Transcripts For CSPAN3 Hearingon 20240704

During the entirety of those 13 years i have expressed concerns. You can see the rest of this online at cspan. Org but we will taken out to capitol hill for a hearing to examine the effectiveness of vaccine safety reporting after the roll out of the covid19 vaccine. This includes officials from the cdc and the fda. You are watching live coverage on cspan3. I advised members and remind them of all the rows of corn. The issues we are debating are important. The members feel deeply about. I understand that. While vigorous disagreement is part of the legislative process, members are reminded that we must adhere to established standards of decorum and debate. This is a reminder that is a violation of house rules and the rules of this committee to engage in personalities regarding other members or to question the motives of a colleague. Remarks about type are not permitted by the rules and are not in keeping with the best traditions of our committee. This is a very serious matter. The chair will enforce these roles of the courtroom at all times and urge all members to be mindful of their remarks today. If the chair finds the member to be in violation, remember will be suspended of speaking for the remainder of the hearing but i never organize myself for the purpose of making an opening statement. Good morning. Vaccines are crucial Public Health tools which save millions of lives as a physician myself, i have administered many doses of vaccines especially covid19 vaccines. In 2020 i volunteer to participate in the Moderna Vaccine trials. Having this hearing is not an antivaccination hearing and i am not antivaccination. I should not even have to say that. Unfortunately, i do. I am sure as i sit here and there are people getting ready to use that very thing to discredit this hearing. Unfortunately, in an error of sound bites and new cycle whiplash, it seems there is little time for nuance conversation about these topics. Today, i hope we can have that conversation about process. Sometimes we do not know and weaknesses in the system until it is truly tested. Now is the time to safeguard for the future. And about how we can do better next time if there is things we recognize that could have been done better. It is not a time to look at the things we did well as well. But we need to restore trust in Public Health. I am very concerned with the hesitancy by so many today to vaccinate their children. That is a great concern of mine. Testifying before us today or two senior officials who made the post marketing vaccine Safety Systems. These systems are absolutely critical to keeping the American People safe. Also, to earning and preserving their trust. In the trust of the positions that care for patients. Our witnesses will discuss how the systems work, what they can do, what they cant do and the challenges that they face. That is a bear process. Their testimony is important to design better systems in the future, as needed. One such system, the vaccine adverse reporting system is perhaps the best known of the Surveillance Systems it has been the source of attention and controversy since the beginning of the covid19 vaccine rollout. However, concerns about these data is usually does met with submissive replies but they can point to the fact that vaers is unable to prove causality. It contained reports of people being hit by a car after vaccination. They say that vaers is being misused by antivaccine advocates and that it is misinformation. They are all legitimate concerns of the American People, especially this seems to ignore many legitimate questions that have been raised. For example, how does the government utilize this data . We want to know during her testimony before this Committee Last june, director wolinsky assured us that the cdc had a responsibility to come. Every single report in vaers. It is unclear if that is happened or that is true. People have submitted reports to vaers have told my staff that they were never contacted by the cdc or fda officials. Our recent british medical journal investigation now has two. It seems that both sides agree that there is something wrong here. Further, while serious injuries caused by vaccines are rare, but government has assumed the responsibility to compensate for them. In doing so, then seek dancing magnifiers have been shielded from liability for the government has an important duty, one that is essential in preserving trust in vaccines and how we measure completely and honestly about them appearing before us today is commander george grimes. Dr. Grimes is director of Injury Compensation Programs and oversees the Countermeasure Injury Compensation Program or see icp as well as the vaccine injury compensation. They are covered under cicp. Where as most other widely distributed vaccines are covered under vicp. As of january 2024 cicp has compensated 11 claims out of the more than 12,000 that have been filed for covid19 vaccines. Because of its design cicp payments are also smaller than vicp. An average of about 3700 compared with 500,000 in vicp. It appears that cicp may not be designed or equipped to handle a vaccine that was so widely distributed and mandated for many as covid19 vaccines were. I have concerns that we would not be able to expect people to line up and get vaccinated during the next pandemic if they feel that, in some way, they are going to be abandoned. This testimony is important to design better systems for the future and establishing best practices. I hope this hearing will provide us with an opportunity to discuss what lessons were learned during the pandemic, about our vaccine safety and Surveillance Systems. These lessons, i believe, are critical in preparing for future pandemics, which is the mission, one of the missions of the subcommittee. I look forward to a robust and ontopic discussion about these issues and i want to thank everyone for being here, especially our witnesses for being here. I would now like to recognize Ranking Member louise for his opening statement. Thank you and thank you to the witnesses for your participation in todays hearing. Our nation vaccine Safety Systems play a Critical Role in protecting Public Health. Every day scientists, physicians and Public Health officials Work Together as part of this is him to monitor the safety and efficacy of vaccines to ensure the best possible products reach everyday americans. Their efforts have helped protect us from the threat of deadly diseases for decades. Their efforts during the covid 19 pandemic help contribute to one of the most successful vaccine rollouts in history, which under president bidens leadership, led to the country out of the depths of the pandemic. In total, these efforts saved 3. 2 million lives. It prevented 18. 5 million hospitalizations and save the United States an estimated 1. 5 trillion in medical cost. As a physician who went out into underserved communities to administer vaccines during the height of the pandemic, i saw firsthand the difference these vaccines made in helping our communities overcome covid19. At the end of the day, we were able to save so many lives, prevent so much illness and reduce a mounting of medical costs on our system because these vaccines were shown, repeatedly to be safe and effective due to extensive clinical data. Since then, our nations robust vaccine Surveillance Systems and countless other studies have only reaffirmed the safety of these vaccines by monitoring for and evaluating serious adverse events which remain rare. This system has worked well. In fact, we saw it identify safety signals in vaccines during the pandemic when it detected cases of thrombosis with tts associated with the johnson and johnson vaccine. Resulting in the cdc and fda releasing updated recommendations for vaccine products. I do want to be clear that while adverse events are rare, they are not impossible. That is why we must continue to invest in a strong and capable vaccine safety and Surveillance System that is efficient and in assuring the best quality vaccines reach the American People. It is why we must ensure that when an adverse event does arise, people can receive the protection and compensation that they needed. There is good bipartisan work. I know we can do this on this front to strengthen the National Vaccine Injury Compensation Program and countermeasures Injury Compensation Program to make them more efficient. I hope that i hope that we discussed those reforms here today. Todays hearing does have the potential to generate forward looking policy solutions that improve peoples lives however, it only does so if we approach this topic with care. If we dont, i worry that we are opening a pandora box that i fear we will not be able to close again. Right now, we are already witnessing an alarming rise in overall Vaccine Hesitancy, which has been fueled by disinformation spread online during the last four years. As this disinformation has pestered, immunization rates among americans have fallen for covid19, polio, measles, mumps and rubella. This should be alarming to us all. We have already seen outbreaks of measles pop up and under vaccinated communities in the last year, including in philadelphia and columbus. We have already seen an additional 300,000 covid19 deaths in the u. S. That could have been prevented if not for a growing distrust in vaccines. I worried that the liberalization of medicine, the politicalization of science and vaccines will hurt us all in the end. In the manufacturing of distrust and Public Health norms and institutions that we have held true for so long will make us less prepared to combat a future pandemic but republicans already 2. 4 times more likely than democrats or independents to believe that covid19 vaccines are unsafe. Childhood vaccination rates are already at historic low. We are already in the process of undoing decades of progress in overcoming Infectious Diseases at unless we handle each opportunity to discuss this with email care, we are hurtling towards an even more grim future. I urge for a constructive and civil conversation among us all today but focuses on strengthening our current safety and Compensation Programs enhancing confidence in our Public Health institutions and building a brighter, healthier future for us all. I yield back. Thank you, dr. Ruiz. Our Witnesses Today are dr. Daniel jernigan. He is the director of the National Center for emergency zoonotic Infectious Diseases at the centers for Disease Control and prevention. Dr. Peter marks. Dr. Marks is a director for center for biologics evaluation and research at the u. S. Food and drug administration. Dr. George reed grimes is the director of Injury Compensation Programs at the u. S. Health resources and services administration. Pursuant to committee on oversight and accountability rule, the witnesses will please stand and raise their right hands. Do you solemnly swear or affirm that the testimony that you are about to give is the truth, the whole truth, and nothing but the truth, so help you god . Thank you. You may be seated. Let the record show that the witnesses all answered in the affirmative. The slight cub subcommittee appreciates you all for being here today and we look forward to your testimony that me remind the witnesses that we have read your written statements and they will appear in full in the hearing record. Please limit your oriole statements to five minutes. As a reminder, please press the button on the microphone in front of you so that it is on and the members can hear you. When you begin to speak, the light in front of you will turn green. After four minutes the light will turn yellow. When the red light comes on, your five minutes has expired and we would ask that you please wrap up. I now recognize dr. Marks to give an opening statement. 23, chair, and members of the select subcommittee. Thank you for the opportunity to testify to talk about the covid19 response and ongoing vaccine safety efforts. Vaccines work. We know from clear and compelling evidence that vaccines save lives of millions of children and adults every year by producing immune responses that prevent diseases such as measles, influenza and covid19. Though they may not provide perfect protection, vaccines can often prevent the most serious consequences of disease including hospitalization and death. The American Public can rest assured that vaccines that are off the ride authorized and approved are safe and effective. The Vaccine Development process and fdas stringent regulatory and scientific evaluation process and continue safety surveillance ensure about the Health Benefits of available, approved and authorized vaccines far outweigh any risk. Regarding covid19 vaccines, fda helped make these critical medical countermeasures available as quickly as possible without compromising our scientific and regulatory standards. During a onceinalifetime pandemic that was a Public Health emergency, fda scientists and employees worked around the clock cooperatively, intensively and efficiently alongside researchers and manufacturers to minimize the time between the Clinical Development process, manufacturing scale up in the regulatory review process. Hundreds of americans were dying from covid19 daily at this time. And every day we can make Vaccines Available sooner counted. Every day counted and we made them count. Between december 2020 and may 2023, over 270 Million People received more than 675 million doses of covid19 vaccines in the United States, including over 650 million doses of the mrna vaccines. The covid19 vaccines have had a Tremendous Positive impact over the course of the pandemic globally. Ultimately saving millions of lives since their introduction. The vaccines continue to be among the most effective Public Health measures worker preventing the serious consequences of covid19. A large part of what has made this Public Health success possible is the deployment of sophisticated safety monitoring in fact, Covid Vaccines are the most closely monitored vaccines that have ever been rolled out in u. S. History. The safety of the approved and authorized covid19 vaccines has been monitored by the fda for both passives and active safety Surveillance Systems in collaboration with cdc and other governmental and nongovernmental partners. Fda also participates in Ongoing International vigilance efforts and these are in addition to the safety surveillance efforts required of the vaccine manufacturers. These surveillance tools work. In early 2021, days after pass of safety surveillance reporting through the vaccine adverse events reporting system detected that six at a more than 6 million patients who had received the hansen covid19 vaccine had developed a rather where blood clotting disorder. They recommended causing the use of that until the risk to be evaluated. Another example is the detection of myocarditis that followed the use of covid19 vaccines which led fda to modify labeling and the cdc