Watch the AMA's daily COVID-19 update, with insights from AMA leaders and experts about the pandemic.
Featured topic and speakers
In this episode of the AMA’s COVID-19 update, JAMA's editor-in-chief, Howard Bauchner, MD, weighs-in on vaccine developments, current COVID-19 case rates and trends, as well as approaching Thanksgiving gatherings. Includes a look ahead at soon-to-be-published JAMA papers.
Learn more at the AMA COVID-19 resource center.
Speakers
- Howard Bauchner, MD, editor-in-chief, JAMA scientific publications
Transcript
Unger: Hello, this is the American Medical Association's COVID 19 Update. Today, we're discussing the latest trends and research on COVID-19 with Dr. Howard Bauchner from his vantage point as editor in chief of JAMA and the JAMA Network in Chicago. Dr. Bauchner prefers that I address him as Howard. I'm Todd Unger, AMA's chief experience officer in Chicago.
Howard, we're seeing a real surge in daily cases across the nation, but we've also had some good news on the vaccine front. What does it all mean and is the end in sight? Let's start with vaccines.
Dr. Bauchner: Yeah, I think there's a number of trends. I'm sure we'll get to them over time. Obviously, the announcements from Moderna and Pfizer about these messenger RNA vaccines are indeed exciting. I would say as a journal editor, as a physician, people want to see the data.
We've seen many of these announcements and then people, when they are able to consume all of the data, it's somewhat less positive than some of these announcements. That the effectiveness of the two vaccines is similar is encouraging because they use the same platforms. This messenger RNA enters the cell, leads to the development of the spike protein, that the body makes immunologic response, and then when it sees a live spike protein, it can react to it. That's the protective nature of it.
I think there was more data from Pfizer this morning about it working throughout different age groups, particularly the elderly. But I think many people really want to understand the safety data, and that has not been part of either of the two announcements.
Unger: When do you think we'll get a look at that?
Dr. Bauchner: Well, Pfizer announced this morning that they're going to try to file for an Emergency Use Authorization sometime in the next few days. Now I do want to point out that not Pfizer but one or two of the other companies have said they will get an EUA in the coming months. They should not say that. That's not their decision about whether they get an EUA. That is up to the Food and Drug Administration. And I really want to applaud Steve Hahn, who as commissioner has been very clear about the process that the FDA will go through. So, companies can apply for an EUA, but that doesn't necessarily they'll be awarded an EUA, and there will be some additional checks and balances that have already been announced.
So, for example, it appears as though the FDA will share the data with an advisory panel, and then that advisory panel, indeed I don't know if they'll have a formal vote, but indeed will make a recommendation to the FDA. Although, the FDA obviously will make the final decision.
I think of many of the issues that have transpired over the last couple of weeks to months, I do not believe the Executive Branch or the Secretary of Health and Human Services will interfere with the process. I think everyone recognizes if they did, that would really undercut anyone's trust in the approval process.
So, I have a lot of faith that it will be well handled by the FDA, the FDA advisory panel and then of course the Advisory Committee on Immunization Practices will make their own recommendations. And then some states have announced that day two will look at the data before they distribute the vaccine. That's given me some pause. I'm not sure how many groups we want looking at the same data, but I do think there will be many checks and balances.
Unger: You mentioned the word distribution, obviously there's a big job ahead of us, even once we get to the approval process. Any sense about the timeline and what the next few months will look like?
Dr. Bauchner: Well, I do think if an EUA is filed in the next week or so, and let's say it takes the FDA and the FDA advisory panel a couple more weeks, that probably brings us into mid-December, maybe late December, maybe as late as January 1. The first 20 million doses or so are likely to go to health care workers, and those doses are likely to be distributed through hospitals. I think most people are guardedly optimistic that the first phase of distribution will go well. Procurement of supplies by hospitals is done every day. There's 35 or 3,600 acute hospital facilities in the U.S.
