Moderna says it’s on track to report initial COVID-19 vaccine results next month
Moderna is on track to report initial results from its coronavirus vaccine trial next month, company executives said Thursday.
The company is one of the front-runners to produce a vaccine for COVID-19. During an earnings call, Chief Medical Officer Tal Zaks said the trial is operating as planned, and an independent data-monitoring committee is expected to conduct an interim review in November.
The first review from the board will come after the trial reports that 53 cases of COVID-19 have been diagnosed among its sample, and the second interim analysis will come at 106 cases.
The company will need to show the vaccine has at least a 74 percent efficacy rate at the first review, and a 57 percent efficacy rate at the second.
The Food and Drug Administration (FDA) requires at least a 50 percent efficacy rate for the final analysis, though Moderna has said they want to have at least a 75 percent efficacy rate overall.
Moderna finished enrollment in its 30,000 person study earlier this month, and expects two month follow-up safety data, as required by the FDA, in the second half of November, after which it will file for an emergency use authorization.
The company said it is preparing to distribute the vaccine globally and is scaling up for the launch. It has already received $1.1 billion in deposits from governments in advance of vaccine delivery.
“We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,” Moderna CEO Stéphane Bancel said in a statement. “Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”
Bancel said the company expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion doses in 2021.
In August, Moderna said it will charge between $32 and $37 a dose for its experimental coronavirus vaccine for some “low volume” customers, and will charge less for higher volume orders.
Bancel said the company will be charging “well below value” during the pandemic, but will follow market pricing once the virus is under control and considered endemic.
Under the Trump administration’s Operation Warp Speed, Moderna has an agreement to sell the U.S. 100 million doses of the vaccine at $25 per dose. The federal government has an option to buy an additional 400 million doses.