Friday, August 07, 2020

Moderna's coronavirus vaccine trial set to begin this month

Mar 07. 2020
File photo /Syndication Washington Post, Bloomberg
File photo /Syndication Washington Post, Bloomberg
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By Syndication Washington Post, Bloomberg · James Paton · NATIONAL, BUSINESS, SCIENCE-ENVIRONMENT, US-GLOBAL-MARKETS · 

Human studies of Moderna Inc.'s experimental coronavirus vaccine are set to begin this month, positioning it to be first among a host of shots that companies are developing to fight the contagion.

The Moderna product is moving very rapidly and will enter human trials "within a couple of weeks," said Richard Hatchett, chief executive officer of the Coalition for Epidemic Preparedness Innovations, a group overseeing development of shots against deadly infections. The estimated start of a trial of Moderna's vaccine is March 19, according to a U.S. government website.

Moderna declined to comment.

As concerns about the lung virus mount, health officials and the public have been closely watching Cambridge, Massachusetts-based Moderna's progress. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said in late February that the trials might begin within two months.

Human tests of drugs and vaccines usually progress in three phases to evaluate such measures as safety and effectiveness. Moderna's vaccine could hit the second phase of these tests as soon as this summer, Hatchett said.

"We're working closely with Moderna, with our partners at NIH and with regulators to make sure any vaccine that is developed -- I can't underscore this enough -- is safe and effective," he said.

Shares of Moderna rose as much as 5.4% Friday in New York.

Participants haven't yet received the vaccine, though the enrollment process has begun, the U.S. institute said Friday in an emailed statement. The early stage trial will be held at Kaiser Permanente Washington Health Research Institute in Seattle, it said.

The urgency is rising as the number of coronavirus cases globally surges past 100,000, but vaccine developers face a number of hurdles in getting a product to the finish line. A CEPI-coordinated push to deliver a vaccine against the coronavirus will be in jeopardy without almost $2 billion in additional funding, the organization said separately Friday.

Vaccine developers have said it takes about 12 to 18 months to design and test new shots. Moderna's approach is considered to be among the fastest-moving in the business.

"You never know what might trip a vaccine development program up," such as manufacturing, purification or safety problems, Hatchett said. "What we do know is this one will be the first one to enter clinical trials globally, I'm 99% certain."

The experimental shot induces the body's own cells to make virus-like proteins that stimulate an immune response and prepare for an actual infection. Other companies working on coronavirus vaccines include Inovio Pharmaceuticals Inc., Sanofi and Johnson & Johnson.

The world would be "lucky" to have a vaccine against coronavirus within a year, U.K. Chief Medical Adviser Chris Whitty told lawmakers earlier this week.


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