UPDATE; August 2, originally published July 31
Operation Warp Speed has moved along at a rapid clip. But some people involved in the process fear pressure to deliver an October surprise for President Trump.
“DEADLINE: Enable broad access to the public by October 2020,” the first slide read, with the date in bold. It escaped no one that the proposed deadline also intersected nicely with President Trump’s need to curb the virus before the election in November.
Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation, according to interviews with administration officials, federal scientists and outside experts.
Even in a less politically charged environment, there would be a fraught debate about how much to accelerate the process of trials and approval. The longer that vaccines are tested before being released, the likelier they are to be safe and effective.
Despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” said Dr. Paul A. Offit of the University of Pennsylvania, who is a member of the Food and Drug Administration’s vaccine advisory committee. “They are really worried about that,” he added. “And they should be.”
Dr. Fauci to the rescue?
Dr. Anthony S. Fauci, the nation’s top infectious disease expert, reassured members of Congress and the public last Friday that the United States would likely have a safe and effective coronavirus vaccine by the end of this year or early in 2021, and pointedly cast doubt on efforts by Russia and China.
Dr. Fauci Reassures Congress “U.S. Will Likely Have Vaccine By Year’s End or Early 2021”
“I do hope that the Chinese and the Russians are actually testing the vaccine before they’re administering the vaccine to anyone,” Dr. Fauci said, adding, “I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines.”
Dr. Fauci also cast doubt on a study, touted by Mr. Trump and conservatives, conducted by Henry Ford Hospital in Detroit that showed an apparent benefit for hydroxychloroquine, the anti-malaria drug that President Trump has touted as a Covid-19 treatment. “That study is a flawed study,” Mr. Fauci said.
– what to expect
On Jan. 20, just nine days after Chinese health authorities published the DNA sequence for a new coronavirus that had sickened dozens of people in China, Dr. Michael Osterholm, an epidemiologist at the University of Minnesota, wrote in an email: “I’m certain this will cause our next pandemic.”
The next day the Centers for Disease Control and Prevention confirmed the first U.S. case of someone infected with what became known as COVID-19. Since then, as outbreaks intensified and the virus spread to Europe, and then the Americas, Osterholm, a flu expert with experience working in the CDC who heads up the Center for Infectious Disease Research and Policy, has become one of the nation’s leading voices on the pandemic, weighing in on everything from masks to contact tracing.
“Everyone is looking at the vaccine as being a light switch: on or off. And I look at it as a rheostat, that’s going to take a long time, from turning it on from its darkest position to a lightest position. If you’re anticipating a light switch, you’re going to be concerned, confused, and in some cases very disappointed in what it might look like in those first days to months with a vaccine”, said Dr. Osterholm.
The White House has described the COVID-19 pandemic, when the president, on the rare occasion, acknowledges the full extent of it, has repeatedly set expectations of the virus is at the stage of the “beginning of the end”. Dr. Osterholm and others within the medical community disagree with that optimistic assessment.
Dr. Osterholm went on to add… “We will be dealing with this virus forever. Effective and safe vaccines and hopefully ones with some durability will be very important, even critical tools, in fighting it. But the whole world is going to be experiencing COVID-19 ‘til the end of time.
“We’re not going to be vaccinating our way out of this to eight-plus billion people in the world right now. And if we don’t get durable immunity, we’re potentially looking at revaccination on a routine basis, if we can do that. We’ve really got to come to grips with actually living with this virus, for at least my lifetime, and at the same time, it doesn’t mean we can’t do a lot about it.”
The one of the main questions yet be answered and Administration’s, so-called “Wrap Speed” eight billion dollar (and counting) to push drug companies to rush development of a viable vaccine, are we going to see some of these vaccines fail in clinical studies?
One of the challenges we have, Dr. Osterholm explained, is what do we mean by fail? “What’s the definition? Some people right now have a view that any vaccine that isn’t like the measles vaccine is going to be a challenge, meaning they’ve got to work 93% to 98% of the time. I don’t think there’s any sense that that’s going to happen with this vaccine.
That doesn’t mean that there isn’t going to be an effective vaccine at 50%, 60% or 70%.”
Osterholm went on to explain, “We’ve never had a pandemic due to coronavirus before.”
“We’ve had influenza pandemics. With an influenza pandemic, you do get true waves, meaning you get a first big peak of cases, then the numbers come down substantially without any human intervention. It’s nothing we do. We’ve never understood why that happens, and then a few months later you get a second wave. At this point, that’s not what’s happening here.”
“This is like a forest fire and wherever there’s human wood to burn, it’ll do it. What we see, though, are these spikes in cases where human mitigation strategies ended, or they’re not adhering to them … This is just one constant pressure that’s occurring.”
Pandemic response failure – a befuddled White House response and an absence of Federal leadership — on this point, Osterholm explain, “We’ve failed because we declared victory over the virus when we had no business doing so. This virus has been poised to be transmitted in our communities, and we thought we had done enough to get it down, and then we gave up.”
At Today’s House hearing
Democrats on the House panel wasted little time in pointing out that the caseload is much lower in Europe and Asia than in the United States. Mr. Clyburn, the No. 3 House Democrat and chairman of the subcommittee, displayed a chart showing the disparity. Pressed to explain, Dr. Fauci said countries in those parts of the world were more aggressive about shutting down as the pandemic raged.
“When they shut down, they shut down to the tune of about 95 percent, getting their baseline down to tens or hundreds of cases a day,” Dr. Fauci said.
By contrast, Fauci went on to explain that, “…only about 50 percent of the United States shut down, and the baseline of daily cases was much higher — as many as 20,000 new cases a day — even at its lowest. More recently, the United States has recorded as many as 70,000 new cases a day.
Representative Jamie Raskin, Democrat of Maryland, suggested that lack of social cohesion and political leadership was to blame. To that Dr. Fauci said, “I think there was such a diversity of response in this country from different states that we really did not have a unified, bringing everything down.”