to provide advice on the mrna Covid Vaccines to Healthcare Providers about how to reduce the risk. Vaccines are one of the most highly effective Public Health measures. They are responsible for saving millions of lives every year. The benefits of available, approved and authorized vaccines in the United States, when used appropriately, continue to far outweigh any risks. Staying up to date on vaccination has been and continues to be the best way to reduce the risk of death and serious illness or hospitalization from various Infectious Diseases, including covid19 thank you for the opportunity to testify today but i look forward to answering your questions. I now recognize to give an opening statement. Distinguish members of the subcommittee, it is an honor to appear today to discuss edcs ongoing work to monitor the safety and effectiveness of vaccines. I serve as the director of the National Center for emerging and Infectious Disease at cdc which includes the Immunization Safety Office cdc works to protect against Public Health threats through prevention, detection and response. Vaccines are a cornerstone of that work. They have played a leading role in eradicating smallpox and eliminating wild poliovirus from the United States and averting millions of illnesses and deaths from childhood vaccine preventable diseases. During the covid19 Public Health emergency, over 676 million doses of covid19 vaccines were administered in the u. S. There are estimated to have prevented millions of hospitalizations and deaths. These Public Health successes have been made possible by shared commitment to ensuring vaccines are safe. As such, vaccine safety monitoring is a top priority for the cdc and we collaborate closely with the fda and other partners. We utilize multiple data systems in a complementary and layered approach to detect possible safety signals and investigate them rigorously and act promptly when appropriate. The vaccine adverse event reporting system or vaers is a system where individuals, Healthcare Providers and manufacturers can report adverse events following vaccination that may need to be investigated further. Vaers is not designed to determine if a vaccine caused a reported event. Rather it is an Early Warning system where we evaluate reports of serious adverse events and use complementary systems to further analyze potential safety concerns. These other systems include the vaccine safety datalink, which uses Electronic Health records of a robust analysis and the clinical immunization Safety Assessment project, which offers consultation to providers on patients adverse events. During the covid19 response, the cdc established a Smart Phone App where individuals can report Health Impacts after vaccination and we also established a covid19 registry to monitor pregnancy and infant outcomes over time following vaccination the cdc is committed to transparency and regularly shares information on vaccine safety with our federal and state partners. In addition there have been more than 30 Public Meetings of the Advisory Committee on immunization practices featuring research on covid19 vaccine safety and effectiveness. This approach to safety monitoring works. I will share two examples with you and underscore dr. Marks comments. During the first six weeks of the j j vaccine was authorized for use. The cdc identified six cases of a rare and lifethreatening blood clot through vaers. When additional review identified a causal relation between the j j vaccine and the blood clots, the cdc and fda acted within days to inform clinicians and the public and can be an emergency meeting of the practice and recommended a positive in the demonstration of the j j vaccine. Further investigation led to preferential recommendation for mrna Covid Vaccines over j j and currently the j j vaccine is not available in the United States. The second of is myocarditis. In april 2021 cdc observed high reports of myocarditis following the vaccination particularly in young men through the vaers system. After confirming these events using the vaccine safety datalink, the cdc quickly updated clinical considerations while continue to recommend covid19 vaccinations. Further research has shown that the risk of myocarditis is substantially lower following vaccination then following infection. As these examples show vaccine safety monitoring by the cdc and our partners is rigorous and transparent. The data continues to show that staying up to date on covid19 vaccines is an effective and safe way to prevent severe illness, hospitalizations and death. The development and administration of covid19 vaccines is a remarkable Scientific Achievement. After the most robust and comprehensive safety monitoring in our history, the science shows that we would all have confidence in the covid19 vaccines and that they are safe and effective. I appreciate the opportunity to discuss the vaccine safety efforts and look forward to your questions. We went tonic. I never can mind recommend dr. Grimes for his opening statement. Thank you for the opportunity to speak with you today about the work of the health resources. I am commander read grimes, director of the Countermeasure Injury Compensation Program or see icp. The public registry and Emergency Preparedness act of 2005 or the prep act provided compensation for injuries or death directly caused by the administration or use of a countermeasure. They have received approximately 13,000 claims alleging a covid19 countermeasure injury filed with the see icp since the declaration of 2020. Of these 9600 alleged covid19 vaccines as a countermeasure. For context the program received about 500 claims over its 10 year history prior to covid19. While injuries are rare and the claims we have received for covid19 represent a small fraction , less than 0. 001 of all covid19 vaccine administrations in this country, the case for the cicp is higher than it was prior to 2020. When i became director in december 2021, i immediately focused on the need to increase the cicps capacity to process claims. The prep act as a High Standard for an individual to be compensated by the cicp. By law, we are required to establish the covered countermeasure directly caused a covered injury, which must be determined based on compelling and reliable, valid and Scientific Evidence. As a result the cicp conducts medical reviews of each cicp claim to determine if it meets the statutory standards. This detailed review includes an iterative process of obtaining and reviewing comprehensive medical documentation from cicp requesters as well as closely reviewing and monitoring the medical literature. For compensable claims, the cicp must also collect detailed Financial Information given that the program, by statute, can provide composition only after other thirdparty payers. At the prime of the prep act declaration, the cicp had no appropriation and only four staff. We requested and congress provided a direct appropriation for the first time in the history of the program in fiscal year 2022. With these funds, we have been able to increase hiring and have 35 fulltime staff working to process claims. We have also implemented other process improvements to resolve claims at a faster rate. In 2023 we average more than 90 claims result each month, which is up from zero per month the year before i started in this role. Additionally, we are proving Information Technology and other Communication Channels with requesters. While the program has made significant improvements, there is more to be done the president s fiscal year 2024 budget requested 15 million to operate the cicp. With these funds, we want to continue to increase our capacity to analyze and resolve claims, including through increased staffing and i. T. Infrastructure improvements. We are committed to working with congress to meet the programs resource needs to increase the rate of cicp resolutions. The cicp is also in the process of establish and injuring table for covid19 vaccine injuries that are presumed to be directly caused by a covered countermeasure. In order to establish this table, hhs must meet the standard set by congress. The injury table is another tool that will allow us to streamline the claims review process and more expeditiously addressed requests. Finally, i wanted to address the National Vaccine Injury Compensation Program or vicp. The vicp was established under a different statute, the National Childhood vaccine injury act of 1986. For a vaccine to be covered on the trend vicp, certain conditions must be met, including a recognition from the cicp for for routine administration to children or individuals who are pregnant. The vaccine must be subject to an excise tax. Covid19 vaccines currently do not qualify for vicp coverage, which would require congressional action. We at hrsa are carrying out these programs as directed by congress per thank you for the opportunity to be here today to discuss hrsas work and we look forward to continue to work with congress on these critically important programs. Thank you, all, very much for your testimony. I recognize myself for questions. I want to say a couple things before we start. I want everyone to understand, especially those serving on the government side, public reception perception becomes reality. Because of that, words matter. Words matter. For those of us, as members of congress, or as physicians at home, we are face to face with people. We are sitting face to face with somebody. We are not just looking at data on a sheet and making decisions. It needs to be done, what you are doing, but there is a difference. That is why i say words matter. Let me give you an example. When you say safe and effective, that is relative in your mind. It is relative in your mind but it is not to the person at home. They hear 100 safe and 100 effective. That is what they hear. This is why words matter. Dr. Foutch he in his testimony would say, you can never say that any treatment is 100 safe. In essence, that is what people heard and are still hearing today. We have to change that. The doctor on the ground with a member of congress on the ground is one on one with somebody explains that to them, hopefully. Yes, this vaccine saved hundreds of thousands of lives and i will advocate for that for any time and that is why it was for emergency use because people were dying and we knew from the trials that they could save lives and keep people out of the hospital. We also knew that you could still get covid. We never really heard that from the federal level. We just heard, it is safe and effective. Now we have a society that thinks that the polio vaccine and the other vaccines are not necessarily safe and effective, the way they have been. We never explained mrna technology is different from the technology of the other vaccines that have been around forever. And you lump them together. When people come to my office to tell me i had ad adverse event of some type, i am one on one with them. It is not something on a piece of paper. So, words matter. That is one of the things i want to stress across the board from the subcommittee at the end of the day. Early on, i will tell you that i even said to secretary a czar, America Needs to be hearing from the doctors treating Covid Patients. Not the politician who says if trump makes this vaccine, im not taking it. Is that helpful . We need to hear from the doctors treating Covid Patients. The doctors administrating the vaccines and the doctors we are trying to save lives. That is what the public needed to hear from. We have to be careful with our words. I am grateful. Dr. Jernigan, you gave a caveat today but it kept you from being hospitalized in most cases , or dying especially if you are amongst the most runnable. I appreciated that. That is the type of messaging we have to have going forward. I am grateful we live in a country that has the systems in place. They are there to protect the American People and to provide for Better Health in america. There is ways we can do better and that is what i want to talk about today. I will start by asking this question about vaccine safety and surveillance. I want to ask each of you this question. At least dr. Jernigan and dr. Marks. Is any pharmaceutical 100 safe . Thanks very much for that question, chair wenstrup. No pharmaceutical is 100 safe or even the water we drink is not 100 safe if you drink too much you can die from complications of water poisoning. Well said. Thanks for the question. As clinicians we all recognize that no medical integration is riskfree. I will go to dr. Grimes. There is a reason we have a Compensation Program. Yes, sir. There is a reason we have a Compensation Program and we are dedicated to diligently caring that out. I cannot say it any better than my colleague sitting next to me have. It is important we properly surveil for these inevitable injuries. Unfortunately, inevitable, injuries. No matter how many or how few. Would you agree with that, dr. Marks . I would agree fully with that but if we want to maintain confidence in the vaccines and the other medical products that we authorize or approve, we must have very robust safety Surveillance Systems in place. Dr. Jernigan. I agree we need those comprehensive and multiple vaccine safety Monitoring Systems. Dr. Grimes. I could not agree more. I agree with that. Do you feel with what we currently has is sufficient i do not mean that in and adversarial way. What are some of the things you think we could do better. As i said at the beginning, sometimes it takes Something Like a pandemic to recognize where we can do better. In the bane of Surveillance System being sufficient, any ideas that you can add to that . Thanks so much for that question. I believe we had a very good safety surveillance mechanism in place that included overlapping systems and including passive and active systems. I do believe we could do better. I think there were challenges in getting data in real time that limited us in our ability to understand what was happening on the ground and hopefully, we can work Better Together with all of the individual states to have a more unified safety Surveillance System should this ever happen again or, for that matter, even on an ongoing basis for our medical products. Thank you. Throughout the pandemic, we stood up with the most intensive vaccine safety monitoring in u. S. History. We really see the benefits of having a robust vaccine safety Monitoring System and sustaining that will be a critical feature for us moving forward. Dr. Grimes. I would defer to my colleagues to my right. They are the experts. A fair enough. One of the things as i had the pleasure of meeting with you all individually. What occurred to me in hearing some of the concerns, especially during this pandemic and it came on quickly. You had workforce challenges, if you well, understandably, considering that. And every component of what you do. One of the ideas i had i am an army reservist. One of the things i