Please ensure Javascript is enabled for purposes of website accessibility

Report: Moderna and Feds Fight Over Coronavirus Vaccine Clinical Trials

By Eric Volkman – Jul 7, 2020 at 6:53PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The two sides are apparently arguing over several issues, including protocols and information sharing.

Gearing up for a phase 3 clinical trial of its coronavirus vaccine candidate, mRNA-1273, Moderna (MRNA 0.60%) is apparently butting heads with federal government officials. Tensions between the company and the officials have delayed the start of the trial. This is according to a report on Tuesday by Reuters that cited three sources familiar with the vaccine project.

The sources say that Moderna and the government, specifically the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), plus outside medical experts brought in by the NIH are at odds over numerous elements of the testing. These include the protocols of the trials, patient monitoring, and information sharing.

Gloved hands holding a vial of medicine.

Image source: Getty Images.

According to the article's sources, Moderna was several weeks late in submitting those protocols due to a dearth of employees to handle the work. This is apparently a key reason the start of the trial has been delayed, although the company insists that it will occur this month as planned. One of the interviewees said that Moderna "could be on schedule if they were more cooperative."

Both Moderna and government entities involved in the mRNA-1273 project have denied strains in the relationship. The Department of Health and Human Services, the NIH's parent agency, characterized its work with Moderna and other parties involved in the project as "extremely cooperative."

Moderna acknowledged "differences of opinion," but denied it was being difficult.

Moderna, a young biotech considered to be a leading coronavirus stock these days, was granted $483 million in funding from the government to develop and produce mRNA-1273. The company is part of the federal Operation Warp Speed program aimed at rapidly developing an effective coronavirus vaccine, and its mRNA-1273 is the first candidate to be entering a phase 3 trial.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Moderna, Inc. Stock Quote
Moderna, Inc.
MRNA
$122.96 (0.60%) $0.73

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
327%
 
S&P 500 Returns
105%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/28/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.