June 2018 ACIP Meeting – Agency updates & Unfinished business

>> So good morning to everyone As my wonderful colleague and soon-to-be chair of the ACIP said this morning, it’s the longest day, and we’ll try to make it the shortest meeting There’s a few things that we skipped over yesterday because we were worried about timing And I think the most important of which is that I neglected to use my gavel to start the meeting So this morning, I’m going to use my gavel, the Stanley Plotkin gavel, to start the meeting We need something Anyway, welcome back The other thing that we skipped over yesterday that we’d like to do before we do the agency updates is just to ask our departing members if they’d like to say a couple of words about their time on the ACIP And I thought I’d start, if it’s all right with Ms. Pellegrini >> Thank you I’d love to >> This is, this is hard, right? Like this is hard This is a hard group to leave Not only because you feel like you’re doing important, valuable, really important work, but because the people are so amazing The members of this committee are like a family, right? We just– you all, we all care so much about each other And I think that shows in the meetings, and it shows in the work, as well, because it has been an incredible privilege to work with such a group of committed, passionate, brilliant people who care so much about this work, who are doing their level best day in and day out to do the right thing, who want to prevent suffering, who want to help people of all ages and keep them healthy and keep them happy and keep them being able to do the things that they want to do in their lives And I think this will always end up being one of the great highlights of my career So the CBC staff is, of course, without parallel Again, a group of incredibly just brilliant, committed, passionate, but also compassionate people And it has been an amazing experience It has been a learning experience And I will always– I will never be able to go to the general mirror without looking and going around, looking around and going, where is everybody? So thank you all for your wisdom, for teaching me, for everything you do every day, and for your friendship and your caring [ Applause ] >> Thank you Dr. Riley? >> So Cindy has always been a very hard act to follow So I won’t even try But I, too, would like to thank everybody on the committee and everybody in this room for the privilege of having this job for four years Prior to this, I spent four years on the outer circle, and I always was dying to get into the inner circle And then it’s one of those things where once you get in, you’re like, what have I been wishing for all along? So one thing that has been really special to me is that I think I have been impressed by how much energy and attention has been paid to pregnancy in the last 10 years because I think before 2009, I felt like it was a constant fight to bring any pregnancy issues to the forefront And then after 2009, people woke up And then since then, there’s really been a lot of attention and interest paid into a very special group that has very different physiology And so for that, I am very, very thankful, and it’s been a pleasure to be part of that And then the other thing that’s really been an eye-opener to me is that I really didn’t understand the power of public health until I was on the inner circle And I have so much respect for the people of CDC and what they do It’s incredible that you can manage to make such huge decisions for an entire country And so that’s been another really important thing to me And when I think about evidence-based medicine, and how do you apply it, the funny thing is that at the end

of the day, I’m sitting in this chair as a mom and as a black woman, and so it has a different picture for me But it’s incredibly hard to think about the entire population And so thank you for that opportunity [ Applause ] >> Thank you, Dr. Belongia >> Thank you It’s hard to follow two eloquent presentations And I would just say, I echo all of those feelings And what I said yesterday with regard to the work group also applies to my experience more generally as an ACIP member It’s been a tremendous privilege to be working with friends and colleagues, both the members and the CDC staff I have been incredibly impressed It’s the highlight of my professional career And I leave knowing that policy, affecting policy decisions are in really good hands This is a highly functional federal advisory committee I don’t think it gets any better than this Not everybody agrees with the decisions, but I don’t think anybody can make any credible claim that it’s not done clearly and transparently and openly And it’s just how it should, in fact, work And I also sort of have been humbled by sort of the challenge of turning science into policy and making tough decisions with incomplete data And I know that tradition will continue after I leave And my last request is I think we need an ACIP alumni association Just a thought Thank you [ Applause ] >> I completely agree And we’re going to make you president [ Laughter ] I think it would be great Thank you all so much, again And thank you for your service And now I think we’ll