Voices of the Virus

The Impact of Mandates ‘Has Been Dramatic’

From vaccine mandates, to combating disinformation spreaders, to scaling up rapid testing and ensuring Big Pharma is held accountable for global supply, Dr. Céline Gounder tells Democracy how we can navigate our way out of this pandemic.

By Céline Gounder

Tagged Biden AdministrationCOVID-19pandemicvaccine

Pandemic fatigue has reached new highs while tens of millions of Americans remain unvaccinated and frustration among the vaccinated has increased. Meanwhile the Biden Administration’s vaccine mandate has been welcomed by many while being a source of extreme controversy for those who see it and other mandates as excessive government infringement. Meanwhile, there have been important updates in the science of the pandemic, including hopeful new antiviral medications, and the latest thoughts on masks and ventilation.

Finally, is the Administration doing its part to stem the virus globally and help ensure the vaccine is shared with the Global South? And, as cases fall in the United States and other countries, is there a light at the end of the tunnel? To take a deeper look at where we are and to answer some of these questions, associate editor Sophia Crabbe-Field spoke to infectious disease physician, epidemiologist, filmmaker, and journalist Dr. Céline Gounder. Dr. Gounder has worked on the editorial board of TEDMED, and been featured in  publications including The New Yorker and The Atlantic. In November, 2020 she was named as a member of President Elect Biden’s COVID-19 Advisory Board. The conversation took place on October 6.

Sophia Crabbe-Field: You were on the Biden transition team’s COVID-19 Advisory Board. So I just wanted to ask if you could speak a little bit to that experience and whether you’ve seen the kind of policies that you were discussing at that time reflected in Biden’s policy toward the COVID-19 pandemic since then?

Dr. Céline Gounder: Oh yeah. I would say a lot of what the Advisory Board recommended to the incoming Administration was very much reflected in their policies, in their plans. And so I think most of us were quite satisfied that the work that we had done had a real impact.

S.C-F: I wanted to start with the issue of mandates and ask: How do you feel things have gone so far with Biden’s vaccine mandates and other vaccine mandates that have been implemented for health workers, for school teachers, for example, in various states? How effective do you feel they’ve been and what is your position on them more generally?

CG: So I live in New York City. I work in New York City. I’m at Bellevue Hospital. New York has really been at the forefront of implementing a whole range of public health measures, including vaccine mandates. We first saw these mandates with health-care workers and then more recently in schools with school staff and also in long-term care facilities and the impact has been dramatic. We’re seeing it among health-care workers, nursing home workers, school staff: vaccination rates of well over 90, 95 percent. So it’s had a profound impact. And I anticipate it’ll be similarly effective in many other parts of the country.

I think, just as one example, Tyson Foods, which is a food processing company, they’ve seen their workforce vaccination rates shoot up with these kinds of requirements. I think Americans are just more receptive to a mandate coming from their employer, from the private sector, than from the government telling them what to do. And I think also to some degree it provides people cover, who, for political reasons, social reasons, may have been reluctant to get vaccinated. But when it’s like, “ I’m going to lose my job if I don’t get vaccinated,” it’s a lot easier perhaps in certain social circles to justify getting vaccinated in that situation.

SC-F: So in your personal experience, what are some of the top reasons that people still give who may not be anti-vaccine, but who are sceptical of the vaccine for their position?

CG: I think they tend to be reflective of some common disinformation strategies and perhaps the most common one is around unreasonable expectations. So when I say unreasonable expectations, I mean holding vaccines to a different standard of evidence than they would just about anything else. And the goalposts on that level of evidence have also shifted over time where initially people said, “Well fine, there’s an FDA Emergency Use Authorization, but that’s an emergency authorization. I want to wait until there’s a full FDA approval.” Well, now we have a full FDA approval, I hear people saying, “Well, but it still hasn’t been long enough. I want to see more data.” I don’t know where this number comes from, but I’ve even seen people say, “I want 14 years of follow-up data on vaccination.”

