April 5, 2021 – The Philippines has now secured 20 million doses of COVID-19 Vaccine Moderna
CAMBRIDGE, Mass.— (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a supply agreement with the 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 , 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 , Chief Executive Officer of . “We appreciate the confidence in , and our mRNA platform demonstrated by the Government of . 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 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 and investigators from NIAID’s . The first clinical batch, which was funded by the , was completed on and underwent analytical testing; it was shipped to the on , 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on , 63 days from sequence selection to Phase 1 study dosing. On , the granted the Moderna COVID-19 Vaccine Fast Track designation. On , 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 , the Phase 2 study completed enrolment.
Results from the second interim analysis of the -led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on in . On , results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in . On , an interim analysis of the original cohorts in the -led Phase 1 study of the vaccine was published in . On , announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On , a letter to the editor was published in 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).
The COVID-19 Vaccine Moderna has been granted temporary approval by , the , 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.
In 10 years since its inception, has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. has been named a top biopharmaceutical employer by Science for the past six years.
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 vaccine against the novel coronavirus, and plans for the supply and distribution of the Moderna COVID-19 Vaccine to the government of , and a potential agreement to provide additional doses to the government of and the private sector, and the receipt of regulatory authorization to distribute the vaccine in . In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “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 press release 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 is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; 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 (SEC) and in subsequent filings made by with the , which are available on the SEC’s website at www.sec.gov. Except as required by law, disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release 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.