Coronavirus Vaccine: All eyes on Moderna

Grant Boone
May 10, 2020

"The U.S. Food and Drug Administration (FDA) completed its review of the Company's Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273) allowing it to proceed to the Phase 2 study", Moderna said.

The phase 1 NIAID study began on March 16, 2020, and enrolled 45 adult participants ages 18 to 55 years in 3 original dose cohorts (25 µg, 100 µg and 250 µg).

Cambridge, Mass. -based Moderna made the announcement on Thursday that mRNA-1273 will move to Phase II "shortly" and a Phase III study could happen as soon as the "early summer" this year. "With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first [biologic license application] approved as soon as 2021", Moderna CEO Stéphane Bancel said.

Moderna CMO revealed that they are under the work of phase three in which more vaccines can be distributed to the public and assessed for safety. So-called challenge studies, where treatments or preventatives are tested directly against the infection in informed volunteers, might speed the path of vaccines to the public. That is, of course, if the vaccine is proven to be safe and effective.

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Earlier this week, Pfizer Inc and BioNTech SE said they began delivering doses of their coronavirus vaccines for initial human testing in the United States, hoping to get emergency use approval in the USA as early as October.

Most traditional vaccines introduce an inactive or weakened version of the virus itself into the body to train the immune system to create antibodies to fight it, whereas this vaccine takes one step back and uses a molecule called messenger RNA (mRNA) to instruct cells to build viral proteins themselves, according to a previous Live Science report.

The World Health Organization in a new report says intentionally infecting healthy volunteers with the coronavirus might accelerate the development of a vaccine.

In tests done at the National Institute of Health's Rocky Mountain Laboratory in Montana, a single dose of the Oxford vaccine was effective at protecting rhesus macaque monkeys from developing COVID-19, the disease caused by the coronavirus - even after the monkeys were exposed to large quantities of the virus.

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