NAV

BNT162b1 SARS-CoV-2 Vaccine

Identification

Generic Name
BNT162b1 SARS-CoV-2 Vaccine
DrugBank Accession Number
DB15695
Background

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

Indication

Not Available

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Contraindications & Blackbox Warnings
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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
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Toxicity

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
Affected organisms
Not Available

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, 3CompletedPreventionCoronavirus Disease 2019 (COVID‑19)1
1CompletedPreventionCoronavirus Disease 2019 (COVID‑19)1
1, 2Active Not RecruitingTreatmentAdverse Reaction to Vaccine / Coronavirus Disease 2019 (COVID‑19) / Protection Against COVID-19 and Infections With SARS CoV 2 / Respiratory Tract Infections (RTI) / Viral Disease / Viral Infections / Virus Infection, RNA1

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 at July 13, 2020 15:13 / Updated at July 16, 2020 16:16