COVID-19 Vaccine (Pfizer-BioNTech)

Background

The Pfizer-BioNTech COVID-19 vaccine is an mRNA based vaccine which is approved in the United States to prevent symptomatic COVID-19 infection. The Pfizer-BioNTech was the first COVID-19 vaccine to be approved for distribution in the United States, and it was granted Emergency Use Authorization by the United States Food and Drug Administration (FDA) on 11 December 2020.

The approved vaccine dosing regimen is an intramuscular injection given as two doses, 30 μg each, administered 21 days apart. The vaccine is approved for individuals 16 years of age and older.

The vaccine is intended to prevent the COVID-19 illness, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Pfizer-BioNTech vaccine targets the SARS-CoV-2 spike glycoprotein (S).[1]

Clinical Features

Administration

  • Type: SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles (LNPs).
  • Dosage Forms: 2 doses of 30 μg each, administered 21 days apart.
  • Routes of Administration: Intramuscular
  • Common Trade Names: Pfizer-BioNTech COVID-19 Vaccine, Pfizer Vaccine

Adult Dosing

The adult dosing of the vaccine is 2 doses of 30 μg each, administered 21 days apart.

Pediatric Dosing

The Pfizer-BioNTech COVID-19 vaccines has only been approved for individuals aged 16+. However, the dosing in individuals aged 16 and 17 is the same as the adult dosing of the vaccines.

Special Populations

Pregnancy Rating

It is unclear as to the effect of the vaccine in pregnant women, as Pregnancy was an exclusion criteria from the phase 3 clinical trial for this vaccine.[2]

Lactation risk

Renal Dosing

  • Adult:
  • Pediatric:

Hepatic Dosing

  • Adult:
  • Pediatric:

Contraindications

  • Allergy to class/drug

Adverse Reactions

Serious

Common

Pharmacology

  • Half-life:
  • Metabolism:
  • Excretion:

Mechanism of Action

Comments

See Also

External Links

Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA

References

  1. FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020
  2. FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020