go into the agency updates Would you like to start, Dr. Messonnier? Sorry >> Good morning, everybody Actually, usually I go last I wasn’t ready Okay, I have some brief updates The first is a report that we have been investigating an outbreak of group A strep in Colorado And these are cases associated with injection drug use, and among homeless people This is really a new phenomenon for us This question of infectious disease is associated with injection drug use And one of the questions that’s been raised is whether there’s any association with the opioid epidemic So you may be hearing more about these outbreaks, and, of course, questions are raised about the utility of vaccines that prevent these cases The National Immunization Conference that many of those in the room attended was May 15th to 18th More than 1,500 local state, federal and private sector immunization stakeholders and partners gathered to explore science, policy, education and planning issues And this year’s conference was held in conjunction with the National Adult and Influenza Immunization Summit Presentations for the NIC are actually available online Speaking of pregnant women, we are working to improve immunization rates among Medicaid-covered children and pregnant women Our Immunization Services Division hosted a special meeting on May 31st entitled that And this is part of a CDC-funded cooperative agreement focused on immunization barriers The meeting brought together members of the community of practice states; Colorado, Indiana, Kentucky, Montana, New Mexico, Project Partners, CMS, and leaders in Medicaid, Public Health ad Immunization from around the country I also want to just note that as many of you know, this is the 100-year commemoration of the 1918 pandemic And I expect that you’ll see a variety of events throughout the year, both CDC sponsored and a variety of partners at state and local health departments and partner organizations On May 7th, CDC and Emory University convened a panel of experts from academia and government to discuss and debate current pandemic influenza threats, and the future of pandemic preparedness Sessions included historic overviews of the 1918 pandemic, current threats and challenges, and perhaps the highlight for many people was a panel of former CDC directors who reflected on leading a variety of high profile outbreaks For those of you who are NDC, which I expect many of you are, there’s also a really great exhibit at the Smithsonian It’s called Outbreaks, Epidemics in a Connected World It’s at the National Museum of Natural History The exhibit uses case studies of HIV, AIDS, Ebola and Influenza

to highlight the social, emotional and cultural impacts of epidemics There are a variety of special events being planned in conjunction with the exhibit And they’re also working on a traveling exhibit if folks are interested This is going to be open to the public for the next three years And finally, I have a couple staff announcements, although I don’t actually know if she’s in the room But Sonja Rasmussen, who is currently the Director of the Office of Infectious Diseases, is retiring from CDC after 20 years of federal service After leaving CDC, Dr. Rasmussen will be joining the University of Florida as a professor in pediatrics, where she’ll be providing clinical care to patients with genetic conditions, teaching and continuing her research in public health As Laura knows, one of her passions is certainly diseases in pregnant women and vaccination in pregnant women, and we’ll sort of carry that with us from both you and her Beginning July 2nd, Michael Iademarco, who is currently the Director of the Center for Surveillance, Epidemiology and Lab Science will be serving as acting director of OID And there is a search planned for a new director, so I certainly encourage you all to send great candidates our way And finally, Ms. Brooke Barry has accepted a position as the Associate Director for Policy for National Center for Immunization and Respiratory Diseases She’ll be overseeing our policy office and providing strategic advice, guidance, and direction to our programs Many of you know Ms. Barry from her most recent role as the Associate Director for Policy with NCRDs’s Immunization Services Division where she’s been since I think 2012 So please join me in welcoming her Thank you >> Thank you Dr. Wharton? >> Thank you I have a few updates from the National Vaccine Program Office We collab– NVPO collaborated with a number of partners, including NIH, CDC, FDA and other agencies in responding to a request from the– written in the 21st Century Cures Legislation for a report on vaccine innovation, barriers, and how to address them And that report was posted online since the February meeting, and it’s available on the NVPO website NVPO just wrapped up a series of stakeholder meetings, organized in collaboration with regional health administrators in Dallas, Omaha, Denver, Philadelphia, Chicago and San Francisco And these meetings convened stakeholders around adult immunization, and we hope to be able to support some similar meetings in the future They were generally, I think, really well-received, and some good planning came out of those