House hearing on vaccine distribution, availability
The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce will hold a hearing entitled, "Pathway to Protection: Expanding Availability of COVID-19 Vaccines."
production of Koven 19 vaccines in the United States due to the cove in 19 public health emergency. Today's hearing is being held remotely. All members, witnesses and staff will be participating via video video conferencing and is part of our proceeding. Microphones will be set on mute for the purposes of eliminating inadvertent background noise members and witnesses. I'll remind you now I have a feeling will need to do it again during the hearing to a mute your microphone each time you wish to speak. And if any time during the hearing I'm unable to chair the hearing, the chairman of the full committee, Frank Pallone, will service chair until I'm able to return. Documents for the record can be sent to Austin Flack at the email address we've provided to staff. All documents will be reviewed and entered into the record as appropriate. At the conclusion of the hearing, the chair now recognizes herself for purposes of an opening statement. Today, the sub committee continues its oversight of the ongoing Cove in 19 Pandemic. Over the last year, we've held hearings examining various aspects of this crisis, including the federal government's response to sponsor Cova, 19, the ramping up of testing and the development of vaccines. Last July, we heard testimony from several of the companies representative today's hearing about the status of their clinical trials and their production plants as they worked diligently to develop a safe and effective vaccine. And I want to thank all of you for coming in July and all of the work that you've done when we're back today, in a much better position to Fight Cove in 19, with two vaccines authorized and possibly more on the way, we're now in the midst of one of the most public important public health campaigns in American history. So it's often said vaccines don't save lives, Vaccinations dio. And as of course, we just passed the grim milestone of half a million American deaths from Provo 19. We don't have a lot of reason to celebrate, but with the vaccination program underway, there's hope that we can begin to turn the tide against the virus. Frankly, it's nothing short of a scientific marvel that multiple covered 19 vaccines have been demonstrated to be safe and effective in such a short amount of time. But all of us know we're not out of the woods. The most pressing challenge that we have right now is the lack of supply of vaccine doses. We saw the frustration late last year when the initial vaccine allocations to state were less than what was needed to vaccinate high risk priority populations. And while we continue to commend manufacturers efforts to develop the vaccines, some of the companies are here today are still short of the number of doses they promised to initially deliver when they testified before this subcommittee in July. Many of the companies received significant federal investment to build their manufacturing capacity last year, even while the clinical trials were ongoing so that we would be able to deliver millions of vaccines Justus soon as they were authorized. Two vaccines have been authorized and production is ramping up. But we still have way insufficient supply to meet current demand. Things are improving lately, with the company's increasing production and the Biden administration increasing weekly allocations to states as well as providing greater transparency around future allocations, which we heard a couple of weeks ago from state health officials and with additional companies seeking authorizations. We have hope that the supply will increase substantially in the coming months. But frankly, we still face a lack of vaccine supply. To meet current demand, Americans around the country are lining up, sometimes for hours, to secure their shots. Many high risk individuals have not been vaccinated vaccinated, and millions more are waiting for their turn. Last week, President Biden said that every American who wants of exceed should be able to get one by the end of July. That is a welcome goal, and one that the company is joining us today will be will play a central role in hopefully achieving. That's why it's critical for us to here from our witnesses today a straightforward assessment about where the manufacturing capacity stands, how much vaccine they expect to be able to produce and when they will be able to meet those milestones. And indeed, emerging various virus variants may require us to develop even new vaccines or booster shots. So if that's so, these shots will only put more pressure on manufacturing capacity. This hearing is an opportunity to examine ideas to speed up the vaccination effort, whether it's something that companies could be doing differently, or something more that the federal government could be doing to help. We're all in this together. So we look forward to exploring solutions today. Finally, while these vaccines are undoubtedly good news, we must remember they're only part of the solution to ending this pandemic. Although that