had a, is we have a reserve component in each one of your categories of interest. We can call up experts in the field that can handle the increased load during a pandemic. To me, that would really aid our National Security and our National Health security. It is just a thought but i would love to get your opinions on it. I know you face many challenges by the overload of what took place. Dr. Marks. Chair wenstrup , thank you so much for that question. I really appreciate the opportunity to reflect on this issue when the pandemic happened , we at the fda were dealing with our usual files that we have. There are many vaccines that are important for everyday life. We did not have a codger of people to just move over. We had to pull people to work on the covid19 vaccines. Many of them had to learn how to deal with emergency use authorization. I cannot agree with you more that if we had a codger of people ready to move over, very familiar with a majors use authorization and able to quickly move to reviewing vaccines and a pandemic setting, that would greatly help us in the future. You pointed out the workforce and certainly in Public Health with this estate territory at the cdc, we have an aging workforce but we need more Public Health people working in the field we at the cdc really having to act as a Response Agency to not structure it that way. Having some additional ways to quickly mobilize folks to stand up systems quickly and implement innovations rapidly, that requires a robust workforce that we really need going forward. Thank you for the question. I think we in the cicp, at the beginning of the pandemic, has a four staff , as i mentioned in my opening comments. We needed to scale up to do the volume of the work. That is one of the things we look tough for the future, are the opportunities and strategies to optimize scalability and flexibility to perform the essential functions of our critical programs. I appreciate that, as someone who has endured mass casualty events. You know, being able to be prepared for that or at least have a call up ability to do that. I think that is something i hope we can look into as a congress to consider that type of reserve work force that is ready to go on day one. As of february 2024, vaers reports for covid19 vaccines total significant rehire than all other vaccines combined as reported. This is a surprising figure. Dr. Marks was the government prepared for an avalanche of report due vaers . It kind of goes with what we just mentioned. Thank you so much for that question. I apologize about your name before. It shows when you are nervous, things can happen. The point is extremely well taken. We tried to be prepared for that. The avalanche of reports was tremendous. It requires retasking people on the fly and i will let my cdc colleague speak to this. We had to usually staff up and had many meetings working to increase our ability to go through these reports. As you already mentioned, what the public sees on the public vaers page is just a small fraction of the information that we ultimately collect and sift through. It is very important to determine whether an adverse event is truly related to the vaccine. One of the things we often receive is that we do not make Additional Information available. I would say to you that it is a challenge. What we have learned is that it is very challenging to make available, essentially, protected health information. If you have a z. I. P. Code that someone was pregnant if you have a zip code of someone in ohio that they were pregnant and they had covid, you could potentially re identify those. This is one of the challenges that we face in making available information. I think we like to work to make the most of Information Available as possible. Do you have any concept on that, dr. Marks, as far as this number, you know, childhood vaccines, they are spaced out. This was a vaccine that was being administered would it be a larger swath of the population . Was the number higher . Was at the same per capita, if you will . Does that make sense . Our seasonal influenza campaigns often administer about 150 million doses over the course of a number of months. Here, we had millions of doses rolled out on top of each other at a tremendously rapid rate. In addition, we encourage people , part of the emergency use authorization process, we were encouraging safety reporting because we thought we needed to know, at any potential adverse event so that we could try to investigate and find out if there was something we were missing. Did you have anything to add to that, dr. Jernigan . I now recognize dr. Ruiz for questioning. One of the greatest Public Health challenges of our time. I agree with the chairman, words matter. What we say here today will have a significant ramifications on whether millions of americans will place their trust in safe and effective vaccines, including the covid19 vaccine. Before i get to my question i would like to enter into record a letter the select subcommittee received for more than 50 medical and Public Health organizations and experts ahead of todays hearing. Here you go. This letter, which was led by vaccinate your family and signed by a Broad Coalition that includes the American Academy of pediatrics, the association of state and tory alto Territorial Health officials, state and city health officials, the american Public Health association, the american heart association, doctors for america and many more warns us of the potential damage that could be dumb if todays hearing fails to handle the subject of vaccine safety carefully and without advice. Just this morning a group of six leading medical societies representing more than a 560,000 physicians issued a joint statement. They wanted to acknowledge the overwhelming evidence based science and recognize how covid19 vaccines protect and save millions of lives. I would also like to enter the statement into the record. Without objection. As a position and as Ranking Member of the select subcommittee, i want to ensure that todays conversation remains rooted in the facts. The facts are that while delivering effective covid19 vaccines to the American People at a historic pace, our federal Public Health officials went to painstaking links to evaluate their safety and they are continuing to do so. Dr. Marks, your division of the fda is responsible for evaluating data to authorize and approve products, including the covid19 vaccine. Could you explain for us the rigorous standards of the fda has followed in its authorization and approval processes for the covid19 vaccines thanks so much for the question. The covid19 vaccines, before we even started to receive data, we put forth guidance, first in april and then in october of 2020 which described our expectations for the safety and efficacy of these vaccines. That is the standard that we would use before we can issue an emergency use authorization. For the initial amusing we had data which was equal to what we have or equal to what we would have required for a biologic license application and we required effectiveness data that was near or equal to what we would have required for a biologic license application. We cannot speed up time. In order to get the vaccines, we actually about the safety to be authorize with just two months of media follow rather than the six to 12 but we would comment that would capture adverse effects. When we went to finally do the biologic license application we go through very large data sets. The Pfizer Vaccine had 43,000 people involved in Clinical Trials with about 21 or 22,000 had received the vaccine initially and then thousands more received it after six months. We went through tremendous amount of data and looked at the adverse events and looked at the effectiveness data. That plus looking carefully at the manufacturing. What has the data shown a guarding the safety . It includes that there are some initial discomfort, potentially in the arm, fatigue that could occur. There are rarely more serious side effects that we identified that we identified myocarditis and where allergic reactions. Thankfully, by putting mitigation strategies in place, both of those have been decreased in occurrence. Dr. Jernigan, your division is responsible for operating Surveillance Systems that detect Adverse Health effects. Mild or serious. Could you please explain the multitiered system that the cdc has in place to monitor for safety concerns regarding vaccine that have been brought to market . Thanks for the question. Like i said, we have been putting through the most intensive vaccine safety monitoring in u. S. History. That includes five different systems at the cdc. The first of those is the vaccine adverse event reporting system, that we talked about. It is an open door to get the reports in the second is the vaccine safety datalink. It is a large health record, about 13. 5 million records in it. We look for trends. We have a pregnancy Monitoring System but we have the smart phone enabled app called vsafe. We have a clinician immunization Safety Assessment program. We have medical experts that can provide input in this safety monitoring. That system has been tremendous with us being able to follow what is going on with vaccine issues. What we have found, so far, at least with the datalink, is that there are lower rates of death in those that are vaccinated compared to the unvaccinated. There are lower rates of cardiac complications compared to those that have been unvaccinated. What we are looking for in the vaers system is signals of things that might be a problem we need to follow up on. This process works. We were able to find, like we mentioned in the opening statements, there were six cases of blood clot problems, a very rare problem that we identified very early. We were able to indicate that two clinicians. We can follow a sciencebased process that we have at the cdc. The site is evaluated and the data is analyzed. It is provided to the Advisory Committee for immunization practices. We know that the Committee Advises and provides it to the director to decide. But sciencebased process is what we have been following and utilizing the data. Lets talk about the vaers for a second but that is a system where individuals can report their symptoms that they believe may be associated with the vaccine. How do you determine if its, in fact, is associated with the vaccine or it is not associated with the vaccine . Vaers is a front door were anyone it is a screening mechanism. Correct. They can put in anything they think may be associated with that vaccine. We have a lot of reports that may not be associated with the vaccine but there is a process for reviewing those. Every serious adverse event in vaers is followed up medical records are collected and autopsy records are collected to identify that. We do not use vaers to determine if an adverse event is caused by the vaccine. We do not use it to look at trends about whether the vaccine is more common in causing a problem versus what is in the population. We use different data sets to do that. One cannot subscribe the data from vaers to being the actual rate of death or serious illness because that is an initial screening. And then the investigation that occurs afterwards will determine whether it was, in fact, related to the vaccine or not . Correct. There are cases, for example, where death was reported that you found that it was not due to the vaccine, correct . Correct. For instance, a hospice patient, one of the more learnable people to get vaccinated. They may have a Standing Order for do not resuscitate. That patient may die two days after getting the vaccine. It may not be associated with the vaccine. There are reports of vehicle injury and folks that have been vaccinated. There are even reports of Family Members who died caring for a vaccinated patient but the death was not in the vaccine patient. There are a number of those reports. What we want is to be able to say, what is the impact of the vaccines . We look to other data sets to give us that information. As i mentioned in my opening statement, this rigorous Surveillance System has demonstrated its effectiveness for the covid19 vaccines and detected exceedingly rare cases of thrombosis or tts among patients who received the j j vaccine, for example. Dr. Jernigan, did you explain how the detection of these cases reflect the effectiveness of the vaccine safety Surveillance System . These indicate that the process works. You mentioned the tts associated with the j j vaccine. These systems have been able to pick up myocarditis and show the risk of getting myocarditis is much lower when those are vaccinated then the unvaccinated. It is even a system we have been able to pick up signals that turn out not to be signals. It is called ischemic stroke. It is picking up a signal but will be followed, it went away. We get signals that in times are bare and sometimes are not. It allows us to see things early so we can act quickly and change recommendations. Dr. Marks, my understanding is that bobby detection of these cases at the eight limited the use of the j j vaccine. Could you explain how the fda rhesus decision . Thank you for the question. We evaluated the data that came in regarding the vaccine itself, the j j vaccine. There were also another vaccine that was like that vaccine that was being used outside of the United States, which had a similar issue. We look at the totality of the data and then we changed the back sheets for providers and for patients making a recommendation that this not be the first line vaccine to be used but that it be used in those were a single dose vaccine, which that particular vaccine was, was desirable rather than a two dose regimen. In this instance, our Surveillance Systems worked as designed for detecting where but serious adverse events and forming a policy decision to best protect patients and consumers. Is that correct secure that is correct. What would you say to americans who believed that action taken to address these adverse events draw into question the safety of the Broader University of covid19 vaccines . I would say i think what we see here in vaccine safety surveillance that may be confusing for the public sometimes is that as an amateur radio operator, i sometimes listen to very weak signals. Sometimes that means you turn up the game. We have the game of our vaccine safety Surveillance System turned up very high. That is the ability to detect signals. Sometimes we hear things that turn out not to be true, as dr. Jernigan just noted. I think we have the game turned up high. And we have found signals. And we continue to look for signals. We sometimes find them. As i speak, we are in the process of evaluating whether there are signals that have been detected are real or whether they turn out to be just a statistical anomaly. I am not an amateur radio guy. I am a doctor but it sounds like what youre talking about is specificity. Or sensitivity. So, you