FDA approves Comirnaty, first COVID-19 brand name approved in U.S.
The brand name has also been approved by regulators in Japan and Australia, among other countries.
"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, was also developed by Brand Institute and its wholly owned subsidiary, Drug Safety Institute. ■