And that’s not the standard to which we hold other drugs and therapeutics. It’s certainly not the standard to which we have held, just as one example, monoclonal antibodies. And so why is it that we have this different standard and expectation that we’ll have more data on vaccines and that they will be perfect? That is a common talking point of people who are disinformation spreaders, to frame it in those terms. And I think that continues to be one of the most common things you’ll hear people say who are still reluctant to get vaccinated.

SC-F: What is your sense of why we have this different expectation for vaccines?

CG: I think it’s more to do with the fact that it’s a common tactic utilized by disinformationists. And it’s not just with vaccines. It’s also around climate change, proving smoking causes cancer. You had similar sorts of language used in the early days of science on that. And I just think this is another space in which you see that kind of tactic utilized.

SC-F: So I’ve also heard people bring up the fact that there’s been changing information with the Delta variant in terms of effectiveness of vaccines or the idea that immunity wanes, for example. What would be your response be to that and are there takeaways from the Israel experience that the U.S. should keep in mind?

CG: I think, especially in a scary moment like a pandemic, people want to have something they can count on and that includes information. They want to be able to say, “Okay, this is how it is. This is how I can move forward, how I can plan my life.” And the pandemic has not really allowed for that. We are continuing to have to adapt and learn. It really has been a fire hose of information that we’re having to digest. I think the uncertainty adds to the anxiety, and I fully understand that. But it does complicate the messaging because people view it as flip-flopping or, even worse, lying when in fact it’s not that at all; it’s speaking to the best of our knowledge at that point in time. And as our knowledge changes, what you say will evolve as well.

SC-F: Moving a bit away from vaccines, is: What was your response to the Biden Administration’s announcement today on rapid testing? Do you think the Administration is doing enough and why do you think they haven’t done more, earlier to make these more widely available?

CG: I think the focus for so long has been on vaccines and vaccinations. Initially that was a problem with vaccine supply. Then it became a problem with vaccine distribution, getting vaccines into arms. And then more recently it’s become a problem of vaccine demand. There’s plenty of vaccine in the U.S., but some people don’t want to get the shots or are not seeking them out. And I think there’s finally been an understanding that vaccines are really powerful tools, but they are not silver bullets and that you still need to combine vaccinations with other tools. And I think testing is one of those other really important tools.

Many of us have been advocating for scale-up of cheap, rapid, point-of-care, at-home testing for months, really over a year now. And I will say Dr. Rochelle Walensky, who is the CDC director now, was among those who had done research looking at how much testing would you need to do to prevent transmission on a college campus, for example. So she was at the forefront of thinking about how you use testing to reduce risks even before we had vaccines. I think there has been a bit of tunnel vision about too much focus on vaccines and not enough on some of these other tools. I do think the timing is interesting. We have had the approval of another rapid test, so that certainly makes it easier to do something like this, to expand access and to buy supply and make it available to Americans.

We also have the winter holidays coming up. The vaccines work really well, but as long as you have high levels of community transmission, you will have some number of breakthrough infections. And so, in that setting having testing as another measure is really important. I think families ideally would be testing every morning or every other morning before they hang out together over the holidays. And that would be a really great way to ensure safety, but that’s not going to happen when most places you go you’re still having to pay $25 a test. And so if you talk about a family of four testing every day, that’s $100 a day, that’s out of reach for most families. The goal should be to make these$1 a test, or even free. If you look at other countries, Singapore has mailed rapid tests to people’s homes. In the UK, you can walk into a pharmacy and get a rapid test for free. I think that’s what we should be aiming for.

SC-F: So, my next question, the Administration in May stated its support for the TRIPS waiver. There have been some positive steps in terms of global access but I know there’s still been criticism as well of the Administration with the sense that they’re still not doing enough to ensure that low-income countries have access to vaccines and that Moderna and Pfizer are held accountable for scaling up production. What do you think the next steps should be for the Biden Administration in terms of helping to ensure that low-income countries have access to vaccines? Do you think they’re doing enough?