authorized vaccines are highly effective at preventing people from getting seriously ill from Kobe 19, they might not prevent people from unknowingly spread the virus to others. Therefore, it can't be said enough, so I'm gonna say it right here. It's essential that Americans continue mitigation efforts like wearing masks and practicing social distancing. Even if you've been vaccinated, these vaccines will be an enormous aid in fighting the virus. But we all need to do our part if we're to defeat it once again. I want to thank these witnesses for being here today. The ongoing work of each of your company's is critically important to the country in the world, and this committee remains ready to assist in those efforts. And now, at this time, the chair will recognize the ranking member of the subcommittee, Mr Griffith for five minutes for purposes of an opening statement. Mr. Griffith, thank you very much. Shared to get. And I appreciate you having this important hearing on the availability of covert 19 vaccines. I also want to thank the witnesses for taking the time to join us. Today. Two of the companies before US, FISA, Pfizer and Moderna have covered 19 vaccines that have been granted emergency use authorizations US by the FDA. One company, Johnson and Johnson, has filed in U A application, and two companies, AstraZeneca and Novavax, have ongoing phase three clinical trials. Thanks to the last administration's great partnership with private industry, Pfizer and Moderna started shipping vaccines across the United States within 24 hours of receiving their US They have committed to supply 600 million doses to the United States government by the end of July. That will mean we will have enough supply to vaccinate 300 million people. In addition, Mork, over 19 vaccine doses will be available should more companies receive authorization or approval from the FDA. This timeline is unprecedented, especially since the path from clinical trial production to commercial scale manufacturing is highly complex. For example, according to the U. S. Government Accountability Office report, the traditional vaccine timeline from the exploratory stage all the way to the large scale manufacturing and FDA review, and Licenser takes approximately 10 years and sometimes longer. But in just 11 months since our first reported case of covert 19 to companies received us from the FDA for their vaccines, as of February 18/73 0.3 million doses of covert 19 vaccine have been delivered across the United States. This is a remarkable achievement. We should applaud these efforts that have been undertaken by manufacturers to help crush the virus. However, as we've heard that a subcommittee hearing a few weeks ago with representatives from a handful of states vaccine supplies remain the number one hurdle to vaccinating Americans at a faster pace. The challenge is, is that the vaccine manufacturing process takes time. The immediate availability of vaccine doses was made possible because of the efforts of the private sector as well as their partnerships with the federal government. Because manufacturing was being done at risk and in parallel with the clinical trial process, we were able to move fast. In addition to at risk manufacturing, the vaccine manufacturers have looked for ways to increase and expand their manufacturing capacity. Some efforts undertaken by manufacturers include rearranging existing capacity, acquiring additional facilities, partnering with other companies to increase their production capacity or hiring and training additional personnel toe work in the manufacturing facilities. Some companies have even looked to increase the number of doses included in their vials, which conserves, resource is and supplies. Other companies have been able to increase efficiencies in their processes by incorporating lessons learned. All of these efforts not only allowed vaccines to read reach Americans faster, but it also highlights private sector innovation. But to be clear, expanding capacity takes time. This is a complex process that includes the availability of every piece of equipment and material needed, making sure that the equipment is approved and assuring all of the processes and people in the facility are validated. There have also been disruptions to manufacturing supply chains and processes throughout the pandemic. With the demand for medical supplies at an all time high across the world and disruptions in the workforce, we have faced challenges in securing materials for vaccine production. The federal government, including Operation Warp Speed and the use of the Defense Production Act, EPA, have helped to boost and secure essential supplies that are needed to manufacture Cove in 19 vaccines, while the Deepa has been a useful tool thus far. We must be judicious. And how we utilize it is it can lead to major disruptions in our healthcare supply chain. Finally, Cove in 19 continues to mutate, causing new new variants to emerge that seemed to spread more quickly and easily Thank thankfully, vaccine manufacturers are already looking for ways to stay ahead of these variants. I look forward to our discussion today to learn more about your manufacturing