Moderna said that its vaccine candidate COVID-19 mNR-1273 had passed its maximum life test, the PHASE III COVE trial of more than 30,000 patients (NCT04470427), being 94. 5% effective in the prevention of COVID-19, a result acclaimed by CEO Stéphane. Bancel as a “game changer”.
As a result, Moderna said it will apply to the FDA for an Emergency Use Authorization (USA) “in the coming weeks. “This USA, Said Moderna, will be supported by the definitive knowledge on the protection and efficacy of the test, with an average duration. at least two months.
The INDEPENDENT DATA Safety Monitoring Board (DSMB) of the NIH-denominated COVE trial conducted an initial interim investigation showing only five instances of COVID-19 in the mNR-1273 group, compared to 90 in the placebo group. the study is particularly fewer cases shown and judged coVID-19 two weeks after the immediate dose of vaccine compared to randomized patients for placebo.
“This is a turning point in the progression of our COVID-19 candidate vaccine,” Bancel said in a statement. “This positive interim investigation of our Phase III exam gave us the first clinical validation that our vaccine can save you COVID-19 disease, adding serious illnesses. “
Appearing at CNBC this morning, Bancel said of the effectiveness rate: “I think it’s a game change,” given the polls in which respondents expressed their reluctance to take a COVID-19 vaccine: “Knowing that we have a vaccine that people more, it’s just a glorious feeling.
Jefferies analyst Michael Yee was also positive about the first Data from Modern’s Phase III.
“These effects are very strong and recommend that mNS-based technologies be able to offer opposite coverage of COVID-19,” Yee wrote this morning in a study note. “In fact, the PFE [Pfizer] and now the mRN have a much higher power and it will be attractive to see if other platforms show this superior power. “
Investors will agree with Yee and Moderna: the company’s consistent percentages rose 12. 88% in pre-marketing at 8:32 a. m. to $101. 71 consistent with the consistent percentage since the close of $89. 39 on Friday, before falling to $95. 02 in the first trades at 10:35 a. m. , a gain of 6%.
Second Phase III vaccine
Moderna is the current developer of a leading COVID-19 vaccine candidate vaccine that reports positive Phase III knowledge in recent days. Last week, Pfizer and BioNTech said their BNT162b2 RNA-based vaccine, the lead candidate for their BNT162 COVID-19 vaccine program, has completed their Phase III trial with a 90% effectiveness in preventing COVID-19 in participants with evidence of past infection. SARS-CoV-2, in the first provisional efficacy investigation of the Phase III trial of 43,538 corporate participants (NCT04368728).
Modern’s 95 instances of COVID-19 included 15 older adults (65 years or older) and 20 participants who recognized themselves as belonging to communities of color: 12 Hispanic or Latino, 4 black or African American, 3 Asian-American, and one multiracial participant).
The COVE exam includes more than 11,000 participants from communities of color, said Moderna, which represents 37% of the population studied, representing the diversity of the United States as a whole. This includes more than 6,000 participants who identify as Hispanic or latinx. and more than 3000 participants who identify as black or African-American. “
By comparison, of the 43538 participants in the Pfizer/BioNTech Phase III trial, approximately 42% of global participants and 30% of US participants. But it’s not the first time They had “diverse racial and ethnic backgrounds,” BioNTech and Pfizer said, offering a more accurate breakdown.
Another significant difference between the two main vaccines: Modern states that its vaccine remains solid between 36 and 4. 6 degrees Fahrenheit (2 to 8 degrees Celsius) and can be maintained for six months at minus four degrees F (minus 20 degrees C), at minus 9 four degrees F (minus 70 degrees C) for BNT162b2.
Yee said investors and others deserve to monitor several other “key differences” between mRN-1273 and BNT162b2 when Moderna and Pfizer/BioNTech, respectively, publish detailed knowledge about their candidate vaccines in peer-reviewed journals that will result in “vital populations: (1) efficacy in others over 65 to 75 years [years] and maximum threat and a weaker immune system, (2) efficacy in ethnic populations, (3) relief of “serious” COVID-19 cases (ARNM revealed some of that today) and (4) the durability of antibody levels ».
MNS-1273 is a new mNR vaccine encapsulated in lipid nanoparticles (LNPs) that encode a stabilized form prior to the fusion of the Spike (S) protein. MNR-1273 is one of 20 “Front Runner” applicants among more than 300 COVID-19 treatments included in the update “COVID-19 drug”
Secondary test success
Moderna also stated that mNR-1273 met a secondary endpoint that analyzes severe cases of COVID-19, adding 11 serious cases as explained in the protocol. All 11 cases occurred in the organization of placebo and none in the organization of the mSA-1273 vaccine.
In addition, Moderna stated that the maximum adverse occasions in the COVE study to date have been mild or moderate. Grade 3 (severe) occasions with a frequency of 2% or more after the first dose included pain in the injection (2. 7%), and after the dose at the moment, fatigue (9. 7%), myalgia (8. 9%), arthralgia (5. 2%), headache (4. 5%), pain (4. 1%) and erythema/redness in injection (2. 0%).
“These adverse occasions requested were short-lived,” Moderna added.
Moderna is conducting the COVE trial with the National Institute of Allergy and Infectious Diseases (NIAID) and the Advanced Biomedical Research and Development Authority (BARDA).
Modern and its partners presented the COVE trial on July 27, after the vaccine generated positive early Phase I data. In September, Modern researchers published the effects of research comparing a two-dose vaccine of mRN-1273, administering doses 28 days apart in 40 healthy adult participants through two degrees of doses (25 and one hundred mg) in two cohorts of age (56 to 70 and 71 years) with effects reported up to day 57Array one month after the dose at the moment.
The company also published The Phase I knowledge reporting that mNR-1273 showed immunogenicity in patients 55 years of age or older than more or less equal to or greater than the knowledge observed in younger patients at the dose used through the company in their Phase III trial. .
In today’s announcement, Moderna said it plans to produce 20 million doses of its vaccine until the end of this year and remains on track to manufacture between 500 million and one billion international doses through 2021.
The U. S. government has committed up to $2. 5 billion for mSA-1273, adding up to $1. 525 billion for the manufacture and delivery of one hundred million doses of the vaccine through Operation Warp Speed, the program through which President Donald Trump’s administration committed the country to delivering three hundred million doses of the SARS-CoV-2 vaccine through January 2021.
Washington also invests in BNT162b2 from Pfizer / BioNTech. In July, the Department of Health and Human Services (HHS) and the Ministry of Defense (DoD) ordered one hundred million initial doses of the vaccine in July for $ 1. 95 billion, which the corporations agreed will offer a lower rate under a agreement signed in the framework of Operation Warp Speed. Under this agreement, the US federal government has the option to purchase an additional 500 million doses.
Corporations did not disclose the value of the additional 500 million doses if Washington agreed to order them, but said their agreement was conditional on Pfizer’s approval or approval of the vaccine’s emergency use.