CAMBRIDGE, Mass. – Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a supply agreement with the Government of The Philippines for 13 million doses of the COVID-19 Vaccine Moderna.

Under the terms of this agreement, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the Company will work with regulators to pursue necessary approvals prior to distribution.

A separate agreement with the Philippine Government and private sector for the supply of an additional 7 million doses is also anticipated.

“We thank the Government and the private sector for their collaboration to bring the COVID-19 Vaccine Moderna to the Philippines,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We appreciate the confidence in Moderna, and our mRNA platform demonstrated by the Government of the Philippines. We remain committed to making our vaccine available on every continent to help end this global pandemic.”

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. 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 the NIH on February 24, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine.

On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination).

Authorized Use

The COVID-19 Vaccine Moderna has been granted temporary approval by Swissmedic, the Swiss Agency for Therapeutic Products, based upon the recommendation of the Human Medicines Expert Committee (HMEC), which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.