Moderna’s Work on a COVID-19 Vaccine Candidate
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 mRNA-1273, our vaccine candidate against the novel coronavirus.
View Moderna’s standard Informed Consent Form and Authorization To Use and Disclose Protected Health Information for Protocol Number mRNA-1273-P301.Oct 22
Moderna completed enrollment of the Phase 3 study of mRNA-1273.Sep 29
Interim results from the older adult age cohorts (ages 56–70 and ages 71+) in the Phase 1 study of mRNA-1273 published in The New England Journal of MedicineSep 08
Moderna signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.Aug 11
Moderna announced a supply agreement with the U.S. government for an initial 100 million doses of mRNA-1273.Jul 28
Non-human primate preclinical viral challenge study of mRNA-1273 published in The New England Journal of MedicineJul 27
The Phase 3 study of mRNA-1273 being conducted in collaboration with the NIH and BARDA beginsJul 26
BARDA expands agreement to support larger Phase 3 program for mRNA-1273Jul 14
Interim results from the NIH-led Phase 1 study of mRNA-1273 published in The New England Journal of MedicineJul 08
Moderna completed enrollment of its Phase 2 study of mRNA-1273.
The cohorts of older adults and elderly adults in NIH-led Phase 1 study of mRNA-1273 completed enrollment.Jun 25
Moderna and Catalent announced a collaboration for fill-finish manufacturing of mRNA-1273.Jun 11
The cohort of younger adults (n=300) and the sentinel group of older adults (n=50) in Moderna’s Phase 2 study of mRNA-1273 completed enrollment.May 29
The first participants in each age cohort were dosed in Moderna’s Phase 2 study of mRNA-1273.May 18
Moderna announced positive interim Phase 1 data for mRNA-1273.May 12
Moderna received FDA Fast Track designation for mRNA-1273.May 06
Moderna reported that Anthony S. Fauci, M.D., Director of NIAID, participated in an interview with National Geographic, which described his assessment of the results of certain preclinical testing related to the ongoing Phase 1 clinical study of mRNA-1273.May 01
Moderna and Lonza announced a worldwide strategic collaboration with the goal to enable manufacturing of up to 1 billion doses of mRNA-1273 per year.Apr 27
Moderna submitted an IND to the U.S. FDA for Phase 2 study of mRNA-1273.Apr 16
BARDA awarded Moderna up to $483 million to accelerate development of mRNA-1273 to enable large-scale production in 2020 for pandemic response.
The NIH-led Phase 1 study of mRNA-1273 completed enrollment of three dose cohorts (25 µg, 100 µg and 250 µg) and expanded to an additional six cohorts: three cohorts of older adults (ages 56 ‑70) and three cohorts of elderly adults (age 71 and above). Mar 27
The NIH announced that Emory University in Atlanta would begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273.Mar 23
While a commercially-available vaccine is not likely to be available for at least 12–18 months, Moderna reported it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.1
Moderna confirmed that it is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials.2Mar 16
The NIH announced that the first participant in its Phase 1 study of mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.Mar 04
The FDA completed its review of the IND application filed by the NIH for mRNA-1273 and allowed the study to proceed to clinical trials.Feb 24
Moderna shipped the first clinical batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study.Feb 07
The first clinical batch of mRNA-1273 was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.Jan 13
The NIH and Moderna’s infectious disease research team finalized the sequence for mRNA-1273. Moderna mobilized toward clinical manufacture.
NIAID, part of NIH, disclosed their intent to run a Phase 1 study using mRNA-1273 in response to the coronavirus threat. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).Jan 11
Chinese authorities shared the genetic sequence of the novel coronavirus.