processes, actions you have taken to expand your manufacturing capacity. And whether you feel mawr capacity or re sources are needed to meet the demands for Cove in 19 vaccines. I also look forward to hearing about any challenges manufacturers air facing and how we might address them. We're all in this fight together as you heard, uh, chair to get, say, and I want to thank you all for the important work you've already done. Thank you, Madam Chair. Now you back. I think the gentleman turn now recognizes the chairman of the full committee, Mr Pallone, for five minutes for purposes of an opening statement. Thank you chairwoman, to get I know that this was ah hearing that you've been wanting to do for a while, so I'm glad that it worked out today and we're able to get the manufacturers here. Obviously, we're continuing our oversight of this effort to develop and produce Cove in 19 vaccines through the American people, and one of my top priorities this year is to ensure we have the tools and resource is needed to crush the virus. I do believe it's a new day because unlike under Trump undivided now we have a national planet effort to coordinate and get vaccine and testing and contact trusting and supplies out the states. Um, but we need to have the tools on resource is for that national plan on. We're going to do that with the Reconciliation Act, which I think will be on the house for this Thursday or Friday. But among the most powerful tools in this arsenal to crush the virus is obviously a safe and effective vaccine. That's why this committee is working tirelessly to find solutions for rapidly expanding the availability of covert 19 vaccines across the country. The pain and devastation inflicted by this pandemic cannot be overstated as we mark the tragedy of half a million lives lost to covert in the U. S. Nearly 10 million jobs have been lost, and long term unemployment is on the rise. Life expectancy in the United States fell by for an entire year in the first half of 2020 a decline not seen since World War Two, with communities of color suffering the largest declines. In order to achieve herd immunity, which is essential to ultimately defeating the virus, we must vaccinate the majority of the population. And that starts with securing widespread access to vaccines and ensuring reliable production lines are in place. Unfortunately, the initial vaccine roll out under the Trump administration was mired in confusion, poor planning and limited supply. Thankfully, the Biden administration has taken decisive action to get the vaccine effort back on track. So just last week, President Biden announced that states will receive their largest weekly dose allocations ah, 57% overall increase from when he took office. Administration also announced it was doubling the number of doses being sent directly to pharmacies and will begin sending vaccines directly to community health centers, actions that will facilitate broader access across the country. And thanks to these efforts were already seeing encouraging results before the disruptions caused by last week's winter storm. An average of 1.7 million vaccine doses were being a minister per day, marking a nearly two fold increase over the past month. And this trend is promising and many experts believe we need to be administering close to three million doses per day to stay ahead of the virus. So I recognize the goal is challenging. But the stakes of our nationwide vaccination vaccination campaign could not be higher. Ah, protracted rollout would only result in more Americans becoming effective and would also increase the likelihood that new variants will become dominant in the United States. And I noted in the subcommittee's last hearing, We're currently in a race to keep vaccines ahead of the new virus variants, and in order to win this race, we have to increase our vaccine supply as swiftly as possible. So today we're gonna hear from five leading manufacturers of covert 19. We must acknowledge there have been setbacks on vaccine productions and supply. Congress needs to hear what steps each company's taking to rapidly expand vaccine production. What hurdles might stand in the way and what additional help is needed to increase supply. Simply put, all options must be on the table, while increasing vaccine supplies essential more, much more is needed. Actually vaccinate hundreds of millions of Americans quickly and equitably. To that end, Democrats in Congress are moving swiftly to pass the American rescue plan, and this is the Biden proposal that commits the resource is and support necessary to crush the virus. This legislation, which we dealt with last week and should be on the floor at the end of the week, would invest more than 20 billion to expand the federal government's ongoing work to aggressively ramp up vaccine distribution administration, including by establishing mobile vaccination units and and underserved communities, expanding community vaccination centers and facilitating clear communication with the public. And I also pleased that this committee passed its portions of this legislation without delay and the full House. As I said, we'll vote later this week, and so we