COMIRNATY/ Pfizer-BioNTech COVID-19 Vaccine
Proper Name
COVID-19 mRNA vaccine (nucleoside-modified)
Indication
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.
Description

The active substance consists of a single-stranded, 5'-capped mRNA that is translated into a codon-optimized sequence encoding the spike antigen of SARS-CoV-2. The vaccine is based on the spike glycoprotein (S) of SARS-CoV-2.

Manufacturing Platform

PARAMETER

DATA

Manufacturer

Pfizer Inc.

Transgene

-

Indication

Comirnaty is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.

Virus and Serotype

mRNA

Cell Substrate

-

Manufacturing platform

The RNA is synthesized from linear DNA via an in vitro transcription (IVT) step. The IVT step is followed by a number of purification and filtration steps. Lastly, the RNA undergoes a final filtration before being dispensed and stored frozen.

Dose in vial/final container

One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution. 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).

Dose / patient

30 µg of RNA in 0.3 mL

SUPPORTING CLINICAL TRIALS:

NCT

TITLE

COUNTRIES

NCT04368728

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

United States, Argentina, Brazil, Germany, South Africa, Turkey

NCT04380701

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults

Germany
Key Regulatory Milestones

11/20/2020 - Sponsor submitted an Emergency Use Authorization (EUA) request to FDA for an investigational COVID-19 vaccine (BNT162b2)

12/10/2020 - A meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was convened.

12/21/2020 - EMA Conditional approval

12/31/2020 - WHO Recommendation

 

Advisory Committee

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on December 10, 2020, to discuss Pfizer’s EUA request. The committee discussed potential implications of loss of blinded, placebo-controlled follow-up in ongoing trials including how this may impact availability of safety data to support a biologics license application. Some pointed out the importance of long-term safety data for the PfizerBioNTech COVID-19 Vaccine as it is made using a technology not used in previously licensed vaccines. The committee voted in favor of a determination that based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older.

Package Insert
Comirnaty : EPAR - Product Information
Advanced Facts
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