I know, I'm sorry - it's never ending. But, I have been reading more Pfizer documents and stumbled across some other peer-reviewed data that should probably be reported by the media. However, once again, they feel data and actual Trial Protocols are not in the public interest. It's probably some Russian propaganda thing again - data and science!
Oh well, back to us conspiracy theorists to do some actual journalism.
The FDA (Food and Drug Administration) in the US released their briefing document regarding Pfizer's vaccine.
There are some notable highlights which I shall go through, but please - read it yourself.
Page 6 - "Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population."
Page 8 - in relation to being allowed to be issued: "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."
That has to make you giggle - from the behaviour of the politicians and media, you'd think this was a serious, deadly virus that doesn't have a recovery rate of 99.6%. Since suicides and care home deaths do not even get a comparison to covid deaths, there's little chance people will care about a few hundred thousand vaccine induced deaths.
Page 13 - "Assessments for illness visits include a nasal (midturbinate) swab, which is tested at a central laboratory using a reverse transcriptionpolymerase chain reaction (RT-PCR) test"
All it takes to prove effectiveness is a PCR test. These are absolute trash.
Page 15 - "HIV-positive participants and adolescents 12 through 15 years of age were included in the reactogenicity subset with implementation of protocol amendment 6 (finalized on September 8, 2020) and amendment 7 (finalized on October 6, 2020), respectively. Solicited reactogenicity data in adolescents 16-17 years of age are not available for the reporting period. Reactogenicity data from a total of 100 adolescents 12 through 15 years of age enrolled in C4591001 phase 2/3 were provided in the EUA submission. However, 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. Therefore, the reactogenicity data for participants 12 through 15 years of age are not presented in this document."
Page 31 - "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."
Page 35 - "The frequency and severity of systemic AEs were higher in the younger than the older age groups. Within each age group, the frequency and severity of systemic AEs was higher after Dose 2 than Dose 1, except for vomiting and diarrhea, which was generally similar regardless of dose. For both age groups, fatigue, headache and new/worsened muscle pain were most common."
Page 38 - "Reports of lymphadenopathy were imbalanced with notably more cases in the vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Bell’s palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination. One case (onset at 3 days postvaccination) was reported as resolved with sequelae within three days after onset, and the other three were reported as continuing or resolving as of the November 14, 2020 data cut-off with ongoing durations of 10, 15, and 21 days, respectively. 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. 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."
Page 41 - "A total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1. The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate."
Page 41 - "The most common SAEs in the vaccine group which were numerically higher than in the placebo group 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%), and syncope (0.02%). Occurrence of SAEs involving system organ classes and specific preferred terms were otherwise balanced between treatment groups, including no imbalance overall in cardiovascular serious adverse events."
Page 41 - "Appendicitis was reported as a SAE for 12 participants, and numerically higher in the vaccine group: 8 vaccine participants ([appendicitis [n=7], appendicitis perforated [n=1]) and 4 placebo participants (appendicitis [n=2], appendicitis perforated [n=1], complicated appendicitis [n=1]). All of the vaccine participants (n=8) and 2 placebo participants were younger than 65 years of age. The cases were considered unrelated to vaccination by the study investigators and occurred no more frequently than expected in the given age groups. FDA agrees that there is no clear basis upon which to suspect that this imbalance represents a vaccine-related risk."
Page 42 - "It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. "
How convenient. This is why we keep being inundated with "long covid" nonsense. I can see the headlines now.
Page 43 - "A total of six deaths occurred in the reporting period (2 deaths in the vaccine group, 4 in placebo). In the vaccine group, one participant with baseline obesity and pre-existing atherosclerosis died 3 days after Dose 1, and the other participant experienced cardiac arrest 60 days after Dose 2 and died 3 days later. Of the four deaths in the placebo arm, the cause was unknown for two of them, and the other two participants died from hemorrhagic stroke (n=1) and myocardial infarction (n=1), respectively; three deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate."
Page 44 - "Pfizer submitted a Pharmacovigilance Plan (PVP) to monitor safety concerns that could be associated with Pfizer-BioNTech COVID-19 Vaccine. The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk. Use in pregnancy and lactation and vaccine effectiveness are areas the Sponsor identified as missing information. In addition to the safety concerns specified by the Sponsor, FDA requested that the Sponsor update their PVP to include missing information in pediatric participants less than 16 years of age."
Page 46 - "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."
So, there is no evidence it is effective over 2 months.
Page 46 - "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."
Great, the people who actually may need protection do not even know if it is effective for them yet, but they're going to get it anyway. Adverse reactions be damned!
Page 47 - "The primary endpoint was evaluated in individuals without prior evidence of COVID-19 disease, and very few cases of confirmed COVID-19 occurred among participants with evidence of infection prior to vaccination (although more cases occurred in the placebo group compared with the vaccine group). Therefore, available data are insufficient to make conclusions about benefit in individuals with prior SARS-CoV-2 infection. However, available data, while limited, do suggest that previously infected individuals can be at risk of COVID-19 (i.e., reinfection) and could benefit from vaccination."
