The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and Health Sciences Authority in Singapore — and it intends to seek prequalification (PQ) and/or emergency use listing (EUL) with the World Health Organization.
This is the second potential vaccine against the novel coronavirus to formally enter the emergency use authorization process at FDA. The agency is already reviewing an application from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX). The goal of Operation Warp Speed in the U.S. is to start shipping out millions of doses of vaccine in mid-December, as long as vaccines receive an EUA.
MRNA shares were up nearly 18% to $149.52 apiece near the close of trading today.
Moderna’s announcement of an EUA application comes after a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases of COVID-19. Data analysis indicated a vaccine efficacy of 94.1%. All of the 30 severe cases in the study involved people in the placebo group; none of the severe cases received Moderna’s mRNA-1273 vaccine.
“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,” Moderna CEO Stéphane Bancel said in a news release.
“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,” Bancel said.
Moderna plans to submit data from the Phase 3 COVE study to a peer-reviewed publication.
Pfizer’s BNT162b2 vaccine candidate appears to have a lower adverse event rate than Moderna’s mRNA-1273 vaccine. Moderna reports that the most common solicited adverse reactions from its mRNA-1273 vaccine include injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Moderna, however, seems to have the upper hand in terms of its vaccines’ storage requirements. Moderna’s candidate is stable for 30 days between 2° and 8° C. Pfizer currently specifies that its vaccine candidate should be stored at –70° C.