Moderna’s mRNA COVID-19 vaccine (mRNA-1273) fast-tracked by FDA

Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced on May 12, that it was granted Fast Track designation for the company’s mRNA vaccine candidate (mRNA-1273) against COVID-19 by the United States Food and Drug Administration (FDA).

Moderna’s mRNA COVID-19 vaccine Phase 3 study to begin this summer

Moderna’s fourth mRNA program will receive fast-track designation and finalising protocol for the Phase 3 study of the mRNA-1273 COVID-19 vaccine is expected to begin in early summer of 2020.

Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna said:

“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus.”

“As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”

Fast Track is designed to promote the creation and accelerate the review of therapies and vaccines for emergency conditions in order to meet the present urgent medical demand. Fast-track approval strategies may benefit from early and consistent interaction with the FDA, in addition to rolling marketing project submissions.

Previously, the American biotech company was granted fast track designation for its Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) investigational programs.

On May 6, the FDA finalised its review of the Investigational New Drug (IND) application for mRNA-1273 allowing it to move to the Phase 2 clinical trial which is set to take place very soon. Moderna is finalising the protocol for a Phase 3 analysis which is scheduled to commence in early summer 2020.

Financing from the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Assistant Secretary for Preparedness and Response (ASPR) by the United States Health and Human Services Department (HHS) has supported the planning of these clinical studies. BARDA will also sponsor late-stage clinical development projects and the scale-up of mRNA-1273 production at both Moderna’s facilities and its strategic partner, Swiss pharma giant Lonza Ltd.

The mRNA-1273 COVID-19 vaccinations Phase 2 Study

Moderna has obtained initial input from the FDA regarding the design of the proposed Phase 2 trial to assess the safety, reactogenicity and immunogenicity of two mRNA-1273 vaccinations provided 28 days apart. Moderna plans to recruit 600 healthy individuals across two adult cohorts aged 18-55 (n=300) and older adults aged 55 and over (n=300). Each participant is intended to be administered a dosage of placebo, 50 μg, or 250 μg. After the second vaccine patients will be followed up over 12 months.

More about mRNA-1273

mRNA-1273 is a messenger RNA against SARS-CoV-2 encoding for a prefusion optimised Spike{S} type protein developed by Moderna in partnership with researchers from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of the NIH. The first clinical sample, sponsored by CEPI, was completed on 7 February 2020 and underwent analytical testing. It was delivered to NIH on 24 February, only 42 days from sequence selection. On March 16, Moderna confirmed that the first participant in its Phase I clinical trial was administered with mRNA-1273, a mere 63 days from sequence selection to Phase 1 study dosing.

For more information, please visit: modernatx.com

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