Before the opening bell this morning, biotechnology company Moderna Inc. (MRNA:NASDAQ), which is focused on developing therapeutics and vaccines employing messenger RNA (mRNA), announced that "the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%."
The firm advised that it Phase 3 COVE trial enrolled greater than 30,000 study participants in the U.S. and is being carried out in collaboration with both the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Moderna stated that "the primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine."
Moderna's CEO Stéphane Bancel remarked, "This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease...We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic."
The company stated that based on these interim safety and efficacy data "it intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months)."
In addition, Moderna noted that it is presently working closely with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and COVID-19 vaccine distributor McKesson (MCK:NYSE) to be make preparations for the distribution of mRNA-1273 should the company receive the expected EUA and approvals from agencies in other countries across the globe.
The firm expects that it will have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. by the end of December 2020 and plans to be able to manufacture 500 million to 1 billion doses worldwide in 2021. The firm said that logistically it anticipates that vaccine distribution, storage and handling will be quite feasible using existing infrastructure and distribution channels.
The company explained that the Phase 3 COVE Study was a randomized, controlled study testing mRNA-1273 at the 100 mg dose level in 30,000 adults in the U.S. The firm stated that the pre-established primary endpoint is the prevention of symptomatic COVID-19 disease and the secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The COVE study participants included over 7,000 individuals over the age of 65 as well as over 5,000 people who were under 65 years of age, but were deemed to be at higher-risk due to chronic diseases such as diabetes, cardiac disease and severe obesity.
The firm noted that "mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID's Vaccine Research Center." Moderna commented that under a federal contract totaling $955 million, BARDA is supporting ongoing research and development of mRNA-1273.
Moderna Inc. is headquartered in Cambridge, Mass., and is engaged in the development of transformative medicines based on messenger ribonucleic acid (mRNA). The firm is pursuing mRNA science to minimize the undesirable activation of the immune system by mRNA and to maximize the potency of mRNA once in the target cells. The company has a diverse development pipeline of 24 programs with multiple clinical studies underway. Its therapeutics and vaccine development programs span infectious diseases, oncology, cardiovascular diseases, and rare genetic diseases.
Moderna started the day with a market capitalization of around $35.4 billion with approximately 395.7 million shares outstanding and a short interest of about 6.4%. MRNA shares opened more than 12% higher today at $100.31 (+$11.00, +12.32%) over Friday's $89.31 closing price and reached a new 52-week high price this morning of $100.50. The stock has traded today between $93.30 and $100.50 per share and is presently trading at $98.45 (+$9.06, +10.14%).[NLINSERT]
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