CG: Yeah, TRIPS waiver is a piece of it, but it’s not nearly enough. One, it’s not only up to the Biden Administration. This requires other countries to buy in as well, countries like Germany or Japan, which also have significant pharmaceutical industry presences who may not be as supportive of the TRIPS waiver. Also having the right to produce the vaccine is not the same thing as being able to. To produce a vaccine, you need to have the recipe for production, you need to have access to the raw materials, you need the manufacturing know-how, and that would require much more support whether it’s from the U.S. government or from some of the pharmaceutical companies.

I do think the U.S. government does have certain levers at its disposal, particularly patents on some of the technology that is used in the Moderna and Johnson & Johnson vaccines. And so they could be using these levers to get Moderna and J&J to share the scale up of manufacturing. I think the goal on this front really should be regional self-sufficiency, both with respect to production of raw materials as well as vaccine production, not just fill and finish, which is the very last step in bottling the vaccine in vials, but really the whole soup to nuts of that production.

What happened in India with the Serum Institute is an important example of what can happen when you don’t have manufacturing locally across the globe. You have a country that is one of the biggest vaccine producers in the world in a country that was hit by its own surge back in the spring and shut its borders to vaccine exports, which were being sent to the Global South. Meanwhile, we had invoked, in the U.S., the Defense Production Act on certain raw materials. And so the raw materials the Serum Institute needed to produce the vaccine were in limited supply to them. And then whatever they were able to manufacture had to be kept in India for use locally. And so then you have other parts of the world, especially Africa, as well as parts of Latin America, that have really been left high and dry in terms of vaccine supply orproduction. They need to be able to produce it locally. What’s also interesting is there is a fill and finish plant in South Africa, and yet the vaccine that was being filled and finished in South Africa was then being sent to the EU. And so I think ensuring that there’s local manufacturing, but also local distribution is really important here.

There’s been, around the conversation around boosters, the question of should we be giving booster doses of vaccine in the U.S.? People have been saying it’s not a zero-sum game. And I think that is true if you do what’s necessary to massively scale up manufacturing in the rest of the world, but we haven’t committed to that in a way we need to. I think you’re still looking at late 2022 before there’s really supply for the rest of the world. And so, yeah, there is a choice to be made. It’s not just the doses that we would be using here in the U.S., it’s that you’re also leading by example, and we’re setting an example for the rest of the world. And so if we start to give booster doses to everyone, if the EU follows suit, if say India, Brazil, other big countries follow suit, that has a real impact on the global vaccine supply. You talk about India, that’s 1.4 billion people, with a “B.” That alone is essentially a 10th of what it would take to vaccinate the world. So I think it’s important to understand it’s not just about what we are using ourselves, but what example we’re setting for others.

SC-F: How big of a deal is this new Merck drug that’s coming onto the market and are there any other potential therapeutics or studies or anything that sort of looks promising to you that’s coming down the pipeline?

CG: So molnupiravir this is the Merck and Ridgeback antiviral drug. There are also drugs in development by Pfizer and Roche that are similar. I do think this adds to our arsenal. I don’t think it’s going to be a game changer the way vaccination is. I think of it as kind of like a car wreck. You don’t want to have a car wreck in the first place, but if you do get into a car wreck, having your seatbelt and airbags is good. I think, similarly, you don’t want to get COVID in the first place, but then if you do having that backup of molnupiravir or other antivirals is good. I think one major advance on monoclonal antibodies is that it’s a pill as opposed to an IV infusion. So it’s a lot easier to distribute.