Our next National Vaccine Advisory Committee Meeting will be on June 25th from 2:00 to 5:00 p.m. via webcast And this meeting will include a presentation from the HPV Implementation Working Group on a draft report, which we expect to be discussed and voted on by the committee And finally, I also have a personnel announcement to make Many of you know Captain Angela Shen who has been in NVPO for a number of years She is retiring from the U.S. Public Health Service this summer And her last day on the job will be later this month So if those of you who haven’t heard about that, I wanted to make sure that you knew Thank you very much >> Thank you Dr. Bagel [phonetic] >> Good morning So given the focus on influenza vaccines at this meeting, I thought it was appropriate to give a few updates on NIH flu studies So first, the strategic plan There’s a strategic plan released in February, published in Journal of Infectious Disease, that maps NIAID’s vision for how we get from our current vaccines to a point where we would have universal influenza vaccines And goes through the details of both understanding transmission better, characterizing immunity better We will make the link to the JID in the minutes For H7N9, in March, NIAID launched two clinical studies with the new H7N9 We’ve done H7N9 in the past This is with a 2017 virus And will be a total of 570 volunteers arranged in the ages from 19 up to 64 That’s with and without adjuvant Other H7N9 studies are in planning Additionally in May, NIAID began testing the universal influenza

vaccine called M001 This is a safety and immunogenicity study, and will enroll 120 healthy participants So the links for all of those will be in the minutes Finally, two program funding updates in June, 2018, NIAID’s advisory council approved several concepts that I think would be of interest to ACIP So number one is what’s called CIVICs, the Collaborative Influenza Vaccine Innovation Centers It’s a consortium of multiple centers that we focus on developing innovative flu vaccines with a robust, durable, broadly protective immunity So we think that plus the strategic– this group will help implement the strategic plan and will help move that field forward considerably The second is a new funding mechanism or model for supporting some of the clinical trials that evaluate vaccines now Currently, we work through the BTUs, which most of you know, and some of the members of the ACIP are BTU members also So the council proved a different mechanism for setting that up and for funding that And it would include two groups Number one is what’s called a leadership group That would set up through a cooperative agreement, which is a grant type of mechanism And this leadership group would have subject matter experts and allow rapid implementation of a variety of studies And then we would also have VTUs set up as cooperative agreements, also with some base funding Together, that infrastructure should allow more collaborative approaches, faster responsive approaches when I had to implement vaccine studies So the links for that council announcement will be provided This, just as a reminder, this is an approval from council, so it still needs to be put out as an announcement But this is the first big step towards that, that path And that’s it from the NIH >> Thank you Dr. Ruben? >> Hi. Good morning So the National Vaccine Injury Compensation Program has continued to process and increase number of claims In fiscal year 2017, 1,243 claims were filed with the VICP In that same fiscal year, 252.2 million was awarded to petitioner And 29.8 million was awarded in attorneys’ fees and costs And these fees includes compensated, dismiss, and also interim attorney cases And thus far, in fiscal year 2018, the data that I have, as of April 30, there’s been 100, I’m sorry, 115.4 million has been awarded to petitioners, and 16.6 million has been paid for attorneys’ fees and costs More data can be obtained at our website As of April 30, 2018, the Countermeasures Injury Compensation Program, CICP, has compensated 39 claims, totaling 5.5 million Also, VICP outreach efforts continue to focus on making providers and the public aware of the safety program That’s it for my update >> Thank you So we are losing another one of our extremely valuable members after this meeting, Dr. Wellington Sun, who I believe has been the FDA liaison the entire time I’ve been here So we’re very sad to see him go, and we wish him all the best, and we thank him so much for all his contributions I think it’s fair to say that we, over the course of his tenure, have really begun to understand the FDA much better, and the committee has felt much stronger sense of continuity with the FDA So we thank you so much for that [ Applause ] >> Thank you, Dr. Bennett That’s very kind So I will make a few remarks later, but let me go through the agency update first So since the last ACIP meeting in February, a couple of things that are occurring at the FDA First, we had a Vaccine Advisory Committee meeting in May of this year, which Dr. Baker was a very important participants This was an advisory committee The development of group B strep vaccines

