Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
"We thank the WHO for their data review and for their issuance of an Emergency Use Listing for our COVID-19 vaccine. We are actively participating in discussions with multilateral organizations, such as COVAX, to help protect populations around the world," said Stéphane Bancel, Chief Executive Officer of Moderna. "This EUL is an incredible step forward as we continue our quest to ensure that people on every continent have access to our mRNA vaccine so that we can defeat the devastating COVID-19 pandemic."
The EUL process assesses novel health products during public health emergencies with the goal of making medicines, vaccines and/or diagnostics available to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The EUL pathway involves an assessment of late-stage clinical trial data as well as data on safety, efficacy and quality by independent experts and WHO teams.
The EUL also allows many countries around the world to expedite their own regulatory approval processes to import and administer a vaccine. It also enables UNICEF and the PAHO Revolving Fund to acquire the vaccine for distribution to countries in need. An EUL is a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in participating countries, including lower-income countries.
The WHO based its decision on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020. Moderna will continue to share data with the WHO as it becomes available.
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 the National Institute of Allergy and Infectious Diseases’ (NIAID) 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 National Institutes of Health (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.
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the government of India has issued a registration certificate and a permission to import the COVID-19 Vaccine Moderna for restricted use in an emergency situation.
"I want to thank the government of India for this authorization, which marks an important step forward in the global fight against the pandemic," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are committed to making our COVID-19 vaccine available around the world."
Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
Moderna's COVID-19 vaccine is authorized pursuant to a Registration Certificate and a Permission to Import the vaccine for restricted use in an emergency situation in India, in adults aged 18 years and older.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with 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. Moderna 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 14 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years.
