Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna, said, “Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency. We look forward to launching this Phase 2 study as soon as possible, which will provide important information about the safety, reactogenicity and immunogenicity of mRNA-1273.”
A Phase 3 Study Could Begin in the Fall of 2020
Subject to data from Phase 1 and Phase 2 studies, and discussions with regulators, a Phase 3 study could begin in the fall of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA) supported the planning for these studies and will also support the late-stage clinical development programs as well as the scale-up of mRNA-1273 manufacturing.
BARDA Acting Director Gary Disbrow, Ph.D. said, “Safe, effective vaccines are critical to ending this pandemic and preventing future outbreaks of SARS-COV-2. The next steps announced today for this particular vaccine highlight the value of collaboration among government agencies including BARDA and NIAID, and the private sector, to move vaccines and other medical countermeasures forward as rapidly as possible.”
About the NIAID-led Phase 1 Study
An open-label Phase 1 study of mRNA-1273 is being conducted by the NIAID under its own IND application. The Phase 1 study, which began on March 16, 2020, completed enrollment of 45 healthy adult volunteers ages 18 to 55 years in the original three-dose cohorts (25 µg, 100 µg, and 250 µg). The study is enrolling six additional cohorts: three cohorts of older adults (ages 56-70) and three cohorts of elderly adults (ages 71 and above). Data from the original cohort of healthy adult volunteers ages 18 to 55 years will be reported once available.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the NIAID). The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
About the Moderna Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia.
Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies the company designated prophylactic vaccines as a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production.
Moderna has built a fully integrated manufacturing plant that enables the promise of the technology platform. The firm has nine development candidates in its prophylactic vaccines modality. They include:
Vaccines against respiratory infections:
- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
- Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby:
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections:
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, and Zika). Moderna’s CMV vaccine is currently in the Phase 2 dose-confirmation study.
Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Our enthusiasm for Moderna does not only emanate from its mRNA-1273 vaccine against the novel coronavirus (SARS-CoV-2), but also from its new mRNA approach, its rich and promising pipeline products and its solid scientific and technological capabilities which are behind all what Moderna has accomplished.
What we also consider important is Moderna’s capability, including its unprecedented speed in creating and handing the vaccine over to the authorities.
We also believe that no one vaccine against the novel coronavirus (SARS-CoV-2) will be enough to cover a Pandemic; several companies would have to create, develop and manufacture a sufficient amount to protect the world. We are happy to know that more public and private firms as well as institutions are developing prophylactic vaccines around the world.
In America, in addition to Moderna, Inovio (INO) seems to be doing a good job with its vaccines too.
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Moderna: Speeding down the Road Towards Developing a Prophylactic Vaccine Against the Novel Coronavirus (SARS-CoV-2)
Moderna Submitted an IND for Its mRNA Vaccine Candidate for Novel Coronavirus
Moderna (MRNA) announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its mRNA vaccine candidate, mRNA-1273, against the novel coronavirus, SARS-CoV-2. The filing is for the evaluation in Phase 2 and for late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH).
The firm’s press release stated that Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study which is expected to begin in the second quarter of 2020. The Phase 2 trial will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
Details from Moderna acknowledged that each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose, at both vaccinations; Moderna intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above; the participants will be followed through 12 months after the second vaccination.