The U.S. government will pay as much as $1.5 billion to buy 100 million doses of Moderna's experimental coronavirus vaccine, securing supplies of a shot that it's helped to develop and advance quickly into late-stage clinical trials.
Source: Biopharma Dive, August 11, 2020
Moderna has already benefited substantially from federal funding, which the company is using to pay for the recently started Phase 3 trial of its candidate in some 30,000 volunteers. Government scientists developed some of the technology that underpins the vaccine, and the National Institutes of Health led the initial human study.
The deal implies a per-dose price of roughly $15, in between the costs suggested by similar deals the Trump administration struck with Johnson & Johnson last week, and with Pfizer and German vaccine developer BioNTech in July. Doses secured by the U.S. will be available for free in the country, although doctors could still charge for administration.
Through "Operation Warp Speed," the Trump administration has invested roughly $11 billion into funding the testing, manufacturing and supply of seven experimental coronavirus vaccines — part of an aggressive bid to ready millions of doses for use by early next year.
While deals were struck with other companies earlier, the U.S. government has been involved most closely with Moderna. NIH researchers worked together with Moderna scientists to design and test in animals what became the company's vaccine candidate, now called mRNA-1273. Four of those NIH employees are listed as inventors on patents disclosed in that research.
After Moderna quickly completed clinical manufacturing of the first batches of mRNA-1273, the National Institute of Allergy and Infectious Diseases, an NIH division, led the Phase 1 study from which the shot's initial safety profile was established.
Now, should the Phase 3 study currently underway produce positive data, the U.S. will get access to 100 million doses, and potentially many more.
Earlier, smaller preorder deals agreed to by the company and other countries set a price of between $32 and $37 per dose, which works out to as much as $64 to $74 per person. The U.S. appears to be obtaining Moderna's vaccine at a much lower price of $15 per dose, although that doesn't account for the $1 billion in development funding already provided.
The implied U.S. price tag appears to put Moderna in line with other vaccine manufacturers to recently cut deals with the government. But calculating, and comparing, vaccine prices across these agreements is difficult as they each fund different elements of testing and manufacturing.
A price of $15 per dose, or $30 per Moderna's two-shot regimen, however, would be in the same range as what the U.S. pays for influenza vaccines.
As with other agreements, the U.S. has an option to acquire additional doses, in this case 400 million.
Enrollment in the Phase 3 trial of Moderna's vaccine could be complete by September, company executives said recently, which could enable the company to meet the aggressive timelines for development set out by the U.S. government.
Author: Ned Pagliarulo