know, it sounds like we want to detect as much as we can and rule out the false positives, correct . And doctors language sorry the idea here is indeed to have a very sensitive system to pick up any signal or we go back and try to make sure it is truly related to the vaccine. I heed the warnings we received ahead of todays hearings and keeper discussions rooted an objective information. Public competency vaccines which have saved millions of lives continue to be the most significant Public Health intervention of our time is not something we should be undermining for partisan gains. I think you and i yield back. I recognize from kentucky. I want to talk about the vaccine approval process and safety signals that were downplayed. Dr. Marks pfizer summitted the full approval application may 18, 2021. Correct . That is correct. January 18, 2022 was the original required action due date, correct . That is correct. You worked with dr. Philip krause and dr. Marion gruber on this, correct . Thank you. When pfizer submitted the application, dr. Krause oversaw the approval process. According to documents and testimony they believed they could and should approve the vaccine faster than eight months. The proposed the end of october 2021. You, dr. Marks, requested september 15, 2021. They hesitated but obliged. You, dr. Marks, said you wanted it approved even faster than september 15. But they declined. According to them, after they declined you and former fda commissioner Janet Woodcock relieve them from the roles in the approval process. They said they felt substantial pressure for you to approve this vaccine faster than they thought was defensible. My question is, did anyone instruct you to speed up the approval timeline faster than september 15, 2021 . Chair 23, thank you for that question. What was going on during that summer the change the situation was the week ending july 10, 2021 there were 1600, 1645 deaths. In the week ending august 14, there were 9406 deaths. There were an increasing number of deaths from covid19 and there was clear knowledge that having an approved vaccine would help americans feel more comfortable getting vaccinated. So we felt speeding up the vaccine approval process let me interrupt. Did anyone instruct you or is this a decision you made on your own . This was a decision i had made on my own. Why were you pressuring the doctors and then removing them from the approval process when they disagree . The approval process was one that was needed to move as rapidly as possible. We may go back to that. To recall a conversation regarding the need to approve the vaccines in order for it to then be mandated . There was an acknowledgment that an approval could allow Vaccine Mandates to occur. But they were not conversations over that. So, dr. Gruber wrote license states cannot require mandatory vexation. Do you recall this conversation . I dont know what youre referring to. But, there is probably, its just a statement of fact that once you have a license , a mandate could be placed. You recall why dr. Gruber and dr. Krause expressed concern about accelerating the approval of the vaccine . They were concerned about the workload. Dr. Gruber wrote taking a thorough approach was important because of increasing evidence of association of this vaccine and development of myocarditis especially young men. Do you recall seeing safety signals regarding market it is in young men at this time . Yes, there were safety signals known and they were placed on the label. But chair 23 23, did you have conversations regarding the vaccine approval with the department of defense . I cant recall any conversation directly with the department of defense. Did anyone else at fda have conversations regarding vaccine approval with department of defense . I cant speak to the conversation of others. Im just not aware of it. Did you express your desire to approve the vaccine by august 20 . I did. And it was ultimately approved august 23, correct . Correct. Just for the record, the military mandate was issued on the 24th. That is interesting timing. Thank you, i yield back. I recognize for michigan. I am concerned that americas confidence in the safety and efficacy of vaccines is of critical importance to our nations Public Health. For hundreds of years dating back to 1796 vaccines have saved lives and reduce the threat of deadly diseases from polio to measles to covid19. However, we are now witnessing a startling decline in immunization levels across the board and i am deeply concerned about what this means for our nations ability to respond to Public Health threats in the future. We are having diesel breakouts. We have one in washington, d. C. From exposure at the airport. I want to focus on what we can and should do to promote Vaccine Confidence with constructive reforms that enhance Community Engagement and strengthen the vaccine systems. One way i think we can go about this is approaching people with compassion. But making sure their questions are answered honestly, trustworthy, Accurate Information that breaks through some of the noise, by the way, that is a lot of false information online. During the height of the pandemic democrats pass the American Rescue plan which not only helped get vaccines out to the American People, but also invested in communitybased outreach programs to help increase vaccine uptake. These programs focus on meeting people where they were to equip them with transparent, reliable information about vaccine safety and development. Dr. Jernigan, i like to get your thoughts, short, how does the cdc work to provide people with timely, Accurate Information regarding vaccine safety and efficacy . Thanks. At cdc we are committed to transparency and we regularly share that information on vaccine safety with federal partners, state partners. Their different communication mechanisms we have through the web, through other media, et cetera. I think it is important that people know about the known side effects of the vaccine or rare adverse events that may occur after vaccination. The subcommittee is probably tired of hearing me talk about getting after a swine flu shot which by the way i was mandated to get an assured it was safe and effective. And it was obviously neither. And i was scared to death to get the Covid Vaccine. I sought out Accurate Information from physicians at u of m and any dr. I knew walking down the street. Some of the may not have been qualified, to reassure me about the safety of the covid19 vaccine and i finally did get it and prepared today. But unfortunately im still here giving everybody a hard time. Well, fortunately i should say. But ultimately, i supported the Biden Administrations common sense policies to increase vaccine uptake because i believed we had systems in place. The systems we are discussing today were working to ensure that adverse events could be detected and meaningfully addressed. Dr. Jernigan, can you please speak to the ways in which the cdc provides transparent information regarding rare adverse events that may occur from various vaccines including covid19 vaccines . Thanks. As we mentioned, there are number of different Surveillance Systems that we monitor. Once we see any signal there we communicate that to the general public to Healthcare Providers to provide that information to the Advisory Committee and then recommendations can be changed. We are committed to transparency. We provide information on risk benefit analysis at 30 different Advisory Committee meetings in the last three years. We get that information out so people can understand. Do you think doctors are getting it . And what steps do you think congress should take to support and strengthen these efforts . For example, what role does comprehensive funding from Congress Play in cdcs ability to operate these Surveillance Programs . Certainly we want to work closely with Healthcare Providers. Its really the connection between the Healthcare Provider and the patient where the decisions that understanding comes from many times. We want to get that information out. We have Safety Systems right now, one level before the pandemic, a very high level in terms of the activities we are doing now and we are not needing to go back to where we were before. We need to sustain those systems that are broad now and help us with new vaccines coming out and get the most information about safety. In the rare instances when something does go awry ended adverse event occurs, people need to know. There is protection and compensation available to them should they needed. Had were nations vaccine work to adjudicate valid claims or competent individuals quickly as possible . The queue for the question. The countermeasures Compensation Program or cicp were required by statute to make a determination based on the compelling reliable valid Scientific Evidence that a serious physical injury or death was directly caused by the countermeasure. We have at least three advanced practice providers that review each claim and a claim is reviewed for legal sufficiency to ensure that it meets with the statute set by congress. Thank you. I am out of time. I hope we will Work Together to make sure people do keep confidence in vaccines the prevent death ultimately. I recognize new york. Thank you for holding this important hearing on vaccine safety and injury compensation. I like to extend my gratitude to all the witnesses for taking the time to share their expertise with us today. In march 2020 our world experienced profound and undeniable shift in the rapid spread of covid19 with the fear and uncertainty. Then in an extraordinary triumph of science and innovation in vaccine was developed in record time. This grantmaking moment held the promise of protection and a return to normalcy. However subsequent actions from overstating vaccine efficacy to the implementation of sweeping mandates and the suppression of open scientific debate eroded public trust. These decisions left lingering questions about vaccine safety, sparking both valid concerns and unfounded fears. We have systems expressly designed to monitor vaccine related harms and provide recourse for injuries but fortunately the action surrounding the covid anti vaccine have highlighted areas where the systems may have fallen short and we can start rebuilding trust for safe and effective vaccines in the future. After all we do know that vaccines really are often times lifesavers. But i do want to point specifically to the concerns about postvaccination heart issues particularly myocarditis and young people. In fact, myocarditis is one of the injuries that have been compensated for. Id like to know from both dr. Jernigan or dr. Marks, what specific monitoring or guest safety monitoring or Research Projects are underway by the cdc or the fta to dive deeper into this issue. I am happy to start. Thank you for that question. We have had multiple go rounds in our adverse event reporting systems that use active surveillance. One of them is called the best system, to look among large databases, claims databases and Electronic Healthcare records to look at the incidence of myocarditis in vaccinated individuals versus nonvaccinated individuals. Some of that work has now been published. I think it leads us to understand that after the first covid19 vaccines where the primary series was given two doses three or four weeks apart, there was a risk in the younger age range of males that was about one in 10,000 to one and 20,000 individuals got myocarditis. Now with the spacing out of the vaccines, that risk is almost undetectable. And there was a recent study published in the jama pediatrics 3 million individuals 517 years who had received 5. 9 million vaccine doses, which really only again, there was a signal for myocarditis only after the primary vaccination series with the pfizer mrna vaccine in those 12 to 17 years of age. And now that signal is not being seen more recently. I think we have learned something about how to deploy the vaccines. I think that is why cdc, i can turn over to dr. Jernigan, has changed the recommendation for how they be used. Yes. Quickly add to that. We do have systems, the datalink monitoring other systems and continuing to monitor for myocarditis. As more time passes is the fda actively conducting safety surveillance on those who receive the early covid19 vaccines . Are there specific Health Markers you are studying that may signal trends requiring further inquiry . Thank you for the question. In fact every time we go through do the safety surveillance we start back and it goes back to 2020. In some cases where we are looking for certain things we might use a different window. But indeed we have to look from the beginning period of surveillance. I can turn over to dr. Jernigan because he can speak to cdc in that regard. With regard to myocarditis we have certainly been monitoring the issue with various different data systems. I think the most recent data demonstrates there is eight times less likely to get myocarditis if youre vaccinated compared to those unvaccinated. Not just myocarditis, everything. Repeat the question . As more time passes is the fda conducting extended surveillance on those who received the early covid19 vaccines . Most of the reports we get for adverse events are the few weeks following the vaccination. In terms of monitoring these overtime, we do have vaccine effectiveness systems in place at cdc. Im out of time. Thank you much. Now recognize ms. Ross for north carolina. Thank you very much, thank you for being here today. I just want to correct the record on some misrepresentations the we have heard here, but we have also heard in the public regarding the covid19 vaccine and vaccine Safety Systems more broadly. In listening to todays hearing, one might be led to believe that reports submitted to the vaccine adverse event reporting system or vaers, are the most meaningful measure of Adverse Health events and should be the sole emphasis for evaluating whether the covid19 vaccines are safe. However, my understanding is that vaers is just one Surveillance Program within a multilayered vaccine Safety System that cdc operates. And that submissions to vaers which are unverified can be submitted by anyone regardless of how likely a vaccine is to have created an adverse event. And, can act as Early Warnings for deeper investigations through these other Surveillance Programs. Is that correct, dr. Jernigan . Yes, so vaers is a system for getting information in quickly identifying trends. But its not that it is that we used to determine causality or the impact of the vaccine. Can you explain in more detail how vaers prompts this deeper investigation or other safety Surveillance Programs at the cdc . Yes, i think over the last several years there have been over 676 million doses of vaccine have been administered. We had a significantly exceedingly rare number of adverse events reported. Theres a lower number of serious adverse events. Each of