Page 47 - "The study enrollment and follow-up occurred during the period of July 27 to November 14, 2020"
Page 47 - "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."
Page 47 - "COVID-19 disease may have long-term effects on certain organs, and at present it is not possible to assess whether the vaccine will have an impact on specific long-term sequelae of COVID-19 disease in individuals who are infected despite vaccination. Demonstrated high efficacy against symptomatic COVID-19 should translate to overall prevention of COVID-19- related sequelae in vaccinated populations, though it is possible that asymptomatic infections may not be prevented as effectively as symptomatic infections and may be associated with sequelae that are either late-onset or undetected at the time of infection (e.g., myocarditis). Additional evaluations will be needed to assess the effect of the vaccine in preventing long-term effects of COVID-19, including data from clinical trials and from the vaccine’s use postauthorization."
Page 48 - "A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality. However, non-COVID vaccines (e.g., influenza) that are efficacious against disease have also been shown to prevent diseaseassociated death.11-14 Benefits in preventing death should be evaluated in large observational studies following authorization."
It's perfect. The death rates are already low because the pandemic ended in May. So, the low death rate can now be attributed to this vaccine to show it was a success. Then they can lower the future amplifications of the PCR tests to show fewer positive tests - another win. I wonder if every death after 28 days of the vaccine will be attributed to the vaccine, like the covid deaths have been? Somehow, I doubt this will be the case.
Page 48 - "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."
So, there is no evidence that transmission is prevented, and we'll have to carry on wearing masks and social distancing. I hope you're beginning to grow up and think for yourself. This is just beyond stupid.
Page 49 - "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."
Page 49 - "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."
So, you may be messed up or you may not be. Russian roulette anyone?
Page 49 - "Available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure."
Everything I'm reading just screams this vaccine is completely pointless, and carry more risks and unknowns than the virus itself. However, I'm a nobody and my opinion doesn't matter in the slightest. You need to make your own mind up. But, at least you have actual information about the vaccine.
Some other points to consider:
1. The placebo group was given a meningitis vaccine, which also causes many of the same adverse reactions witnessed in the vaccine group. The same was in the animal trials.
2. PCR amplification numbers are not known - higher amplification rates = more cases, lower amplification rates = less cases. I think you can see my concern.
3. Whilst the percentages of adverse reactions may be small (large enough for my liking) it is important to remember we're rolling this out to all 7 billion people. So, these will turn into real figures quickly.
4. The virus effects sound less risky and less severe unless you're unlucky enough to have a weak immune system, which this vaccine trial didn't even address or provide any data on.
5. There are no long term trials. We are the long term trial.
6. I fear this now sets a precedent where people have now accepted rushed medicine. I expect more of this to come. The Pharmaceutical Companies cannot believe their luck. Well done people.
7. We have antivirals that are effective and are risk free. Why one earth do we need this vaccine with no long term testing? Please tell me. I'm obviously to extreme and conspiratorial to make this blind leap of faith for absolutely no reason.
8. Six deaths have occurred. One due to being immunocompromised. How does this look good to you? This is who the vaccine was meant to protect. Even if only two were in the vaccine group, that's still a risk. Why are we prepared to sentence a certain number of people to death which is unavoidable by not rolling out this vaccine so quickly, yet you lockdown a whole country and plunge everyone into poverty to prevent deaths from a virus? If you believe you hold the moral high ground because you're in favour of a rushed vaccine which will kill people, but somehow believe deaths attributed to a virus are unnacceptable, you're a hypocrite.
Personally, I think you're insane to accept this vaccine, let alone want it. They pretty much don't know anything about it long term, but are ready to roll it out to 7 billion people. Yet, I'm the conspiracy theorist for saying we should slow down and closely look at the data (which shows we do not need a vaccine at all.) Again, we have antivirals that actually work with no long term risks. However, I guess they're pretty cheap which is hardly a win for the Pharmaceutical Gangsters. But, could it all just be for money? I have suspicions there's other reasons for this insanity - however, we can save that for another day.
Peter Doshi (BMJ associate editor) gives a more balanced view of the vaccine protocols. I think you should read it.
Pfizer FDA Briefing Document - https://www.fda.gov/media/144245/download?fbclid=IwAR1TKL2fFhb_MziSZ2kY4J972hf45HuFV_cBl5_GbhCG5QgC4tykyjFrYk0
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2 - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext?fbclid=IwAR0reuIRm91ciM15k3zm1zATNNR3CJ0-EfI0AD0PsFpKXxstkQzPctnKgS4
Meningitis vaccine is the placebo - https://www.theguardian.com/world/2020/nov/09/covid-19-vaccine-candidate-effective-pfizer-biontech
Peter Doshi - https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-effective-vaccines-lets-be-cautious-and-first-see-the-full-data/