FDA Approves SPIKEVAX®, Moderna's mRNA COVID-19 Vaccine

The SPIKEVAX® brand name was developed by Brand Institute, the global leader in pharmaceutical and healthcare-related name development

MIAMI, Feb. 1, 2022 /PRNewswire/ -- Brand Institute is proud to announce its successful partnership with Moderna in naming their FDA-approved COVID-19 vaccine: SPIKEVAX®, the second COVID-19 vaccine to be fully approved by the regulatory agency.

 "The entire Brand Institute and Drug Safety Institute Team congratulates Moderna on the FDA approval of SPIKEVAX®," said Brand Institute's Chairman and CEO, James L. Dettore. "This approval indicates that the vaccine has met the FDA's rigorous standards for safety, effectiveness and manufacturing quality required for approval."

Conceptually distinct from other approved COVID-19 vaccine brand names, SPIKEVAX® refers to the "spike" glycoprotein, one of the key characteristics of SARS-CoV-2. The mRNA vaccine, SPIKEVAX®, gives instructions for cells to produce copies of the "spike" protein, which subsequently becomes a target for the generation of neutralizing antibodies against it. In doing so, the body develops immunity to SARS-CoV-2 viral infection.

"Our naming research indicated that SPIKEVAX® was not only a great fit for the product but also highly memorable and unique," Dettore said. "SPIKEVAX® has many of the name characteristics and attributes we pursue when creating a new pharmaceutical or vaccine brand name."

SPIKEVAX® has also been approved by the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, Health Canada, and the Ministry of Health, Labour and Welfare (MHLW) in Japan. The approval of the vaccine and its brand name by other global regulatory agencies will follow their respective guidelines, policies and procedures.

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Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Brand 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.