the serious adverse events does they ask for autopsy and medical victims. Using different systems. Like our Safety Assessment program that can evaluate findings. We also have other data sets that can tell us if there is increased signal across the general population that we need to be worried about. Thank you for that. And then for the reasons you just explained, it seems that the vaers data on its own does not provide a strong basis for evaluating causality and that doing so does require this multilayered approach. Is that correct . Correct. How far are you into the multilayered approach for the Covid Vaccines . In terms of using the different systems, they are an ongoing basis. We presented at each of the Advisory Committees and what we are finding in the systems regularly. Just to be abundantly clear, using the vaers that exclusively to make claims about Covid Vaccines causing Adverse Health effects would be flawed. Vaers is not intended to determine if a vaccine is causing an adverse event. Thank you. Dr. Marks, my colleagues have attempted to distort an email you sent in july 2021 regarding the authorization of the pfizer booster. They claim this is evidence of political interference that undermined Patient Safety in favor of expediting the timeline for this product. Dr. Marks, id like to give you an opportunity to correct the reppert on the misrepresentations of this email that had been made and just give you, i have 1 15, its all yours. Thank you so much for the opportunity, at the time that these boosters were authorized, just before we had an increasing number of deaths starting to run into the thousand per day in the u. S. And there was great urgency to think about what we could do to try to reduce that number of deaths. It had become clear that immunity was waning. And that potentially giving a booster could restore immunity and decrease the number of deaths. And so we moved with all due haste, not because of any kind of external pressure, but because of internal pressure, we felt compelled to try to save american lives because thousands of people were dying. And as somebody who was one of the architects of operation warp speed, i had a pretty good idea of how to find efficiencies to move forward. It was critical to move as fast as we could. And by the way, the data that has now been published show that introduction of that first booster was probably responsible for saving hundreds of thousands of lives as we entered the delta and omicron waves. Thank you. Thank you so much for that explanation. Mr. Chairman, i yield back. Now recognize arizona for five minutes. Thank you for all being here. Dr. Jernigan, we spoke over the phone in august of 2021. I was asking about vaers because i had lots of constituents reaching out to me saying there was tons of adverse effects. There were thousands of deaths, et cetera. Were very concerned. I asked how many were confirmed and at that time you said, four. There were four cases that you confirmed deaths that were caused by the vaccine. And i suggested at the time that the cdc and fda do a better job of telling the public not just how many cases were reported, but how many were actually confirmed. If i heard you right, just recently you said, we dont want to give out too much information because of privacy rights. But certainly we could put out how many were confirmed deaths, couldnt we . Congresswoman, thank you for that question. I fully agree with you that we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what is in vaers. We nearly fell prey to it at this hearing. There are only handfuls, and i will ask dr. Jernigan to comment on this. There only handfuls we can actually associate. Can ask why you havent done it . This was august 2021. It seems very logical to me that if you are saying, the public shouldnt count on vaers because anyone can report to that, which the can, why wouldnt you, is actively report to the public, we confirmed this really low number of cases that actually were caused by vaccines. It has been years now. Why havent you done it . We did present that in various settings including as i believe at the Advisory Committee of immunization practices. It was mentioned at our eckstein Advisory Committee, perhaps the knot is broadly that is there an easy place where the public can find this . I remember you gave us some kind of link back in 2021 it was difficult to get to if i remember right. So why not spend the time, if the goal is to give confidence to people in getting vaccines, why in the world would you just not say, okay, what we have done is we have investigated these deaths, we have than this, we have than that, and we only found a handful. It doesnt make any sense to me. I want to continue. I am sorry, i have only a short period of time. One of my former constituents, and i think i talk to about this, dr. Marks, from surprise, arizona, steve winger, worked for a company the forest him, mandated him to receive the Covid Vaccine in may 2021. He got the j j vaccine. Within a month of receiving the vaccine he was in the hospital paralyzed from his neck down. He spent over three months in the hospital and was eventually diagnosed with killian barre syndrome. Actually the doctor said right on his medical stuff it was most likely caused from the vaccine. Steve continues to struggle with his injuries today all because he was forced to take an experiment the vaccine at the urging of the Health Agencies. His injury was also reported to vaers and he filed a claim with cicp about two years ago and has not heard back at all. He said not even a form letter. So, i want you to know that, commander, so maybe my office can give you his name so you can at least respond that you got the claim from two years ago. Also, there was a new york man who suffered from hl h after his Covid Vaccine. s initial report was classified as life threatening. s second report filed after his death is classified as hospitalized. The family called to request a correction to the second report to be a fatality and was instructed to file another report and was then sent a form condolence letter from the cdc. And the fatality was in may 2021. The form letter was received december 2022. The family subsequently sent an automated message at the end of 2023 two update their vaers report on his condition. He is dead, they said. The family has been very distressed by the lack of proper investigation done and classification that he is actually died. A lamson, ive run out of time, is that as you have said, youve increase the number, commander, from four personnel to think you said 35. Obviously more work needs to be done if people havent been, you know, the person died and it still says their hospitalized. This is a huge problem. With that i yield back. I recognize Ranking Member of the full committee for maryland for five minutes of questions. Thank you, mr. Chairman. Dr. Marks, you set a moment to that the vaccine booster alone saved hundreds of thousands of lives. How many lives have been saved by the covid19 vaccine in general . Its estimated about in the u. S. About 3. 2 million lives and its estimated globally covid19 vaccines have saved over 14 million lives. Conservatively. And we have lost more than 1 Million People to covid19. That is correct. About 1. 1 million. I kept a daily record of the number of people dying which got up to about 3300, about a World Trade Center disaster per day. Dr. Birx stated that sequence of missteps and mistakes made by the Prior Administration Pandemic Response cost hundreds of thousands of american lives. So, i take it, one of the points you have to make is that the Public Health response of the federal government makes a huge difference in terms of Health Outcomes for the American People. I would agree with that. Whether its measles or tuberculosis or covid19, would you agree that vaccines save lives in aggregate . I think that by definition, for us to approve for authorize vaccine there has to be overwhelming evidence that many more lives are saved then it might be taken by a vaccine. In other words the safety by definition has to be excellent. Got you. Dr. Jernigan, it seems as if, one of the things that is created, has created political social conflict around this is the inevitable fact that even when vaccines save a huge number of lives, millions of lives, as dr. Marks testified, if in a small number of cases there are adverse results, the people who suffer them and their families are understandably very upset about that. Would you agree that that is a general conflict or dynamic that exists with all vaccines . Correct. We recognized no medical information intervention is risk free. I could imagine if i had a Family Member who suffered an adverse reaction to any vaccine , measles, tb, covid19, i would say i just wish they hadnt gotten it. In the first place. And of course if anyone had been able to predict it, they wouldve been told not to get it. On the other hand, if we just said to everybody, there is a tiny number of people who suffer an adverse result therefore nobody should get it, we know a lot more people are going to suffer and die because of it. Is that a basic problem that you wrestle risk within your field . Correct. Any time we to Public Health we have to talk about the risk and benefits and the way we communicate is very important so people take the interventions. Have you detected anything at the cdc through your Surveillance System that has caused you to doubt the safety or the appropriateness of cdcs original and continuing recommendation the people get vaccinated against covid19 . I have dedicated my life to Public Health. I do care deeply about protecting americans and using the best available science. I want to stress that the Covid Vaccine is safe and it is effective. We have safety Monitoring Systems in place have detected certain signals. We have acted on those quickly. Would you agree the covid19 vaccine and its rollout in the Biden Administration has been one of the great achievements of modern science and Public Health . I think over the last four years we had a onceina lifetime event that required an incredible response from all of us. I would agree that the use of vaccines has been a remarkable achievement for us all. There is a paper that someone sent to me called access death rates for republicans and democrats during the covid19 pandemic from the National Bureau of research. Which makes the point that there were substantially weather have been substantially higher death rates for registered republicans when compared to registered democrats. This is been connected to Vaccine Hesitancy or fears. I would like to submit this for the record. I wonder if you would opine on this for a second. Have we ever seen a case like this in the past where there is actually partisan differences in peoples willingness to get a vaccine, the skepticism and death rates arising from such difference . I think you point out the importance of us getting to so folks can be vaccinated. Thank you very much. I will submit this for the record, mr. Chairman. I recognize georgia for five minutes of questioning and without objection submitted. Im not a doctor but i have a phd in recognizing bull when i hear it. We knew early on, as affect everyone knew early on that the people that were at risk of hospitalization and dying of covid were those that were obese, had diabetes, were over the age of 65, we also knew the children were at no risk. Practically zero risk of being hospitalized or death from covid19. We knew the young people, healthy young people were not at risk. However, dr. Marks, you rushed through this process of authorizing these vaccines even though you knew the side effects. You knew about myocarditis and you knew about the studies. Lets be very real about the situation we have. Here we have, lets talk about the reports on vaers. Some people are trying to belittle the reports. But these reports come from people. People that died. People the got injured. And in december, in the middle of december, i think it was the 10th or 11th, the first vaccine was approved. It was authorized under emergency use. Boom. 10,596 reports in less than a month. 2021, 706,000 reports on vaers for vaccine injuries and deaths. 2022, 206,676. 2023, and it was going down because the mandate. Stopped. Now lets talk a little more about the vaccine. Here we have reports, deaths, 18,372 permanent disabilities 17,842. Hospitalizations 86,452. Emergency room or office visits, 315,048. Serious adverse events, 113,449. This is from the Congressional Research service about vaers. All kinds of injuries. Miscarriages. Heart attacks. Myocarditis, permanent disability. Neurological problems. And it goes on and on. These other reports from people being forced to take vaccines. It shouldnt have happened. Mr. Grimes, ive told you the number of reports, however under cicp there only 10,640 of these covid19 claims currently pending or are in review. As of january 1, 2024, cicp only compensated 11 of the 40. Wait, its make that number clear. Only 11 people have been compensated. Only 11 people have been compensated. Out of the 40 covid19 claims that determined were eligible, only 40 were determined eligible. That is amazing. The average award was only about 3700. On the other hand the average vicp over the last 35 years was approximately 490,000. If you die or get injured your average payout is 3700. I like to recognize someone in the room today. Breanne. She has met with you, dr. Marks. She has met privately with you about her vaccine injuries. She participated in the clinical trial. She was injured. And then she was dropped from the trial for the covid19 vaccine. Her medical expenses are 433,000 per year. She filed with cicp. Dr. Grimes, she has no response. Could you raise your hand . Perhaps you can meet with her after this meeting. Dr. Marks, you admitted to her vaccine injuries are real. That they are real. Although you rushed through the authorization. And now, youve authorized the children should receive these vaccines and even babies as young as six months old. That is shameful. I am not asking you a question. Im going to continue speaking. This is my time. The National Institute of health also saw miss dressing for hurt neurological complications that have been quite severe. They studied her and then they dropped the study and asked her to be quiet about it. These are the real stories of back to back that vaccine injuries. They were totally wipe off of social media. There has been thousands of Peer Reviewed medical studies, thousands of them studied vaccine injuries. They are real. People are dying. People are having heart attacks, strokes, blood clots, and many other countries are dropping the covid19 vaccine and saying we shouldnt give them to children. Its time to be honest about the vaccine injuries. We need to stop allowing covid 19 vaccines to be given out to children. The times expired. Now recognizing mr. Garcia from california. Thank you. Im