Military Deeply Embedded In ‘Operation Warp Speed’ Leadership

Stat: New Document Reveals Scope And Structure Of Operation Warp Speed And Underscores Vast Military Involvement
When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.” The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. (Florko, 9/28)

Stat: The 8 Most Important Leaders Of Operation Warp Speed 
Below are the eight most important people leading Operation Warp Speed. It is based on an organizational chart obtained and published by STAT, as well as interviews with more than a dozen officials close to leaders of the initiative. Their mission: to help develop and distribute a coronavirus vaccine in record time or risk contributing to the coronavirus response as a dark moment in the nation’s history. (Florko, 9/28)

Also —

The New York Times: A Top Trump Official Dismisses A Report That He Pushed The F.D.A. To Soften New Vaccine Guidelines.
The White House chief of staff, Mark Meadows, dismissed reports that he had pressured the Food and Drug Administration to soften new, stricter guidelines that the agency was preparing for the emergency authorization of coronavirus vaccines.“Why would we do that?” he asked Margaret Brennan on the CBS program “Face the Nation”on Sunday. (9/27)

Atlanta Journal-Constitution: How Long, Really, Before There’s A COVID-19 Vaccine? Experts Weigh In
The director of the Centers for Disease Control and Prevention has told governors that, by Election Day, they need to have plans in place for distributing a COVID-19 vaccine. Not that he thinks that most Americans would have access to such a vaccine by then, even if one becomes available. (Oliviero and Stirgus, 9/26)

Stat: A Guide To How — And When — A Covid-19 Vaccine Could Be Cleared
In a U.S. pandemic response dominated by missteps, the effort to develop vaccines to prevent Covid-19 has so far been a triumph. Vaccines against the coronavirus that causes the disease are now racing through giant clinical trials as a result. (Herper, 9/28)

Modern Healthcare: Tracking Patients’ COVID-19 Vaccinations Likely To Challenge Providers
COVID-19 and the hope for a solution—a vaccine—have shined a light on yet another long-standing problem in healthcare that is likely to get worse: patient identification. The coronavirus crisis, responsible for more than 200,000 deaths in the U.S., has brought renewed focus on patient matching, a subtle but still crucial patient safety and operational challenge hospitals have been grappling with for decades. (Cohen, 9/26)

In other vaccine news —

FiercePharma: As Phase 3 Kicks Off, Novavax And Endo Ink Manufacturing Pact For COVID-19 Vaccine
Maryland biotech Novavax has kicked off late-stage testing for its COVID-19 shot in the U.K. as the hunt for a vaccine hits critical mass—and its U.S. and India trials aren't far behind. To help supply those pivotal trials and a potential commercial rollout, Novavax is partnering with a major generics player. Endo's Par generics unit will handle phase 3 clinical supply and commercial fill-finish responsibilities for Novavax's recombinant COVID-19 vaccine, NVX-CoV2373, at its Rochester, Michigan, plant, the partners said Friday. (Blankenship, 9/25)

AP: Drugmaker Novavax Begins Late-Stage Vaccine Trial In UK
U.S.-based Novavax has begun a late stage trial of its potential COVID-19 vaccine in the United Kingdom because the high-level of the coronavirus circulating in the country is likely to produce quick results, the pharmaceutical company said. Novavax plans to test the effectiveness of its vaccine in a trial involving 10,000 people between the ages of 18 and 84, according to a statement issued late Thursday. At least 25% of the subjects will be over the age of 65, and 400 participants will also receive a licensed flu vaccine. (Kirka, 9/25)

Reuters: Australian Firm Says Its Nasal Spray Reduced Coronavirus Growth In Animal Study
Australian biotech company Ena Respiratory said on Monday that a nasal spray it is developing to improve the human immune system to fight common cold and flu significantly reduced the growth of the coronavirus in a recent study on animals. A study on ferrets showed the product dubbed INNA-051, which could be used complementary to vaccines, lowered the levels of the virus that causes COVID-19 by up to 96%, the company said. The study was led by British government agency Public Health England. (9/27)

AP: China Pushes Emergency Use Of COVID Vaccine Despite Concerns
After the first shot, he had no reaction. But Kan Chai felt woozy following the second dose of a COVID-19 vaccine approved for emergency use in China. “When I was driving on the road, I suddenly felt a bit dizzy, as if I was driving drunk,” the popular writer and columnist recounted in a webinar earlier this month. “So I specially found a place to stop the car, rest a bit and then I felt better.” His is a rare account from the hundreds of thousands of people who have been given Chinese vaccines, before final regulatory approval for general use. It’s an unusual move that raises ethical and safety questions, as companies and governments worldwide race to develop a vaccine that will stop the spread of the coronavirus. (Wu and McNeil, 9/26)

Politico: Ranking Countries’ Likelihood To Secure A Future Coronavirus Vaccine
As soon as drugmakers began testing their coronavirus vaccine candidates, rich countries moved aggressively to lock in deals guaranteeing millions doses for their populations. A global coalition of international organizations is trying to ensure that doesn’t leave poor countries out in the cold. We’ve mapped where 15 countries, plus the European Union, stand when it comes to their likelihood of having access to a vaccine once it proves safe and effective against the virus. (Paun and Heath, 9/24)