FDA approvals, CDC recommendations and WHO COVID announcement with Andrea Garcia, JD, MPH

. 10 MIN READ

AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.

In today’s AMA Update, AMA Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, covers the latest news from the World Health Organization, Centers for Disease Control and Prevention, and the Food and Drug Administration's upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting this June. Including the U.S. Public Health Emergency (PHE) for COVID-19 ending on May 11, 2023. AMA Chief Experience Officer Todd Unger hosts.

Find more information and register for "Infection Prevention and Control Post-COVID-19 PHE: A Town Hall with CDC’s Project Firstline" on May 11.

Learn more at the AMA COVID-19 resource center.

Speaker

  • Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association

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Unger: Hello and welcome to the AMA Update video and podcast series. Today we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Welcome back, Andrea.

Garcia: Thanks, it's good to be here.

Unger: Well, it's been quite a week, a lot of changes, all of which seem to be signaling that we are entering a new phase of the pandemic. But first, I want to talk about some good news with a different virus, a new vaccine that's been approved to treat RSV. Andrea, tell us more about that.

Garcia: Yeah, well, that's exciting news. And last Wednesday, we saw the FDA approved that first vaccine that will prevent lower respiratory tract disease caused by respiratory syncytial virus or RSV. That represents a culmination of about six decades of work. And that approved vaccine was developed by GSK.

It's specifically for older adults. But other vaccines aren't far behind. There is a Pfizer vaccine that's under consideration, both for older adults and for pregnant people. And that vaccine for pregnant people is important because it would help protect against RSV in infants from birth to six months of age.

And then there's also a monoclonal antibody treatment that offers vaccine-like protection for babies. That was developed by Sanofi and AstraZeneca. That's also under consideration. This is all really good news. Because we know that RSV can have serious and even life-threatening implications for older adults, infants and young children, as we saw over the course of this past winter.

Unger: And interesting that you said it's the culmination of six decades of work. Because a lot of that talk about that vaccine just feels like it was much more recent. But, clearly, work has been going on for a long time.

Garcia: Yeah, and you know, I think we're finally at a point where we're going to see GSK rolling out their vaccine hopefully in the fall. And that'll be before that winter RSV season. It's been approved by the FDA in adults 60 and older.

It's still going to have to go through that consideration by the ACIP, which is the CDC's advisory committee. And they make recommendations on appropriate use of the vaccine. So that's probably going to take place at their June meeting.

And then there are a couple of other advisory committee meetings coming up. So FDA's VRBPAC will meet on May 18 to consider that vaccine for pregnant persons. But all around, I think it's going to be good news to hopefully have these RSV products in place before winter.

Unger: Amazing, think about the tripledemic from the past season, now effective vaccines for really all three of those legs of that particular stand. We'll continue to follow as news develops on this front. Andrea, another big and somewhat surprising headline this week, Dr. Rochelle Walensky, director of the CDC, announced that she'll be stepping down at the end of June. What can you tell us about that?

Garcia: Well, I think that came as a surprise to many, many health experts. And there are still a lot of unanswered questions. But I think what we do know is that Dr. Walensky submitted her resignation to President Biden last Friday.

She cited the end of the public health emergency declaration as a good time to make a transition. She didn't explain exactly why she was stepping down. But she did express mixed feelings about the decision and said she's never been prouder of anything she's done in her professional career.

She took the helm of the CDC in January of 2021. That was on the heels of President Biden's inauguration. And now after more than two years, we're going to see her last day as CDC director on June 30. And we know that an interim director has not yet been named.

Unger: Andrea, I'm sure there's been a lot of speculation as to what led to the move. What are you hearing?

Garcia: Well, I think there are a number of theories sort of swirling in the media. But no one, I think, except Dr. Walensky can say for certain.

We did hear Dr. Megan Ranney, who's the deputy dean for Brown University School of Public Health and a physician who's also been prominent in the media throughout the pandemic and who I know has been on AMA Update before, as she commented on Dr. Walensky's departure, saying, I know it hasn't been easy, not just because of COVID, but because of the politicization of science. And then Dr. Ranney also went on to explain that she's received hate mail and personal attacks. But what she's experienced is really only the tip of the iceberg compared with how Dr. Walensky has been treated.

