Moderna said today that its COVID-19 vaccine candidate mRNA-1273 passed its most important test, the 30,000+ patient Phase III COVE trial (NCT04470427), by showing itself to be 94.5% effective in preventing COVID-19—an outcome hailed by CEO Stéphane Bancel as a “game changer.”

As a result, Moderna said, it will seek an emergency use authorization (EUA) from the FDA “in the coming weeks.” That EUA, Moderna said, is expected to be supported by final safety and efficacy data from the trial, with a median duration of at least two months.

The COVE trial’s independent, NIH-appointed Data Safety Monitoring Board (DSMB) has carried out a first interim analysis showing just five cases of COVID-19 in the mRNA-1273 group, compared with 90 seen in the placebo group. The study’s primary endpoint is significantly fewer COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine compared with patients randomized to placebo.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Bancel said in a statement. “This positive interim analysis from our Phase III study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”

Appearing on CNBC this morning, Bancel said of the efficacy rate, “that’s a game changer, I believe,” given surveys in which respondents have expressed reluctance to take a COVID-19 vaccine: “Knowing that we have a vaccine that would help more people who would take it is just a wonderful feeling.”

Also positive on Moderna’s early Phase III data was Jefferies analyst Michael Yee.

“These results are very strong and suggest mRNA-based technologies can deliver so far for COVID-19 protection,” Yee wrote this morning in a research note. “Indeed, PFE [Pfizer] and now MRNA both have very high end efficacy and it will be interesting to see if other platforms show this high of efficacy.”

Investors appeared to agree with both Yee and Moderna: The company’s shares soared 12.88% in premarket trading as of 8:32 a.m., to $101.71 a share from Friday’s close of $89.39, before dipping to $95.02 in early trading as of 10:35 a.m., a 6% gain.

2nd Positive phase III vaccine

Moderna is the second developer of a leading COVID-19 vaccine candidate to report positive Phase III data in recent days. Just last week, Pfizer and BioNTech said their RNA-based vaccine BNT162b2, the lead candidate of their BNT162 COVID-19 vaccine program, aced its Phase III trial by showing itself more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, in the first interim efficacy analysis of the companies’ 43,538-participant Phase III trial (NCT04368728).

Moderna’s 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants who identified as being from communities of color—including 12 Hispanic or Latinx, four Black or African-Americans, three Asian Americans, and one multiracial participant).

The COVE study includes more than 11,000 participants from communities of color, Moderna said, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.”

By comparison, of the 43,538 participants in Pfizer/BioNTech’s Phase III trial, approximately 42% of global participants and 30% of U.S. participants had “racially and ethnically diverse backgrounds,” BioNTech and Pfizer said, without furnishing a more precise breakdown.

Another significant difference between the two leading vaccines: Moderna says its vaccine remains stable at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), and can be stored for six months at minus 4 degrees F (minus 20 degrees C), versus minus 94 degrees F (minus 70 degrees C) for BNT162b2.

Yee said that investors and others should watch for several other “key differences” between mRNA-1273 and BNT162b2 when Moderna and Pfizer/BioNTech, respectively, publish detailed data on their vaccine candidates in peer-reviewed journals will be results “in populations of particular importance: (1) efficacy in elderly pts above 65–75 [years old] and most at risk and weaker immune system, (2) efficacy in various ethnic populations, (3) reduction in “severe” COVID-19 cases (MRNA disclosed some of this today), and (4) durability of antibody levels.”

mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. mRNA-1273 is one of 20 “Front Runner” candidates among the more than 300 COVID-19 therapeutics included in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker.”

Secondary endpoint success

Moderna also said mRNA-1273 met a secondary endpoint analyzing severe cases of COVID-19, and including 11 severe cases as defined in the study protocol. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

Additionally, Moderna said most adverse events in the COVE study to date were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%).

“These solicited adverse events were generally short-lived,” Moderna added.

Moderna is conducting the COVE trial with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

Moderna and its partners launched the COVE trial on July 27, after the vaccine generated early positive Phase I data. In September, researchers for Moderna published results of an analysis assessing a two-dose vaccination with mRNA-1273, with the doses given 28 days apart in 40 healthy adult participants across two dose levels (25 and 100 µg) in two age cohorts (ages 56–70 and ages 71) with the results reported through Day 57, one month after the second dose.

The company has also published Phase I data reporting mRNA-1273 to have shown immunogenicity in patients 55 years old and older that was roughly the same or higher than data seen in younger patients at the dosage the company is using in its Phase III trial.

In today’s announcement, Moderna said it plans to produce 20 million doses of its vaccine by the end of this year, and remains on track to manufacture 500 million to 1 billion doses globally in 2021.

The U.S. government has committed up to $2.5 billion toward mRNA-1273, including up to $1.525 billion toward manufacturing and delivering 100 million doses of the vaccine, through Operation Warp Speed, the program through which President Donald Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021.

Washington is also invested in Pfizer/BioNTech’s BNT162b2. In July, the Department of Health and Human Services (HHS) and Department of Defense (DoD) in July ordered an initial 100 million doses of the vaccine for $1.95 billion—which the companies agreed to offer for free under an agreement signed as part of Operation Warp Speed. Under that agreement, the U.S. federal government has the option to purchase 500 million additional doses.

The companies have not disclosed the price of those additional 500 million doses should Washington agree to order them—but have said their agreement is subject to Pfizer successfully manufacturing and obtaining approval or emergency use authorization for the vaccine.

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