sorry you had to go through that. That was a lot of conspiracy theories and wild accusations. Which we know have been debunked by medical science and we should be clear that vaccines work and save lives. And they have millions of lives in this country. Its really unfortunate we are here having this hearing trying to poke holes and cause more Vaccine Hesitancy amongst the public. But we know we are here because Committee Members on this committee have demanded we have this hearing. And we continue to cave and give those members everything that they want. We also know we have a member of this committee the just actually made some comments who has been on social media demanding that we hold this exact same hearing. This is the same person we know that has on countless posts spread misinformation, encouraged parents to refuse vaccinations for their children which we just heard. And even compared our pandemic effort responses to the holocaust. I want to read something which is in the public record, im not saying anything thats not in public record, a member of this committee actually said, the same person attacking vaccines, said that vaccinated employees getting a vaccination logo just like the forced jewish people to wear a gold star. I want to read that again. Vaccinated employees getting a vaccination logo just like the nazis forced jewish people to wear a gold star. That is the insanity of attacks were having as a debate around the lives saved around vaccinations. This is a member has held shadow hearings with the idea that its a bio weapon to start it target i want to read you this quote. Its in the public record. Have the Covid Vaccines resulted in increasing cancers and our turbo cancers real . Mr. Chairman, this is in my opinion, insanity. We know that is not the case. Dr. Marks, can you clarify once again, for the American People, do the vaccines cause turbo cancers . I dont know what it turbo cancers. It was first used in the paper in mouse experiments describing inflammatory response. We have not detected any increase in cancers with the covid19 vaccines. Thank you. Thank you for correcting the record. May i add something . I need to apologize to the 1000 or so parents of children who are under four years of age with died of covid19 who were unvaccinated because, there were deaths and are continuing to be deaths in children. And that is the reason why the need to get vaccinated. Thank you. I agree with you 100 . And the fact we are not having parents that are choosing to vaccinate their kids less than before, because of the attacks on vaccinations is shameful and its shameful that members of congress continue to put down vaccinations as an opportunity to get arc unities healthier. Dr. Marks, i want to thank you for the work you did. My mom passed away from covid 19. My stepfather passed away in covid19. Both wouldve taken the vaccine in an instant if it was available. Anytime folks, especially folks on this subcommittee, on the pandemic attack vaccines, it is personally insulting to all the families that have lost loved ones. We have saved millions of lives because of the vaccine. Its unfortunate we keep causing this harm. I just want to say lastly, that, dr. Marks, do you agree additional lives wouldve been saved, the lives of the folks were not vaccinated, that we lost, over 1 million, obviously in this country, wouldnt a vast majority of those lives been saved had they been vaccinated . Multiple city show 85 of the death that occurred were in unvaccinated individuals. If we wouldve been able to reach a higher vaccination rate by playing on fear and mistrust and by amplifying over and over again a Vaccine Hesitancy across the nation. Now, when you do that, you really played with fire. In this case the fire that the gentleman from california mentioned also about how we lose loved ones. How people die and how that rate of death accelerated over and over again. I really want to thank god that jonas the great neurologist in 1955 did not run into the nonsense when he developed the vaccine for polio. Parents were clamoring because they wanted their children to be able to walk and have a good life. There was a sense of sense and sensibility the went along with it. So, when it is done right it is done right. So many children and others who were vaccinated for polio successfully, and were there some bad stories along the way . I am sure there was. Just as we have heard, when you are dealing with science there is not a 100 certainty in everything. Mr. Chairman, my colleagues on both sides of the aisle know that Covid Vaccines, even under accelerated Development Timelines have proven over and over again to be safe. I would ask unanimous consent, mr. Chair, that i submit into the record this article from the general interest news site locks including, will america continue to turn away from vaccines . Objection. Dr. Jernigan, can you explain for the committee again, if you dont mind, there are some people watching around the nation who have tuned in late and perhaps missed earlier discussion, can you explain for the committee again if you might, the multilayered process of vaccine safety monitoring that the cdc implemented for covid19 . Thanks. I have worked in Public Health since 1994. Responded to multiple Infectious Disease emergencies and this is the most robust vaccine safety Monitoring System we have ever had. There are five different systems. We use all of those to determine the impact of those vaccines in the association with safety. All those systems are used by cdc. Can you also cooperate that this seems to be, at least, by all standards, an incredibly thorough process that meets on the merits of scientific approach and scientific rollout for such . Wire the system so crucial in maintaining vaccine competency in the u. S. . We want to make the best recommendations with the best available science. For that at cdc we use a sciencebased process to get to the recommendations. Making sure science is first and making sure we have the data and making the right recommendations with the best available science. Thank you. I want to thank all of you again for being here with us. Mr. Chairman, yield back. Now recognized dr. Miller meeks from iowa. Thank you, i want to the witnesses for testifying before the select committee today. I want to also say that i am eight former director of the state department of health in iowa. Public health. I was vaccinated and gave vaccines in all 24 counties of my district. However, i have never been for a Vaccine Mandate for covid19, both when i was disturbing vaccines as well as today. Dr. Marks, Covid Vaccine covid19 remains a public challenge given growing Vaccine Hesitancy and fatigue. As a Public Health director and as a state senator, Vaccine Hesitancy and fatigue is not new. This is been an issue but has been greatly enhanced through covid19 Vaccine Mandates. To optimize the effectiveness of covid19 vaccines, i understand that the fda has recommended periodic updates to vaccine composition. As we have seen with influenza, a clear framework for strain selection supports the timely availability of a supply of platforms. I believe that multiple fda approved vaccine options can play a role in preserving Consumer Choice of products and ensuring equity of access both of which can contribute to increased consumer acceptance and uptake vaccines without forcing americans to receive a specific option. Can you please speak to how the agency is taking steps to ensure vaccine manufacturers have the essential time needed to adapt their products accordingly and scale of production for vaccines for new virus variants . Thanks for the question. I would certainly agree with you that fda, we take seriously the need to have choice among vaccines. That will allow greater vaccination rate because we understand some people may not feel comfortable with certain types of vaccines. They may want a more traditional vaccine rather than a newer vaccine. That is why we have been continuing to work with manufacturers to try to make sure that when we roll out the next update we will have a diversity of choice, at least more than one type of vaccine that will be available. So, you will see, as we move into the spring, as you noted, we will go through a strain selection process. We are already having dialogue with manufacturers to help them get prepared. Theres a lot of framework they can do it risk to prepare for this so they can hopefully have the choice were talking about. Thank you. Dr. Grimes, as you know, covid 19 vaccines are covered under the Countermeasure Injury Compensation Program. Cicp, which is overseen by hrsa instead of the National Vaccine Compensation Program, vicp. With fda being responsible for responsible approving vaccines and her so being responsible for adjudicating cicp for the covid shots, i am concerned that there is too much government involvement and overlap with covid19 vaccine claim adjudication. Furthermore, the cicp was not designed for epidemic as large as covid19 pandemic was. Adding to the argument that vicp is the appropriate location to house the covid19 vaccine injuries in addition to the rsv and vaccines which are available. While i recognize that adding vaccines to vicp is through eight . 75 excise tax on pharmaceutical manufacturers which would require congressional action, and nonetheless warrants attention by the select subcommittee. When a new vaccine is approved and marketed, what steps are required to ensure access to compensation under the vicp program and what happens if the new vaccine is not added to the list of taxed vaccines . Thank you for that question. As you know we have two programs administered through here so. The cicp and vicp. Both are in my division. With the National Vaccine Injury Compensation Program it is a tripartite system where we work with the department of justice and with the u. S. Court of federal claims to do separate duties to adjudicate the claims. For vaccine to be covered under the cicp, three criteria must be met. One is the routine recommendation by the cdc for routine administration in children or individuals were pregnant. The second is the excise tax imposed by congress as you note. And the third is a notice of coverage that the secretary of hhs would add. For a rsv or covid 19 vexing to be added to the program all of those would need to be met. Dr. Grimes, what is the rate of denial for compensation for claims for the 19 vaccines in cicp . Thank you, i dont have the rate. But we have adjudicated 2214 claims. I think its about 98 . If i could quickly followup, i understand there is a current backlog of claims in cicp by about more than 10,000. Why is there a backlog of claims for the covid19 vaccines . Think you for the question. At the beginning of the covid 19 pandemic we had not had a direct appropriation with the cicp. We also had only four staff. When we received our first direct appropriation in fiscal year 2022, we were able to ramp up quickly and now we have over 35 staff who are assisting to adjudicate claims. Thank you. My time is expired but id like to submit additional questions to be answered after the hearing. So ordered. Thank you very much. Now recognizing hawaii for five minutes of questions. I am deeply concerned about some of the dangerous rhetoric we have heard throughout todays hearing. Which appears purposely gained at undermining competency in vaccines. Words matter and side effects. Head of the hearing the select subcommittee received a letter from the association of and Territorial Health officials. An organization representing Public Health officials from red states and blue states alike. This letter underscores the importance of informing the public truthfully about the safety and effectiveness of vaccines. I am urging the select subcommittee to engage this topic responsibly and with the utmost integrity. I would like to enter this letter into the record. Without objection. Im concerned with todays hearing my republican colleagues have failed to handle this subject with the care our Public Health officials of asked for. Recklessly amplifying the spread of misinformation about the covid 19 vaccine. What my colleagues on the other side of the aisle a claim todays hearing is only about the covid19 vaccine they cannot and must not ignore the fact that the covid misinformation intentional spread of misinformation the covid19 vaccine has resulted in acrosstheboard decreases in immunization levels over the last few years. In fact, the world is experiencing the Largest Global decline in decades in the number of children receiving basic immunizations. A recent survey at the University Pennsylvania found the number of americans who viewed vaccines as less than effective has increased since april 2021. According to the survey roughly one in three americans think its likely safer to get covid 19 than to get the vaccine. One in six americans believe vaccines cause autism. Americans are now less likely to consider getting measles, mumps and rubella vaccine than they were in april 2021. As a mother of two boys i am deeply concerned about what this means for children. Especially when we are seeing outbreaks of previously control diseases like polio and measles popup not just in other countries but right here in the u. S. Since measles was declared limited in the u. S. In 2000, we have seen outbreaks, mostly and especially in under vaccinated communities. These have included outbreaks of eight cases in philadelphia december 2023. And an outbreak of 85 cases among unvaccinated children in central ohio in 2022. The savings of vaccinations medical and Economic Loss in human life cannot be ignored. Cdc estimates that immunizations for children born between 1994 and 2021 will prevent over 1 million deaths. 29 million hospitalizations and save 32. 2 trillion in societal costs. And already we know 19 vaccines have saved more than 2. 