Unger: I can only imagine. Andrea, you mentioned that an interim director has not yet been chosen. What is the expected frame for something like that?

Garcia: So the administration hasn't made any announcements about a transition plan. The Washington Post suggested that it could play out a number of ways. And one thing that could happen is a new director could be chosen by July 1. Or someone could be tapped to be acting director.

I think the thing to keep in mind is CDC directors do not currently require Senate confirmation. That will be changing in January of 2025. That same Washington Post article did note that the day-to-day leadership of the CDC is likely going to fall to senior officials like Nirav Shah, who was a former top state health official, both in Maine and here in Illinois.

He joined CDC as its principal deputy director earlier this year. Sherri Berger, who is currently the acting chief strategy officer, she's a longtime CDC veteran. And then Dr. Debra Houry, who is the chief medical officer, also formerly led the CDC Injury Center for a long time, I know you're going to be having a conversation with her later today.

Unger: That's right, my talk with Dr. Houry about the end of the public health emergency is going to air tomorrow. And we're going to continue to follow CDC leadership transition and share with you as we learn more. On the same day that Dr. Walensky submitted her resignation, the World Health Organization also made an announcement. Andrea, what can you tell us about that?

Garcia: Yeah, last Friday, we saw the WHO announced that COVID-19 no longer qualifies as a public health emergency of international concern. This comes more than three years after the WHO first declared the coronavirus an international crisis. That was on January 30 of 2020. And to give some perspective, at that time, it wasn't named COVID-19 yet. And there were no major outbreaks beyond China.

Unger: What then does removing that particular designation mean exactly?

Garcia: Yes, so that WHO public health emergency declaration triggers a series of international rules that really guide the response to threatening disease outbreaks. WHO officials have said that even though the emergency phase is over, the pandemic hasn't finished. They noted recent spikes in Southeast Asia and in the Middle East and noted that thousands of people are dying from the virus every week and millions of others are suffering from debilitating long-term effects. However, they did note that the pandemic has been on a downward trend for more than a year now. And that is why that designation is being removed.

Unger: And with these announcements, both from the WHO and the CDC, where do we go from here?

Garcia: So I think right now, everyone is rightfully focused on learning from this and making changes so we're better prepared moving forward. Dr. Michael Ryan, who's the executive director of the WHO Health Emergencies Program, said it's now incumbent on the heads of state and other leaders to negotiate a wide-ranging pandemic treaty to decide how future health threats should be based. I don't think anyone wants to be in the situation we were in at the start of the pandemic ever again where we know hospitals were bartering for different supplies, patients were fighting to get into emergency rooms to get care but our hospitals were overwhelmed, of course, leading to patient deaths.

Unger: Good to have that behind us, those were very, very tough days. And I think we all remember what a terrible time that was. And another sign though that we're moving beyond crisis mode, the CDC updated its "Infection Prevention and Control Recommendations" earlier this week. What do physicians and hospitals need to know about that?

Garcia: As we've previously discussed with the end of the public health emergency, we know CDC is not going to be receiving the data they need to publish the community transmission levels for SARS-COV-2. And those community transmission levels influenced infection control recommendations for health care facilities. So CDC published their updated "Interim Infection Prevention and Control Recommendations" for health care personnel.

Those updates include admission testing in nursing homes now being at the discretion of the facility, and facilities generally being encouraged to look beyond SARS-COV-2 and making broader masking or resource control decisions based on both facility and patient level characteristics and local metrics that could reflect increasing respiratory virus transmission in the community, so not just COVID, but flu and other respiratory viruses as well. For those who are interested in learning more, the CDC's Project Firstline will be hosting a town hall event on May 16 at 11:30 Central time. And we're going to include the link to that event in the description of the episode.

Unger: Excellent, and I'm sure we're going to continue to hear more updates like this as we emerge from crisis mode. Andrea, thanks so much for being here and giving us perspective on that. That's it for today's episode. We'll be back soon with another AMA Update. And you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us. Please take care.


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.

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