really look forward to getting a bill on the president's desk as soon as possible, and I just want to thank our witnesses for taking the time to be with us today. Your work is really vital, and this committee recognizes your extraordinary efforts. If we all work together, I'm confident that this historic vaccination campaign will succeed. And we will crush Cove in 19. So thank you again, Madam Chair, for putting this together today. I couldn't think of a more A more important, uh, reason, Uh, toe, have a hearing with your subcommittee. Thank you. Thank you, Diana. Thank you so much, Mr Chairman. The chair now recognizes the ranking member of the full committee, Mrs Rogers, for five minutes for purposes of an opening statement. Thank you. Chaired the get and Republican leader Griffith for this hearing on Cove in 19 decks. Vaccines made possible by the Trump administration and the incredible success of Operation warp speed vaccines normally take more than 10 years to develop. Thanks. Toe operation warp speed. We have to safe and effective vaccines in less than one year and one more on the way and others on the way. Operation warp speed is one of the greatest health achievements in history, and it will help us win the future. It puts us on a path to crush this virus to restore our way of life and also provide a new model of innovation for future life saving breakthroughs. President Biden entered the White House and inherited AH vaccine program. With a million Americans being vaccinated a day, President Trump set ambitious and bold goals. President Biden should, too. And that's why the Energy and Commerce Republicans will continue to push for a plan to vaccinate two million people a day in the 1st 100 days of this administration. To be certain. Mass vaccinations like our ongoing effort, are complex and difficult. Thanks to American ingenuity and grit, we continue to lead the world. Last week, the CDC said that 72.4 million doses have been delivered and more than 56.2 million off those have been administered Pfizer projects. It will supply 120 million doses to the U. S. By the end of March, 20 million more than initially promised. Madonna expects 100 million doses two months earlier than expected, based on current projections. By the end of July, we'll have enough vaccine for 300 million people, well more than the estimated 260 million currently eligible, and we have more vaccines on the horizon. Johnson and Johnson submitted their emergency use authorization for their one dose vaccine, which is scheduled to be reviewed Friday. Authorizing this vaccine would significantly boost our supply. Our current efforts and projected supply are promising. We want to make vaccines available so that everyone who wants one can get one. So we have more work to dio. New Covic variants have emerged posing new threats. Thankfully, recent lab studies show that Pfizer and modernist vaccines are effective against the South African African variant, and all manufacturers report that their vaccine candidates are effective against hospitalization and death. We seem poised to tackle these new challenges, and we must remain focused to ensure we dio distribution issues need to be a fixed. Earlier this month, we heard from five states who made clear supply limitations are the number one barrier to getting more shots in people's arms. Hopefully, our projections for increased supply and new vaccines will resolve this to crush the virus. States also need to resolve self inflicted problems. My home state is no exception. The Seattle Times revealed that the Washington's Department of Health ignored basic logistics in their rollout plan. It was called a quote bureaucratic nightmare. Had Washington planned better, the most vulnerable could have been vaccinated much faster. I also recently learned of Governor Inslee's unacceptable, unfair and irresponsible intervention in Whitman County. After vaccinating all phase one B tier one eligible people who wanted the vaccine, Whitman County was ready to vaccinate the next group teachers. But Governor Insley interfered. He threatened to withhold vaccines if they proceeded. One school superintendent called the governor's decision demoralizing. I agree we should be doing everything we can to get our kids back to school. That means supporting counties that air, delivering the vaccine with efficiency and speed. I know that this has been a very long year, full of fear of the unknown, the uncertainty and more isolation. This week marks 500,000 lives lost social distancing, school closures, long hours and nights for people on the front lines, the rise of suicides and overdoses. It all adds up, and it's taking a toll. People are tired. Many are in despair. I'm especially worried about the mental health of our Children, So my message today is this. There is hope our vaccine supply is expected to increase. Distribution is becoming more efficient. We will get through this pandemic. It's American innovation and ingenuity that's going to end this crisis and give people hope, the ability to heal and the courage to dream again, we will emerge stronger than ever before. That's our mission today. Thank you, Madam Chair, I yield