I’ll just get right to it.
I, personally, would not take the Pfizer vaccine because of the “unknowns” I have listed below. These came directly from the Pfizer report submitted for FDA Emergency Use of the vaccine.
Pfizer recruited around 38,000 participants for their trials. Only 170 participants out of the 38,000 were used for the study.
First concern: Too few tested
They compared 8 in the vaccinated group who did not get COVID to 162 in the placebo group who got COVID.
If you divide 8 by 162, you’ll see why they Pfizer says the vaccine works around 95% of the time. But until you have a LOT more than 170 people and are able to replicate a study a couple of times, you can’t really know if you would see the same results in the general population.
Second concern: #20, “vaccine-enhanced disease.”
This term means that the vaccine actually makes you susceptible to something that would make you much sicker than the disease itself. – They found this with the mRNA vaccine in previous coronaviruses studies with animals. Even though the vaccine worked in vitro (in the lab), when the animals were exposed to coronavirus in their environment down the road, their immune systems went into overdrive, causing organ damage and killing the animals. They do not know if the same thing will happen to people who receive the COVID vaccine. The study was too short to find out. Every one who has the vaccine is likely be exposed to one of the seven coronaviruses that impact humans in the future. 20% of coronaviruses are even responsible for the common cold!
When you read the following and are making your decision, keep in mind the following:
80% of those who have COVID have no to few symptoms
94.9% – 99.9% of those who get ill with COVID can be cured
40% of those that die from COVID are over the age of the average life expectancy (age 78) in this county
Here are the “unknowns”:
01. Impact on immunocompromised individuals: UNKNOWN. No data. Too few participants.
02. Impact on individuals previously infected: UNKNOWN. Excluded from the study.
03. Impact on pediatric patients (under 16): UNKNOWN. Excluded from the study.
04. Impact on pregnant or lactating individuals: UNKNOWN. Excluded from the study.
05. Future vaccine effectiveness due to virus mutations: UNKNOWN. Study period too short.
06. Long-term effects of COVID-19 disease: UNKNOWN. Not looked at in the study
07. Asymptomatic infection: UNKNOWN. Not looked at in the study.
08. Effectiveness against mortality: UNKNOWN. Study size too small and too short in duration.
09. Vaccine effectiveness against transmission of SARS-CoV-2: UNKNOWN. Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination.
10. Vaccine-induced disease enhanced: UNKNOWN. Risk of vaccine-enhanced disease over time, potentially associated with waning immunity, needs to be evaluated in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.
11. Duration of protection: UNKNOWN. 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.
12. Effectiveness in certain populations at high risk of severe COVID-19: UNKNOWN. 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.
13. Effectiveness in individuals previously infected with SARS-CoV-2: UNKNOWN. 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.
14. Effectiveness in pediatric populations: UNKNOWN. The representation of pediatric participants in the study population is too limited. No efficacy data are available from participants ages 15 years and younger.
15. Future vaccine effectiveness as influenced by characteristics of the pandemic, changes in the virus, and/or potential effects of co-infections: UNKNOWN. The study enrollment and follow-up occurred during the period of July 27 to November 14, 2020, in various geographical locations. The evolution of the pandemic characteristics, such as increased attack rates, increased exposure of subpopulations, as well as potential changes in the virus infectivity, antigenically significant mutations to the S protein, and/or the effect of coinfections may potentially limit the generalizability of the efficacy conclusions over time.
16. Vaccine effectiveness against asymptomatic infection: UNKNOWN. 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.
17. Vaccine effectiveness against long-term effects of COVID-disease: UNKNOWN. 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.
18. Vaccine effectiveness against mortality: UNKNOWN. 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.
19. Vaccine effectiveness against transmission of SARS-CoV-2: UNKNOWN. 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.
20. Vaccine-enhanced disease: UNKNOWN. 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.
21. Benefit/Risk profile: UNKNOWN. 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.
22. Adverse events considered plausibly linked to vaccination: UNKNOWN. They generally start within 6 weeks of vaccine receipt. Therefore, a 2- month follow-up period may allow for identification of potential immune-mediated adverse events that began within 6 weeks of vaccination. From the perspective of vaccine efficacy, it is important to assess whether protection mediated by early responses has not started to wane. A 2-month median follow-up is the shortest follow-up period to achieve some confidence that any protection against COVID-19 is likely to be more than short-lived.
FDA Briefing Document: https://www.fda.gov/media/144245/download
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