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Manufacturer

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Registration Date 18 Mar 2020
Revision Date 18 Mar 2020
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mRNA-1273

(4)

Medicine Pharmaceuticals

COVID-19 vaccine

Applications

Coronavirus COVID-19

Properties

Immunogenicity Protein production

Manufacturer's Description

Moderna is proud to be among the many groups working to respond to this continuing global health emergency. This page summarizes key milestones in our work to advance our vaccine candidate (mRNA-1273) and responds to frequently asked questions.

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. Our approach is to use mRNA medicines to instruct a patient’s own cells to produce proteins that could prevent, treat, or cure disease.

On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus.
On 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. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
On February 7, 2020, the first clinical batch, including fill and finishing of vials, was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.
On February 24, 2020, the clinical batch was shipped from Moderna to the NIH for use in their Phase 1 clinical study.
On March 4, 2020, the U.S. Food and Drug Administration (FDA) completed its review of the Investigational New Drug (IND) application filed by the NIH for mRNA-1273 and allowed to the study to proceed to begin clinical trials.
On March 16, 2020, the NIH announced that the first participant in its Phase 1 study for mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.
This Phase 1 study will provide important data on the safety and immunogenicity of mRNA-1273. Immunogenicity means the ability of the vaccine to induce an immune response in participants. The open-label trial is expected to enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks.

mRNA is an emerging platform. Over the past few years, we have demonstrated its potential in vaccines across more than 1,000 subjects in our clinical trials. This includes successful early-stage (Phase 1) clinical trials against five other respiratory viruses (two pandemic influenza strains, RSV, hMPV, and PIV3). Over the last four years, we have started 9 clinical trials for mRNA vaccines.

However, it is important to emphasize that we are still early in the story. Our most advanced vaccine program (CMV) is in Phase 2 clinical testing and we have no approved drugs to date.

Despite this, we are doing everything we can to help in the current emergency by working to develop a safe and effective vaccine for this novel coronavirus.

We had previously collaborated with the NIH on a vaccine for MERS-CoV, which is a different type of coronavirus than the current pandemic. While the program was only at the research stage, it provided significant insights as we launched our efforts for mRNA-1273. Before the Phase 1 study for mRNA-1273, we had not previously tested a coronavirus vaccine in humans.

mRNA is an information molecule and we design our mRNA vaccines using the sequence of the virus, not by working on the virus itself. Our mRNA platform provides significant advantages in speed and efficiency, across basic science, manufacturing, and clinical development.

Moderna currently has 9 development candidates in its prophylactic vaccines modality. To date, Moderna has demonstrated positive Phase 1 data readouts for 6 prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3 and CMV).

For mRNA-1273, we were able to leverage our experience in vaccines to move rapidly on design and manufacture of material for the Phase 1 clinical trial. This included our broad understanding of the safety of our platform to date across more than 1,000 subjects. We also benefited from the use of our well-established manufacturing capabilities, which produced over 100 batches of mRNA medicines for use in human clinical trials in just the last two years.

Phase 1 safety and immunogenicity data from the trial being run by the NIH is expected to guide our next steps. Given the pandemic, we have started to work in parallel to responsibly accelerate further development.

The Company is actively preparing for a potential Phase 2 study under its own Investigational New Drug (IND) filing to build on data from the ongoing Phase 1 study being conducted by the NIH. To continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data. Manufacture of the mRNA-1273 material for the potential Phase 2 trial, which could begin in a few months, is underway. Moderna continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.

Our goal is to generate data that will demonstrate the safety and effectiveness of mRNA-1273 against infection caused by SARS-CoV-2.

Moderna has already started to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit. We are working around-the-clock to make sure a vaccine is available as quickly and as broadly as possible. We will continue to work together, with government, industry and other third parties to enable the best chance for success.

Moderna’s COVID-19 vaccine shows positive early results in the first human trial. The preliminary findings, in the first eight people who each received two doses of the experimental vaccine, must be repeated in far larger tests in hundreds and then thousands of people, to find out if the vaccine can work in the real world. 

In the clinical evaluation/regulatory stage