So, I think regardless of the temperature which the vaccine needs to be stored, the first 20 million doses, because they're going to health care workers, it will roll out generally smoothly. And then hospitals are going to have to make decisions about who gets it within their environment and whether or not that will then be extended to nursing home, skilled nursing homes and elderly residents of those nursing homes. That's the first 20 million, it's the next 50 or 100 million that people are really concerned about.
Once you leave the hospital environment, vaccine distribution through practices is far more complicated. Storage is more complicated for some of the vaccines. It's two doses, so people will have to be called back. You're going to have to track who gets which dose and when because you're going to have to follow patients for potential side effects. So, I have a lot of confidence in phase one, health care workers. I think everyone is much more concerned about the next 100 million people.
Unger: Well, while we wait for vaccine approval and widespread distribution, you talk about what you're seeing on the research front in terms of therapies. Are we seeing any movement there in terms of viable options for physicians to prevent COVID from progressing and keep patients out of the hospital?
Dr. Bauchner: Yeah. So, some good news. I'd like to go over some really good news because I think most of what we hear is so dire. The numbers are concerning. I've described them as frightening, 150,000 cases plus. In all my conversations with people, I don't think anyone anticipated this number of cases in early November, and this is without flu and people know there's been this concern about influenza.
It's not simply the number of cases because that does likely reflect additional testing. It's a number of patients in the hospital, and over the last few days, that's been 65 to 70,000. And I think you've seen across the country, particularly in the Midwest and certain areas in the south hospitals beginning to say, there's both a supply issue as well as a bed issue.
That's the concerning news. The good news though is that mortality is definitely come down. Some data's crossed my desk. For patients who are hospitalized, not intubated, mortality is probably now substantially under 10%, and so that is really encouraging news. So, I think many more people who are ill, but not intubated are surviving. I think for those intubated, it still remains relatively high at 35 to 40%. But I do think we've made substantial gains in treatment.
Prevention is a different issue. I think people have awaited monoclonal antibodies. Lilly has announced and has published one study, an early Phase 2 study that's encouraging, but I think not nearly as definitive as people had hoped. In part, the numbers are very small, 400 or 500 patients treated with different doses of the monoclonal antibody. Viral titers came down, some clinical improvement, but the real issue is does it prevent progression?
Last week, JAMA published a very provocative paper, Hypothesis Generating. It was a randomized clinical trial about the use of a particular type of antidepressants in preventing progress to more serious disease from people who had mild disease. So, I think at this point that study and monoclonal antibodies are providing the best promise for prevention from mild disease to serious disease. Although clearly this study in JAMA was preliminary.
Unger: That's really interesting news. Before we started our segment today, we were talking our respect of holiday plans. That's something on everybody's minds right now. Can you talk a little bit about ... There are lots of warnings about getting together, what research are you seeing that would help inform what people are planning for the holidays?
Dr. Bauchner: Yeah, there were some announcements about 10 days ago or two weeks ago that people had thought that the surge was being fueled by small groups. I think now people have looked at additional data and are less clear about that. It's clearly contributing. The story continues to evolve, but I was struck ... A couple of weeks ago, I had a chance once again to talk with Dr. Fauci and I asked Tony, "Can we talk about Thanksgiving and Christmas?" And he once again was preesh and he said, "Howard, let's just get through Thanksgiving before we even talk about Christmas. It was really interesting." And he said, and this was three weeks ago, "Small numbers, small numbers, small numbers." Then the numbers exploded and then there was data that through some tracking and tracing, there was concerned that small groups were contributing to the additional numbers.
I think people are really changing their Thanksgiving plans. I spoke to the senior staff at JAMA yesterday and I think everyone's going to keep the numbers in low single digits, four, five, six people. For me, I mentioned, I usually go to my brother's house and there's 20 to 25 people. This year, it's just my own house. My two children, my sister-in-law and my daughter-in-law. So, there’ll only be six people. So, I think people have really changed their plans.
