By Jaimy Lee
MarketWatch photo illustration/Getty Images, iStockphoto
Regardless of the outcome of this week’s presidential election, not much is going to change with how the first COVID-19 vaccines are likely rolled out to Americans.
“No matter who wins the election, this administration’s in charge until Jan. 20, at a minimum, and that process is the process that this administration will be putting in place, the funding, the plans for distribution,” Dr. Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston and founder of Ariadne Labs, told MarketWatch on Monday.
Much of the focus on COVID-19 vaccines has been whether or not they are safe or effective, and when the first candidates will receive regulatory authorization or approval, which will make them available to the public
But even when we get to that point, distributing a vaccine to hundreds of millions of Americans isn’t going to be easy. With the exception of Johnson & Johnson’s /zigman2/quotes/201724570/composite JNJ -0.57% coronavirus vaccine candidate, all of the front-running candidates require two doses. Some need dry ice and have extremely cold storage requirements. And the vaccines are expected to be allocated first to the groups of people, like front line health care workers and nursing-home residents, who are most at risk of contracting the virus.
This is why Ariadne Labs, an organization created by Brigham and Women’s Hospital and Harvard T.H. Chan School of Public Health, and the Surgo Foundation recently launched an online tool for states to figure out how to allocate the doses of vaccine that become available to them.
“This is going to be wrenching,” Gawande said. “We think it’s tough having these discussions around masks — we’re going to have the discussions around which county’s firefighters will get vaccinated and which ones won’t be able to.”
MarketWatch: Why do states need something like this? What is at stake?
Dr. Atul Gawande: Look, we could see results from vaccines in the next month. Even if it slips a couple of months, it’s still a miracle. It’s amazing that we could be in a place where we might have a vaccine available. However, companies such as Moderna /zigman2/quotes/205619834/composite MRNA -1.56% have indicated that they will have 20 million doses that would be available by January. [The company told investors last week it plans to have 20 million doses of its COVID-19 vaccine candidate ready by the end of the year.] It’s a two-vaccine regimen. So that means enough for 10 million people. Pfizer /zigman2/quotes/202877789/composite PFE +0.71% indicated that they would have about 20 million courses available. [The drug maker said it’ll have between 30 and 40 million doses ready by the end of the year, according to a FactSet transcript of a recent earnings call. Pfizer’s experimental vaccine candidate also requires two doses.] And so if we have 10 to 20 million people who can be vaccinated, there are 19 million high-risk health care workers and first responders.
We’re already in a realm where we might end up having to ration but we also want to make sure we’re getting to the next level priority groups, like nursing home residents, people who are especially at risk, for the chronically ill, perhaps critical workers. That means this is going to be wrenching. We think it’s tough having these discussions around masks — we’re going to have the discussions around which county’s firefighters will get vaccinated and which ones won’t be able to.
Then we have the further problem. The Centers for Disease Control and Prevention (CDC) estimates that to carry out that distribution, the costs for the states would be about $6 billion for workers, for shipping, for the complex cold-chain requirements. [CDC director Dr. Robert Redfield told Congress in September that vaccine distribution will cost between $5 billion and $6 billion .] The administration has released $200 million so far and promised $140 million so far. It’s not even nearly enough. We have to be prepared for some severe challenges and distribution.
MarketWatch: There’s a lot of attention on when we’ll get clinical data for COVID-19 vaccines and when the first vaccine will be made available. But the timeline for distribution is going to vary. What other challenges do you think are going to exist in this distribution process?
Gawande: A lot of attention has been on whether people will accept the vaccinations. I’m actually less concerned. As the public sees health care workers taking vaccinations and being the first ones to do it, as we see the effectiveness, and we see the clinical results, that will then build confidence depending on what the evidence is, and what we’re seeing about the initial safety from the initial groups.
I think that it [will be] almost the other way around. Given the shortages, there will be clamoring and a great deal of concern about getting enough vaccines for my community, for my family, for my state. Having that distribution process be as apolitical as possible, as free from being governed by favor as much as possible, is crucial. No matter who wins the election, this administration’s in charge until Jan. 20, at a minimum, and that process is the process that this administration will be putting in place, the funding, the plans for distribution. I do know this is one area that the [White House] Coronavirus Task Force is active.
There’s inevitably challenges because it depends on what vaccine ends up being approved, and whether it’s successful. They’ve made a bet on six vaccines. But if it’s an AstraZeneca /zigman2/quotes/200304487/composite AZN +5.29% vaccine that is highly successful, or a vaccine from another country, we will have a lot of work to do to access supplies.
MarketWatch: I was going to ask you about whether you think Americans are losing trust in the Food and Drug Administration’s oversight of vaccines. I’m curious how that intersects with what you just said about seeing health care workers be first to get the vaccines.
Gawande: The FDA has done a very good job of asserting independence and being transparent and clear that the process will not be political. Peter Marks, who oversees vaccine approvals [as director of the FDA’s Center for Biologics Evaluation and Research], has been very public, including with an extraordinary USA Today op-ed , laying out exactly how his department will be considering the evidence, looking for evidence of safety, and assessing every vaccine trial candidate as it comes through. That gives a lot of people in health care confidence that they can recommend whatever the FDA concludes, and that will help build broad confidence.