Time is of the essence to provide
a vaccine against this pandemic virus.
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 a COVID-19 vaccine.
View Moderna’s standard Informed Consent Form and Authorization To Use and Disclose Protected Health Information for Protocol Number mRNA-1273-P301.
Takeda Pharmaceutical Co., Ltd submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute Moderna’s vaccine candidate against COVID-19 in Japan.
Moderna completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 and shipped doses to the NIH for a Phase 1 clinical trial that will be led and funded by NIAID.
Moderna announced new capital investments to increase capacity at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to approximately 1.4 billion doses of its COVID-19 vaccine, assuming a 100 μg dose.
Results from in vitro neutralization studies of sera from individuals vaccinated with Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2.
The first participant was dosed in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 in Japan, led by Takeda Pharmaceutical Co., Ltd.
Interim safety and primary efficacy results from the Phase 3 COVE study of the Moderna COVID-19 Vaccine were published in the New England Journal of Medicine.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the Moderna COVID-19 Vaccine in people 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. FDA.
About mRNA-1273, Moderna's Vaccine Candidate Against COVID-19
Moderna’s Ten Years of Research
Since 2010, Moderna has focused on building our mRNA technology platform by leveraging the role mRNA plays in instructing cells to create proteins. Our platform produces mRNA that can be delivered to cells without provoking an immune response against the mRNA itself. Moderna is using this platform to pursue mRNA medicines for a broad spectrum of diseases.
Before there was ever a COVID-19 pandemic, our ten years of research and clinical trials taught us valuable lessons about designing both mRNA therapeutics and mRNA vaccines. This includes, in particular, how to manufacture and formulate mRNA that can produce the targeted proteins – the spike protein, in the case of coronaviruses like the SARS-CoV-2 virus – in the body. Clinical trials of our mRNA vaccine candidates against a variety of viruses have repeatedly demonstrated that they induce the desired immune response.
By the time of the COVID-19 pandemic, we had already been working for years on vaccines for infectious diseases, including on other coronaviruses and their spike proteins. As part of our mRNA technology platform, we had also already developed an mRNA delivery system that was specifically designed for vaccines.
Once the COVID-19 pandemic struck, we were well positioned to adapt our existing mRNA technology to try to address the global public health crisis. We worked closely with the NIH and other government and non-government partners to design and implement a robust COVID-19 vaccine clinical trial program that prioritized safety. Our speed in developing the Moderna COVID-19 vaccine was ultimately a product of our many years of research and investment in mRNA vaccines.
1 Any emergency use would be subject to authorization by the appropriate regulatory agencies, based on the emergence of clinical data for mRNA-1273 that would support use of the vaccine prior to licensure.
2 As has previously been disclosed, the ability of the Company to make millions of doses per month is contingent on investments in the scale up and further buildout of the Company’s existing manufacturing infrastructure.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel Coronavirus, the conduct and timing of the Phase I study of mRNA-1273, the planning, conduct and timing of a potential Phase 2 and any subsequent trials of mRNA-1273, and potential manufacturing capabilities. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this summary and FAQ are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this summary and FAQ in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Moderna COVID-19 Vaccine is investigational and not approved by FDA.
IMPORTANT SAFETY INFORMATION
- Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
- Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
- Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
- Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
- There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.
- Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
- Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words "Moderna COVID-19 Vaccine EUA" in the description section of the report.