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 VaccineInjury 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 Healt