Moderna announced that it is seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 mRNA vaccine candidate.
The mRNA-1273 is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein. It was co-developed by Moderna and investigators from NIAID’s Vaccine Research Centre.
The company has already commenced the rolling review process with the European Medical Agency (EUA), Health Canada, SwissMedic, the UK Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore.
Moderna is also planning to achieve prequalification (PQ) or emergency use listing (EUL) its mRNA-1273 Covid-18 vaccine candidate from the World Health Organisation (WHO). It also intends to request for conditional marketing authorisation for the vaccine candidate from EMA.
The company also stated that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to assess the safety and efficacy data package for mRNA-1273 candidate.
Moderna is coordinating with the US CDC, Operation Warp Speed and McKesson, a Covid-19 vaccine distributor contracted by the US government, as well as global stakeholders to prepare for distribution of mRNA-1273 vaccine, as it is expecting EUA and similar global authorisations and approvals.
The company is planning to produce between 500 million and one billion doses of vaccine across the globe in 2021.
According to the company, the mRNA-1273 candidate has demonstrated an efficacy rate of 94.1% in the primary analysis of the phase 3 study.
The phase 3 COVE study, which recruited over 30,000 participants in the US, is being carried out in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
The phase 3 COVE trial is a randomised and 1:1 placebo-controlled study assessing mRNA-1273 at the 100µg dose level in 30,000 participants in the US aged 18 and older.
Moderna CEO Stéphane Bancel said: “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, hospitalisations and death.”
In May this year, Moderna first announced that it secured fast track designation from the FDA for its mRNA-1273 Covid-19 vaccine candidate.