Moderna files for regulatory approval for Covid-19 vaccine

Moderna has filed for emergency regulatory approval for its Covid-19 vaccine candidate with authorities in the US and EU, the company has announced.

The biotechnology company has requested an Emergency Use Authorisation (EUA) with the US FDA and an application for Conditional Marketing Authorisation (CMA) with the European Medicines Agency (EMA).

The announcement follows data from a primary efficacy analysis of Moderna’s Phase 3 study of its mRNA-1273 vaccine. Data from 196 cases from the study indicate that the company’s Covid-19 vaccine candidate has an average efficacy of 94.1%. Efficacy was consistent across age, race, ethnicity and gender, Moderna stated. The 196 Covid-19 cases included 33 adults above 65 years of age, with 42 participants identifying as being from diverse communities.  

From the data, 185 cases of Covid-19 were observed in the placebo group versus 11 cases in the mRNA-1273 group. In the placebo group 30 severe cases were reported and one death occurred throughout the study.

No serious safety concerns have been identified by Moderna relating to mRNA-1273. The most common adverse reactions have included fatigue, myalgia, and headaches.

The Phase 3 study known as COVE has included over 30,000 participants in the US. The study’s first interim analysis also concluded an efficacy rate of around 94% based on 95 cases of participants with Covid-19 – five of which received the mRNA-1273 vaccine with the remainder receiving a placebo.

“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, chief executive officer of Moderna.

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273. Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine. We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”

The UK has purchased 7 million doses of Moderna’s vaccine, though supplies are not expected until March next year.

Moderna states it is on track to have approximately 20 million doses of its Covid-19 vaccine available by the end of 2020. In 2021, Moderna is aiming to manufacture between 500 million to 1 billion doses of mRNA-1273.