BNT162b2
BNT162b2 is a COVID-19 genetic vaccine product developed by Pfizer and BioNTech. It uses a gene transfer platform combining messenger RNA (mRNA) and lipid nanoparticle technology to cause the recipient's cells to express the SARS-CoV-2 spike protein.1)
Design
Components
FDA Ingredient Disclosure Non-medicinal contents of each dose of Pfizer. 2)3)
BNT162b2 uses a number of patented materials and products in its design and function. BioNTech in particular claims ownership of patents including:4)
- Patents directed at RNA;
- Patents specifically directed at pharmaceutical compositions involving LNPs and mRNA.
BioNTech patents claimed for BNT162b2 (non-exhaustive) | |||||
---|---|---|---|---|---|
Title | Patent/Published Application | Applicant/Assignee | Filing Date | Status | Invention Type |
Particles comprising a shell with RNA | US 10,576,146 | BioNTech | March 15, 2018 | Active | Lipids/LNP + mRNA |
RNA formulation for immunotherapy | US 10,485,884 | BioNTech | March 5, 2013 | Active | Lipids/LNP + mRNA |
Particles comprising a shell with RNA | US 9,950,065 | BioNTech | September 26, 2013 | Active | Lipids/LNP + mRNA |
Particles comprising a shell with RNA | US2020/0155671 | BioNTech | January 22, 2020 | Pending | Lipids/LNP + mRNA |
Methods and compositions for stimulating immune response | US2020/0197508 | BioNTech | March 21, 2018 | Pending | RNA immune response |
Method for reducing immunogenicity of RNA | US2019/0153428 | BioNTech | August 24, 2016 | Pending | RNA immunogenicity |
Formulation for administration of RNA | US2019/0321458 | BioNTech | July 14, 2017 | Pending | Pharmaceutical composition (PC) of Lipids/LNP + mRNA |
Lipid Particle Formulations for Delivery of RNA and Water-Soluble Therapeutically Effective Compounds to a Target Cell | US2018/0263907 | BioNTech | March 30, 2016 | Pending | Lipids/LNP + mRNA |
Stable formulations of lipids and liposomes | US2017/0273907 | BioNTech | September 17, 2015 | Pending | Lipids/LNP + mRNA |
Method for Cellular RNA Expression | US2014/0030808 | BioNTech | December 2, 2011 | Pending | RNA expression |
Lipid particle formulations for delivery of RNA and water-soluble therapeutically effective compounds to a target cell | WO2016/156398 | BioNTech | March 30, 2016 | Published | Lipids/LNP + mRNA |
Particles comprising a shell with RNA | WO2015/043613 | BioNTech | September 26, 2013 | Published | Lipids/LNP + mRNA |
Particles comprising single stranded RNA and double stranded RNA for immunomodulation | WO2013/087083 | BioNTech | December 15, 2011 | Published | Lipids/LNP + mRNA |
Vaccine Trials
Participants
Pfizer Trial Report
Critiques of Trial Protocols
- February 27, 2023: Pfizer/BioNTech C4591001 Trial - Positive PCRs & Symptomatic Subjects by OpenVAET
Large Skewed Data Exclusions
The exclusions in the Pfizer data violate the intention to treat (ITT) principle that is part of the RCT process. https://academic.oup.com/ejo/article/37/5/457/2599978
June 8, 2021 (America's Frontline Doctors) Serious violations and manipulations of trial protocol: how Pfizer obtained FDA emergency authorization for children. https://americasfrontlinedoctors.org/frontlinenews/serious-violations-and-manipulations-of-trial-protocol-how-pfizer-obtained-fda-emergency-authorization-for-children/?fbclid=IwAR1wr4vUcJQUDrlLF08LzvvqdR_tOlcPMWxiYfT7Qm5oD7LBcdsBh4hJuTo
https://twitter.com/AotearoaMouse/status/1470541136024326145?s=20
Refusal to Release Safety Reports and Raw Data
Pfizer is trying to halt the release of documents studying its vaccine. However, due to a FOIA request submitted by Aaron Siri, some of those documents have been released.
Emergency Use Authorization
Efficacy of BNT162b2
Efficacy in Preventing Death
Efficacy in Preventing Hospitalization
Efficacy in Preventing Infection
Efficacy in Preventing Symptoms
Efficacy in Preventing Transmission
Pharmacovigilance
Marketing
National Contracts
Pfizer has been criticized for an array of strong arm tactics while negotiating contracts for its vaccines with various nations.
Safety
Noteworthy Safety Events
- December 10, 2021 at GreatGameIndia (article) - Pfizer vaccine batch suspended after 120 children hospitalized in Vietnam.