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Summary Basis for Regulatory Action Template Date: November 11, 2015 From: CDR Elizabeth J. Valenti, Chair of the Review Committee BLA/ STN#: 103821/5344 Applicant Name: Emergent BioDefense Operations.

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With official FDA approval, the company was allowed to start marketing the vaccine with an official name, Comirnaty. Pronounced koe-mir'na-tee, the term was designed to represent a mash-up of the words Covid-19, community, immunity, and mRNA, the technology used in the vaccine, writes Insider's Dr.

We asked the naming agency behind both Comirnaty and its non-proprietary name, tozinameran—industry heavyweight Brand Institute, which began working with BioNTech in April. Pfizer joined the effort shortly after, when the duo's vaccine collaboration was announced.

Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.

Spikevax (elasomeran) contains mRNA encapsulated in lipid nanoparticles. The mRNA encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation.

One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles). Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

VAXNEUVANCE does not contain preservatives. The shelf life for the final drug product is 18 months from the date of manufacture when stored at 2°C to 8°C.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232