FDA Approves COMIRNATY®, The First COVID-19 Vaccine Approved By The Agency And The First COVID-19 Vaccine Brand Name Approved In The U.S.

- The COMIRNATY® brand name was developed in partnership with Brand Institute, a Miami-based naming agency and the global leader in pharmaceutical and healthcare-related name development

MIAMI, Aug. 25, 2021 /PRNewswire/ -- Brand Institute is proud to announce its role in naming Pfizer and BioNTech's FDA-approved COVID-19 vaccine: COMIRNATY® (koe mir' na tee). The name was first announced by Swiss regulatory authority, Swissmedic, in December of 2020, and by the European Medicines Agency (EMA) soon after. The brand name has also been approved by regulators in Japan and Australia, among other countries.

In a joint press release issued on December 21, 2020, following the EMA's authorization of the vaccine, BioNTech and Pfizer commented, "The vaccine will be marketed in the EU under the brand name COMIRNATY®, which represents a combination of the terms COVID-19, mRNA, community and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency, and with safety at the forefront, during this global pandemic."

"The entire Brand Institute and Drug Safety Institute Team congratulates Pfizer and BioNTech on the FDA approval of COMIRNATY®," said Brand Institute's Chairman and CEO, James L. Dettore. "This approval is a critically important step in the fight against COVID-19 and communicates to the public that the agency's high standards of efficacy and safety have been met."

FDA approval of a pharmaceutical or vaccine product's brand name is also a significant step toward the development of a global brand.

"Developing a global brand name is an increasingly challenging endeavor as global health agencies employ an intensive review of proposed drug names with the goal of minimizing medication errors and ensuring patient safety," Dettore said. "We are honored to have developed a name that is fulfilling the requirements for approval set forth by global health authorities including the FDA."

The COVID-19 vaccine's nonproprietary name (INN), tozinameran (toe zi na' mer an), was also developed by Brand Institute and its wholly owned subsidiary, Drug Safety Institute.

About Brand Institute and our wholly-owned subsidiary, Drug Safety Institute

Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,500 marketed healthcare names for nearly 1,000 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year. Drug Safety Institute is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.

Contact: Scott PiergrossiPresident, [email protected]

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