Moderna’s mRNA-1273 vaccine has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for the prevention of Covid-19.
As per the EUA, the mRNA-1273 vaccine can be administered to individuals aged 18 years or older.
Following the EUA, Moderna has commenced delivery of the Covid-19 vaccine candidate to the US government.
The firm will supply nearly 20 million doses to be supplied to the US government by the end of this month.
By Q1 2021, the company expects to make 85-100 million doses available in the US. The US government has so far ordered 200 million doses of the mRNA-1273 vaccine and has the option to buy up to an additional 300 million doses.
Moderna CEO Stéphane Bancel said: “We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.
“It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today.
“We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”
Moderna said that it will continue to record further data about the mRNA vaccine and will aim to submit a biologics license application (BLA) in 2021 to the FDA for requesting full licensure.
mRNA-1273 is now the second Covid-19 vaccine candidate after Pfizer and BioNTech’s mRNA vaccine BNT162b2 to have been granted the emergency use authorisation by the FDA.
FDA Commissioner Stephen Hahn said: “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
The FDA’s EUA for the mRNA-1273 vaccine has been driven by the totality of scientific evidence provided by Moderna, which includes data analysis from the phase 3 COVE study. The primary efficacy analysis undertaken on 196 cases during the late-stage study showed a vaccine efficacy rate of 94.1%, said the company.