NHS doctor expreses concerns over lack of published data Pfizer BioNtech’s BNT162b2 mRNA vaccine

Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines

"It will also be apparent in what we say about workforce expansion that someone other than a registered healthcare professional may actually be administering unlicensed vaccines – and as a basic issue of fairness, we think they should benefit from the same immunity from civil liability as a registered healthcare professional who is performing the same role, if the person who is not a healthcare professional is following one of the proposed new protocols."

https://www.gov.uk/government/consult...​

https://ec.europa.eu/health/sites/hea...​

DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 6 November 2001 on the Community code relating to medicinal products for human use

https://uk.reuters.com/article/us-ast...​

AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries

https://media.tghn.org/medialibrary/2...​

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)Protocol C4591001Page 1A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

https://www.nature.com/articles/s4158...​

Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

https://www.clinicaltrials.gov/ct2/re...

​6 Studies found for: BNT162b

https://www.cdc.gov/vaccines/acip/mee...​

Pfizer/BioNTechCOVID-19 mRNA vaccine

Overview for ACIP Meeting

https://assets.publishing.service.gov...​

REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS2 Version 3.2 10/12/2020

This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.

https://cormandrostenreview.com/report/​

Review report Corman-Drosten et al. Eurosurveillance 2020 External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level:

https://archive.is/6m4N2#selection-81...​

ClinicalTrials.gov

https://archive.vn/BNoWt

Phase​ I/II study of COVID-19 RNA vaccine BNT162b1 in adults

https://archive.vn/s9nMz​

https://archive.vn/uVYJB​

Trial record 6 of 6 for: BNT162b Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose).

Condition or disease  Intervention/treatment  Phase  SARS-CoV-2 Infection COVID-19 Biological:

BNT162b1 Biological:

BNT162b2 Other:

Placebo Phase 2 Phase 3 Study Design Go to Study Type  :

Interventional (Clinical Trial) Estimated Enrollment  :

43998 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment Masking:

Triple (Participant, Care Provider, Investigator) Primary Purpose:

Prevention Official Title:

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Actual Study Start Date  :

April 29, 2020

Estimated Primary Completion Date  :

August 1, 2021

Estimated Study Completion Date  : January 29, 2023

...............................................................................................................

Further details on Pfizer's data sharing criteria and process for requesting access can be found at:

https://www.pfizer.com/science/clinic...​.

URL:

https://www.pfizer.com/science/clinic...​

https://www.nejm.org/doi/suppl/10.105...​

https://www.ebi.ac.uk/biostudies/stud...​

https://europepmc.org/article/MED/330...​

https://www.nejm.org/doi/10.1056/NEJM...​

https://clinicaltrials.gov/show/NCT04...

