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 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 a 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 mr., Pellegrini. Thank. You I'd love to. This. Is hard right like this this is hard it's 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. If. Members of this committee are like a family, right, we 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, CDC staff is of course. Without. Parallel. Again. A group, of incredibly. Brilliant. Committed. Passionate but, also compassionate. People. And. It. Has been. An. Amazing, experience it, has been a learning experience and. I. I. Will. Always I will, never be able to go to the general mirror without. Looking and going around looking around going where is everybody. So. Thank, you all for your for your for. Your, wisdom for teaching me for, your for. Everything you do everyday and for your friendship and your caring. Thank. You dr.. Riley. So. Um Cindy's 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 I prior. To this I was 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, over 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 ten 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 I 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 at 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 when, I think, about evidence-based, medicine and, how do you apply it the funny thing is 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. Thank. You dr. polenta. Thank. You it's, hard to follow too, eloquent. Presentations, and I would just say I echo. All of those feelings, and. And. What I said yesterday with, regard to the workgroup, 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 am been, incredibly, impressed it's a highlight, of my professional. Career and. I leave knowing that. Policy. Of vaccine, policy, decisions. Are in really good hands this is a highly. Functional, Federal Advisory Committee I don't, 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 it was just how it should in fact work. And. I. Also sort of been. Humbled by sort of the challenge of turning science into policy, and in making, tough decisions with, incomplete, data and. I know that that tradition will continue after I leave and my, last request is I think I think we need an ACIP, Alumni Association so. Just. A thought thank. You. I. Completely. Agree and we're gonna make you president 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. miss Sonia. Okay. Good morning everybody actually, usually I go last down 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, diseases 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, to 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 in influenza, immunization summit. Presentations. For the ni C 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. Where 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, and New Mexico project. Partners, CMS, and leaders. In Medicaid, public health and immunization, from around. I, also. Want to just note that as, many of you know this is the hundred 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 and 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 a highlight for many people was a panel, of former. CDC, directors, who reflected, on meeting, a variety of high profile outbreaks, for. Those of you who are in DC, 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. Um, Sonia. 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 the 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 will sort of carry that with us from both you and her, beginning. July 2nd, Michael yeah DeMarco who is currently the director of the Center, for surveillance, epidemiology and, lab science will be serving as Acting Director of oh I D and there, is a search, plan, for a new director so I certainly encourage you all to send great, candidates, our way, and. Finally, miss. Brooke Berry 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 miss, berry from her most recent role as the associate director for policy, within Sierra D'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. Collapse, in VPO collaborated. With a number of partners including, NIH, CDC FDA, and. And other agencies, in. Responding. To a a, request. From the, when. Written into 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 NBP o website. In. VPO just wrapped up a series, of stakeholder. Meetings organized. In collaboration with regional. Health administrators. In Dallas.
Omaha, Denver Philadelphia. Chicago in 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, 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, and NVP Oh for a number of years she is retiring, from the US Public Health Service this summer and her, last day on the job will be later this month so in. Those, of you who haven't heard about that wanted, to make sure that you knew thank you very much. Thank. You dr., bagel. 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 was a strategic plan released and in February. Published in Journal of infectious disease, that. Maps my, ads. Vision. For, how. We get from our current vaccines, to a point where we would have universal. Influenza. Vaccines. And and then, goes through the details of both understanding. Transmission, better characterizing. Immunity, better. We. Will make the. Link to the J ID in. The in the minutes. For. H seven and nine in. March not launched. Two clinical. Studies. With, the new. H seven and nine we've, done a seven and nine in the past, this. Is with a 2017. A, virus. And and will. Be a total, of 570. Volunteers. Ranged. In, ages from 19 up to 64. That's. With and without. Adjuvant. Other. H7n9. Studies. Are in planning. Additionally. In May and, I had began testing the universal, influenza vaccine, called M zero. Zero one. 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. To program, funding, updates. In June. 2018. My. Ads. 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. Will be focused on developing, innovative. Flu. Vaccines. With. A, robust. Durable broadly. Protective. Immunity. So. We think that plus, the strategic, that this group will help implement the strategic plan and will, help remove 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 BT years which most of you know and some of the members, are of. The ACIP are. BTU. Members. Also, so. That the council approved a different. Mechanism for. Setting. That up and for funding that and and it wouldn't include, two. Groups number one is what's called a leadership group that. Would be 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, VTE. Use set. Up as cooperative. Agreements. Also with some base of. 