back. Madam Chair, you're mute. Commuted, Madam chair. See, I had to tell everybody else time you knew you had to tell me. Once again, I ask unanimous consent that members written opening statements be made part of the record and without objection, so ordered. I now want to introduce the witnesses for today's hearing. John Young, who is the group president and chief business officer for Pfizer. Dr. Steven Ho, who is the president of Moderna. Dr Richard Nettles, who's the vice president of medical affairs at Janssen Pharmaceutical Companies. Johnson and Johnson. Um, Dr Rude Dauber, who's the executive vice president and president of Bio Pharma, calls pharmaceuticals business unit at AstraZeneca. And John Trasvina, who's the executive vice president, chief commercial officer and chief business officer at Novavax. I want to thank everyone once again for appearing today. I know you're very busy and your testimony is very important. I know all of you are aware that this committee holds an investigative hearing, and when we do so, we take all of our practice of taking testimony under oath. Do any of you have any objection to testifying under oath today? Let the record reflect. The witnesses have responded. No. The chair then advises you under the rules of the house and under the rules of the committee, you're entitled to be accompanied by council. Do any of you wish to be accompanied by council during your testimony today? Let the record reflect. The witnesses have responded. No. And so if you would would you please raise your right hand? So you may be sworn in? Do you swear the testimony that you're about to give is the truth, the whole truth and nothing but the truth introduced. I d o Let the record reflect. The witnesses have responded affirmatively, and you are now under oath and subject to the penalties set forth entitled 18 Section one Oh, one of the U. S. Code. The chair now will be pleased to recognize our witnesses for five minutes Summaries of their written statements. You can see, right, um, in the second level of the screen, there is a timer that will count down and it turns red when you're five minutes have come to an end. So first, I'd like Thio Recognize you, Mr Young for five minutes for your opening statement. Thank you, Chairman, to get Ranking Member Griffith and members of subcommittee. Thank you for inviting me to testify today. I'm John Young, chief business officer of Pfizer and, um, be part of this town. When I appeared before this committee last July, we were in the middle of our journey to develop a cove in 19 vaccine. Since then, our vaccine became the first to be granted emergency use authorization by the FDA. This you A was based on data from our phase three study which demonstrated our vaccine met the FDA is stringent safety requirements on indicated efficacy of 95% consistent across age, gender and racial demographics in participants reflecting the diversity of the United States population. As of February the 17th, we have shipped approximately 40 million doses, the point of use as directed by the US government to date, no serious safety concerns have been identified that have changed the favorable risk benefit profile of the vaccine to get our vaccine two points of use we provide. The government are rolling weekly forecast of doses available for shipment, enabling the government bride states with a three week forecast. The US government then allocates those his weekly to the states. Providers submit orders through the CDCs Be tracks system, which are submitted to us on weekday. Orders are shipped the day after. We recognize the need to vaccinate more people more quickly. I have worked hard to significantly increase production. Since July, we've increased projected 2021 global production from 1.3 billion doses to at least two billion doses. Pfizer has made significant investments in R. U S manufacturing sites, including ST Louis, Missouri, on Dover, Massachusetts. Kalamazoo, Michigan. And Pleasant Prairie, Wisconsin. We added new lines that are site in McPherson, Kansas started lipid production at our site in Groton, Connecticut, added to contract manufacturers, Further improvements have come from the FDA is approval of a six those label for each vial. Doubling batch sizes. Increased yields per batch reduced cycle times on deployment of faster laboratory tests to reduce release times. As a result of these improvements, we expect to increase the number of doses available from approximately 4 to 5 million doses per week at the beginning of February 2 more than 13 million doses per week by the middle of March, we're on track to make 120 million doses available for shipment by the end of March, under an additional 80 million doses by the end of May. We anticipate all 300 million contract ID doses will be made available for shipment to the points of use as directed by the US government by the end of July, enabling the vaccination of up to 150 million Americans. We continue to gather evidence on safety and efficacy to support the use of our vaccine by important sub populations of patients not indicated under the current U. A. We're conducting studies in patients between 12 to 15 years of age on hope to