Moderna seek permission to sell Covid 19 vaccine in US and Europe

The pharmaceutical company Moderna on Monday, November 30, 2020 announced it would request authorization to market its COVID-19 vaccine from the United States Food and Drug Administration (FDA) and the European Medicines Agency.

Regulators will analyze the mRNA vaccine test data and decide if it is safe and effective enough to recommend its implementation.

According to the company, the efficacy analysis of the phase 3 study of the vaccine included 30,000 participants with an efficacy of 94.1 percent, good tolerability, and no serious safety concerns identified.

The phase 3 study has exceeded the mean 2-month follow-up post-vaccination, as required by the FDA for emergency use authorization.

The first injections can be administered from December 21 if the process goes smoothly and approval is granted, Moderna’s CEO Stephane Bancel announced.

The Moderna vaccine’s most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and redness at the injection site.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with an efficacy of 94.1 percent and, more importantly, the ability to prevent severe COVID-19 disease,” he said.

“We believe our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illnesses, hospitalizations, and deaths.”

Agency report