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Why Are COVID19 Vaccine Manufacturing Information Intentionally Redacted

The document discusses the Emergency Use Authorization (EUA) of COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Janssen, detailing their FDA decision memorandums from December 2020 to February 2021. It highlights the use of lipid nanoparticles (LNPs) in the Pfizer and Moderna vaccines for effective nucleic acid delivery, while noting that LNPs are not mentioned in the Janssen EUA. LNPs are recognized as a significant advancement in drug delivery systems, first approved in 2018 and gaining prominence with the COVID-19 vaccines.

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Emanuel McCray
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47 views2 pages

Why Are COVID19 Vaccine Manufacturing Information Intentionally Redacted

The document discusses the Emergency Use Authorization (EUA) of COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Janssen, detailing their FDA decision memorandums from December 2020 to February 2021. It highlights the use of lipid nanoparticles (LNPs) in the Pfizer and Moderna vaccines for effective nucleic acid delivery, while noting that LNPs are not mentioned in the Janssen EUA. LNPs are recognized as a significant advancement in drug delivery systems, first approved in 2018 and gaining prominence with the COVID-19 vaccines.

Uploaded by

Emanuel McCray
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Pfizer-BioNTech COVID-19 Vaccine Emergency Use Moderna COVID-19 Vaccine Emergency Use Janssen COVID-19 Vaccine

Authorization Review Memorandum. Authorization Review Memorandum. Janssen Biotech Inc.,


FDA Decision Memorandum. December 11, 2020. FDA Decision Memorandum. December 18, 2020. a Janssen Pharmaceutical Company of Johnson & Johnson
Available from Available from FDA Decision Memorandum. February 27, 2021.
https://www.fda.gov/media/144416/download. https://www.fda.gov/media/144673/download. Available from
https://www.fda.gov/media/146338/download.
Notes:
1. “Lipid” is not mentioned in J&J EUA. Both Pfizer and Moderna vaccines are formulated in lipid nanoparticles (LNPs).
2. Lipid nanoparticles (LNPs) are the most clinically advanced non-viral gene delivery system. Lipid nanoparticles safely and effectively deliver nucleic acids, overcoming a major barrier preventing
the development and use of genetic medicines. LNPs are composed of lipids. They are a novel pharmaceutical drug delivery system (and part of nanoparticle drug delivery), and a novel
pharmaceutical formulation. LNPs as a drug delivery vehicle were first approved in 2018 for the siRNA drug, Onpattro. LNPs became more widely known in late 2020, as some COVID-19 vaccines
that use RNA vaccine technology coat the fragile mRNA strands with PEGylated lipid nanoparticles as their delivery vehicle (including both the Moderna and the Pfizer–BioNTech COVID-19
vaccines.
LNP Resources:
(a) https://www.precisionnanosystems.com/workflows/formulations/lipid-nanoparticles
(b) https://en.wikipedia.org/wiki/Solid_lipid_nanoparticle.

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