soon begin studies and Children under the age of 11. Last week we initiated a study in pregnant women. We are laser focused on the potential impact. Emerging variants of the Sara's cop to virus could have on the ability of our vaccine to protect against covered 19 RMR. Any vaccine affords the opportunity to provide boosting doses of needed and the ability to rapidly alter the marina sequence in the vaccine to address potential changes in the virus. If evidence suggests that you might reduce protection from the current vaccine with 95% protection against the original strain, we've now performed in vitro studies on immune responses elicited by the vaccine against new variants such as those from the UK and South Africa. Based on these data, we believe the vaccine should provide protection from these variants. Riel World evidence from the UK and Israel appears to confirm this the UK strain and to date we've seen no real world evidence that suggests a significant reduction in protection provided by our current vaccine. However, we're preparing to respond quickly and hope to initiate a study to investigate the effectiveness of a third booster or vaccine and trial participants who have already received two doses. We're discussing clinical child designs with the FDA to investigate safety and immunity, immunity, ethnicity, often updated vaccine that involves a change to the marani construct the target, an emerging variant. We will fight every step of the way until it's devastating. Pandemic is under control. In closing, I would like to Express Fiza sincere thanks to the more than 46,000 trial participants, the hundreds of investigators on the thousands of fires and biotech scientists, clinicians and manufacturing professionals who have worked day and night knowing every moment matters. Thank you for the opportunity to be with you today. Thank you so much, Mr Young Doctor Hope I'm now pleased to recognize you for five minutes for an opening statement. Chairwoman to get ranking member Griffith, Chairman, Pallone, ranking member Rogers and distinguished members of the subcommittee Thank you for the opportunity to appear before you today. My name is Steven Hog, and I serve is the president of Madonna. Since we last spoke in July, the collaborative effort to end this pandemic has made remarkable progress. We've also confronted new challenges and seen continued suffering and hardship. We know that much work remains and that this is not over. Until all of us are safe. The work could not be more pressing. Half a million people have died in the United States alone, and many more have been made ill. The pandemic has cost jobs, shuttered businesses, closed schools, burden families and disrupted countless traditions. We also know the communities of color and essential workers have been disproportionately impacted by the burdens of covert 19. We must bring this pandemic to an end. When I testified before the subcommittee last July, Madonna was days away from starting the Phase three clinical trial for our covert 19 vaccine Canada, and we were cautiously optimistic that it could play an important role in ending the pandemic with the support of the U. S government. We had also begun to modify our facilities, procure supplies, hire and train staff and established partnerships with leading pharmaceutical manufacturing companies to give us a head start on producing the vaccine. We've made significant progress since then. The Phase three trial showed our vaccine was 94% effective at preventing covert 19, leading to an emergency use authorization from the FDA in December 2020. Less than two weeks later, we had delivered the 1st 17.8 million doses to the federal government. Given the importance of vaccine availability to ending this pandemic, I'd like to take this opportunity to provide you with an update on our ongoing efforts to manufacture and deliver our vaccine to the United States. Two weeks ago, we had delivered over 45 million doses of our vaccine to the federal government Last week, we delivered another nine million doses, bringing the total number of doses delivered to over 54 million. We currently are on track to deliver the 1st 100 million doses of the vaccine by the end of March. To do this, we have doubled our monthly deliveries since the end of 2020 and we were aiming to double them again by April 2, more than 40 million doses a month. Our success scaling up production recently allowed us to move up our timetable for deliveries. We're now targeting delivery of the 2nd 100 million doses of our vaccine by the end of May and a 3rd 100 million doses by the end of July, a full two months ahead of schedule. I want to provide you with a brief overview of our manufacturing process. First, Madonna and its manufacturing partner, Lanza, create the vaccine facilities in Massachusetts and New Hampshire. Our Phil finished partner, Catalan, then fills the vaccine into vials at their facility in Indiana. Can lengthen follows a rigorous process for inspecting, testing and packaging the vials for delivery at every step we and our partners are committed to maintaining the highest standards for quality. Now, on any given day, millions of doses of