COMIRNATY/ Pfizer-BioNTech COVID-19 Vaccine

Proper Name: COVID-19 mRNA vaccine (nucleoside-modified)

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.

Advisory Board:

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.

Indications: 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.

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

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

Package Insert