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1. VAERS (Vaccine Adverse Event Reporting System
2. COVID-19 VACCINE. PFIZER AND MODERNA 
3. These are some (not all) death cases reported 2021 
4. # COVID-19 VACCINE. PFIZER AND MODERNA
5. #-
6. VAERS ID # 936805-1.
7. AGE 25. MALE
8. Vaccinated 12/22/2020. Found unresponsive and subsequently expired at home on 1/11/2021. Moderna vaccine.
9. -
10. VAERS ID # 943397-1
11. AGE 28. MALE
12. Vaccinated 12/23/2020. Died 1/14/2021. Patient was found unresponsive at work in the hospital. Patient pupils were fixed and dilated. Pfizer vaccine.
13. -
14. VAERS ID # 939050-1
15. AGE 32. FEMALE
16. Vaccinated 12/28/2020. Died on 1/4/21 at 7:20am. Moderna vaccine.
17. -
18. VAERS ID # 921667-1
19. AGE 39. FEMALE.
20. Vaccinated 12/29/2020. It was reported that the staff member deceased somewhere between 1/3/2021 and 1/4/2021. Pfizer vaccine.
21. -
22. VAERS ID # 923219-1
23. AGE 41. FEMALE
24. Vaccinated 12/30/2021. Died. 1/1/2021. Pfizer vaccine. The patient didn't experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On January 1, 2021, at lunch time, two days after receiving the vaccine, the patient was found unresponsive in her bed by her partner.
25.  
26. -
27. VAERS ID # 933578-1
28. AGE 43. MALE
29. Vaccinated 1/8/2021. Died 1/9/2021. Moderna vaccine.
30. -
31. VAERS ID # 937527-1
32. AGE 44. FEMALE
33. Vaccinated 12/23/2020. Died on 1/4/2021. Pfizer vaccine.
34. -
35. VAERS ID # 929764-1
36. AGE 45. MALE
37. Vaccinated 12/28/2020. Died 12/29/2020. The patient was found deceased at home about 24 hours after immunization. Moderna vaccine.
38. -
39. VAERS ID # 939270-1
40. AGE 48. MALE
41. Vaccinated 12/22/2020. Died 12/31/2020. Pfizer vaccine.
42. -
43. VAERS ID # 918518-1
44. AGE 50. FEMALE
45. Vaccinated 12/31/2020. Died 12/31/2020. Moderna vaccine.
46. -
47. VAERS ID # 938118-1
48. AGE 51. FEMALE
49. Vaccinated 1/5/2021. Died. 1/10/2021. Pfizer vaccine. On 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm.
50. -
51. VAERS ID # 946293-1
52. AGE 51. MALE
53. Vaccinated 1/7/2021. Died 1/12/2021. Moderna vaccine. He became increasingly hypoxic around 1800hours on 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. He expired on 1/12/2021@2325 at medical center.
54. -
55. VAERS ID # 930910-1
56. AGE 52. FEMALE
57. Vaccinated on 1/8/2021. Died 1/8/2021. Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm. Moderna vaccine.
58. -
59. VAERS ID # 933739-1
60. AGE 54. FEMALE.
61. Vaccinated 1/8/2021. Died 1/10/2021. 2 days later.
62. Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Two EEGs were given to determine that patient had no brain activity. Pfizer vaccine.
63. -
64. VAERS ID # 934968-1
65. AGE 54. MALE
66. Vaccinated 1/4/2021. Died 1/6/2021. Pfizer vaccine. The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:1
67.  
68. VAERS ID # 921768-1
69. AGE 58. FEMALE
70. Vaccinated 1/4/2021. Died 1/4/2021. Pfizer vaccine.
71. -
72. VAERS ID # 920815-1
73. AGE 58. FEMALE
74. Vaccinated 12/30/2020. Died 1/4/2021. 6 days later. Moderna vaccine.
75. -
76. VAERS ID # 930154-1
77. AGE 60. MALE
78. Vaccinated 1/5/2021. Died 1/8/2021. Moderna vaccine.
79. -
80. VAERS ID # 933090-1
81. AGE 60. MALE
82. Vaccinated 1/5/2021. Died. 1/9/2021. Pfizer vaccine.
83. -
84. VAERS ID # 941743-1
85. AGE 60. FEMALE
86. Vaccinated 1/12/2021. Died 1/13/2021. Moderna vaccine. Found to be deceased at 3am
87. -
88. VAERS ID # 932898-1
89. AGE 61. MALE
90. Vaccinated 12/17/2020. Died. 12/30/2020. Pfizer vaccine. The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20.
91. -
92. VAERS ID # 942085-1
93. AGE 62. FEMALE
94. Vaccinated 1/2/2021. Died 1/8/2021. Pfizer vaccine. On 1/8/21 at 0615 resident was shaking. Reported all over pain. At 0850 she was not responsive.
95. -
96. VAERS ID # 940955-1
97. AGE 66. FEMALE.
98. Vaccinated 1/11/2021. Died 1/11/2021. Pfizer vaccine. Cardiac Arrest. Patient was found pulseless and breathless 20 minutes following the vaccine administration. received the second dose of BNT162B2. took the first dose on 21Dec2020. MD found no signs of anaphylaxis.
99. #-
100.  
101.  
102.  
103.  
104. To search, type in VAERS ID #
105. Search on CDC website:
106.  
107. #MoreYouKnow
108.  
109. P.S.- Aplogogy: System Temporarily Down
110. VAERS component is temporarily down for maintenance.
111. Please bear with us for the next few hours.
112. We apologize for your inconvenience
113.