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. Is. Will. Be provided. This. Just, as a reminder this is an approval from from. Council so it still needs to be put. Out for. As. As, an announcement, but this, is the first big step towards that that path and, that's it from the NIH. Thank. You dr., Rubin hi, good morning so. The National Vaccine injury compensation program, has, continued, to process an increased number of claims in, fiscal. Year 2017. 1243. Claims were filed with the VI CP in. That same fiscal year two, hundred fifty two point two million was, awarded to petitioners, and twenty. Nine point eight million was awarded, in attorneys, fees and costs and these fees includes. Compensated. Dismiss, and also enter him attorneys. Cases. And, thus. Far in fiscal year 2018. The data that I have is a sub April 30, it's, there, it's been a hundred on, sorry, one hundred fifteen. Point four million has been awarded to petitioners, and sixteen point six million has been paid for attorneys, fees and costs more data can be obtained. At our website as of. April 30 2018. That countermeasures. Injury compensation program, CICP. Has, compensated 39, claims totaling, 5.5, million also. On v.i.c p outreach efforts continue, to focus in making providers, and the, public aware of the safety news program that's it from athlete. Thank. You so. We are losing another one of our extremely, valuable members, after, this meeting dr.. Wellington son 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. Thank. You dr. banner that's very kind um, 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 there. Occurring. At the FDA first. We had a. Vaccine. Advisory, Committee meeting in May. Of this. Year of, which dr.. Baker, was a was a very important, participant this. Was a Advisory. Committee on 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. The. Use of various. Clinical. End points for the pivotal, trial such as and early. Onset disease, or late onset disease, or combinations, of other, clinical. Entities. We. Also. Discussed, the, use of immuno logic, endpoints, to demonstrate, vaccine, effectiveness as, a potential, approach. And. The need for developing, standardized, assays, and serologic. Correlative, protection, from. Animal. Studies as well as. Epidemiologic. Studies, we. Also discussed, a potential, role for. Colonization. As, a way, to evaluate effectiveness. And. Then. Other, activities. We are working very closely with the CDC on. The, topic, of the, the use. Of the. Anthrax. Vaccine, in mass vaccination event, scenarios. Making. Working. Through the the, regulatory mechanisms. To. Make the vaccine available. To all age groups so. That their work is ongoing and. Your, vote yesterday well. I'm sure I'll be a very important, part of those considerations, the. Other thing, that are also looking over the horizon are. Because. Of the. Increasing. Importance, of. Role. Of the. The. Use of real-world evidence, and. Informing. Vaccine effectiveness post-marketing. There's a lot of ongoing activities. And. Related, to vaccines, and real world evidence and what what, can be used. That. What would qualify what, what can be used 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. The ACIP. Executive. Secretaries. That I've worked with dr.. Larry Pickering. Amanda. All. The chairs dr., dr., Baker, John. Tempe and of, course dr. Bennett, and. The. Directors. And. Sugar doctors, and chuckit and dr., Nance, Missoni a also. All the ACIP. Staff, who, made all. These meetings so. Smooth Gene. Smith. Jessica. MacNeil Stephanie. Thomas Natalie, green bar. Because our. Vonda. The. Work leaders, I worked really closely with mark fisher lisa, grohskopf. Lauri. Markowitz, erin staples. My. Thanks to all them. So. I've. Always looked, forward to coming to these ACIP. Meetings, because I know that. I. Learn. So much but, but. I'm also, but. Also there's there's, some trepidation always. Coming, here. Am, I going to be having. To explain some FDA decision or and. Will. I be able to answer the questions that are asked of me so. These are these all my my anxieties, were before, these meetings but. 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, is accountability and. Transparency. Here. So. I have come to really appreciate the. Importance. Of the the, close collaboration, between. And. The partnership, between, FDA. ACIP. And, the, CDC, in. Promoting, the public health through vaccines. So, it has been a real pleasure and, privilege. For me to have served with you in these last last eight years thank, you. Thank. You. Dr., Weiser, 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, you, need health service administered, three hundred and fifty two thousand, eight hundred and sixty-six doses of influenza vaccine to. Patients, seen at IHS tribal and, urban health facilities. Our. Influenza, vaccine coverage among children six months the seventeen years was thirty nine point one percent and. Coverage, among adults 18 years and older was thirty five point five percent 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, and influenza. Vaccine, coverage among federal i HS health care personnel was. Ninety five point eight percent 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 mbpo and. IHS, participated, in the region five and region nine meetings in Chicago and in San Fran San Francisco.
Presenting. At the meetings information, on IHS, efforts to implement the in vac and CDC standards. For adult immunization practices, in, our facilities, and to improve access to adult immunizations, in, American Indian Alaska Native communities and. Lastly. Is something, that we're also very proud of as the development of an adult immunization, composite, measure which I think that communities heard of before. IHS. Implemented, a new composite, measure consisting, of age based ACIP, recommended, immunizations. For all adults nineteen, years and over across. All of IHS, the. Measure includes TD, and Tdap, zoster. And pneumococcal vaccines, and has, been developed as a government, performance, and 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. Mandie you have a 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 posted and, included in the minutes thank, you.