Characterization of BNT162b2 mRNA to Evaluate Risk of Off-Target Antigen Translation.
J Pharm Sci
; 112(5): 1364-1371, 2023 05.
Article
in English
| MEDLINE | ID: covidwho-2184494
ABSTRACT
mRNA vaccines have been established as a safe and effective modality, thanks in large part to the expedited development and approval of COVID-19 vaccines. In addition to the active, full-length mRNA transcript, mRNA fragment species can be present as a byproduct of the cell-free transcription manufacturing process or due to mRNA hydrolysis. In the current study, mRNA fragment species from BNT162b2 mRNA were isolated and characterized. The translational viability of intact and fragmented mRNA species was further explored using orthogonal expression systems to understand the risk of truncated spike protein or off-target antigen translation. The study demonstrates that mRNA fragments are primarily derived from premature transcriptional termination during manufacturing, and only full-length mRNA transcripts are viable for expression of the SARS-CoV-2 spike protein antigen.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19
/
BNT162 Vaccine
Type of study:
Experimental Studies
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
J Pharm Sci
Year:
2023
Document Type:
Article
Affiliation country:
J.xphs.2023.01.007
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