."

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"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."

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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

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"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."

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"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."

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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

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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.

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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.

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