It’s still fairly expensive. And so there are real concerns about access. If you don’t have insurance, what does that mean? Does that mean you can’t have access? Antivirals are best used in the outpatient setting before you’re admitted to the hospital. And so even if you’re uninsured, an emergency room cannot turn you away, but your local retail pharmacy drug store, if you walk in and you want a prescription for molnupiravir but you don’t have insurance, there’s currently no system to get that to you. Now, the U.S. government has purchased a supply of molnupiravir, but it remains to be seen how that’s going to be distributed, so that may help address some of the access issue.

Another key piece is that it’s only effective if taken very early in the course of infection. So I think there will be real potential, for example, if you had a high-risk exposure. Let’s say you are a nursing home resident, and one of the caregivers is diagnosed with COVID and you may have been exposed, to treat everybody prophylactically with an antiviral like this I think would make a lot of sense, before people get sick. I think if people are very early in having symptoms, like a day or two of having symptoms, before they are short of breath, before they’re so sick they need to go to the hospital, you can have a real impact in terms of abridging the infection and shortening the course of disease.

But a key piece there is that you need to be able to test people early enough so that they have access. And so what you would ideally want is a system where, either through telemedicine or probably best through walking into a retail pharmacy, or maybe into a primary care doctor’s office, you walk in, you get the test. If it’s positive, the pill’s given to you onsite to take, but again if you don’t have insurance, we don’t currently have a system for that. And so that’s going to create real access issues. And then you also just need to have the test supply available to people. It needs to be easy to do, easy to access, and so that infrastructure needs to be set up pretty quickly here.

SC-F: I wanted ask you about both masks and ventilation in terms of where we are right now and where we should be. Should we be using N95s? Is it okay for people to still be using cloth masks? And where do we need to go in terms of ventilation in offices and classrooms and elsewhere?

CG: I think given how infectious the Delta variant is, and the fact that, especially in areas where there’s still a lot of transmission, even if you’re vaccinated, there’s still a risk of breakthrough infection. So if you have, for example, a vaccine that is, for example, 90 percent effective against infection, if the level of risk in your community is 1000 per 100,000, if you reduce that by 90 percent, you don’t go to zero, you go from a 1000 to a 100 per 100,000. If you start out at a risk of 100 per 100,000 and you reduce that by 90 percent, you get down to 10 from 100.Again that’s not zero. So it’s a relative risk reduction from what’s happening in the community. So it does make sense, especially if there’s a lot of transmission in the community to layer other interventions. And masking I think is an important one.

I think we’ve learned over the course of the pandemic that some masks are better than others. A mask is better than no mask. I think of it sort of as a hierarchy of cloth masks are definitely better than nothing. But they’re lowest on the hierarchy. Next best, I would say, above that would be a surgical mask, but surgical masks don’t fit tight around the face, so you still have some leakage around that. Better yet would be the KN95 or KF94s. I think for the lay public, those make the most sense, that’s what I wear when I’m out in public. Those provide a tighter seal around the face. And the top endand the standard in the health-care setting would be a KN95. That’s what I wear at work. I think what I would recommend now is for health-care workers to practice universal precautions, assume every patient has COVID, wear an N95andsome sort of eye protection, whether that’s glasses or goggles or a face shield. And for the lay public, the KN95 or KF94.

And then with respect to ventilation, I think ventilation, to an even greater degree than testing, has really been under-emphasized over the course of the pandemic. And it still remains under-emphasized. I think it’s for a few reasons. I think, one, it requires sort of longer term thinking because, while you can purchase sort of portable air filtration units, what you really want to be doing is planning for a more long-term protection, whether it’s COVID or other infectious diseases. And that means upgrading ventilation systems as well as our air filtration systems in buildings.

There is money in the America Rescue Plan and the CARES Act before that, in the infrastructure bill, in the budget reconciliation bill. There is money for these activities. But, for example, in schools, what I’m hearing is that school districts have not aggressively pursued that money. It’s for a few reasons. One is that they don’t necessarily have the expertise on staff to assess their own school buildings, to come up with a plan, to apply for the money, to contract with vendors to do the work, and all that takes time. And then there are also deadlines onwhen the money needs to be spent.