I think some of it will depend upon what local public health officials say, and I really ask people to listen carefully. You know in the Midwest, Minnesota, Wisconsin, Illinois, Michigan, there's been a huge explosion and I think public health folks there have really asked people to keep Thanksgiving to small numbers. I think the CDC put out some information yesterday, small numbers, open windows. I think that may depend on where you live. Possibly have it outside. Be careful about utensils. So, I do think people have really changed their plans.
Unger: They get a little chilly here in Chicago. Yes. Well, given your background is as a pediatrician, I'm interested in your perspective on information that suggests emergency department visits have dramatically increased for mental health issues in school aged kids and adolescents compared to last year. Do think we understand the toll that this pandemic and remote learning is taking on children and teens?
Dr. Bauchner: Yeah. In some regards, people often say that children are resilient, and they'll manage. We often have different views about children, how much emotional or intellectual struggles they could have because of the pandemic. On the other hand, we'll often say that they're quite resilient.
Firstly, I'd be very careful about putting them in one group. Children, birth to 20-years-old, it really may be very different for the five, six, seven-year-old versus the 15 or 16-year-old. It obviously is going to depend upon what resources a family can provide or a school system can provide. I think there's been increasing concern that for children who are really struggling educationally, Zoom really only enhances that struggle. For other children, they may be doing fine. So, I think it really is going to vary from individual to individual, family to family.
I'm guardedly optimistic that all of the news that I've heard is that in the fall of 2021, if we begin to think about it now with immunizations coming to a wider and wider number of people, that we will definitely begin to get people back to college in-person, back to schools in-person for all of next year. I know this year, it's just really vary tremendously around the country.
The toll, I think we don't quite know yet. JAMA, interestingly enough, has an article coming out in a week or two about the resiliency amongst the elderly, which is very different than what people have talked about. Now these are community dwelling elderly, and there's four or five small surveys that have suggested they have done far better than people have anticipated.
Unger: Well, that's nice news. Well, getting to that vision of the fall, very positive possible future requires that of course people do get vaccinated, and one obstacle to that is just the continuing amount of misinformation that we're seeing on the vaccine front. How do you view your role and JAMA's role in the months ahead to combat that?
Dr. Bauchner: We've just published, next week we'll publish another five or six articles on the vaccine approval process. What people need to be aware of, common questions that they ask, a number ... Kevin Phillips group from Penn is going to ... we're going to publish a paper about behavioral approaches to trying to make people understand about the vaccines.
I think ultimately, we really will be reliant on the data that's made available to the public and then interpreted by their local clinician physician or at the national level folks like Dr. Fauci get on TV and talk about the data. I do think people are very nervous about the side effects. I think they'll be trusting about the effectiveness, although the numbers will be small. 90% effective when there's been 90 cases. I think the public needs to understand how do we come up with that estimate?
I think what will really make a difference around the vaccination rates is what people know about the safety. What are they told about the safety? What do they understand about the safety? I think people do want their lives to return to normal, and they know one of the ways for that to happen is to be vaccinated. But I think more of this is going to turn on the safety rather than on the effectiveness. I think once you're above 70 or 80 or 90% people go, "Oh, that's effective. But tell me, is it safe?"
And then there are, it's going to be complicated. These are new vaccines. I think when you say messenger RNA or DNA, it makes people nervous without understanding exactly how it's being used in the vaccine. And I think we need, the scientific community needs to be humble and to say, "Look, we have safety data out for two months or four months or six months. We think it will be safe for a lifetime, but we can't be 100% sure."
Unger: Well, thank you Howard so much for sharing your perspective and for all the work that you and the team at JAMA are doing to keep the focus on science and data so that we can move back to that time of being normal again.
That's it for today's COVID-19 update. We'll be back soon with another segment. If you'd like more information on COVID 19, visit ama-assa.org/covid-19. Thanks for joining us. Please take care. Happy Thanksgiving.
Dr. Bauchner: Happy Thanksgiving, everyone. Make sure it's safe and with small numbers. Bye-bye.
Unger: Bye-bye.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
