mRNA-1273 Vaccine Description
mRNA-1273 is an mRNA vaccine candidate against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
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 24th, 42 days from sequence selection.
The first participant in the NIH-led Phase 1 study of the mRNA-1273 vaccine was dosed on March 16th, 63 days from sequence selection to Phase 1 study dosing. A Phase 2 study is expected to begin in Q2 2020, following safety data from an ongoing Phase 1 study.
Moderna previously collaborated with the NIH on a vaccine for MERS-CoV, which is a different type of coronavirus than the current SARS-CoV-2 pandemic. This program was only at the research stage and was not tested in humans.
mRNA is an information molecule and Moderna designs its mRNA vaccines using the sequence of the virus, not by working on the virus itself. This mRNA platform provides significant advantages in speed and efficiency, across basic science, manufacturing, and clinical development.
mRNA-1273 Vaccine Dosage
- Phase 1 study: Healthy adult volunteers ages 18 to 55 years, received three dose cohorts (25 µg, 100 µg, and 250 µg).
- Phase 2 study: Each subject will be assigned to receive a placebo, a 50 μg, or a 250 μg dose at both vaccinations.
mRNA-1273 Vaccine News
- May 18, 2020 - Moderna announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the NIAID. “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer.
- May 12, 2020 - Moderna, Inc. announced that the U.S. FDA has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). Previously, on May 6th, the FDA said it completed the review of the Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. And, Moderna said it is finalizing the protocol for a Phase 3 study, expected to begin in the early summer of 2020.
- May 8, 2020 - 'If Moderna’s coronavirus vaccine proves to work, the company anticipates working “very closely” with the U.S. government to determine 'who' will get the first mRNA-1273 doses, CEO Stephane Bancel told CNBC.
- May 7, 2020 - Stéphane Bancel, Moderna’s Chief Executive Officer, said in a press statement, “The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first Biologics License Application approved as soon as 2021."
- May 1, 2020 - Moderna, Inc. and Lonza Ltd. today announced a 10-year strategic collaboration agreement to enable larger-scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
- April 27, 2020 - Moderna, Inc. announced that it has submitted an IND application to the U.S. FDA for the company’s mRNA vaccine candidate (mRNA-1273) against the SARS-CoV-2 coronavirus to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases.
- April 23, 2020 - The USA Today reports the Seattle volunteers who got shots in the first trial of a possible coronavirus vaccine are now getting the second shot — an indicator the early trial is progressing well. The doctors at Kaiser Permanente's Vaccine Treatment and Evaluation Unit in Seattle don’t know the results of the first round of tests, said Lisa Jackson, who is leading the study.
- April 16, 2020 - Moderna, Inc. announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate the development of the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus SARS-CoV-2.
- March 27, 2020 - The NIH announced that Emory University in Atlanta will begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273.
- March 16, 2020 - Moderna, Inc. announced that the first participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health under its own Investigational New Drug application.
- February 24, 2020 - Moderna, Inc. announced that it has released the first batch of mRNA-1273, the Company’s vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health to be used in the planned Phase 1 study in the U.S.
- January 23, 2020 - Moderna, Inc. announced a new collaboration to develop an mRNA vaccine against the novel coronavirus SARS-CoV-2.
- January 13, 2020 - The U.S. National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the Company’s vaccine against the novel coronavirus. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat and Moderna mobilized toward clinical manufacture. The manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
mRNA-1273 Vaccine Definition
Messenger RNA, or mRNA, plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell.
mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes, the cell’s protein-making machinery. mRNA medicine instructs a patient’s own cells to produce proteins that could prevent, treat, or cure disease.
The mRNA sequence to the cells responsible for making the protein via one of several modalities. Reaching different types of cells requires different delivery methods.
mRNA-1273 Vaccine Clinical Trial
- NCT04283461 Phase 1 - Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) to Prevent SARS-CoV-2 Infection:
- Pending - Phase 2 - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.