The company intends to deliver around 20 million doses to the US government by the end of December 2020
Moderna gets FDA authorization for Covid-19 Vaccine. (Credit: pearson0612 from Pixabay.)
Moderna has received the US Food and Drug Administration’s (FDA) emergency use authorisation for its Covid-19 vaccine mRNA-1273, in individuals aged 18 years and older.
On 11 December 2020, the US Government exercised its option for additional 100 million doses of Covid-19 vaccine. The company intends to deliver around 20 million doses to the US government by the end of December 2020.
In November 2020, the European Commission reached an agreement with the company for 80 million doses of mRNA vaccine, with an option to increase the purchase to a total of 160 million doses.
EC has now exercised its option to buy additional 80 million doses of Moderna’s Covid-19 vaccine candidate mRNA-1273.
The biotech firm is planning to continue collecting additional data, to file a Biologics License Application (BLA) with the FDA seeking full licensure in 2021.
Moderna chief executive officer Stéphane Bancel said: “I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.
“I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine.”
Operation Warp Speed to manage allocation and distribution of mRNA-1273
Under Operation Warp Speed, the Department of Defense (DoD), in partnership with the Department of Health and Human Services (HHS) and the US Centres for Disease Control and Prevention (CDC), would manage allocation and distribution of the vaccine in the US.
The vaccine allocation and distribution will be prioritised according to populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP).
The US FDA has granted EUA to the vaccine candidate based on the totality of scientific evidence, including a data analysis from the Phase 3 clinical study.
Moderna announced the results of primary efficacy analysis conducted on 196 cases, which demonstrated 94.1% efficacy rate for its vaccine candidate.
In the Phase 3 study, most common solicited adverse reactions (ARs) after the two doses include injection site pain, erythema, swelling, and ipsilateral lymphadenopathy.
The US CDC advisory committee on immunisation practices (ACIP) recommended the use of Moderna’s Covid-19 vaccine in people aged 18 years and above.
Bancel added: “We appreciate the confidence in Moderna and mRNA-1273, our COVID-19 vaccine candidate, demonstrated by today’s increased supply agreement with the European Commission.
“As we shift our focus now to prepare for the delivery of our vaccine candidate, pending a positive opinion from the EMA and other regulators, we remain committed to working with governments and partners globally to address this pandemic.”