Moderna Inc., an American biotechnology company based in Cambridge, Massachusetts, has just announced positive Phase 1 clinical data for its nascent COVID-19 vaccine. This means that Moderna’s potential COVID-19 vaccine has demonstrated the ability to catalyze the production of antibodies that guard against the virus that causes COVID-19, SARS-CoV-2, in human patients. So far, the vaccine being trialed has not caused any significant side effects.
Moderna’s announcement, which comes via CNBC, notes that the company is developing an mRNA vaccine. An mRNA vaccine is a new type of vaccine that aims to develop immunity in patients with the introduction of an RNA (or Ribonucleic acid) containing vector, such as a lipid nanoparticle. Note that mRNA, or “messenger RNA,” acts as the messenger between DNA and protein production, as DNA can’t leave the nucleus of a cell.
The above video explains how Moderna’s potential COVID-19 vaccine works.
Moderna’s potential COVID-19 vaccine, dubbed mRNA-1273, works by injecting a patient with vectors (such as the aforementioned lipid nanoparticles) that contain the RNA sequence of SARS-CoV-2. The vectors infiltrate a patient’s cells, allowing said cells to identify and make copies of the spike proteins that make up the SARS-CoV-2 virus. These cells, which develop the same spike proteins associated with SARS-CoV-2, then interact with the body’s immune system, allowing it to generate suitable antibodies.
“These interim Phase 1 data, while early, demonstrate that [the potential COVID-19 vaccination] elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 [micrograms],” said Tal Zaks, the Chief Medical Officer at Moderna. The press release goes on to note that the potential COVID-19 vaccination “elicited neutralizing antibodies in all eight of [the study’s] participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2.”
Due to an easing of FDA regulations in regards to medicines, tests, and equipment related to COVID-19, the approval process for Moderna’s potential COVID-19 vaccine is moving rapidly. The company notes in its press release that on May 12, the FDA granted mRNA-1273 Fast Track designation finalizing the protocol for a Phase 3 study, which is expected to start in July of this year.
“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July….” said Stéphane Bancel, Moderna’s Chief Executive Officer. He added that the company is “investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
Moderna’s leaders discuss the potential benefits of mRNA vaccines in the above video.
Featured Image: Sanofi Pasteur