Why Moderna is seeking Authorization From U.S. FDA & Global Regulators ?

Moderna, Inc. (NASDAQ: MRNA) said on May 25 that a clinical study of its COVID-19 vaccine mRNA-1273 showed 100 percent effectiveness in the 12 to 17 years age group. Moderna CEO Stéphane Bancel said the company would submit the study data to the U.S. Food and Drug Administration and other regulators globally in early June and seek authorization. The Massachusetts-based biotechnology company’s stock rose around 2 percent to US$167.34 when the market opened for trading on Tuesday.

The Centre for Disease Control and Prevention (CDC), coordinating the covid response, said only a few kids compared to adults get infected with SARS-CoV-2, but they can still become sick and spread the virus. Vaccinating children is considered crucial for herd immunity. Moderna said the mRNA-1273 met its primary immunogenicity endpoint and the safety and tolerability profile was consistent with the Phase 3 study in adults. No cases of COVID-19 were found in participants who were administered with two shots, while four children who received the placebo were found positive.

Earlier in May, the FDA gave Emergency Use Authorization for Pfizer - BioNTech’s covid vaccine for 12 to 15 years old in the U.S. The vaccine, jointly developed by Pfizer and Germany’s BioNTech, showed 100 percent effectiveness.