Tozinameran (BNT162b2) Vaccine: The Journey from Preclinical Research to Clinical Trials and Authorization.

AAPS PharmSciTech
Nimrat KhehraMayur S Parmar

Abstract

Vaccination development and production was an essential question for the prevention and global control of COVID-19. The strong support from governing authorities such as Operation Warp Speed and robust funding has led to the development and authorization of the tozinameran (BNT162b2) vaccine. The BNT162b2 vaccine is a lipid nanoparticle-encapsulated mRNA that encodes for SARS-CoV-2 spike protein, the main site for neutralizing antibodies. Once it binds with the host cells, the lipid nanoparticles enable the transfer of the RNA, causing S antigens' expression of the SARS-CoV-2, conferring immunity. The vaccine is administered as a 2-dose regime 21 days apart for individuals 16 years and older. Pfizer-BioNTech's BNT162b2 vaccine was the first candidate to receive FDA-Emergency Use Authorization (EUA) on December 11, 2020. During phase 2/3 clinical trials, 95% efficacy was reported among 37,706 participants over the age of 16 who received the BNT162b2 vaccination; additionally, 52% efficacy was noted 12 days following the administration of the first dose of BNT162b2, reflecting early protection of COVID-19. The BNT162b2 vaccine has exhibited 100% efficacy in clinical trials of adolescents between the ages of 12 and 15. Clinical tr...Continue Reading

References

Oct 15, 2020·The New England Journal of Medicine·Edward E WalshWilliam C Gruber
Dec 8, 2020·JAMA Internal Medicine·Kristen R Choi
Dec 9, 2020·Nature·Heidi LedfordRichard Van Noorden
Dec 11, 2020·The New England Journal of Medicine·Fernando P PolackUNKNOWN C4591001 Clinical Trial Group
Jan 22, 2021·JAMA : the Journal of the American Medical Association·Tom Shimabukuro, Narayan Nair
Feb 2, 2021·Nature·Annette B VogelUgur Sahin
Feb 23, 2021·Lancet·John F R RobertsonMarcia Stewart
Mar 9, 2021·The New England Journal of Medicine·Yang LiuPei-Yong Shi
Mar 11, 2021·The New England Journal of Medicine·Florian KrammerViviana Simon
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