2 million lives as has been referenced in the hearing. Lets be clear, no parent, no parent at all wants to do their children harm. But many parents are sadly getting interestingly acting upon false information like what we have heard in this hearing room today. I would like to discuss today how we can make sure parents get the best and most Accurate Information they need so we can promote confidence and prevent bricks of deadly diseases. Dr. Marks, please explain how the fda evaluates vaccines to make sure they are effective for age groups they are intended to be used for . Thanks, congresswoman, for that question. Every week every vaccine is required to have manufacturing information to show its high quality and we have to have information on the effectiveness and safety in the specific age population is being described in. We have to understand its going to function similarly in that age group that we are authorizing or approving it for. It is a process that we take very seriously at the agency. And there is a very dedicated group of people that spend their time poring over data to make sure that in the thousands of records that are submitted to us, thousands of pages for instance, over 1 million, 8 million pages for biologics for the mrna vaccine, we get the authorization or approval right. Thank you. If parents of questions about vaccines for their children, what steps do you recommend they take to get their questions answered . And im not talking about the internet. I think chair wenstrup and i talked about this the other day. The primary is conversations between parents and their providers. And that the writer doesnt have to be a physician, it can be a Nurse Practitioner or someone in a Doctors Office that is a physician assistant. But having that conversation that individual conversation where people can ask questions and have them answered. At least, i have spent a lot of time during the covid pandemic doing that. It makes a huge difference. I believe in the privacy of the provider and patient relationship. Thank you. I am out of time but i would reiterate today we have seen republican lawmakers across the country to so distrust in life saving vaccines. I hope this committee can correct course. Thank you all for being here. We often hear from agencies that they can everything if only they had more funding, more authority, more data. The covid19 pandemic showed us that we had a different problem in the structure that governs our approach to Public Health. Early on, the government provided millions of dollars to pharmaceutical companies for Development Much of this work was aided by taxpayerfunded scientists, then we purchase the vaccines back from the pharmaceutical companies. Next the da in the cdc which were responsible for evaluating the save and effectiveness of the becks. To them for emergency use. Then not content with recommending the vaccines and allowing the American People to make their own decisions, they blatantly tried to force everyone to get the vaccines ignoring constitutional considerations and signs. At the same time they provided defectors with Liability Protections ensuring they cannot be sued for any adverse effect. Instead a government bureaucrat is to decide whether or not someone was injured and offer them a minuscule amount of money as compensation if they manage to make it through an arbitrary process which is very intensive. Right now we have the same Agency Funding the research, approving and mandating and then finally adjudicating the vaccines, concentrates too many other critical government functions in the same hands. One of the big issues on top of this is that the misinformation that came out during covid was fostered by the federal government in the sense that we had the federal government colluding with social Media Companies to discourage scientific opinion that went against what was the stated mandate at the time. To help you the record i would like to ask a couple of things. Dr. Marks, you stated that vaccines work at the outset that i dont think this committee is designed to question that. But there is an attempt in this conversation to throw the covid 19 a new, different, scientific approach to vaccines with a new data set that is still developing and all those kinds of rings with the well established vaccines for polio work chickenpox or meningitis with these types of things when i think americans, rightfully so after watching the government over the past couple of years, could have some concerns about covid19 and the information presented here to want to ask you each a couple of questions. Simple yes or no. Does the covid19 that prevent the disease from you receiving the disease . You cannot have a yes or no answer to that question. It will reduce your risk of serious outcomes. Right. Im not debating whether or not it helps people mitigate some of the but what they do a very good job of inventing death and hospitalization. They may not event, they may not prevent infection. I agree. The mantra at the time was to stop the spread. So we were understood that we other did not receive it or could not transmit it when it was released. Can you receive or transmitted after receiving the covid19 vaccines . Having worked in disease for 30 years and seen the benefits of vaccine can you receive or transmitted after receiving the vaccine . We need to make the best recommendations its a yes or no question. Its very simple. Can you receive we make the best recommendations for the public can you still get covid after getting the covid19 vaccine . Yes. Yes. Okay. Does it prevent you from transmitting it . Although there is data that shows earlier in the pandemic, there was some reduction in transmission, the data on that is very challenging to pin down. It does not absolutely prevent transmission. It does not prevent transmission. Thank you very much. I would ask you, dr. , why does the cdc website listed as a vaccine preventable disease and why does it call it a recommended immunization . They refer to things that benefit from getting the vaccine. When the over that does not prevent you from getting the disease. No one is questioning that. The issue right now and why we are seeing a bunch of vexing hesitancy is because the information coming from the federal government has been marked yet best on this subject and people dont know what to trust. My question to you is what you list this along with other that are proven to have a long set of Scientific Data as a vaccine that prevents disease . All vaccines have variable levels of effectiveness this is a vaccine preventable disease just like the others are. Okay. Youve done a great job of villa bowstring my time. I yield back. We now recognize the gentleman from pennsylvania. For five minutes. Thank you for convening this panel today. This is incredibly or tent discussion topic. As our continued work on the committee to get to the bottom of the origins of covid 19 and the government response. Understanding how enteral agencies tracked the rollout of the covid19 back in and documented in tenses of injury or adverse effect is radically in court and for any future responses. As a doctor, having accurate and uptodate information before treating patients during a Public Health emergency is of utmost importance. While federal Health Agencies have several cysts for vaccines safety surveillance, the most wellknown during the pandemic became the vaccine adverse event reporting system or vaers. The government also has two systems for adjudicating and compensating vaccine related injuries. The countermeasures Injury Compensation Program and the vaccine Injury Compensation Program. Two of the key differences that covered the covid19 vaccine and that which covers most other vaccines are to adjudicate the claims and the damages. In cicp, claims are adjudicated by hrsa. Whereas in vicp, they are adjudicated by the court of federal appeals. Who pays for the appropriated funds whereas in vicp, it comes from taxes levied on manufacturers on each vaccine. Before the covid19 pandemic, cicp was a very Small Program due to its limited scope. Claims have exploded know that white they distributed him even mandated countermeasures are covered under the program. As of january 1st of this year, the total number of claims ever filed was 13,000 106 and covid 19 claims account for 12,854. Nearly 96 of the total. Because of the design and their limited resources adjudication of lames is a lengthy and burdensome process. Its also reap hoarded that 10,600 40 of these claims are currently pending or under review. Commander grimes, how is the cicp structured to ensure fairness to petitioners and how does this compare to the traditional litigation system . Thank you for that question. We administer the program by statute. We call the requester, they file a request for benefits and then must submit article records to show that there is compelling, reliable, valid, medical and Scientific Evidence to support that it was direct caused by the User Administration of the covered countermeasure which could be the covid19 that seen. Could be a smallpox vaccine. Lets stay focused on the covid19 vaccine because thats what our obligation is in the select subcommittee. You feel its more appropriate to have petitioners for covid 19 claims to be paid by the vaccine manufacturer or by the american taxpayer . Stationers are for the National Vaccine Injury Compensation Program and those are through the routine administer ration with an excise tax levied on it whereas requesters for the cicp are paid for compensated claims through appropriated funds and administration claims of the program is also paid for through those appropriated funds. Is a physician im also worried that in some cases, Health Practitioners dont know where and how to work adverse effects which is critical to ensuring that all vaccine events are accounted for. Im also concerned how these events and potential risks are reported to Healthcare Providers. For each of you, could you take turns and describe what your agency insures against any adverse effect that are reported and how those reports are managed and how this information is conveyed to the frontline individuals who are dealing with this. Dr. Marks. Thank you for the question. Each vaccine label, whether it was the authorized vaccines are the approved vaccines, has the information on where to report adverse events to the adverse event reporting system. When we get those, we combined with cdc and sort through those events and we take them seriously and investigate them to sort out whether there are any sick is there. Dr. Jernigan. We provide information to the vaccination sheet. So that they understand the potential risks. We also communicate to the public and take information and put that together to him indicated with the Advisory Committee and recommendations can be changed if needed. Commander, do you see any faults in this system . Am here to testify on behalf of the director of the division of Injury Compensation Programs. Not the cdc and fda systems. When our recognize dr. Mccormick for five minutes. Thank you, mr. Chair. I will cut straight to the point because i know we are on a timeline. I am last. Congratulations on that. I want to point out that it was President Trumps operation warp speed that had unprecedented delivery of vaccination in record time but i think it is ironic that this Scientific Achievement will be forever tainted by the governments handling of covid 19 created from the vaccine policy and the federal programs that surround it. To avoid myself of partisanship in this case, i would like to highlight that theres democrats who have touted this program that President Trump not only came up with, who received the vaccination himself and admits openly to getting the booster, as well, so there are some ironies in this argument all the way around. The question is why has america become so distrustful of vaccinations . As Michael Dickson of wanted out, why is it that they no longer want to get a vaccination that may have potential benefit . A couple points on this, first of all, when you insert yourself between a doctor and a patient, and some duct is contradict you and you censor them, even when youre not a doctor treating patients, people are going to say, why does the government have authority to do that . To censor my doctor . And secondly, when you start requiring people to do something instead of encouraging, the natural resistance of a freedom loving people that work founded on this intervals will be to resist what you are requiring. It should not be any surprise to us when people say im not going to do what youre telling me i have to do to the doctor may agree with me and not you. You are the government. Why do we insert ourselves in inappropriate ways . And when we talk about the evolution of science when you have immunity and you are still requiring about a nation that can cause a hyper immune response. We are scientists. We can admit that theres risk versus benefit on every decision and the government says we will do this without taking science into account. No wonder people are mistrustful of our recommendations. Lets talk about the vaccination liability compensation bid. It came to my attention last february covid19 vaccine injuries, claims were sent to cicp and constantly lost, ignored or denied or caught up with little to no transparency. March 3rd last year, several of my colleagues wrote a letter to hrsa regarding the Injury Compensation Program and the failure to respond in a reasonable timeframe. I appreciate, commander grimes, unlike a lot of others, you responded and you actually came by my office. I appreciate that. I think you care. You pointed out that you had four people working for you based on the prePandemic Response force on injury and you are trying to respond to 13,000 people with four employees. Since then, youve got 35 people, i believe. My accurate saying that there are 13,000 claims approximately . Approximately 13,319 countermeasure claims. About 9600 of which allege vaccine. Of those, how many have been posed . 2200. About. The number is 35 employees handling those claims, right . Yes. Its okay. Got to be quick because we are on a timeline here how many claims are we processing per month now . In the year 2023, we processed 90 claims per month over the year and the velocity increased throughout the year. Is 2200 claims. How many have been shown to have some merit for injury . Currently, about 40 have been found to have an injury that was directly caused by a countermeasure. The small percentage, correct yes, sir. Just to do the math, each employee is handling 2. 7 cases per month. 40 out of 2200 cases that have been processed so far. The 13,000 means we have 10,800 cases and backlog. The vast warmth employees seeking process faster. At 2. 