May 1, 2020

'Operation Warp Speed' seeks a coronavirus vaccine this year. Is that even possible?

Daily Briefing

    The Trump administration is launching a project called "Operation Warp Speed" that aims to speed up development of a vaccine against the new coronavirus and get millions of Americans vaccinated by the end of this year—a goal that some public health experts warn could jeopardize patient safety.

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    What is 'Operation Warp Speed'?

    Bloomberg, which first reported on Operation Warp Speed on Wednesday, called the initiative "a Manhattan Project-style effort" with the goal of "drastically cut[ting] the time needed to develop a coronavirus vaccine" and "making enough doses for most Americans by year's end."

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    According to the New York Times, the White House before Wednesday had "made no public announcement of the new effort … and some officials [were] apparently trying to talk [Trump] down" from the initiative, "telling him that it would be more harmful to set an unreasonably short deadline that might result in a faulty vaccine than to wait for one that is proved safe and effective."

    But HHS confirmed the effort following Bloomberg's report, according to the Times. Michael Caputo, HHS' assistant secretary for public affairs, said, "Operation Warp Speed is clearly another extension of President Trump's bold leadership and unwillingness to accept 'business as usual' approaches to addressing the Covid-19 crisis."

    Under the project, a group of private pharmaceutical companies and government agencies—including the Department of Defense (DOD), FDA, and HHS—will work together to reduce the development time for a vaccine against the new coronavirus by up to eight months, Bloomberg reports. The project's goal is to develop 300 million doses of the new vaccine, or enough doses to vaccinate a majority of Americans, by January 2021, according to Bloomberg.

    The project will tap into DOD's animal research resources to quickly test experimental vaccines in animals and then launch human clinical trials for promising candidates, according to an official working on the project. Officials involved with the project also are considering using a so-called "master protocol" to test the potential vaccines, meaning the federal government would employ its resources to launch one large clinical trial that would test multiple vaccines at once, Bloomberg reports.

    In addition, Bloomberg reports that officials involved with the project plan to begin mass production of the most effective experimental vaccines at the same time they enter larger trials, meaning there could be mass production of some vaccines that ultimately fail to prove safe and effective. An official told the New York Times that the federal government would protect pharmaceutical companies involved in the project from liability if they end up producing a vaccine that has adverse risks such as sickness or death.

    The project is projected to cost billions of dollars and will largely be funded by the federal government, Bloomberg reports.

    According to Bloomberg, an official involved with the project said the administration has been holding meetings for the project for up to one month. It's unclear which experimental vaccines the project will test, but some experts speculate the project may consolidate vaccine development efforts that are already underway, including vaccines being developed by Johnson & Johnson and Moderna under grants issued by the Biomedical Advanced Research and Development Authority, Bloomberg reports.

    Timeline too optimistic?

    According to The Hill, Trump in early March called on pharmaceutical executives to "accelerate" production of a vaccine for the new coronavirus, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and other public health experts have said a vaccine likely would not be available for at least 12 to 18 months.

    Even that timeline might be too optimistic, Bloomberg reports. Bloomberg notes that it took five years for an Ebola vaccine that started clinical trials in 2014 to get FDA's approval—and that "five-year effort" was "considered remarkable for its speed." According to the Times, it's taken more than ten years for some vaccines to be developed and receive the required regulatory approvals.

    Still, Fauci during an interview on NBC's "Today Show" on Thursday didn't completely rule out the possibility of having hundreds of millions of doses of a vaccine against the new coronavirus ready by the end of this year. He noted, "I was saying in January and February that it would be a year to 18 months, so January is a year."

    Fauci continued, "We want to go quickly, but we want to make sure it's safe and it's effective." He added, "I think that is doable if things fall in the right place" (Jacobs/Armstrong, Bloomberg, 4/29; Sanger, New York Times, 4/29; Samuels, The Hill, 4/29; Sullivan, The Hill, 4/30).
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