Moderna On Track for Early Data Readout for Covid-19 Vaccine in November

 

Moderna has indicated they are projected to have data to report by the end of the month on their COVID-19 vaccine program. The company said they needed 53 patients in the study to be diagnosed with COVID-19, and the trial hit that figure yesterday. At this time the data is blinded so they don’t know yet if the sick patients received the vaccine or the placebo, but they are preparing the data for the Data and Safety Monitoring Board (DSMB).

Earlier this week, Pfizer and BioNTech reported that their COVID-19 vaccine is about 90% effective in the first interim analysis of data from the Phase III clinical trial. Barring any unexpected glitches, they will likely apply for Emergency Use Authorization (EUA) by the end of November and begin distribution before the end of the year.

The Moderna Phase III clinical trial of its mRNA vaccine is being conducted in 30,000 people, half receiving the vaccine, half a placebo. The trial guidelines call for an interim data analysis, the first to be conducted when at least 53 participants in the trial contract COVID-19. Once that benchmark is hit, the DSMB will run statistical analysis to provide an initial readout of the vaccine’s efficacy and safety. If that all comes together the way they hope, they will likely submit an EUA to the U.S. Food and Drug Administration (FDA) and if approved begin distributing the vaccine to high-risk populations and health care providers by the end of the year.

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), which has been partnered with Moderna on the vaccine development program, told the Financial Times yesterday that the Pfizer readout was good news for Moderna.

“Moderna has an almost identical mRNA. We hope we’re going to see a similar kind of results from Moderna. If we do, then we’ll have two vaccines in play,” Fauci said. 

Of the Pfizer data, Fauci said, “I really quite honestly did not expect that we would have a result as striking as this—more than 90%, close to 95% efficacy—on the first vaccine that went through the gate.”

He went on to say of the Moderna vaccine, “I would really be surprised if we did not see a high degree of efficacy. You know it may not be 95%, it might be 90 or 96 or 89, but it’s going to be up there. I’m fairly certain it’s going to be up there.”

Last week, AstraZeneca reported they expected data on their vaccine program within the next eight weeks, somewhat dependent upon the rate of infection within the communities where the trials are being conducted. That would place the interim data readout somewhere around Christmas. If positive, an EUA application might be possible by the end of the year or sometime in January.

Of their vaccine candidate, Moderna stated, “The Phase III study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease and included more than 7,000 Americans over the age of 65. It also included more than 5,000 Americans who are under the age of 65, but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase III COVE study.”

The company also went on to say, “Moderna also worked to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by COVID-19. The study included more than 11,000 participants from communities of color, representing 37% of the study population and similar to the diversity of the U.S. at large. This included more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.”