7 for employee, it will take us about 10 years to process the remaining claims. The application process to get this denial processed through some sort of appeals process has an even smaller approval rating. Its a judge, jury, executioner. I dont think its right. I think we need to streamline this process. Make sure that you know what paperwork is required and how its processed. We need to spread the process about tenfold to do our job point im out of time and i yield. Mr. Chairman. I would like to ask consent to submit this to the record. Its an article from the New York Times entitled covid shots for children which the world has decided that most Young Children dont to receive covid booster shots. The u. S. Is an outlier. Without objection. I would like to recognize our Ranking Member for a closing statement. Medicine is very nuanced. The human body is remarkably, beautifully made and our physiology is a complete wonder, still. Taking a snapshot of the time and using to go back and define the entire experience of covid in children is again misleading. Now with rates that are low, with the information that we have, our children that are at high risk, immunocompromised should get the vaccine and in certain areas where the rate is low and the risk of getting infected in an otherwise healthy child, then one would reconsider whether that child would need a booster in this situation. Throwing these facts out there without the context and understanding is wrong. Its very misleading. In fact, you know, we have talked about how vaers here is a screening. Not the definitive tool to use the rate of side effect or serious side effect from getting the vaccine. These are individuals who get the vaccine. Whatever the feel afterwards for a certain time period, they report it. We want them to do that we want them to do that. Its a way to screen for this. We want to have High Sensitivity to reduce the false negative. Then with this kind of screening test, you have a high false positive and that is why we need to reevaluate. More indepth investigation on an individual basis to determine whether in fact it was caused by the vaccine. We already laid out the reason scientifically why, of the five systems, the five multilayer systems, there is is not the system to use as the definitive rate of infections. To use it, because it has a false positive, is intentionally, falsely misinterpreting the data that is causing Vaccine Hesitancy. And people know, but they intentionally stills to it as if it is the definitive data. That is the part that its me. It disinformation. Not misinformation. It is intentionally giving false information for their own personal and artisan medical gain. Thats a very sample of what weve been talking about of politicizing science. Lets just go back and summarize that in total, covid 19 vaccines saved 3. 2 million lives. Prevented 18. 5 million realizations. And save the United States an estimated 1. 15 trillion in medical costs. So when we say that the vaccine does not prevent getting sick or it does not stop the spread of disease, lets go back and talk about the nuanced aspect of the use of vaccines, which is supposed to boost your immune system, and if you have a high enough immune response to the virus, then yes. Are those individuals it does prevent them from getting sick. In my right, dr. Jernigan . Am i right dr. Marks x correct. So by lowering the risk of getting infected, it does prevent getting vaccines for those individuals. But it not an absolute. When we talk about absolutes, again, we are intentionally giving this information to the American Public that they do not work. If you lower the risk of getting the illness and getting sick or if you increase the immune response of the symptomatic infection, would you say this reduces the risk of spreading it to other people . I think the more you can lower the viral load the viral load is a medical term that is important to understand. Vaccines increase your immune or is wants, combats the virus, lowers the viral load read if you have a small viral load, you do use the risk of spreading the disease. Is this correct, dr. Martz . Do i have the pathophysiology right . That will be correct. That will be correct. So is it correct to say that indeed vaccines reduce the spread and for some individuals prevent the spread of the virus to other people . Correct . I think we can say that that is a general statement. I would not want to make it as an absolute treatment. Right. That is my point did that is my point. By intentionally abusing absolute statements like that without the nuances, and you know, and people should know better. There just informing the community. What i said was not absolute. I said that it reduces the risk of spread, and for some people, it reduces the spread. So it does and can reduce the spread with that nuance. And its because of the safety and efficacy of these vaccines that we are ultimately able to overcome the pandemic, because of the vaccines that we were able to change the vaccine guidelines over time. Or our social distancing crack this were wearing a mask, correct . And yes, there is work to be done to promote Vaccine Confidence in the United States, and strengthening existing Compensation Programs. We can agree on that. Requires funding, capacity, human resources. We can fix the systems to help make it better but there is no doubt that the multitiered, multisystem vaccine safety apparatus Surveillance Systems is the best in the world. And we should talk about that and that of focusing on these false positives or false narratives so that we can build confidence in the American People. So misusing or platforms as members of congress to spread false or disinformation about vaccines does a disservice to the American People. Manufactures distrust. Spirits oriole accusations manufactured distrust. Fear mongering manufactures distrust. And with increased distrust, you increase Vaccine Hesitancy with fewer people taking the vaccine, more people get infected in the pandemic spreads and more people die. How does this help us prevent or better prepare for the next pandemic . It does not. It makes it worse puts people and lives at risk and harms, actually harms the American People. This is the opposite of helping to prepare and mitigate the harms of the next pandemic. I hope that we can find a path forward with the serious work that needs to be done to save lives in the event of a future pandemic and the people safe in the here and now from current threats. As i said when we started todays hearing, we are already in the process of undoing decades of progress overcoming Infectious Diseases. We must handle each opportunity to discuss this matter with immense care before we reach a point from which we cannot return. I hope going forward, everybody can drop the outrageous false rhetoric that weve heard today and identify a construct of path forward that protects the peoples health. I yield back. Thank you. This hearing should not of been political. Most of it was not. I would say today. Fortunately. But the fact is further evidence that this conversation is completely necessary to take place. I can say that ive invested in all sides of the issues around the pandemic, starting in 2020, being on the Intelligence Committee and also researching what other countries were doing, how were going to try to treat people and save lives, right . Learned a lot. As representatives, we are the conduit to asking their questions. Its not easy for them to just call you and get an answer although i thank you for taking my call early on during the pandemic. Perception is reality. I mentioned that at the beginning. This is what we have to face. Words matter. When you say reduce, it is different than saying prevent and that happened too often. Not necessarily from your voice, but it happened and that is what america heard. I think it began clear today that it is not the beall and endall. It is the initial recycling can if you will and then you decide what actually goes further. But we did not say that. Its the only thing that was out there for the public. What do we expect . I think this matters. You know, we see things on some of these natural items in the drugstore. It will say on their not approved by the fda for human treatment. But its okay to take but it wont necessarily meet all of its claims necessarily. Thats an honest approach. You know, look, there has never been a question that back teens save lives. And from cincinnati. You know how much pride in cincinnati we take because it is the home of albert sabin in the polio vaccine. Its huge. Thats in our dna. We grow up knowing that we take pride in it. We cannot leave behind those who have been injured amply because they do not necessarily at the narrative regarding vaccine safety. We have to take all that into consideration. We heard today that patients and parents should have a conversation with her personal Healthcare Provider to assess vaccine, whether it is appropriate for their particular position or condition, whatever. Dr. Marks, we heard you today, very currently say, i feel, that you have regret about those under five years old with covid. I talked to pediatricians and they say act the sum should be vaccinated if got a, b, c, d or e. One size does not fit all in medicine. Never has or will. That goes back to talking to your doctor and revealing all the data about those that may have died. These are children that maybe would have died if they got the common cold. I dont know. Those are things you have to take into consideration. Ive learned a lot about covid 19. I think if we want to assess someones vulnerability, maybe we should check their levels. I wont go into the science of that that may be understand. Thats what it takes to clear the site which makes it more infectious to humans. Thats another story. This committee, i think we did a good job today. We really look at the facts and discuss openly about where our pet calls are and i am not just leaning the government. Because it is politicians, too. Its politicians that drove a lot of distrust. And what was coming out of Public Health. Just go back to the beginning. President trump said we need to restrict travel. Dr. Proctor recommended that we restrict travel. What happened to President Trump when he said that . He is a racist and politicians say no, theres nothing to be worried about here. Thats a racist comment. Come to chinatown. Lets create a super spreader. Thats a problem on our side, and thats why i say we need to hear from the doctors treating Covid Patients more than anyone else. Lives have been saved. We cannot ignore certain things, you know. Ive mentioned before documents, you are advocating on operation words. We were with you all the way. You have a politician saying in essence if it is your vaccine, not taking it. That does not help us. That creates Vaccine Hesitancy. When a politician stands up and says if you take this, youre not going to the icu and youre not going to dive yet somewhere going to the icu and some were dying. That is a fact. There may be a lot of other reasons for it. China comes out and says, weve got this under control. The w. H. O. Parrots it. Dr. Ling goes to china or the got it all under control. Thats the advice given to the politicians. So of course there is distrust. That came from china themselves. They did not have it under control. Thats what they were telling everybody. That leads to distressed. We must trust and verify. Especially when taking advice from an adversary. The risks have to be put out. Cannot run a commercial. They cannot run it without listing all the risks. Doctors have to sit or its malpractice if they do not go over the risks. We were not doing that. We issued a mandate that is youve got to get it or you lose your job. Go to the drugstore and get it and get their card. Im glad to hear you all agree today, at least i think you do, that it requires the best practice is to have a conversation with your doctor about your personal health and the better data the doctor has, the better we can treat patients. This is what we are after. Saving lives, treating patients better. I mentioned before there is a difference between saying effectiveness data is different from just saying it is effective. There is data that they might say is not 100 effective, right . This is what the public hears. They get confused. Because they now i know some people who had an adverse reaction. Why are we saying it safe . It is not 100 safe. So you may have done work completely 100 right. If it is not messaged clearly or accurately, its a problem. I often ask where is our Surgeon General to be talking about this . The reason i said we need to hear from doctors treating Covid Patients, im reminded of a goal for. Every night america tuned in to hear what the general had to say about the war. Not what a politician had to say about the war. I think that makes a huge difference. We recognize today gratefully that we are telling me American People when we recognize this as a problem, we did something about it. That is important. That builds public trust. If it is perceived that we are just ignoring it and mandating this anyway, it is a problem. I question why we quit talking about convalescent plasma as a form of treatment especially when we knew that the vaccine we had did not prevent you from getting covid. You just got less sick. Were we not focusing on more treatments like that that were very affect in cincinnati xi saw that. Why did we ignore Natural Immunity . I was told i needed a booster to go to germany. Ive been vaccinated, both doses of pfizer. I got covid several months later. The only reason i knew is because i could not garlic salt. That is the only way i knew. And when i got my antibodies check and i wanted to do my t cells, as well. When i got my antibodies check them a been told i needed booster. Strong number was 40. My number was 821 and the got the lab work to show it you have a conversation with your doctor about that. Why did we put this aside . Thats what america under the hood and why are we not talking about the benefits of Natural Immunity . Where were not saying if you have Natural Immunity, youre less likely to get another round of covid. Why were we not looking at this kind of data to see . These are the things we shouldve done. I wanted to do that to the military secretary austin responded. 22 physicians assigned that letter to the secretary of defense and he never responded, never answered our question. We have some things. This could make a difference especially when going forward. Cant ignore the questions they the American People have. If i only sat here in washington, cant have this discussion with you the way i am having it and when you go home and youre the conduit to the government, you know what, if we are not honest, if we cannot be trusted, if we dont get elected. They see people in washington never leave amongst the unelected. Just understand that. Thats why it is in working with have this conversation and why we do better going forward. I think you all for your time today. Thank you for the work that you do we want to be help to make it even better in the future. I think you all again for being here for your working and insight testimony. With that and without objection, all members will have five legislative days to submit materials and additional written questions for witnesses to be forwarded to the witnesses for the response. If there is no further business, without objection, the Sub Committee stands adjourned and you all for attending. Healthcare officials just finished their testimony on how effective back in Safety Systems have been after the rollout of covid 19 back in and concerns arising that they were not able to properly inform the American Public about illnesses related to the fact. If you missed any of the hearing, you can watch it in its entirety at 8 00 p. M. Eastern on cspan two. We will also have it on cspan now, our free mobile video app and online at cspan. Org. Cspan is your unfiltered view of government. We are funded by these Television Companies and more, including cox. Next to the lesserknown president ial that it form hosted by the New Hampshire and to the