And it’s also not visible, right? You can see if somebody purchased a mask, you can see if testing is being done. It’s really hard to see that a school or whatever building has improved their ventilation. And I think that has made it less sexy as something that we spend your money on. But I think it’s a really important tool. And I think one thing that is so important about ventilation and air filtration is it doesn’t require individuals to take action. It’s not like wearing a mask or getting vaccinated where the individual has to take the responsibility to take action. If you upgrade the ventilation and air filtration, that benefits everybody and they don’t have to do anything. It’s much more passive. And I think having that as a piece of the responses is really important for that reason.

SC-F: You mentioned a couple of countries like Singapore and the UK, for example, but I’m wondering if there are other countries that have important lessons for the U.S. I’m thinking, for example, of Portugal, that’s vaccinated almost all of its eligible population. Are any of those lessons applicable to the U.S.?

CG: I think part of what Portugal did so well was not to politicize the pandemic and pandemic response. And unfortunately in the U.S. our pandemic response was politicized from the very beginning. I think the timing was unfortunate that it hit us during a presidential election, which certainly fed into it. We actually saw a similar pattern during Ebola, which hit during our midterm elections in 2014, and it was unnecessarily politicized, and in no small part because it became a political issue during the election. So I think you saw something similar with COVID. I think we are such a polarized country and there’s such little trust in anything public. That has made our pandemic response really difficult because this is not something you can fight as an individual. This requires a public response, a shared community response, and that means people need to be able to trust one another and work together. I think we’re at a point where there is very little trust. I think you have people who view sacrifice on behalf of the community as being taken advantage of, of being cheated. And that just makes it very difficult to get people to work together for the common good.

SC-F: I think what a lot of people are thinking about now is, what will an “end of the pandemic” look like? What doesa return to “normal,” if there is one, or a new normal, look like? Is there any sort of timeline that’s possible to think about? What do things look like looking down the road a bit?

CG: I think right now we’re seeing cases decline. I think we will see another resurgence around Thanksgiving, Christmas, and New Years. It will not be as bad as last year, but we will see an increase in cases and transmission. Again, around that time, people will be traveling, which will set off new chains of transmission. When people see family and friends, they’ll be less likely to take measures to protect themselves against infection because when we people are around those they trust and love they just are less likely to take those measures.

I think after the holidays things will start to get better again. I think over the next few months, you’re going to see an increasing impact of mandates on vaccination coverage. Whether the U.S. will be able to reach that 68 million who haven’t yet been vaccinated with mandates, I don’t know. I’m hopeful we’ll be able to get plenty of those folks vaccinated. Kids under 12 are soon going to be eligible for vaccination. That will also have an important impact. And so I think by early 2022 things will be different. And I think we’ll have a better sense for where things will stabilize.

COVID is not going away. It is going to become an endemic virus, which means it will continue to be transmitted in the community at some level. We just want to get it to be at a much lower level, where you don’t have the death rates that we currently are experiencing. I think a reasonable goal would be to get it to the level of influenza. Now I would argue, we don’t do nearly enough to prevent influenza, that we should be much more aggressive in vaccinating people for the flu and that the 20,000 to 50,000 deaths a year from the flu is unfortunate because much of that is preventable. But, that said, we as a society have decided that that’s a tolerable level of disease and death for which we do not shut down the economy, for which we do not change how we socialize. And so, as a society, that’s what we’ve decided is acceptable. And so I think a similar level of disease and deaths from COVID would be sort of what I think we should be trying to aim for.

Read more about Biden AdministrationCOVID-19pandemicvaccine

Céline Gounder is an internist, infectious disease specialist, and epidemiologist at the NYU Grossman School of Medicine and Bellevue Hospital in New York City. She is the CEO of Just Human Productions and the host of the Epidemic and American Diagnosis podcasts.

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