The U.S. government It has provided Modern with another $1.525 billion for the manufacture and delivery of one hundred million doses of the mRNA-1273 COVID-19 messenger (mRNA) vaccine candidate from the company.
The new financing, combined with $955 million committed in the past with Moderna, more than doubles Washington’s investment in the company to potentially $2.48 billion.
The new investment includes an unspecified amount of incentive bills “for product delivery,” Moderna added. However, the company stated that the U.S. government I had the option to purchase up to 400 million additional doses of mNR-1273.
MNS-1273 is a new mNR vaccine encapsulated in lipid nanoparticles (LNP) that encode a stabilized form prior to the fusion of the Spike protein (S). MNR-1273 is one of 17 “Front Runner” applicants among the more than 280 COVID-19 treatments included in the “COVID-19 DRUG – VACCINE CANDIDATE TRACKER” gen update.
Modern has partnered with researchers from the National Institute of Allergy and Infectious Diseases’s Vaccine Research Center (NIAID) to jointly develop mSR-1273.
NIAID and Moderna are now conducting an approximately 30,000-patient Phase III trial of mRNA-1273. The study, launched last month, is being funded among late-stage clinical activity for which the company won up-to-$472 million from BARDA.
The PHASE III COVE (NCT04470427) test is designed to evaluate the protection of mRN-1273 in 30,000 adult volunteers who do not have COVID-19. The number one endpoint will be the prevention of coVID-19 symptomatic disease. The main secondary assessment criteria come with the prevention of serious diseases in COVID-19, as explained through the need for hospitalization), and the prevention of SARS-CoV-2 infection.
On for September
Records are expected to be completed in September, Moderna said.
Trial participants will receive two intramuscular injections with a difference of approximately 28 days. Participants will be randomly assigned 1: 1 to obtain two hundred mg injections of mRN-1273 or two injections of a salt placebo.
The United States Health and Human Services Decomposers (HHS) and Defense (DoD) announced The Latest Overdue Modern Investment as a component of Operation Warp Speed, the program through which President Donald Trump’s management committed the country to supplying three hundred million doses of SARS-CoV-2 Vaccine through January 2021.
The government says its goal of three hundred million doses is part of a broader strategy to drive the development, manufacture and distribution of COVID-19 vaccines, curative products and diagnostics.
Operation Warp Speed budgets and coordinates the progression of vaccines and diagnostics in Department of Defense and HHS agencies; the latter firm adds the FDA, NIH, the Centers for Disease Control and Prevention (CDC) and the Advanced Biomedical Research and Development Authority (BARDA).
BARDA and the Executive Board of the Joint Defense Program of the Department of Defense for Chemical, Biological, Radiological and Nuclear Defense and the Army Market Command have teamed up to provide funding.
“We appreciate the trust of the U.S. government. On our mNR vaccine platform and ongoing support,” Moderna’s CEO Stéphane Bancel said in a statement. “We are advancing the clinical progression of mRNA-1273 with phase III underway in collaboration with NIAID and BARDA.”
Increased manufacturing
At the same time, added Bancel, Moderna is expanding its production capacity with 3 partner corporations with which the vaccine developer has entered into undisclosed agreements.
In May, Moderna signed a 10-year agreement with Lonza in which corporations agreed to create production suites for Moderna at the Lonza facility in the United States and Switzerland for the production of mNR-1273. The price of this agreement has been disclosed.
In June, Moderna and Catalent agreed to advertise large-scale production of mRN-1273 at the Catalent biological plant in Bloomington, IN. Catalent has agreed to obtain the filling and packaging capacity of the vials, as well as the additional body of workers needed for production operations 24 hours a day, 7 days a week at the site for the production of one hundred million initial doses of the candidate vaccine intended to stock up on the US market. since the 3rd quarter.
And last month, Moderna agreed to partner with Rovi Pharmaceutical Laboratories (ROVI) to carry out large-scale advertising production of mNR-1273 at ROVI’s facilities in Madrid, Spain.
With FDA approval, Moderna said Americans would get mNR-1273 “at no cost to the vaccine itself,” but warned that fitness professionals could qualify the charge of administering the vaccine “as standard with vaccines purchased through the government.”
BARDA has agreed in the past studies and progression for MRNA-1273 with $955 million in federal investment under Contract No. 75A50120C00034. A new investment of up to $1.525 billion for mRA-1273 is provided under U.S. Department of Defense contract W911QY-20-C-0100.
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