Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics." In addition, its team will apply for a conditional marketing authorization with the EMA. Company shares (NASDAQ:MRNA) rose 20.2% to close at $152.74 on Nov. 30.
A meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee to review the safety and efficacy data package for the candidate – an mRNA vaccine encoding for a prefusion stabilized form of the SARS-CoV-2 virus spike protein – will likely be scheduled for Dec. 17, the company said.
The top-line efficacy result was based on an analysis of the primary endpoint of the company's phase III Cove study of mRNA-1273 conducted on 196 cases. Of those, 185 cases of COVID-19 were observed in the placebo group vs. 11 cases in the mRNA-1273 group. Of 30 severe cases logged, all occurred in the placebo group.
There has been one COVID-19-related death in the study, in the placebo group. But Moderna said that a continuous review of safety data in the study remains underway with no new serious safety concerns identified so far.
The trial, which has enrolled more than 30,000 participants in the U.S., is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority (BARDA).
In addition to seeking emergency and conditional use authorizations, Moderna said it has initiated a rolling review process with the EMA, Health Canada, Swissmedic, the U.K.'s Medicines and Healthcare products Regulatory Agency, the Ministry of Health in Israel and the Health Sciences Authority in Singapore. Its team will also seek prequalification and/or an emergency use listing with the World Health Organization, the company said.
Distribution planning already underway
Moderna also said Monday that it is working with the U.S. CDC, Operation Warp Speed, Mckesson and others to prepare for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals. By the end of 2020, it expects to have about 20 million doses of mRNA-1273 available in the U.S., it said, and remains on track to manufacture 500 million to 1 billion doses globally in 2021. The company has a 10-year strategic collaboration agreement with Lonza Ltd. to enable large-scale manufacturing of the vaccine.
The U.S. Department of Health and Human Services, through BARDA, has so far awarded the company $954.9 million to support and accelerate development and testing of the vaccine candidate. Under the terms of the agreement, BARDA will fund the advancement of mRNA-1273 to FDA licensure. The U.S. government has so far agreed to purchase 100 million doses of mRNA-1273 from Moderna under a contract that could be valued at up to $1.525 billion.
In addition to Moderna, Pfizer Inc. and its partner, Biontech SE, are seeking an emergency use authorization for an mRNA vaccine candidate, BNT-162b2. Meanwhile, Astrazeneca plc is seeking an emergency use listing from WHO for its COVID-19 vaccine candidate, developed with Oxford University, AZD-1222.