Business & Finance
Moderna COVID-19 Vaccine Granted Emergency Use Listing Granted by the World Health Organization
3 May 2021 - - The World Health Organization has issued Emergency Use Listing for US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older, the company said.

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 US 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 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 November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

On November 30, 2020, the company also announced that it filed for Emergency Use Authorization with the USFDA and a Conditional Marketing Authorization application with the European Medicines Agency. On December 18, 2020, the US FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar and Taiwan. Additional authorizations are currently under review in other countries.

Preclinical data on the company's variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication.

These variant-specific vaccine candidates include mRNA-1273.351, which is more specifically targeted against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 (Moderna's authorized vaccine against ancestral strains) and mRNA-1273.351 in a single vaccine.

The company's Phase 2 study to evaluate three approaches to boosting is ongoing.
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