vaccine will be at the different stages of the manufacturing process and over time, the build up of this working process inventory allows the entire system to operate more efficiently. The pace of production also increases as the highly skilled personnel working at each step gain experience and greater familiarity with the process. We were continuously with the U. S. Government to identify additional opportunities to accelerate production or address bottlenecks. For example, Madonna recently approached the government about the possibility of adding more doses of vaccine to each file. Doing so would improve output by allowing us to complete manufacturing runs more quickly and reduce the need for some high demand materials. The FDA has given us positive feedback on the proposal and we're now working to enable up to 15 doses per vial in the near term at Moderna. We're grateful for the opportunities we've had to collaborate with the government in our efforts to deliver a safe, effective covert 19 vaccine. We're also grateful for the many companies around the world, including my colleagues testifying today that are working to deliver covert 19 vaccines and treatments. I'd like to thank this subcommittee for its commitment to this cause as well as the diligent work of your staff. We're grateful for the actions you and your colleagues in Congress have taken to support and fund efforts to combat this pandemic. And we remain committed to collaborating with the U. S. Government in this fight. Thank you. And I look forward to answering your questions. Thank you so much. Dr Hoke. Dr. Nettles, you're now recognized for five minutes for your opening statement. Determined to get ranking member Griffith and members of the subcommittee. I'm pleased to have the opportunity to update you on the remarkable progress that Johnson and Johnson has achieved on our vaccine over the past several months, allowing us to request emergency use authorization with the FDA less than three weeks ago. Although we're cautious not to prejudge the outcome of the ongoing FDA review process, we believe that our single dose vaccine will be a critical tool for fighting this global pandemic. In January 2020 Johnson and Johnson launched a major research and development effort for a vaccine. Our pace since then has been extraordinarily extraordinary. We selected a single dose candidate in June, began human trials in July, launched a large scale pivotal trial in September, released top line results last month and sought an emergency use authorization from the FDA on February 4. The clinical trials show that are single dose vaccine addresses theme Most important health care need in the pandemic. The prevention of covered 19 related hospitalization and death 28 days after vaccination. The vaccine provided complete protection against Kobe 19 related hospital in hospitalization and death. The vaccine was 85% effective overall in preventing severe disease, including across countries with newly emerging variants. The vaccine was 72% effective in the United States at preventing moderate to severe disease. Based on these data earlier this month, we saw emergency use authorization from the FDA. The FDA is advisory committee will meet later this week. Assuming necessary regulatory approvals, we're ready to begin shipping immediately and deliver enough single doses by the end of March to enable the vaccination of more than 20 million Americans. Furthermore, we will meet our target to deliver 100 million single dose vaccines to the United States, during the first half of 2021. For many months we have been working to expand our manufacturing capacity and contract with third party manufacturers for additional production. We assessed nearly 100 different production sites, and we selected the sites that we're able to support an accelerated timeline. We're working around the clock to scale our manufacturing capabilities to supply the United States with vaccine. Our plans call for production in the United States, in Europe, in Africa and Asia. Importantly, our vaccine can be distributed using the existing supply chain and routine refrigeration that we used to transport other medicines. Today. The vaccine is based on Johnson and Johnson's Add that technology. We have significant clinical experience with vaccines based on this technology, including vaccines administered for more than a decade. Johnson and Johnson is committed to ensuring that clinical trials include a wide variety of populations, including historically underrepresented communities. The ensemble study for our covert vaccine included approximately 45,000 participants across diverse population, 45% were Hispanic or Latin max, 19% were black or African American, 9% were Native American and 3% were Asian. More than one third of the participants were over the age of 60. We're truly grateful for all the participants who volunteered for our trials. As you know, Johnson and Johnson is making are coated 19 vaccine available on a not for profit basis for emergency pandemic use. Finally, I want to note that the U. S government support has been an important contributor to our ability to develop our vaccine on an accelerated pace. We appreciate our partnership with the government the financial support provided by Congress and this committee is extraordinary leadership on this critically important effort. Thank you for the opportunity to provide this update regarding our vaccine against Kevin. 