BioNTech/Pfizer (BNT162b2) COVID-19 mRNA vaccine: manufacturing, immunogenicity, efficacy and safety

Esraa Alkhalil; Bashar Jarad; Tala Saleh; Wafaa Aldarwish; Dima Joujeh

doi:10.56782/pps.292

Published : 2025-02-05

Vol. 23 No. 1 (2025)

BioNTech/Pfizer (BNT162b2) COVID-19 mRNA vaccine: manufacturing, immunogenicity, efficacy and safety

Esraa Alkhalil

Bashar Jarad

Tala Saleh

Wafaa Aldarwish

Dr. Dima Joujeh

DOI: https://doi.org/10.56782/pps.292

Abstract

The investigation into the Pfizer vaccine for the Coronavirus (COVID-19) is a vital area of study, especially given the ongoing global pandemic. The safety, efficacy, and overall credibility of the Pfizer vaccine remain contentious issues. This research seeks to deliver a thorough and unbiased examination of the vaccine's production process, its functional mechanism, and its immunogenic properties. It also presents the latest scientific findings concerning the vaccine's safety and efficacy based on recent clinical trials. The analysis is conducted with impartiality, ensuring that data and scientific outcomes are reported without prejudice.

BNT162b2 is a nucleoside-modified mRNA vaccine formulated with lipid nanoparticles, designed to encode the spike protein of SARS-CoV-2, which stimulates an immune response in those vaccinated. The Pfizer-BioNTech mRNA COVID-19 vaccine incorporates an advanced cap 1 analog, a specific 5′ UTR region derived from the human α-globin gene, and an optimized downstream Kozak consensus sequence. The mRNA sequence has been enhanced by introducing N1-methyl-Ψ, substituting all uridines, including those in stop codons. The 3′-UTR of the BNT162b2 mRNA includes sequences from the amino-terminal enhancer of split mRNA and mitochondrial 12S rRNA, alongside a 30-mer poly(A) tail and a 10-nucleotide linker, which together improve and extend protein expression.

As of May 30, 2024, the U.S. National Library of Medicine (Clinicaltrials.gov) lists 1,314 clinical trials globally related to COVID-19 mRNA vaccines, with 135 specifically focusing on BNT162b2, most of which are in Phase II and III. Numerous trials have confirmed the vaccine's effectiveness and safety, with no major adverse effects reported in the majority of studies. Access to reliable information on the Pfizer-BioNTech vaccine is vital for public awareness and informed vaccination decisions, emphasizing the importance of ongoing trials to update medical literature, especially as the vaccine is evaluated across various age groups and against new SARS-CoV-2 variants.

Keywords:

SARS-CoV-2, Nucleoside-modified mRNA, Immuno response Mechanism, Clinical trials

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Alkhalil, E., Jarad, B., Saleh, T., Aldarwish, W., & Joujeh, D. (2025). BioNTech/Pfizer (BNT162b2) COVID-19 mRNA vaccine: manufacturing, immunogenicity, efficacy and safety. Prospects in Pharmaceutical Sciences, 23(1), 31–46. https://doi.org/10.56782/pps.292

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BioNTech/Pfizer (BNT162b2) COVID-19 mRNA vaccine: manufacturing, immunogenicity, efficacy and safety

Esraa Alkhalil

Bashar Jarad

Tala Saleh

Wafaa Aldarwish

Dr. Dima Joujeh

Abstract

Keywords:

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