Hans Pennink/AP Photo
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Melissa Harting, of Harpersville, N.Y., gets an injection as part of Moderna's Phase 3 trial for a COVID-19 vaccine in late July.
First Response
I hope you enjoyed Harold Meyerson’s coverage of the political conventions. Now that they’re over, I’m back with Unsanitized until, well, until such time as a vaccine is distributed globally and the coronavirus is eradicated or at least becomes something low-level enough for us to resume our lives.
And since I look forward to that day, let’s talk about vaccines. For a separate story I’ve done a bunch of reporting on the subject, so let’s try to cover the main questions:
When will a vaccine be available? The most chilling part of Donald Trump’s snoozer of a convention speech was when he said he “will produce a vaccine before the end of the year, or maybe even sooner!” This is a dangerous promise because there’s almost no way that can be done on such a fast track without FDA approval before the completion of all the trials.
Several vaccines are in Phase 3 trials right now, but there’s not much to be done to accelerate the process from there. You need 30,000 participants, who must be recruited and split into receiving the vaccine and a placebo. They must be sufficiently diverse to account for the whole population. It’s a two-shot sequence and you have to space the shots out by a couple weeks. Then the vaccine takes time to get through the system if it’s to produce immunity. You have to wait for some people in the trial to get coronavirus with symptoms, or else you don’t have any real data. “For all that to happen by December would be remarkable,” said Dr. Paul Offit of Children’s Hospital of Philadelphia, who is on a vaccine groups at the National Institutes of Health and the FDA.
So any fast-tracked vaccine would have to be approved before the end of Phase 3 results. FDA chief Stephen Hahn is saying just that. We already suspect that Trump pushed the FDA into approving convalescent plasma for treatment, and pushed the CDC into changing its guidelines so fewer people would be tested. Politics is taking precedence over public safety, which is incredibly dangerous. A rushed vaccine to swine flu in 1976, taken by President Ford and 45 million others, ended up paralyzing about 1 in 100,000 people.
And if you do rush it, people might decide not to use it, and it could give fuel to the anti-vaxxer movement, and damage public health for decades. There’s so much riding on this.
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How will we all get the vaccine? We won’t, actually, not at first. The nation can’t wait for every dose to be ready. States will get an emergency allocation for critical populations like essential workers, nursing home residents, and healthcare workers. A process through the Advisory Committee on Immunization Practices (ACIP) will identify precisely who gets the vaccine first.
That brings up a lot of questions. How do you make those fine-grained determinations? How do you deliver the vaccine, through workplaces or on-site mobile facilities, or with vouchers handed out only to those eligible? What happens when somebody jumps the line? “No matter how well articulated a priority scheme is, you will get anecdotes that a doctor administered the vaccine to the mayor’s family,” said Jim Blumenstock of the Association of State and Territorial Health Officials (ASTHO). Other federal vaccine programs work because the patients have a medical home, and insurance. How do you handle it when you have “essential” workers in warehouses or Walmarts who lack insurance, and how do you ensure they come back for the second of two shots if they have no doctor?
Figuring this all out, and explaining it to the public, will require honesty and transparency. Not exactly a hallmark of this administration, so hopefully the bureaucracy will fare better. Without trust in the process, there will be no trust in the vaccine.
When does it get to the general population? Announcing the vaccine’s approval for use sets off what will be the largest logistical project in the history of mankind. Billions of doses would need to be manufactured worldwide, from multiple manufacturers competing for raw materials. There’s currently a sand shortage—you read that right—hampering the production of glass vials. Elements as far-flung as horseshoe crab blood and shark livers and something called a “vaccinia capping enzyme” are all required in large quantities.
Once manufactured, the doses, and the billions of syringes needed to administer them, must be shipped everywhere needed, amid diminishing capacity on cargo ships and aircraft. Some vaccines, like those from Moderna and Pfizer, need to be stored at ultra-low temperatures, and few facilities currently have that capability. And the vaccine may not last very long, necessitating a “just in time” style of logistics, where the vaccine is shipped and then administered in a relatively quick amount of time, with little inventory in reserve.
The various points of dispensing must be outfitted to store and administer the vaccine; whether through workplaces, hospitals, urgent care facilities, outpatient offices, and pharmacies, or mobile pop-up clinics. Workers are going to have to be protected from contracting coronavirus while delivering the vaccine, meaning more shipments of PPE and in all likelihood outdoor dispensation.
Why don’t you just vaccinate the people giving the vaccine? Because it’s not likely to be 100 percent effective. “Best case scenario, this vaccine is 75 percent effective,” said Offit. “You hope to be protected against moderate to severe disease. Will you be protected against mild infection? No, it’s like the flu vaccine. So people could still transmit the virus.”
If you assume 75 percent efficacy, you would need to vaccinate about two-thirds of the population to prevent the spread. But if you can still spread while vaccinated, that number goes up. And we don’t know how long the vaccine will last. So lots of unanswered questions here.
How the heck are we going to do this? There is some existing infrastructure to rely upon. The Vaccines for Children (VFC) program supplies millions of doses per year and was scaled up to deal with potential mass immunizations for H1N1 in 2009. Under this system, providers would register with their state’s health department, and request part of that state allocation. Each state would fill its allocation and forward orders to the CDC, which would ship out doses directly to the providers. This allows for centralized management of inventory and documentation of what’s been administered.
The Trump administration has discussed using the Department of Defense for contracting and logistics, although this would be new territory. “They do logistics with the military on one end and the other,” said Eric Toner, a scientist with the Johns Hopkins Center for Health Security. “This is interacting with a very messy private sector.”
And of course, VFC immunizes a few million children per year; COVID vaccines could increase the scale 100-fold. This will require extreme levels of coordination across multiple manufacturers, federal and state government agencies, tens of thousands of healthcare providers and vaccine distributors, and private and public-sector shippers and logistics specialists. And a competent government leading the way. So, um…
What about the flu? Yes, what about it! Depending on the timing, people will need flu shots and coronavirus shots at the same time. (This is why public health experts are recommending to get flu shots early.) The good news is that the heightened distribution for flu shots—more doses have been produced and more money allocated for distribution—has become something of a dry run for distributing the coronavirus vaccine. So that could smooth the process somewhat.
What if I get sick? Yeah, the drug manufacturers got themselves liability protection months ago.
Days Without a Bailout Oversight Chair
158.
Today I Learned
- Deep dive on Steve Mnuchin’s “overlord of the economy” position. (New York Times)
- Biden economic team now factoring in a big stimulus before the stimulus they’ve already planned. (Axios)
- The medical data trade is loving all these people getting coronavirus testing. (The Markup)
- University of Alabama, with thousands of student cases, threatened professors to stop them from telling students about infected classmates. (Daily Beast)
- Oh great, there’s a herd immunity enthusiast advising at the White House. (Washington Post)
- Restaurants reopening in Miami today, so we’re seeing another premature restart. (WSVN)
- Desperation funneling people to online loans and a cycle of debt. (The Intercept)
- Herman Cain, dead from coronavirus, tweets that coronavirus isn’t that deadly. (HuffPost)
- Coronavirus creating an epidemic of trash. (Wall Street Journal)