to prevent neonatal sepsis invasive disease So a couple of topics were discussed at that particular meeting One was the use of various clinical end points for the pivotal trial, such as early onset of disease or layers of disease or a combination of other clinical entities We also discussed the use of immunologic end points to demonstrate a vaccine effectiveness as a potential approach And the need for developing standardized [inaudible] protection from animal studies, as well as epidemiologic studies We also discussed a potential role for colonization as a way to evaluate effectiveness And other activities, we are working very closely with the CDC, the topic of the use of the Anthrax vaccine and mass vaccination of [inaudible] making a– working through the regulatory mechanisms to make the vaccine available to all age groups So that work is ongoing And your vote yesterday will ensure the very important part of those considerations The other thing that we’re still looking over the horizon are because of the increasing importance role of the use of real world evidence and informing vaccine effectiveness post-marketing There’s a lot of ongoing activities related to vaccines and real world evidence, and what can be used that would qualify, what can we use to inform vaccine efficacy through these types of data other than randomized control trials And then so I would like to end on a personal note, and to my colleagues at the ACIP and CDC As Dr. Bennett said, this is my last ACIP meeting as FDA liaison In August, I will be departing the FDA I would like to thank the ACIP, all of the ACIP executive secretaries that I’ve worked with, Dr Larry Pickering, Amanda, one of the chairs, Dr Baker, John Tentes, and, of course, Dr. Bennett And the directors; Anne Shugut [phonetic], Dr. Anne Shugut [phonetic] and [inaudible] Also all the ACIP staff who have made all these meetings so smooth Jean Smith, Jessica MacNeil, Stephanie Thomas, Natalie Greene, Barbara Cozart, Vonda The work group leaders that I’ve worked really closely with; Mark Fischer, Lisa Grohskopf, Lauri E. Markowitz, Erin Staples My thanks to all of them So I’ve always looked forward to coming to these ACIP meetings because I know that I’m going to learn so much, but I’m also– but also there’s some trepidation always coming here Am I going to be having to explain some FDA decision? Or will I be able to answer the questions that are asked of me? So these are all of my anxieties for these meetings But this is a necessary and good thing, because the ACIP is really a forum for making evidence-based vaccine recommendations and policy And as someone pointed out yesterday, there’s accountability and transparency here So I have come to really appreciate the importance of the close collaboration between, the partnership between FDA, ACIP, and the CDC in promoting the Public Health Group vaccines So it has been a real pleasure and privilege for me to have served with you in these last eight years Thank you [ Applause ] >> Thank you Dr. Wiser [phonetic] >> Good morning So we have three brief updates from Indian Health Service The first is just a report on our influenza vaccine coverage So for the 2017/2018 flu season, Indian Health Service administered 352,866 doses

of influenza vaccine, two patients seen at his, tribal and urban health facilities Our influenza vaccine coverage among children 6 months to 17 years was 39.1% And coverage among adults 18 years and older was 35.5% And these numbers have not changed too much in recent years In addition, this is something that has changed The IHS facilities now have a mandatory health care personnel influenza policy, an influenza vaccine coverage among federal IHS health care personnel was 95.8% for the 2017/2018 flu season So we’re very pleased about that change The second update, we heard about the regional meetings that took place from NVPO And IHS participated in the Region 5 and Region 9 meetings in Chicago and in San Francisco Presenting at the meetings information on IHS efforts to implement the [inaudible] and CDC standards for adult immunization practices in our facilities, and to improve access to adult immunizations in American, Indian, Alaskan native communities And lastly is something that we’re also very proud of is the development of the adult immunization composite measure, which I think the committee’s heard of before IHS implemented a new composite measure consisting of age-based ACIP-recommended immunizations for all adults 19 years and over across all of IHS And the measure includes Td and Tdap, Zoster and Pneumococcal vaccines, and has been developed as a government performance or results act measure, as well as included in the IHS National Immunization Reporting System for this year So we’re very happy about that new development And we’ll report next time on the actual coverage So thank you >> Thank you Mandy, you have an announcement? >> Yeah, I just want to put one thing on the record There were a couple of typos in the Anthrax grade presentation that you all heard yesterday It did not change the final evidence of the grade But I just wanted to make it clear that those slides will be updated, and the corrected slides will be hosted and included in the minutes Thank you