WASHINGTON – Modern pharmaceutical company announced today that it is going to request authorization to market its coronavirus vaccine from both 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%, generally good tolerability, and no serious safety concerns identified to date.
The phase 3 study has exceeded the mean 2-month follow-up post-vaccination, as required by the FDA for emergency use authorization, Moderna says in a statement.
The company also states that the efficacy of the vaccine against the most serious cases of Covid-19 is one hundred percent.
The first injections can be administered from December 21 if the process runs smoothly and approval is granted, said Stéphane Bancel, executive director of Moderna, in an interview with “The New York Times.”
According to the company, the efficacy of the vaccine “was consistent” based on age, race and ethnicity, and gender demographics and, although ongoing reviews are being conducted, “no serious problems have been identified.”
Moderna states that, based on a previous analysis, the most common adverse reactions when the vaccine was administered 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% and, more importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illnesses, hospitalizations and deaths, ”said Stéphane Bancel.