The FDA has told Moderna to expect a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 17. This is a week after Pfizer's meeting on December 10 (Pfizer submitted its EUA request for its mRNA vaccine candidate on November 20).
Moderna is also submitting an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency today. It has already initiated rolling review processes with Europe's EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore. In addition, it intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
mRNA-1273: Phase 3 study
Moderna's mRNA vaccine candidate, mRNA-1273, targets the virus' spike (S) sportein and was co-developed by Moderna and investigators from the US NIAID Vaccine Research Center.
Moderna's primary efficacy analysis of the Phase 3 COVE study was conducted on 196 cases: 185 cases of which were observed in the placebo group compared to 11 cases in the mRNA-1273 group. Moderna says this confirms the high efficacy observed at the first interim analysis earlier this month with a vaccine efficacy of 94.1%.
The primary efficacy analysis included 30 severe COVID-19 cases in the placebo group, and none in the vaccinated group. There was one COVID-19 death in the study, which occured in the placebo group.
Efficacy was conistent across age, race, ethnicity and gender. (The study included 33 adults aged 65+; 29 Hispanic or LatinX, 6 Black or African Americans; 4 Asian Americans and 3 multiracial participants).
Moderna adds that mRNA-1273 continues to be 'generally well tolerated'; no serious safety concerns identified to date.
Stéphane Bancel, Chief Executive Officer of Moderna, 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, hospitalizations and death.
“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.”
Manufacture and distribution
Storage and transporation requirements for the vaccine, updated by Moderna earlier this month, show the vaccine can be stored at standard freezer temperatures of -20°C (-4 F) for up to six months. It can then be kept in standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days.
By the end of 2020, Moderna expects to have approximately 20 million doses of mRNA-1273 available in the US. This will ramp up globally in 2021 to reach 500 million to 1 billion doses.
January 23, 2020: Moderna receives funding award from CEPI to accelerate development of an mRNA vaccine candidate against COVID-19
March 16: First participant dosed in Phase 1 study for mRNA-1273 in the US
April 16: Moderna receives award of up to $483m from US government agency BARDA for its mRNA vaccine development
May 11: Moderna receives FDA Fast Track Designation for its vaccine candidate
July 27: Phase 3 trial begins
October 22: Phase 3 study completes enrolment of 30,000 people
November 13: Swissmedic (Switzerland) becomes the latest to begin its rolling review of the vaccine, following on from similar processes started in October by the UK’s MHRA and Health Canada.
November 16: Moderna releases interim analysis for its Phase 3 trial, reporting 94.5% efficacy and meeting primary efficacy endpoint.
November 30: Request for EUA submitted to US FDA. Release of primary efficacy analysis showing 94.1% efficacy.
December 17: provisional data for FDA VRBPAC meeting
2022: End of Phase 3 trial (participants will be followed for 24 months after the second dose is administered).