Researchers are testing whether four types of so-called “messenger RNA” vaccines can prevent COVID19, the sometimes fatal disease caused by the coronavirus. The hope is the RNA triggers the body to produce proteins associated with the coronavirus. The vaccines are developed by Pfizer and Biopharmaceutical New Technologies. If the vaccines are successful and receive regulatory approval, Pfizer says it can produce millions of doses by the end of the year.NYU continues to recruit healthy candidates to participate in the trial. If someone is between the ages of 18 and 55, and has not been diagnosed with COVID19, they might qualify.
Moderna Eyes Summer for Phase 3 COVID-19 Vaccine Trial
Moderna is finalizing the protocol for a phase 3 trial of its COVID-19 vaccine with a view to starting the study early in the summer. The establishment of the timeline, which follows FDA clearance to run a phase 2 trial, puts Moderna on track to win approval for its mRNA vaccine mRNA-1273 next year.Having been the first group to start testing a vaccine against SARS-CoV-2, Moderna is now on the cusp of phase 2. With the FDA having completed its review of the IND, Moderna expects to start the 600-subject phase 2 “shortly.”
The phase 3 is following closely behind. Moderna is currently finalizing the protocol for the pivotal trial. If the phase 2 and other preparations go as planned, Moderna could get the pivotal clinical trial underway early in the summer, setting it up to gather the data it needs to potentially win full FDA approval for the vaccine next year.
SHERLOCK’s 1 Hour COVID-19 Detection Test Gets FDA Approval
The FDA granted its first emergency authorization for a CRISPR-based test for COVID-19, developed by Sherlock Biosciences, designed to turn results around in about an hour compared to the four to six hours needed for other molecular diagnostics.
The test is based on the company’s namesake technology, SHERLOCK, short for Specific High-sensitivity Enzymatic Reporter unLOCKing, a Cas13a-based CRISPR system that targets RNA rather than DNA. It looks for an RNA sequence specific to SARS-CoV-2, the virus that causes COVID-19, in patient samples taken from the upper airways with a swab or from airways in the lungs known as bronchoalveolar washing.