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
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, 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
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
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
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.
I’m very concerned about the intimations that there could be retaliation against the FDA director for holding that independent stance and he could be fired after the election. [Politico and other news outlets have reported that Trump administration officials have considered firing Dr. Stephen Hahn, who currently serves as the commissioner of the FDA.] What happens over the next two to three months in this period after the election is everything for how many tens to hundreds of thousands of people die over the winter season, and what happens to vaccines.
MarketWatch: How do you think a Biden presidency would affect the course of the pandemic in the U.S.?
Gawande: Well, there’s clearly a stark difference in approach. The President said he’s tired of hearing about “COVID, COVID, COVID” and as the crowd cheered “Fire Fauci,” he said, “Wait and see,” implying that he will fire Fauci. [This occurred Sunday at one of Trump’s reelection campaigns.] Biden has been very clear that he would be embracing a consistent message on wearing masks and requiring masks in public settings, ramping up and creating a national testing strategy and funding it. All of that said, Biden doesn’t come in until the end of January if he wins.
What happens right now in this pandemic is happening now. So this has still got to be about public pressure to bring this administration to support some key things that have to happen. Work with Congress for testing funding. A consistent message backing masks. Opening up hospitalization data, which have been not made public, [such as] your local hospital capacity and volume of COVID cases so that people can plan as this spreads. There are some basic things that can make a huge difference in whether we have another 200,000 deaths by the end of the winter. We could be at half a million deaths by the end of the winter. It’s never too late to save another 100,000 lives. That’s what we have to work on right now.
MarketWatch: What would a Trump reelection look like?
Gawande: It all depends on the Republican party. Because if Trump is re-elected, and Republicans continue to privately carp about the lack of a strategy, but (say) nothing publicly, then we’ll be stuck. But Congress can pass the funding for testing. Congress can pass requirements that hospitalization data be public. Congress can pass stronger messages and requirements around masks.
We already have a 10-state compact that includes both Republican and Democratic states, with Larry Hogan, a key leader in Maryland, the Republican governor, for buying testing, as a group rather than competing state by state for diminishing supplies. The development of interstate compacts where they pull together in a common interest will become much more important in a Trump administration. You’d think that a confederacy of states to take action in the common interest would be what we created the federal government for, but the interstate compacts to replicate that are going to become a very important tool.
MarketWatch: How do you think the pandemic is changing the way Americans think about or use health care? What’s good? What’s bad? Is any of this long-term?
Gawande: The recovery of much of the hospital sector has been faster than I anticipated. Many hospital systems, the larger ones, are in the black. And insurers, because of lower use of health care services broadly, are going to have a very strong year.
However, there’s a couple pieces of critical infrastructure that have become a problem. One is the rural hospitals and rural health systems have been severely damaged. [There has been a] 30% drop in patients coming for health care, especially during the spring and now (that) may be repeated during the fall if things get bad. That, for rural settings that don’t have capital reserves, has been devastating.
A poll just came out from the Harvard T.H. Chan School of Public Health and NPR that found that one in four rural residents have had difficulty obtaining access to care in their area in the pandemic. They’ve needed care and couldn’t obtain it. And the second big area is primary care, which overlaps with that. Primary care practices, especially independent practices that are not part of hospitals, don’t have reserves and have been severely strained, losing patient visits for much of the spring. [A study published in June in Health Affairs estimates a $15 billion net loss to U.S. primary care practices even without another formal lockdown in place.]
And as the outbreaks worsen, on the one hand, coronavirus patients want to get in, but lots of others are not necessarily showing up. We’ve had a 17% jump in mortality for the year since March [according to CDC figures]. Two-thirds of that are COVID cases. But one-third are other cases where people are concerned about coming into the health care setting.
MarketWatch: When you look ahead at where the U.S. is heading this fall and winter, how concerned are you about what’s happening in rural communities?
Gawande: The spread was originally in urban coastal areas in the spring. It then became [present] in bigger cities and moved into rural areas in the summer. And now there is no epicenter. It’s getting worse fast everywhere. Places like North Dakota, South Dakota, Wyoming, Iowa, these are the fastest rates of spread in the country, and they have the least capacity in their health systems to absorb it. Positivity rates, in those places I just described, are over 30% for tests, which means the testing capacity is also not there to keep up. [Positivity rates for South Dakota, Wyoming, and Iowa have exceeded 30% over the past week, according to the Johns Hopkins University’s Coronavirus Resource Center. In North Dakota, the rate has been about 13% over the past week.] It runs well beyond what a tracing capacity can do. I’m deeply worried about those environments. Many of those settings have public officials, however, who are not willing to put in requirements that would bring this under control, like requiring masks and reducing the size of groups in bars and restaurants indoors. I’m very worried we are set up for real trouble. Deaths follow about a month after the cases appear.
MarketWatch: Anything else you’d like to add?
Gawande: I’d only say the answers had been really clear. We have commitment to masks. We have commitment to testing, and then avoiding especially large indoor gatherings, crowded spaces with people, especially without masks. We have 91% of the country that is now saying that they are wearing masks [when out in public], but it’s indoors eating and drinking, where we take off our masks, and the percent who are reporting that they are having these gatherings with family friends in restaurants and bars is now over 50%, where it was only a minority in late spring. I think pandemic fatigue has set in. But the virus does not care.
This Q&A has been edited for clarity and length.
Read more A Word from the Experts interviews:
• Dr. Zeke Emanuel says this is what it will take to fully reopen the U.S.
• People of color shouldn’t be treated equally in COVID-19 vaccine trials, ER doctor says: They should be over-represented
• Trump’s vaccine czar says the first vaccine should be submitted for emergency authorization around Thanksgiving