BNT162b1 SARS-CoV-2 Vaccine

Identification

Name
BNT162b1 SARS-CoV-2 Vaccine
Accession Number
DB15695
Description

BNT162b1 is one of four advanced mRNA-based vaccines being developed through "Project Lightspeed," a joint program between Pfizer and BioNTech.1,2 BNT162b1 is a nucleoside modified mRNA (modRNA) vaccine encoding the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) protein together with a "foldon" trimerization domain derived from T4 fibritin to increase immunogenicity.3 The modRNA is formulated in lipid nanoparticles for delivery via intramuscular injection.2,3 Early results from a phase 1/2 study in 45 healthy adult volunteers demonstrated RBD-binding immunoglobulin levels and 50% serum neutralizing titers higher than those observed in COVID-19 convalescent plasma 28 days after initial immunization of either 10 or 30μg of BNT162b1, with further improvements following a second dose.3

BNT162b1 is undergoing further evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701).4,5 BNT162b1 received fast track designation by the FDA on July 13, 2020.6

Type
Biotech
Groups
Investigational
Biologic Classification
Vaccines
Other vaccines
Synonyms
Not Available
External IDs
  • BNT162b1

Pharmacology

Pharmacology
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Indication
Not Available
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics
Not Available
Mechanism of action
Not Available
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
Medicalerrors
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
JV8KBX6XZG
CAS number
Not Available

References

General References
  1. Gen Eng News: BNT162 vaccine candidates [Link]
  2. BioNTech BNT162 Update [Link]
  3. Mulligan et al. BNT162b1 medRxiv pre-print [Link]
  4. Clinical Trial NCT04368728 [Link]
  5. Clinical Trial NCT04380701 [Link]
  6. FDA fast track designation: BNT162b1 and BNT162b2 [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2, 3RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
1Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
1, 2RecruitingTreatmentCoronavirus Disease 2019 (COVID‑19) / Protection Against COVID-19 and Infections With SARS CoV 2 / Respiratory Tract Infections (RTI) / RNA Virus Infections / Vaccine Adverse Reaction / Viral Infections / Virus Diseases1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on July 13, 2020 15:13 / Updated on July 16, 2020 16:16