19. I would be happy to answer any questions that you may have. Thank you so much, Dr Nettles. And I now pleased to recognize Dr Dawber for five minutes. Dr. Dawber, Thank you so much. Chairwoman, the GATT ranking member Griffith and members of the subcommittee. I'm good over the executive vice president at AstraZeneca. I'm here today to convey AstraZeneca's continued commitments to developing and manufacturing our vaccine candidate for the prevention of covert 19. We greatly appreciate the opportunity to engage with you today on this important topic and I hope to emphasize our dedication to delivering safe and effective solutions for fighting depend emmick in United States and across the world. AstraZeneca is a global science led by pharmaceutical company that focuses on the discovery, development, manufacturing and commercialization off innovative medicines. We're proud to have our North American headquarters in Delaware and one of our three global R and D centers in Maryland's Today our focus on four key elements off AstraZeneca's vaccine program. First, we're proud of our collaboration across all areas off the vaccine program. Our strategic approach has focused on partnering the scientists, governments, organizations like separate Gavi and the W H O A manufacturers for the development, supply and distribution of our vaccine in an equitable manner across the world. AstraZeneca was the first global pharmaceutical company to join Kovacs in June 2020. Together with our partner, the Serum Institute of India, we plan to supply over 300 million doses so 145 countries through Kovacs in the first half of 2021 as part of our global and equitable access pledge. The majority off this supply will go through low and middle income countries. Our agreements with the US government's cover the development and supply off 300 million doses off our vaccine shouldn't receive authorization. The course of the doses under those agreements will provide no profit for AstraZeneca. I would like to take this opportunity to thank the U. S government for its commitment to advancing these efforts. Second, today we have received conditional marketing or emergency authorization in more than 50 countries and recently the wh oh, listen to our vaccine for emergency use against Covert 19 studies conducted today indicated our vaccine is well tolerated and effective. And just this week we were encouraged to see the first real world evidence from over 5.4 million subjects in Scotland demonstrating risk reduction off Covic 19 related hospitalizations by 94%. After the first those of our vaccine, comparable vaccine effects were seen across all age groups, including in those over 80 years of age. In addition, we have completed enrollment in our U. S. Phase three trial, comprising over 30,000 participants, to support FDA authorization. It is important to know that the dozing interval using the used in US trial is four weeks, which may not maximize efficacy. We anticipate that data will be available in the coming weeks and we will submitted to the FDA thereafter. In the UK If vaccination strategy based on the three month dozing interval is in the way, an additional world evidence should become available in the next few weeks. Third, our supply off the vaccine for the U. S government is being produced in the United States and our manufacturing operations are at or near for capacity. We're not currently experiencing significant material or equipment constraints. Despite the speeds in scaling up safety and quality standards have bean and remained off paramount importance. We're working closely with the U. S. Government to ensure transparency around our progress. In addition, we're continually identifying and implementing new ways of working to accelerate production and reduce the time to reach communities while maintaining the highest standards of quality based on current projections. Assuming you A we expected to live up to 50 million doses by the end of April fourth, AstraZeneca has initiated studies to address the emerging threats posed by new covert 19 variants. Initial analysis, while still ongoing, suggest our vaccine shows promise against UK variant off the virus. Additionally, as we speak We're actively studying our vaccine and multiple variants, including the South African variants. Before I close, I would I would like to recognize my AstraZeneca colleagues and our partners for their heroic efforts and unwavering commitment to bring our vaccine to millions of people around the world. Together with the other companies. With us today, we're forging ahead in our collective goal off beating over 19, showing the Gap ranking member Griffith a members of the subcommittee on behalf of US Zeneca. Thank you for the opportunity to participate in today's hearing. Thank you so much on bond now. Uh, last but not least, Mr Tracy. Tracy. No, You're recognized for five minutes. Thank you. Good morning, show.